Peripheral Artery DiseaseMOMENTUMNCT01444378

Absolute Pro® MOMENTUM™

A study testing Stenting using Absolute Pro® and Pro LL® Peripheral Stent Systems in people with Peripheral Artery Disease and Peripheral Vascular Disease, run by Abbott Medical Devices at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

To evaluate the safety and effectiveness of the Absolute Pro® Peripheral Self-Expanding Stent System and the Absolute Pro® LL Peripheral Self-Expanding Stent System for the treatment of subjects with atherosclerotic de novo or restenotic lesions in the native superficial femoral artery (SFA) and/or the native proximal… Read more about this study

Who is it for?: Ages 18 years and older
Conditions the study is for: Peripheral Artery Disease, Peripheral Vascular Disease
What is being tested?: Stenting using Absolute Pro® and Pro LL® Peripheral Stent Systems
Type of treatment: Medical device
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 141 participants
Where: 1 siteUnited States
Study dates: Oct 2011to May 2015
Phase: Interventional
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 years and older
All sexes
No healthy volunteers
Adult, Older adult

General Clinical Inclusion Criteria:

Subject is ≥ 18 years of age.
Subject or legally authorized representative has been informed of the nature of the study, agrees to its provisions, and is able to provide informed consent.
Subject agrees to undergo all protocol-required follow-up examinations and requirements at the investigational site.
Subject is diagnosed as having moderate to severe claudication (Rutherford-Becker Clinical Category 2-3) or ischemic rest pain (Rutherford-Becker Clinical Category 4).
Female subject of childbearing potential must:

have had a negative pregnancy test (serum HCG) within 14 days before treatment;
not be nursing at the time of treatment; and
agree at time of consent to use birth control during participation in this trial.

Subject has life expectancy > 12 months.

Angiographic Inclusion Criteria:

A single de novo or restenotic [not previously treated with stent, brachytherapy, laser, surgical bypass, or endarterectomy] native disease segment of the superficial femoral artery (SFA) and/or proximal popliteal artery (PPA) located within the following parameters: ≥1 cm below the femoral bifurcation in the SFA. ≥3 cm above the proximal margin of the intercondylar fossa.
Disease segment length visually estimated to be ≤ 14 cm (140 mm) and can be treated with one stent.
Disease segment visually estimated to be ≥ 50% stenosis or a total occlusion.
Target vessel reference diameter visually estimated to be ≥ 4.0 mm and ≤ 7.0 mm.
A patent ipsilateral iliac artery, defined as < 50% stenosis, as confirmed by arteriography.
At least one patent distal outflow artery (anterior tibial, posterior tibial, peroneal) defined as < 50% stenosis, that provides in-line circulation to the lower leg and foot.
Total occlusion length ≤ 8 cm.

General Clinical Exclusion Criteria:

Subject is unable to walk.
Subject has undergone any non-iliac percutaneous intervention, e.g. coronary, carotid, < 30 days prior to the planned index procedure.
Subject has received, or is on the waiting list for, a major organ transplant.
Subject is diagnosed as Rutherford-Becker Clinical Category 5 or 6 in either extremity.
Subject is diagnosed as Rutherford-Becker Clinical Category 0 or 1 in the target extremity (i.e., where the investigational stent will be placed).
Subject has elevated serum creatinine > 2.5 mg/dl.
Subject is on chronic hemodialysis.
Subject has documented or suspected uncontrolled diabetes mellitus (DM), unless HbA1c has been assessed as < 7.0% within 3 months prior to index procedure.
Subject has had a myocardial infarction (MI) within the previous 30 days of the planned index procedure.
Subject has had a stroke within the previous 30 days of the planned index procedure and/or has deficits from a prior stroke that limits the subject's ability to walk.
Subject has unstable angina defined as rest angina with ECG changes.
Subject has a groin infection, or an acute systemic infection that has not been treated successfully or is currently under treatment.
Subject has acute thrombophlebitis or deep vein thrombosis in either extremity.
Subject is unable to take required antiplatelet therapy or requires any planned procedure that would necessitate the discontinuation of clopidogrel, prasugrel, ticagrelor or ticlopidine within 30 days following the procedure.
Subject has other medical illnesses (e.g., cancer or congestive heart failure) that may cause the subject to be non-compliant with protocol requirements, confound the data interpretation or is associated with limited life-expectancy, i.e., less than 1 year.
Subject is currently participating in an investigational drug, biologic, or device study.
Subject is unable to understand or unwilling to cooperate with study procedures.
Subject is allergic to nickel, titanium, platinum, contrast media, or any study-required medication that is not amenable to pre-treatment.
Subject has a known bleeding or hypercoagulability disorder or significant anemia (Hgb < 8.0) that cannot be corrected.
Subject requires general anesthesia for the procedure.
Subject has ischemic or neuropathic ulcers on either foot.
Subject has had any type of amputation to the ipsilateral extremity, or a contralateral extremity amputation other than of the toe or forefoot.
Subject is part of a vulnerable population who, in the judgment of the investigator, is unable to give informed consent for reasons of incapacity, immaturity, adverse personal circumstances or lack of autonomy. This may include: Individuals with mental disability, persons in nursing homes, children, impoverished persons, subjects in emergency situations, homeless persons, nomads, refugees, and those incapable of giving informed consent. Vulnerable populations also may include members of a group with a hierarchical structure such as university students, subordinate hospital and laboratory personnel, employees of the sponsor, members of the armed forces, and persons kept in detention.

Angiographic Exclusion Criteria:

Total occlusion of the ipsilateral iliac artery.
Target extremity has multilevel disease that requires other staged procedures within 30 days before or after the procedure.
Target extremity has been previously treated with any of the following: surgical bypass or endarterectomy.
Target vessel has an angiographically significant (> 50% DS) lesion located distal to the target lesion that requires treatment at the time of the index procedure or by a staged procedure within 30 days before or after the procedure.
Target vessel has been previously treated at any location with a stent, or has been previously treated ≤ 5 cm from the proximal or distal margin of the target lesion with brachytherapy or laser.
Target lesion is within or adjacent to an aneurysm.
Target lesion or vessel has angiographic evidence of thrombus that is unresponsive to anti-thrombotic therapies.
Subject has a contralateral superficial femoral or proximal popliteal artery lesion that requires treatment within 30 days before or after the procedure.
Subject has a history of aortic revascularization or has an abdominal aortic aneurysm > 3 cm.
Subject has evidence of thromboembolism or atheroembolism from treatment of an ipsilateral iliac lesion.
.Subject has any condition that precludes safe access to the target lesion or target vessel, e.g. severe calcification, excessive tortuosity.
Target lesion requires use of re-entry, ablative, cutting balloon, atherectomy, or similar devices to cross or treat the lesion.

Trial locations and contacts

1 site in 1 country.

United States1 site

Abbott Vascular
Santa Clara, California, 95054

Other trials in United States

About this study

Official title: Absolute Pro® Peripheral Self-Expanding Stent System and the Absolute Pro® LL Peripheral Self-Expanding Stent Systems in the Treatment of Subjects With Atherosclerotic De Novo or Restenotic Lesions in the Native Superficial Femoral Artery and/or Native Proximal Popliteal Artery.

CAUTION: Absolute Pro® Peripheral Self-Expanding Stent System and the Absolute Pro® LL Peripheral Self-Expanding Stent Systems are investigational devices. Limited by Federal (U.S.) law to investigational use only.

Conditions: Peripheral Artery Disease, Peripheral Vascular Disease
Being tested: Stenting using Absolute Pro® and Pro LL® Peripheral Stent Systems
Keywords: Atherosclerosis, Claudication, Peripheral Arterial Occlusive Disease, Stent
Medical subject headings: Peripheral Arterial Disease, Peripheral Vascular Diseases, Atherosclerosis, Intermittent Claudication, Peripheral Arterial Occlusive Disease 1

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Stenting using Absolute Pro® and Pro LL® Peripheral Stent SystemsDevice
Stenting of the Superficial Femoral Artery (SFA) and/or proximal popliteal artery using either of these devices.

Study groups in NCT01444378
Study group	Role	What they receive
Absolute Pro® and Pro LL® Peripheral Stent Systems	Experimental	Not described Receives: Device: Stenting using Absolute Pro® and Pro LL® Peripheral Stent Systems

What is being measured

The primary outcome is the main question the study is designed to answer.

Major Adverse Event (MAE)
Primary safety endpoint is freedom from MAE which is defined as a composite of:
- Death due to all causes
- Index limb major amputation (at or above the ankle)
- Clinically-driven target lesion revascularization (TLR)
Measured: 30 days
Freedom From Vessel Patency
This is the primary effectiveness endpoint which is defined as the absence of in-stent restenosis (≥ 50%) as determined by duplex ultrasonography or arteriography and without clinically driven TLR. The vessel patency rate was estimated by the Kaplan-Meier method with the standard error estimated using the Greenwood formula.
Measured: 0 to 365 days

Secondary outcomes (97)

Acute Success : Device Success
Device success defined on a per device basis, as the achievement of successful delivery and deployment of the trial device at the intended target lesion and successful withdrawal of the delivery catheter.
Measured: With in 2 days of index post procedure
Acute Success : Clinical Success
Clinical success: Defined on a per patient basis, as the attainment of a final residual stenosis of < 30% by core laboratory assessment using the study device(s) and/or any adjunctive device at all intended target lesion(s) without complications within 2 days after the index procedure or at hospital discharge, whichever is sooner.
Measured: With in 2 days after index post procedure or at hospital discharge (before 1 month)
Acute Success : Technical Success
Technical success: Device success plus attainment of final residual stenosis of < 30%
Measured: With in 2 days of index post procedure
Freedom From Vessel Patency
This is the primary effectiveness endpoint which is defined as the absence of in-stent restenosis (≥ 50%) as determined by duplex ultrasonography or arteriography and without clinically driven TLR. The vessel patency rate was estimated by the Kaplan-Meier method with the standard error estimated using the Greenwood formula.
Measured: 0 to 30 days
Freedom From Vessel Patency
This is the primary effectiveness endpoint which is defined as the absence of in-stent restenosis (≥ 50%) as determined by duplex ultrasonography or arteriography and without clinically driven TLR. The vessel patency rate was estimated by the Kaplan-Meier method with the standard error estimated using the Greenwood formula.
Measured: 0 to 180 days
Ankle Brachial Index (ABI) for the Treated Limb
A measure of the fall in blood pressure in the arteries supplying the legs and is used to detect evidence of blockages in the peripheral vessels. It is calculated by dividing the higher systolic blood pressure in the ankle (dorsalis pedis or posterior tibial) of the one leg by the higher of the two systolic blood pressures in the arms.
ABI=Highest Ankle Systolic Pressure/Highest Brachial Systolic Pressure. The ABI is the ratio of the ankle to arm pressure, and an ABI between 0.9 and 1.3 is considered normal. A reduced ABI (less than 0.9) is consistent with peripheral artery occlusive disease, with values below 0.8 indicating moderate disease and below 0.5 severe disease.
A value greater than 1.3 is considered abnormal suggesting calcification of the walls of the arteries and noncompressible vessels, reflecting severe peripheral vascular disease. For patients in whom the ABI cannot be accurately measured , toe pressure measurement and toe brachial index should be used.
Measured: Pre-Procedure
Ankle Brachial Index (ABI) for the Treated Limb
A measure of the fall in blood pressure in the arteries supplying the legs and is used to detect evidence of blockages in the peripheral vessels. It is calculated by dividing the higher systolic blood pressure in the ankle (dorsalis pedis or posterior tibial) of the one leg by the higher of the two systolic blood pressures in the arms.
ABI=Highest Ankle Systolic Pressure/Highest Brachial Systolic Pressure. The ABI is the ratio of the ankle to arm pressure, and an ABI between 0.9 and 1.3 is considered normal. A reduced ABI (less than 0.9) is consistent with peripheral artery occlusive disease, with values below 0.8 indicating moderate disease and below 0.5 severe disease.
A value greater than 1.3 is considered abnormal suggesting calcification of the walls of the arteries and noncompressible vessels, reflecting severe peripheral vascular disease. For patients in whom the ABI cannot be accurately measured , toe pressure measurement and toe brachial index should be used.
Measured: 1 month
Ankle Brachial Index (ABI) for the Treated Limb
A measure of the fall in blood pressure in the arteries supplying the legs and is used to detect evidence of blockages in the peripheral vessels. It is calculated by dividing the higher systolic blood pressure in the ankle (dorsalis pedis or posterior tibial) of the one leg by the higher of the two systolic blood pressures in the arms.
ABI=Highest Ankle Systolic Pressure/Highest Brachial Systolic Pressure. The ABI is the ratio of the ankle to arm pressure, and an ABI between 0.9 and 1.3 is considered normal. A reduced ABI (less than 0.9) is consistent with peripheral artery occlusive disease, with values below 0.8 indicating moderate disease and below 0.5 severe disease.
A value greater than 1.3 is considered abnormal suggesting calcification of the walls of the arteries and noncompressible vessels, reflecting severe peripheral vascular disease. For patients in whom the ABI cannot be accurately measured , toe pressure measurement and toe brachial index should be used.
Measured: 6 months
Ankle Brachial Index (ABI) for the Treated Limb
A measure of the fall in blood pressure in the arteries supplying the legs and is used to detect evidence of blockages in the peripheral vessels. It is calculated by dividing the higher systolic blood pressure in the ankle (dorsalis pedis or posterior tibial) of the one leg by the higher of the two systolic blood pressures in the arms.
ABI=Highest Ankle Systolic Pressure/Highest Brachial Systolic Pressure. The ABI is the ratio of the ankle to arm pressure, and an ABI between 0.9 and 1.3 is considered normal. A reduced ABI (less than 0.9) is consistent with peripheral artery occlusive disease, with values below 0.8 indicating moderate disease and below 0.5 severe disease.
A value greater than 1.3 is considered abnormal suggesting calcification of the walls of the arteries and noncompressible vessels, reflecting severe peripheral vascular disease. For patients in whom the ABI cannot be accurately measured , toe pressure measurement and toe brachial index should be used.
Measured: 12 months
Clinically-driven Target Lesion Revascularization (CD-TLR)
Revascularization within the borders of the stent, +5 mm unstented vessel at both ends, with diameter stenosis ≥ 50% (determined by duplex ultrasound or angiographic core laboratory) (Note: This does not include coincidental overlap of a percutaneous transluminal angioplasty (PTA) balloon or stent into a study stent, that has <50% stenosis, while treating a non-target lesion in the target vessel) plus one or both of the following:
- Worsening Rutherford-Becker Clinical Category;
- Change in ABI by >0.15 and ABI ≤0.8
Measured: At 1 month
Clinically-driven Target Lesion Revascularization (CD-TLR)
Revascularization within the borders of the stent, +5 mm unstented vessel at both ends, with diameter stenosis ≥ 50% (determined by duplex ultrasound or angiographic core laboratory) (Note: This does not include coincidental overlap of a percutaneous transluminal angioplasty (PTA) balloon or stent into a study stent, that has <50% stenosis, while treating a non-target lesion in the target vessel) plus one or both of the following:
- Worsening Rutherford-Becker Clinical Category;
- Change in ABI by >0.15 and ABI ≤0.8
Measured: At 6 months
Clinically-driven Target Lesion Revascularization (CD-TLR)
Revascularization within the borders of the stent, +5 mm unstented vessel at both ends, with diameter stenosis ≥ 50% (determined by duplex ultrasound or angiographic core laboratory) (Note: This does not include coincidental overlap of a percutaneous transluminal angioplasty (PTA) balloon or stent into a study stent, that has <50% stenosis, while treating a non-target lesion in the target vessel) plus one or both of the following:
- Worsening Rutherford-Becker Clinical Category;
- Change in ABI by >0.15 and ABI ≤0.8
Measured: At 1 year
Any Target Lesion Revascularization (TLR)
TLR is defined as any repeat percutaneous intervention of the target lesion or bypass surgery of the target vessel performed for restenosis or other complication of the target lesion. All TLR should be prospectively classified as clinically-driven or not clinically-driven by the investigator prior to repeat angiography. An independent angiographic core laboratory will verify that the severity of percent diameter stenosis meets requirements for clinical indication and will overrule in cases where investigator reports are not in agreement. The target lesion is defined as the treated segment from 5 mm proximal to the stent and to 5 mm distal to the stent.
Measured: At 1 month
Any Target Lesion Revascularization (TLR)
TLR is defined as any repeat percutaneous intervention of the target lesion or bypass surgery of the target vessel performed for restenosis or other complication of the target lesion. All TLR should be prospectively classified as clinically-driven or not clinically-driven by the investigator prior to repeat angiography. An independent angiographic core laboratory will verify that the severity of percent diameter stenosis meets requirements for clinical indication and will overrule in cases where investigator reports are not in agreement. The target lesion is defined as the treated segment from 5 mm proximal to the stent and to 5 mm distal to the stent.
Measured: At 6 months
Any Target Lesion Revascularization (TLR)
TLR is defined as any repeat percutaneous intervention of the target lesion or bypass surgery of the target vessel performed for restenosis or other complication of the target lesion. All TLR should be prospectively classified as clinically-driven or not clinically-driven by the investigator prior to repeat angiography. An independent angiographic core laboratory will verify that the severity of percent diameter stenosis meets requirements for clinical indication and will overrule in cases where investigator reports are not in agreement. The target lesion is defined as the treated segment from 5 mm proximal to the stent and to 5 mm distal to the stent.
Measured: At 1 year
Target Vessel Revascularization (TVR)
TVR is defined as any repeat percutaneous intervention or surgical bypass of any segment of the target vessel. The target vessel is defined as the ipsilateral superficial femoral artery and the proximal popliteal artery, including the target lesion itself.
Measured: At 1 month
Target Vessel Revascularization (TVR)
TVR is defined as any repeat percutaneous intervention or surgical bypass of any segment of the target vessel. The target vessel is defined as the ipsilateral superficial femoral artery and the proximal popliteal artery, including the target lesion itself.
Measured: At 6 months
Target Vessel Revascularization (TVR)
TVR is defined as any repeat percutaneous intervention or surgical bypass of any segment of the target vessel. The target vessel is defined as the ipsilateral superficial femoral artery and the proximal popliteal artery, including the target lesion itself.
Measured: At 1 year
Death
Measured: At 1 month
Death
Measured: At 6 months
Death
Measured: At 1 year
Freedom From Stent Patency
Primary Stent Patency defined as < 50% stenosis of the stented segment, as determined by duplex ultrasound or arteriography.
Measured: 0 to 30 days
Freedom From Stent Patency
Primary Stent Patency defined as < 50% stenosis of the stented segment, as determined by duplex ultrasound or arteriography.
Measured: 0 to 180 days
Freedom From Stent Patency
Primary Stent Patency defined as < 50% stenosis of the stented segment, as determined by duplex ultrasound or arteriography.
Measured: 0 to 365 days
Freedom From Stent Patency
Primary Stent Patency defined as < 50% stenosis of the stented segment, as determined by duplex ultrasound or arteriography.
Measured: 0 to 379 days
Freedom From Any Ipsilateral Amputation
Amputation is defined as the removal of a body extremity by surgery. For this trial, the definition of amputation will only include amputations of the limb that was treated. A minor amputation will be defined as below the ankle; a major amputation will be defined as at or above the ankle.
Measured: At day 0 (on the day of index procedure)
Freedom From Any Ipsilateral Amputation
Amputation is defined as the removal of a body extremity by surgery. For this trial, the definition of amputation will only include amputations of the limb that was treated. A minor amputation will be defined as below the ankle; a major amputation will be defined as at or above the ankle.
Measured: 0 to 30 days
Freedom From Any Ipsilateral Amputation
Amputation is defined as the removal of a body extremity by surgery. For this trial, the definition of amputation will only include amputations of the limb that was treated. A minor amputation will be defined as below the ankle; a major amputation will be defined as at or above the ankle.
Measured: 0 to 180 days
Freedom From Any Ipsilateral Amputation
Amputation is defined as the removal of a body extremity by surgery. For this trial, the definition of amputation will only include amputations of the limb that was treated. A minor amputation will be defined as below the ankle; a major amputation will be defined as at or above the ankle.
Measured: 0 to 365 days
Freedom From Any Ipsilateral Amputation
Amputation is defined as the removal of a body extremity by surgery. For this trial, the definition of amputation will only include amputations of the limb that was treated. A minor amputation will be defined as below the ankle; a major amputation will be defined as at or above the ankle.
Measured: 0 to 379 days
Embolic Events in the Treated Limb (as Reported by Site)
Embolic Event is defined as formation of a thrombus within the target lesion or stent with migration or atherosclerotic emboli migration to a distal artery.
Measured: At 1 month
Embolic Events in the Treated Limb (as Reported by Site)
Embolic Event is defined as formation of a thrombus within the target lesion or stent with migration or atherosclerotic emboli migration to a distal artery.
Measured: At 6 months
Embolic Events in the Treated Limb (as Reported by Site)
Embolic Event is defined as formation of a thrombus within the target lesion or stent with migration or atherosclerotic emboli migration to a distal artery.
Measured: At 1 year
Rutherford-Becker Clinical Category for the Treated Limb
The Rutherford Becker clinical category is a scale to measure chronic limb ischemia.
Category and Clinical Description:
0 = Asymptomatic, no hemodynamically significant occlusive disease, 1 = Mild claudication, 2 = Moderate claudication, 3 = Severe claudication, 4 = Ischemic rest pain, 5 = Minor tissue loss, non-healing ulcer, or focal gangrene with diffuse pedal ischemia, 6 = Major tissue loss, extending above transmetatarsal level, functional foot no longer salvageable.
Measured: Pre-procedure
Rutherford-Becker Clinical Category for the Treated Limb
The Rutherford Becker clinical category is a scale to measure chronic limb ischemia.
Category and Clinical Description:
0 = Asymptomatic, no hemodynamically significant occlusive disease, 1 = Mild claudication, 2 = Moderate claudication, 3 = Severe claudication, 4 = Ischemic rest pain, 5 = Minor tissue loss, non-healing ulcer, or focal gangrene with diffuse pedal ischemia, 6 = Major tissue loss, extending above transmetatarsal level, functional foot no longer salvageable.
Measured: 1 month
Rutherford-Becker Clinical Category for the Treated Limb
The Rutherford Becker clinical category is a scale to measure chronic limb ischemia.
Category and Clinical Description:
0 = Asymptomatic, no hemodynamically significant occlusive disease, 1 = Mild claudication, 2 = Moderate claudication, 3 = Severe claudication, 4 = Ischemic rest pain, 5 = Minor tissue loss, non-healing ulcer, or focal gangrene with diffuse pedal ischemia, 6 = Major tissue loss, extending above transmetatarsal level, functional foot no longer salvageable.
Measured: 6 months
Rutherford-Becker Clinical Category for the Treated Limb
The Rutherford Becker clinical category is a scale to measure chronic limb ischemia.
Category and Clinical Description:
0 = Asymptomatic, no hemodynamically significant occlusive disease, 1 = Mild claudication, 2 = Moderate claudication, 3 = Severe claudication, 4 = Ischemic rest pain, 5 = Minor tissue loss, non-healing ulcer, or focal gangrene with diffuse pedal ischemia, 6 = Major tissue loss, extending above transmetatarsal level, functional foot no longer salvageable.
Measured: 12 months
Walking Impairment Questionnaire Scores
Measured by the Walking Impairment Questionnaire (WIQ), a disease-specific instrument utilized to characterize walking ability through a questionnaire as an alternative to treadmill testing. It is a measure of subject-perceived walking performance for subjects with Peripheral Artery Disease (PAD) and/or intermittent claudication. The WIQ quantifies patient-reported walking speed, walking distance, and stair-climbing ability, respectively, on a scale of 0 (= worst) to 100 (= best). The highest possible score for each domain is 100%, which indicates no difficulty. Lowest possible score for each domain is 0%, which indicates inability to perform the activity.
Measured: Pre-procedure
Walking Impairment Questionnaire Scores
Measured by the Walking Impairment Questionnaire (WIQ), a disease-specific instrument utilized to characterize walking ability through a questionnaire as an alternative to treadmill testing. It is a measure of subject-perceived walking performance for subjects with Peripheral Artery Disease (PAD) and/or intermittent claudication. The WIQ quantifies patient-reported walking speed, walking distance, and stair-climbing ability, respectively, on a scale of 0 (= worst) to 100 (= best). The highest possible score for each domain is 100%, which indicates no difficulty. Lowest possible score for each domain is 0%, which indicates inability to perform the activity.
Measured: 1 month
Walking Impairment Questionnaire Scores
Measured by the Walking Impairment Questionnaire (WIQ), a disease-specific instrument utilized to characterize walking ability through a questionnaire as an alternative to treadmill testing. It is a measure of subject-perceived walking performance for subjects with Peripheral Artery Disease (PAD) and/or intermittent claudication. The WIQ quantifies patient-reported walking speed, walking distance, and stair-climbing ability, respectively, on a scale of 0 (= worst) to 100 (= best). The highest possible score for each domain is 100%, which indicates no difficulty. Lowest possible score for each domain is 0%, which indicates inability to perform the activity.
Measured: 6 months
Walking Impairment Questionnaire Scores
Measured by the Walking Impairment Questionnaire (WIQ), a disease-specific instrument utilized to characterize walking ability through a questionnaire as an alternative to treadmill testing. It is a measure of subject-perceived walking performance for subjects with Peripheral Artery Disease (PAD) and/or intermittent claudication. The WIQ quantifies patient-reported walking speed, walking distance, and stair-climbing ability, respectively, on a scale of 0 (= worst) to 100 (= best). The highest possible score for each domain is 100%, which indicates no difficulty. Lowest possible score for each domain is 0%, which indicates inability to perform the activity.
Measured: 12 months
Maximum Walking Distance
Measured: Pre-procedure
Maximum Walking Distance
Measured: 1 month
Maximum Walking Distance
Measured: 6 months
Maximum Walking Distance
Measured: 12 months
Stent Integrity by X-ray
Xrays were performed to evaluate stent integrity and to determine the presence of any stent fractures.
Grade of fracture as follows:
0 - No stent fracture(s) identified
1. - Single strut fracture only
2. - Multiple strut fractures
3. - Stent fracture with alignment
4. - Fracture out of alignment (≥ 2 segments)
5. - Spiral Fracture
Measured: 12 months
Toe Brachial Index (TBI)
The toe brachial index is the ratio of the resting ipsilateral toe systolic blood pressure as compared to the highest resting brachial systolic blood pressure. A normal range is 0.9 to 1.3.
Measured: At 1 month
Toe Brachial Index (TBI)
The toe brachial index is the ratio of the resting ipsilateral toe systolic blood pressure as compared to the highest resting brachial systolic blood pressure. A normal range is 0.9 to 1.3.
Measured: At 6 months
Toe Brachial Index (TBI)
The toe brachial index is the ratio of the resting ipsilateral toe systolic blood pressure as compared to the highest resting brachial systolic blood pressure. A normal range is 0.9 to 1.3.
Measured: At 1 year
Duplex Ultrasound: Maximum In-Stent Peak Systolic Velocity (PSV)
In-Stent Restenosis:
Re-narrowing within the margins of the stent following the reduction of a previous narrowing. It is defined as the presence of a hemodynamically significant restenosis (≥ 50%), as determined by duplex ultrasound or arteriography.
Measured: 1 month
Duplex Ultrasound: Maximum In-Stent Peak Systolic Velocity (PSV)
In-Stent Restenosis:
Re-narrowing within the margins of the stent following the reduction of a previous narrowing. It is defined as the presence of a hemodynamically significant restenosis (≥ 50%), as determined by duplex ultrasound or arteriography.
Measured: 12 months
Duplex Ultrasound: In-Stent Peak Systolic Velocity Ratio (PSVR)
In-Stent Restenosis: Re-narrowing within the margins of the stent following the reduction of a previous narrowing. It is defined as the presence of a hemodynamically significant restenosis (≥ 50%), as determined by duplex ultrasound or arteriography. A PSVR of > 2.4 will be used to determine restenosis via duplex ultrasound.
Measured: 1 month
Duplex Ultrasound: In-Stent Peak Systolic Velocity Ratio (PSVR)
In-Stent Restenosis: Re-narrowing within the margins of the stent following the reduction of a previous narrowing. It is defined as the presence of a hemodynamically significant restenosis (≥ 50%), as determined by duplex ultrasound or arteriography. A PSVR of > 2.4 will be used to determine restenosis via duplex ultrasound.
Measured: 12 months
Acute Stent Thrombosis
Stent thrombosis was defined as total occlusion identified within the stent by arteriography and/or ultrasound that occurs within 30 days post-index procedure.
Measured: 0 - 24 Hours Post Study Procedure
Sub-Acute Stent Thrombosis
Stent thrombosis was defined as total occlusion identified within the stent by arteriography and/or ultrasound that occurs within 30 days post-index procedure.
Measured: > 24 Hours - 30 Days Post Study Procedure
Stent Occlusion
Stent occlusion was defined as total occlusion identified within the stent by arteriography and/or ultrasound that occurs > 30 days post-index procedure.
Measured: > 30 Days Post Study Procedure
In-Segment Percent Diameter Stenosis (%DS)
Percent Diameter Stenosis:
The value calculated as 100 * (1 - Minimum Lumen Diameter/Reference Vessel Diameter) using the mean values from two orthogonal views (when possible) by Quantitative Analysis.
Measured: Pre-Procedure
In-Segment Percent Diameter Stenosis (%DS)
Percent Diameter Stenosis:
The value calculated as 100 * (1 - Minimum Lumen Diameter/Reference Vessel Diameter) using the mean values from two orthogonal views (when possible) by Quantitative Analysis.
Measured: Post-Procedure (≥ 1 day)
In-Stent Percent Diameter Stenosis (%DS)
Percent Diameter Stenosis:
The value calculated as 100 * (1 - Minimum Lumen Diameter/Reference Vessel Diameter) using the mean values from two orthogonal views (when possible) by Quantitative Analysis.
Measured: Post-Procedure (≥ 1 day)
Freedom From Ipsilateral Major Amputation
Amputation is defined as the removal of a body extremity by surgery. For this trial, the definition of amputation will only include amputations of the limb that was treated. A minor amputation will be defined as below the ankle; a major amputation will be defined as at or above the ankle.
Measured: At day 0 (on the day of index procedure)
Freedom From Ipsilateral Major Amputation
Amputation is defined as the removal of a body extremity by surgery. For this trial, the definition of amputation will only include amputations of the limb that was treated. A minor amputation will be defined as below the ankle; a major amputation will be defined as at or above the ankle.
Measured: 0 to 30 days
Freedom From Ipsilateral Major Amputation
Amputation is defined as the removal of a body extremity by surgery. For this trial, the definition of amputation will only include amputations of the limb that was treated. A minor amputation will be defined as below the ankle; a major amputation will be defined as at or above the ankle.
Measured: 0 to 180 days
Freedom From Ipsilateral Major Amputation
Amputation is defined as the removal of a body extremity by surgery. For this trial, the definition of amputation will only include amputations of the limb that was treated. A minor amputation will be defined as below the ankle; a major amputation will be defined as at or above the ankle.
Measured: 0 to 365 days
Freedom From Ipsilateral Major Amputation
Amputation is defined as the removal of a body extremity by surgery. For this trial, the definition of amputation will only include amputations of the limb that was treated. A minor amputation will be defined as below the ankle; a major amputation will be defined as at or above the ankle.
Measured: 0 to 379 days
Quality of Life Measures : Physical Functioning (PF)
SF-12 Norm-Based Scores; Quality of Life (SF-12®) is a standardized, validated questionnaire used to evaluate general health outcomes. Scores on the scale are 0% (indicating poor perceived health status) to 100% (indicating excellent perceived health status) possible.
Measured: 1 month
Quality of Life Measures : Physical Functioning (PF)
SF-12 Norm-Based Scores; Quality of Life (SF-12®) is a standardized, validated questionnaire used to evaluate general health outcomes. Scores on the scale are 0% (indicating poor perceived health status) to 100% (indicating excellent perceived health status) possible.
Measured: 6 months
Quality of Life Measures : Physical Functioning (PF)
SF-12 Norm-Based Scores; Quality of Life (SF-12®) is a standardized, validated questionnaire used to evaluate general health outcomes. Scores on the scale are 0% (indicating poor perceived health status) to 100% (indicating excellent perceived health status) possible.
Measured: 1 year
Quality of Life Measures : Role Physical (RP)
SF-12 Norm-Based Scores; Quality of Life (SF-12®) is a standardized, validated questionnaire used to evaluate general health outcomes. Scores on the scale are 0% (indicating poor perceived health status) to 100% (indicating excellent perceived health status) possible.
Measured: 1 month
Quality of Life Measures : Role Physical (RP)
SF-12 Norm-Based Scores; Quality of Life (SF-12®) is a standardized, validated questionnaire used to evaluate general health outcomes. Scores on the scale are 0% (indicating poor perceived health status) to 100% (indicating excellent perceived health status) possible.
Measured: 6 months
Quality of Life Measures : Role Physical (RP)
SF-12 Norm-Based Scores; Quality of Life (SF-12®) is a standardized, validated questionnaire used to evaluate general health outcomes. Scores on the scale are 0% (indicating poor perceived health status) to 100% (indicating excellent perceived health status) possible.
Measured: 1 year
Quality of Life Measures : Bodily Pain (BP)
SF-12 Norm-Based Scores; Quality of Life (SF-12®) is a standardized, validated questionnaire used to evaluate general health outcomes. Scores on the scale are 0% (indicating poor perceived health status) to 100% (indicating excellent perceived health status) possible.
Measured: 1 month
Quality of Life Measures : Bodily Pain (BP)
SF-12 Norm-Based Scores; Quality of Life (SF-12®) is a standardized, validated questionnaire used to evaluate general health outcomes. Scores on the scale are 0% (indicating poor perceived health status) to 100% (indicating excellent perceived health status) possible.
Measured: 6 months
Quality of Life Measures : Bodily Pain (BP)
SF-12 Norm-Based Scores; Quality of Life (SF-12®) is a standardized, validated questionnaire used to evaluate general health outcomes. Scores on the scale are 0% (indicating poor perceived health status) to 100% (indicating excellent perceived health status) possible.
Measured: 1 year
Quality of Life Measures : General Health (GH)
SF-12 Norm-Based Scores; Quality of Life (SF-12®) is a standardized, validated questionnaire used to evaluate general health outcomes. Scores on the scale are 0% (indicating poor perceived health status) to 100% (indicating excellent perceived health status) possible.
Measured: 1 month
Quality of Life Measures : General Health (GH)
SF-12 Norm-Based Scores; Quality of Life (SF-12®) is a standardized, validated questionnaire used to evaluate general health outcomes. Scores on the scale are 0% (indicating poor perceived health status) to 100% (indicating excellent perceived health status) possible.
Measured: 6 months
Quality of Life Measures : General Health (GH)
SF-12 Norm-Based Scores; Quality of Life (SF-12®) is a standardized, validated questionnaire used to evaluate general health outcomes. Scores on the scale are 0% (indicating poor perceived health status) to 100% (indicating excellent perceived health status) possible.
Measured: 1 year
Quality of Life Measures : Vitality (VT)
SF-12 Norm-Based Scores; Quality of Life (SF-12®) is a standardized, validated questionnaire used to evaluate general health outcomes. Scores on the scale are 0% (indicating poor perceived health status) to 100% (indicating excellent perceived health status) possible.
Measured: 1 month
Quality of Life Measures : Vitality (VT)
SF-12 Norm-Based Scores; Quality of Life (SF-12®) is a standardized, validated questionnaire used to evaluate general health outcomes. Scores on the scale are 0% (indicating poor perceived health status) to 100% (indicating excellent perceived health status) possible.
Measured: 6 months
Quality of Life Measures : Vitality (VT)
SF-12 Norm-Based Scores; Quality of Life (SF-12®) is a standardized, validated questionnaire used to evaluate general health outcomes. Scores on the scale are 0% (indicating poor perceived health status) to 100% (indicating excellent perceived health status) possible.
Measured: 1 year
Quality of Life Measures : Social Functioning (SF)
SF-12 Norm-Based Scores; Quality of Life (SF-12®) is a standardized, validated questionnaire used to evaluate general health outcomes. Scores on the scale are 0% (indicating poor perceived health status) to 100% (indicating excellent perceived health status) possible.
Measured: 1 month
Quality of Life Measures : Social Functioning (SF)
SF-12 Norm-Based Scores; Quality of Life (SF-12®) is a standardized, validated questionnaire used to evaluate general health outcomes. Scores on the scale are 0% (indicating poor perceived health status) to 100% (indicating excellent perceived health status) possible.
Measured: 6 months
Quality of Life Measures : Social Functioning (SF)
SF-12 Norm-Based Scores; Quality of Life (SF-12®) is a standardized, validated questionnaire used to evaluate general health outcomes. Scores on the scale are 0% (indicating poor perceived health status) to 100% (indicating excellent perceived health status) possible.
rm-Based Scores.
Measured: 1 year
Quality of Life Measures : Role Emotional (RE)
SF-12 Norm-Based Scores; Quality of Life (SF-12®) is a standardized, validated questionnaire used to evaluate general health outcomes. Scores on the scale are 0% (indicating poor perceived health status) to 100% (indicating excellent perceived health status) possible.
Measured: 1 month
Quality of Life Measures : Role Emotional (RE)
SF-12 Norm-Based Scores; Quality of Life (SF-12®) is a standardized, validated questionnaire used to evaluate general health outcomes. Scores on the scale are 0% (indicating poor perceived health status) to 100% (indicating excellent perceived health status) possible.
Measured: 6 months
Quality of Life Measures : Role Emotional (RE)
SF-12 Norm-Based Scores; Quality of Life (SF-12®) is a standardized, validated questionnaire used to evaluate general health outcomes. Scores on the scale are 0% (indicating poor perceived health status) to 100% (indicating excellent perceived health status) possible.
Measured: 1 year
Quality of Life Measures : Mental Health (MH)
SF-12 Norm-Based Scores; Quality of Life (SF-12®) is a standardized, validated questionnaire used to evaluate general health outcomes. Scores on the scale are 0% (indicating poor perceived health status) to 100% (indicating excellent perceived health status) possible.
Measured: 1 month
Quality of Life Measures : Mental Health (MH)
SF-12 Norm-Based Scores; Quality of Life (SF-12®) is a standardized, validated questionnaire used to evaluate general health outcomes. Scores on the scale are 0% (indicating poor perceived health status) to 100% (indicating excellent perceived health status) possible.
Measured: 6 months
Quality of Life Measures : Mental Health (MH)
SF-12 Norm-Based Scores; Quality of Life (SF-12®) is a standardized, validated questionnaire used to evaluate general health outcomes. Scores on the scale are 0% (indicating poor perceived health status) to 100% (indicating excellent perceived health status) possible.
Measured: 1 year
Quality of Life Measures : Physical Component Summary (PCS)
SF-12 Norm-Based Scores; Quality of Life (SF-12®) is a standardized, validated questionnaire used to evaluate general health outcomes. Scores on the scale are 0% (indicating poor perceived health status) to 100% (indicating excellent perceived health status) possible.
Measured: 1 month
Quality of Life Measures : Physical Component Summary (PCS)
SF-12 Norm-Based Scores; Quality of Life (SF-12®) is a standardized, validated questionnaire used to evaluate general health outcomes. Scores on the scale are 0% (indicating poor perceived health status) to 100% (indicating excellent perceived health status) possible.
Measured: 6 months
Quality of Life Measures : Physical Component Summary (PCS)
SF-12 Norm-Based Scores; Quality of Life (SF-12®) is a standardized, validated questionnaire used to evaluate general health outcomes. Scores on the scale are 0% (indicating poor perceived health status) to 100% (indicating excellent perceived health status) possible.
Measured: 1 year
Quality of Life Measures : Mental Component Summary (MCS)
SF-12 Norm-Based Scores; Quality of Life (SF-12®) is a standardized, validated questionnaire used to evaluate general health outcomes. Scores on the scale are 0% (indicating poor perceived health status) to 100% (indicating excellent perceived health status) possible.
Measured: 1 month
Quality of Life Measures : Mental Component Summary (MCS)
SF-12 Norm-Based Scores; Quality of Life (SF-12®) is a standardized, validated questionnaire used to evaluate general health outcomes. Scores on the scale are 0% (indicating poor perceived health status) to 100% (indicating excellent perceived health status) possible.
Measured: 6 months
Quality of Life Measures : Mental Component Summary (MCS)
SF-12 Norm-Based Scores; Quality of Life (SF-12®) is a standardized, validated questionnaire used to evaluate general health outcomes. Scores on the scale are 0% (indicating poor perceived health status) to 100% (indicating excellent perceived health status) possible.
Measured: 1 year
Vascular Quality of Life (VascuQol) Total Scores
Vascular Quality of Life (VascuQol) : A standardized, validated questionnaire used to evaluate vascular disease-specific health outcomes. VascuQol total score includes scores of Activity Domain, Symptom Domain, Pain Domain, Emotional Domain and Social Domain. Each item is rated as a 7 point response scale, with a score of 1 being the worst and a score of 7 the best possible. The total average score is the sum of all 25 items scores divided by 25. For each separate domain an average score can be calculated (sum of all items of one domain divided by the number of items of that domain). The highest score for each domain is 7, which indicates best health outcome.
There are no sub scales.
Measured: 1 month
Vascular Quality of Life (VascuQol) Total Scores
Vascular Quality of Life (VascuQol) : A standardized, validated questionnaire used to evaluate vascular disease-specific health outcomes. VascuQol total score includes scores of Activity Domain, Symptom Domain, Pain Domain, Emotional Domain and Social Domain. Each item is rated as a 7 point response scale, with a score of 1 being the worst and a score of 7 the best possible. The total average score is the sum of all 25 items scores divided by 25. For each separate domain an average score can be calculated (sum of all items of one domain divided by the number of items of that domain). The highest score for each domain is 7, which indicates best health outcome. There are no sub scales.
Measured: 6 months
Vascular Quality of Life (VascuQol) Total Scores
Vascular Quality of Life (VascuQol) : A standardized, validated questionnaire used to evaluate vascular disease-specific health outcomes. VascuQol total score includes scores of Activity Domain, Symptom Domain, Pain Domain, Emotional Domain and Social Domain. Each item is rated as a 7 point response scale, with a score of 1 being the worst and a score of 7 the best possible. The total average score is the sum of all 25 items scores divided by 25. For each separate domain an average score can be calculated (sum of all items of one domain divided by the number of items of that domain). The highest score for each domain is 7, which indicates best health outcome. There are no sub scales.
Measured: 1 year

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Oct 2011May 2015

First posted30 Sep 2011 (estimated)
Study startOct 2011
Primary completionDec 2014
Study completionMay 2015

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for Peripheral Artery DiseaseStudies of the same condition, open and under way.
More trials run by Abbott Medical DevicesThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase N/A
Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Enrolment: 141 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01444378
Sponsor's protocol ID: 10-110
Acronym: MOMENTUM
Status last verified: Apr 2017
First submitted: 21 Sep 2011
Last updated: 6 Jun 2017
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: Yes

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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Ramipril Treatment of Claudication: Oxidative Damage and Muscle Fibrosis
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Preventing Kidney Injury Using Carbon Dioxide as Contrast Medium in Patients With Peripheral Arterial Disease (PAD) and Chronic Kidney Disease (CKD) Having Arterial Intervention
Peripheral Arterial Disease, Chronic Kidney Diseases
RecruitingPhase 4
Inclisiran Versus Placebo for the Prevention of Major Adverse Cardiovascular and Limb Events in Patients Undergoing Percutaneous Coronary Intervention or Peripheral Endovascular Intervention
Percutaneous Coronary Intervention, Peripheral Endovascular Intervention
Recruiting
Radiotracer-Based Perfusion Imaging of Patients With Peripheral Arterial Disease
Peripheral Artery Disease, Diabetes Mellitus
RecruitingObservational study
Aspiration Thrombectomy Using the Symphony or Prodigy System
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All Peripheral Artery Disease trials

Study at a glance

From the registry record, last updated by the sponsor on 6 Jun 2017. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Absolute Pro® Peripheral Self-Expanding Stent System and the Absolute Pro® LL Peripheral Self-Expanding Stent Systems in the Treatment of Subjects With Atherosclerotic De Novo or Restenotic Lesions in the Native Superficial Femoral Artery and/or Native Proximal Popliteal Artery.
ClinicalTrials.gov ID: NCT01444378
Acronym / sponsor ID: MOMENTUM / 10-110
Conditions: Peripheral Artery Disease, Peripheral Vascular Disease
Keywords: Atherosclerosis, Claudication, Peripheral Arterial Occlusive Disease, Stent
Study type: Interventional
Recruitment status: Completed
Enrolment: 141 participants (actual)
Lead sponsor: Abbott Medical DevicesIndustry (pharma, biotech, devices)
Study start: Oct 2011
Primary completion: Dec 2014 (actual)
Study completion: May 2015 (actual)
First posted: 30 Sep 2011 (estimated)
Results: Posted 6 Jun 2017

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Number of arms: 1

Arm	Type	Receives
Absolute Pro® and Pro LL® Peripheral Stent Systems	Experimental	Device: Stenting using Absolute Pro® and Pro LL® Peripheral Stent Systems

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Stenting using Absolute Pro® and Pro LL® Peripheral Stent SystemsStenting of the Superficial Femoral Artery (SFA) and/or proximal popliteal artery using either of these devices.	Device	Absolute Pro® and Pro LL® Peripheral Stent Systems

Primary outcome

Major Adverse Event (MAE)
Time frame: 30 days
Primary safety endpoint is freedom from MAE which is defined as a composite of: * Death due to all causes * Index limb major amputation (at or above the ankle) * Clinically-driven target lesion revascularization (TLR)
Freedom From Vessel Patency
Time frame: 0 to 365 days
This is the primary effectiveness endpoint which is defined as the absence of in-stent restenosis (≥ 50%) as determined by duplex ultrasonography or arteriography and without clinically driven TLR. The vessel patency rate was estimated by the Kaplan-Meier method with the standard error estimated using the Greenwood formula.

97 secondary outcomes

Acute Success : Device Success
Time frame: With in 2 days of index post procedure
Acute Success : Clinical Success
Time frame: With in 2 days after index post procedure or at hospital discharge (before 1 month)
Acute Success : Technical Success
Time frame: With in 2 days of index post procedure
Freedom From Vessel Patency
Time frame: 0 to 30 days
Freedom From Vessel Patency
Time frame: 0 to 180 days
Ankle Brachial Index (ABI) for the Treated Limb
Time frame: Pre-Procedure
Ankle Brachial Index (ABI) for the Treated Limb
Time frame: 1 month
Ankle Brachial Index (ABI) for the Treated Limb
Time frame: 6 months
Ankle Brachial Index (ABI) for the Treated Limb
Time frame: 12 months
Clinically-driven Target Lesion Revascularization (CD-TLR)
Time frame: At 1 month
Clinically-driven Target Lesion Revascularization (CD-TLR)
Time frame: At 6 months
Clinically-driven Target Lesion Revascularization (CD-TLR)
Time frame: At 1 year
Any Target Lesion Revascularization (TLR)
Time frame: At 1 month
Any Target Lesion Revascularization (TLR)
Time frame: At 6 months
Any Target Lesion Revascularization (TLR)
Time frame: At 1 year
Target Vessel Revascularization (TVR)
Time frame: At 1 month
Target Vessel Revascularization (TVR)
Time frame: At 6 months
Target Vessel Revascularization (TVR)
Time frame: At 1 year
Death
Time frame: At 1 month
Death
Time frame: At 6 months
Death
Time frame: At 1 year
Freedom From Stent Patency
Time frame: 0 to 30 days
Freedom From Stent Patency
Time frame: 0 to 180 days
Freedom From Stent Patency
Time frame: 0 to 365 days
Freedom From Stent Patency
Time frame: 0 to 379 days
Freedom From Any Ipsilateral Amputation
Time frame: At day 0 (on the day of index procedure)
Freedom From Any Ipsilateral Amputation
Time frame: 0 to 30 days
Freedom From Any Ipsilateral Amputation
Time frame: 0 to 180 days
Freedom From Any Ipsilateral Amputation
Time frame: 0 to 365 days
Freedom From Any Ipsilateral Amputation
Time frame: 0 to 379 days
Embolic Events in the Treated Limb (as Reported by Site)
Time frame: At 1 month
Embolic Events in the Treated Limb (as Reported by Site)
Time frame: At 6 months
Embolic Events in the Treated Limb (as Reported by Site)
Time frame: At 1 year
Rutherford-Becker Clinical Category for the Treated Limb
Time frame: Pre-procedure
Rutherford-Becker Clinical Category for the Treated Limb
Time frame: 1 month
Rutherford-Becker Clinical Category for the Treated Limb
Time frame: 6 months
Rutherford-Becker Clinical Category for the Treated Limb
Time frame: 12 months
Walking Impairment Questionnaire Scores
Time frame: Pre-procedure
Walking Impairment Questionnaire Scores
Time frame: 1 month
Walking Impairment Questionnaire Scores
Time frame: 6 months

Results and safety

Results posted to the registry on 6 Jun 2017, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Absolute Pro® and Pro LL® Peripheral Stent Systems	141	124

Primary outcome: Major Adverse Event (MAE)

Time frame: 30 days. Number. Unit: percentage of participants

Measure	Absolute Pro® and Pro LL® Peripheral Stent Systems n = 141
Death due to all causes	0.0
Index Limb Major Amputation (at or above the ankle	0.0
Clinically-driven TLR	0.0

Primary outcome: Freedom From Vessel Patency

Time frame: 0 to 365 days. Number. Unit: percentage of participants

Measure	Absolute Pro® and Pro LL® Peripheral Stent Systems n = 141
Value	60.8

Population analysed: Intention-to-treat (ITT) population. This analysis represents those subjects who were event free at this time point.

97 secondary outcomes are reported in the full results.

Adverse events

Time frame: 12 months (365 days). Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Absolute Pro® and Pro LL® Peripheral Stent Systems	81 of 141 (57.4%)	95 of 141 (67.4%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 6 Jun 2017.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.

Related trials for Peripheral Artery Disease

Active, not recruitingPhase 4
Ramipril Treatment of Claudication: Oxidative Damage and Muscle Fibrosis
Peripheral Arterial Disease
Active, not recruiting
Preventing Kidney Injury Using Carbon Dioxide as Contrast Medium in Patients With Peripheral Arterial Disease (PAD) and Chronic Kidney Disease (CKD) Having Arterial Intervention
Peripheral Arterial Disease, Chronic Kidney Diseases
RecruitingPhase 4
Inclisiran Versus Placebo for the Prevention of Major Adverse Cardiovascular and Limb Events in Patients Undergoing Percutaneous Coronary Intervention or Peripheral Endovascular Intervention
Percutaneous Coronary Intervention, Peripheral Endovascular Intervention
Recruiting
Radiotracer-Based Perfusion Imaging of Patients With Peripheral Arterial Disease
Peripheral Artery Disease, Diabetes Mellitus
RecruitingObservational study
Aspiration Thrombectomy Using the Symphony or Prodigy System
Arterial Thromboembolism, Venous Thromboembolism

Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Bruce H. Gray, DO principal investigator

University Medical Center Greenville

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 6 Jun 2017. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 6 Jun 2017). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Major Adverse Event (MAE) (time frame: 30 days). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01444378.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Jun 2017.