Peripheral Artery DiseasePhase 2BIOFLEX-INCT01319812
Investigational Device Exemption Study to Determine the Safety and Efficacy of the Astron and Pulsar Stents
A Phase 2 study testing Astron Stents and Pulsar Stents in people with Peripheral Artery Disease and Peripheral Vascular Disease, run by Biotronik, Inc. at 35 sites in 2 countries.
Trial summary
The objective of this study is to separately demonstrate the safety and efficacy of BIOTRONIK's Astron and Pulsar stents. The Pulsar stent will be used for the treatment of femoro-popliteal lesions, located in the native superficial femoral artery (SFA) or proximal popliteal artery (PPA), while the Astron stent will… 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?
- Astron Stents and Pulsar Stents
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 463 participants
- Where
- 35 sitesin 2 countries
- Study dates
- Jul 2011to 7 Sep 2017
- Phase
- Phase 2
- 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
Who may be able to join
- To support the objectives of this study, the following initial inclusion criteria must be met for a subject to be enrolled and considered for the index procedure:
- Age ≥ 18 years
- Willingness to comply with study follow-up requirements
- Candidate for PTA
- Life-style limiting claudication or rest pain with an ABI ≤ 0.9 (resting or exercise). Thigh brachial index (TBI) may be used / performed if ABI is inadequate.
- Written informed consent
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- For a subject to receive an investigational stent, the following procedure-related criteria must be met:
- One de novo, restenotic or occluded lesion representing a femoro-popliteal or iliac indication OR Two de novo, restenotic or occluded lesions representing one femoro-popliteal indication and one iliac indication on contralateral limbs - (i.e. one lesion per limb)
- Lesions may be one solid lesion or a series of multiple, smaller lesions to be treated as one lesion
- Subjects with bilateral, SFA/PPA disease (i.e. one SFA/PPA lesion per limb) are eligible for enrollment into the study. The target lesion will be selected at the investigator's discretion based on study eligibility criteria. The contralateral SFA/PPA intervention may be performed at the time of the index procedure (prior to treatment of study lesion); however, the use of an investigational treatment is prohibited. If the contralateral SFA/PPA intervention is not performed at the time of the index procedure, the intervention must be performed at least 30 days after the index procedure. The use of an investigational treatment for the contralateral intervention is prohibited.
- Subjects with bilateral, iliac disease (i.e. one iliac lesion per limb) are eligible for enrollment into the study. The target lesion will be selected at the investigator's discretion based on study eligibility criteria. The contralateral iliac intervention may be performed at the time of the index procedure; however, the use of an investigational treatment is prohibited. If the contralateral iliac intervention is not performed at the time of the index procedure, the intervention must be performed at least 30 days after the index procedure. The use of an investigational treatment for the subsequent contralateral intervention is also prohibited.
- Femoro-popliteal lesions must be located at least 1 cm distal to the profunda femoris artery and at least 3 cm above the knee joint (radiographic joint space)
- Iliac lesions must be located only in either the common or external iliac artery
- Lesions must be treatable with a maximum of two stents
- Angiographic evidence of ≥ 70% stenosis or occlusion (operator visual assessment)
- Lesion length ≤ 190 mm (if de novo or restenotic) or ≤ 100 mm (if occluded)
- Target vessel reference diameter: 2.5 to 6 mm (SFA/PPA) or 6 to 9 mm (iliac arteries) by visual estimate
- Angiographic evidence of patent SFA and PPA (iliac indication) and angiographic evidence of at least one distal vessel runoff to the foot (both femoro-popliteal and iliac indications). Patent is defined as < 50% stenosis.
- For SFA/PPA intervention, a significant stenosis (> 70%) or occlusion of an ipsilateral, inflow artery (e.g. aortoiliac, common femoral) must be successfully treated (use of investigational treatment prohibited) just prior to treatment of the target lesion. Successful treatment is defined as no complications and less than 30% residual stenosis following intervention.
Who cannot join
- To support the objectives of this study, the following initial exclusion criteria must not be present for a subject to be enrolled:
- Subjects pregnant or planning to become pregnant during the course of the study
- Life expectancy of less than one year
- Rutherford-Becker category 5 or 6. Subjects with ulcers caused by venous disease may be enrolled in the study.
- Previously stented lesion(s) in the target vessel
- Target lesion(s) received previous treatment within 30 days prior to enrollment
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- Prior peripheral vascular bypass surgery involving the target limb(s)
- Thrombophlebitis or deep vein thrombosis within the past 30 days
- Known allergy to nitinol (nickel and/or titanium)
- Participation in any other clinical investigational device or drug study. Subjects may be concurrently enrolled in a post-market study, as long as the post-market study device, drug or protocol does not interfere with the investigational treatment or protocol of this study.
- Previous stroke or transient ischemic attack within the last three months prior to enrollment
- Previous coronary or peripheral bypass surgery (non-target limb) within 30 days prior to enrollment
- Intolerance to contrast agents that cannot be medically managed and/or intolerance to anti-platelet, anti-coagulant or thrombolytic medications
- Refuses blood transfusions
- Any medical condition, that in the opinion of the investigator, poses an unacceptable risk for implant of a stent according to the study indications
- For a subject to receive an investigational stent the following procedure-related criteria must not be present:
- INR ≥ 1.6
- Concomitant renal failure with serum creatinine level > 2.5 mg/dL
- Unresolved neutropenia (white blood cell count < 3,000 / µL) or thrombocytopenia (platelet count < 80,000 / µL) at the time of the index procedure
- Unresolved bleeding disorder (INR ≥ 1.6) at the time of the index procedure
- Presence of other ipsilateral, arterial lesions distal to the target lesion requiring treatment within 30 days of the index procedure (either before or after) or at the time of the index procedure
- Additional percutaneous interventional procedures (cardiac and/or peripheral) planned within 30 days after the index procedure
- Presence of a complication following pre-dilation of target lesion
- Presence of a target vessel/lesion that is excessively tortuous or calcified or is adjacent to an acute thrombus that is unresponsive to anti-thrombotic therapies
- Target lesion is located within an aneurysm or associated with an aneurysm in the vessel segment either proximal or distal to the target lesion
- Target lesion requires the use of cutting balloons, atherectomy or ablative devices
- Subjects with less than single vessel runoff to the foot
Trial locations and contacts
35 sites in 2 countries.
35 sites in 2 countries
United States33 sites
Study site
Amarillo, Texas, 79106
Study site
Austin, Texas, 78745
Study site
Camp Hill, Pennsylvania, 17011
Study site
Cincinnati, Ohio, 45267
Study site
Doylestown, Pennsylvania, 18901
Study site
Fremont, California, 94538
Study site
Gastonia, North Carolina, 28054
Study site
Greenville, South Carolina, 29605
Study site
High Point, North Carolina, 27262
Study site
Houma, Louisiana, 70360
Study site
Kansas City, Missouri, 64114
Study site
Kingsport, Tennessee, 37660
Study site
Langhorne, Pennsylvania, 19047
Study site
Lansing, Michigan, 48912
Study site
McKinney, Texas, 75069
Study site
Munster, Indiana, 46321
Study site
New Haven, Connecticut, 06510
Study site
New York, New York, 10065
Study site
Pittsburgh, Pennsylvania, 15232
Study site
Providence, Rhode Island, 02906
Study site
Ridgewood, New Jersey, 07450
Study site
Rock Hill, South Carolina, 29732
Study site
Rockford, Illinois, 61107
Study site
Saginaw, Michigan, 48601
Study site
The Bronx, New York, 10467
Study site
Toledo, Ohio, 43606
Study site
Toledo, Ohio, 43614
Study site
Tupelo, Mississippi, 38801
Study site
Tyler, Texas, 75701
Study site
Waco, Texas, 76712
Study site
Washington D.C., District of Columbia, 20010
Study site
Wyoming, Michigan, 49519
Study site
Ypsilanti, Michigan, 48197
About this study
Official title: The Treatment of Iliac and Femoral Atherosclerotic Lesions Using the Self-expanding Astron and Pulsar Stents
The objective of this study is to separately demonstrate the safety and efficacy of BIOTRONIK's Astron and Pulsar stents. The Pulsar stent will be used for the treatment of femoro-popliteal lesions, located in the native superficial femoral artery (SFA) or proximal popliteal artery (PPA), while the Astron stent will be used for the treatment of the common or external iliac artery lesions.
- Being tested
- Astron Stents, Pulsar Stents
- Keywords
- Vascular intervention, Endovascular, Peripheral stent
- Medical subject headings
- Peripheral Arterial Disease, Peripheral Vascular Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Astron StentsDevice
Also called Astron Stent
Implantation of self-expanding, bare-metal, nitinol stents for treatment of peripheral artery disease affecting the iliac artery.
Pulsar StentsDevice
Also called Astron Pulsar Stent, Pulsar-18 Stent, Pulsar Stent
Implantation of self-expanding, bare-metal, nitinol stents for treatment of peripheral artery disease affecting superficial femoral or proximal popliteal arteries.
| Study group | Role | What they receive |
|---|---|---|
| Astron Stent Group | Experimental | Participants indicated for stenting in iliac atherosclerotic lesions.
Intervention: Device: Astron Stents Receives: Device: Astron Stents |
| Pulsar Stent Group | Experimental | Participants indicated for stenting in superficial femoral or proximal popliteal atherosclerotic lesions.
Intervention: Device: Pulsar Stents Receives: Device: Pulsar Stents |
What is being measured
The primary outcome is the main question the study is designed to answer.
Effectiveness Endpoint for the Pulsar Stent: Primary Patency
The primary effectiveness endpoint for the Pulsar stent group is the primary patency rate at 12 months post-index procedure. Primary patency is defined as freedom from more than 50% restenosis based on the duplex ultrasound peak systolic velocity ratio, comparing data within the treated segment to the proximal normal segment or based on a clinically-indicated TLR with angiographic evidence of > 50% stenosis.
Measured: 12 months
Safety Endpoint for the Pulsar Stent: Freedom From Procedure- or Stent-related Major Adverse Events
The primary safety endpoint for the Pulsar stent is the freedom from procedure- or stent-related major adverse events at 30 days post-index procedure. The major adverse event rate includes mortality, target lesion revascularization and index limb amputation.
Measured: 30 days
Safety and Effectiveness Endpoint for the Astron Stent - Percentage of Participants With Major Adverse Events (MAE)
The primary endpoint for the Astron stent is a composite of the rate of procedure- or stent-related major adverse events at 12 months post-index procedure. The major adverse event rate includes 30-day mortality, along with 12-month rates of target lesion revascularization and index limb amputation. Success was measured against a performance goal of 15%, given a 7.5% expected 12-month MAE rate, with an assumed delta value of 7.5%.
Measured: 12 months
Percentage of Participants With Primary Safety Endpoint (Post Market Analysis)
Freedom from a composite of clinically-driven target lesion revascularization (TLR) and index limb amputation at 36 months.
Measured: 36 Months
Secondary outcomes (37)
Secondary Safety Assessment for the Pulsar Stent: Individual Rates of Mortality, TLR, and Index Limb Amputation
Evaluate the contribution of the individual rates of mortality, target lesion revascularization (TLR) and index limb amputation at 30 days post-index procedure to the primary safety endpoint for the Pulsar stent.
Measured: 30 days
Long-Term Safety Assessment for the Pulsar Stent: Major Adverse Event Rate
Evaluate the long-term major adverse event rate of the Pulsar stent. Likewise, the endpoint will evaluate the contribution of the individual rates of 30-day mortality and 12-month target lesion revascularization and index limb amputation rates to this overall, long-term major adverse event rate.
Measured: 12 months
Stent Integrity Assessment for the Pulsar Stent: Stent Fracture Rate
Evaluate the Pulsar stent integrity as measured by x-ray at 12 months post-index procedure. An independent angiographic core laboratory reviewed x-ray imaging for presence or absence of a stent fracture. Fractures were assessed with Grade I indicating a single tine fracture, Grade II indicating multiple tine fracture, Grade III indicating stent fracture(s) with preserved alignment of the components, Grade IV indicating stent fracture(s) with mal-alignment of the components, and Grade V stent fracture(s) in a trans-axial spiral configuration. Generally, fractures of Grade I are least severe, increasing in severity to Grade V.
Measured: 12 months
Secondary Safety Assessment for the Astron Stent - Distribution of MAE Rate
Evaluate the contribution of the individual rates of 30-day mortality and 12-month target lesion revascularization and index limb amputation rates to the primary endpoint for the Astron stent.
Measured: 12 months
Secondary Effectiveness Assessment for the Astron Stent - Primary Patency Rate
Evaluate the primary patency of the Astron stent at 12 months post-index procedure as measured by duplex ultrasound. Primary patency is defined as freedom from more than 50% restenosis based on the duplex ultrasound peak systolic velocity ratio, comparing data within the treated segment to the proximal normal segment or based on a clinically-indicated TLR with angiographic evidence of > 50% stenosis.
Measured: 12 months
Secondary Effectiveness Assessment for the Astron and Pulsar Stents - Primary Assisted Patency
Evaluate the primary assisted patency rate (freedom from remote Target Vessel Revascularization [TVR]) for the Astron and Pulsar stent at 12 months post-index procedure.
Measured: 12 months
Secondary Effectiveness Assessment for the Astron and Pulsar Stents - Secondary Patency
Evaluate the secondary patency rate (freedom from bypass and amputation of the target limb) for the Astron and Pulsar stent at 12 months post-index procedure.
Measured: 12 months
Functional Assessments for Subjects With the Astron and Pulsar Stents - Ankle - Brachial Index (ABI) Measurement
The purpose of this endpoint is to compare the ABI measurements between baseline and 12 months post-index procedure. ABI is the ratio of systolic blood pressure of ankle relative to systolic blood pressure of arm.
Measured: 12 months
Functional Assessments for Subjects With the Astron and Pulsar Stents - Six-Minute Walk Test
The purpose of this endpoint is to compare the distance walked during the 6-minute walk test between baseline and 12 months post-index procedure.
Measured: 12 months
Functional Assessments for Subjects With the Astron and Pulsar Stents - Walking Impairment Questionnaire PAD Specific Score
The purpose of this endpoint is to compare Walking Impairment Questionnaire (WIQ) Peripheral Arterial Disease (PAD) specific score between baseline and 12 months post-index procedure. The WIQ is a subjective questionnaire completed by participants at baseline and the 12 month visit which asks questions about mobility to assess walking impairment. Larger numbers indicate better outcomes, with a minimum score of 0 and a maximum score of 100. Please see the following publication for further information:
Hiatt WR, Hirsch AT, Regensteiner JG, et al. Clinical Trials for Claudication. Assessment of Exercise Performance, Functional Status, and Clinical Endpoints. Vascular Clinical Trialists. Circulation. 1995;92:614-621
Measured: 12 months
Functional Assessments for Subjects With the Astron and Pulsar Stents - Walking Impairment Questionnaire Walking Distance Score
The purpose of this endpoint is to compare Walking Impairment Questionnaire Walking Distance score between baseline and 12 months post-index procedure. The WIQ is a subjective questionnaire completed by participants at baseline and the 12 month visit which asks questions about mobility to assess walking impairment. Larger numbers indicate better outcomes, with a minimum score of 0 and a maximum score of 100.. Please see the following publication for further information:
Hiatt WR, Hirsch AT, Regensteiner JG, et al. Clinical Trials for Claudication. Assessment of Exercise Performance, Functional Status, and Clinical Endpoints. Vascular Clinical Trialists. Circulation. 1995;92:614-621
Measured: 12 months
Functional Assessments for Subjects With the Astron and Pulsar Stents - Walking Impairment Questionnaire Walking Speed Score
The purpose of this endpoint is to compare Walking Impairment Questionnaire Walking Speed score between baseline and 12 months post-index procedure. The WIQ is a subjective questionnaire completed by participants at baseline and the 12 month visit which asks questions about mobility to assess walking impairment. Larger numbers indicate better outcomes, with a minimum score of 0 and a maximum score of 100.. Please see the following publication for further information:
Hiatt WR, Hirsch AT, Regensteiner JG, et al. Clinical Trials for Claudication. Assessment of Exercise Performance, Functional Status, and Clinical Endpoints. Vascular Clinical Trialists. Circulation. 1995;92:614-621
Measured: 12 months
Functional Assessments for Subjects With the Astron and Pulsar Stents - Walking Impairment Questionnaire Stair Climbing Score
The purpose of this endpoint is to compare Walking Impairment Questionnaire Stair Climbing score between baseline and 12 months post-index procedure. The WIQ is a subjective questionnaire completed by participants at baseline and the 12 month visit which asks questions about mobility to assess walking impairment. Larger numbers indicate better outcomes, with a minimum score of 0 and a maximum score of 100. Please see the following publication for further information:
Hiatt WR, Hirsch AT, Regensteiner JG, et al. Clinical Trials for Claudication. Assessment of Exercise Performance, Functional Status, and Clinical Endpoints. Vascular Clinical Trialists. Circulation. 1995;92:614-621
Measured: 12 months
Acute Procedural Success for Astron and Pulsar Stent
Evaluate the acute procedural success of the Astron and Pulsar stent. Acute procedural success is defined as completion of the assigned procedure, the stented lesion having less than 30% residual stenosis determined by angiography immediately after stent placement and no MAEs before hospital discharge.
Measured: 30 days
Clinical Success
Evaluate the 30-day clinical success of the procedure. The 30-day clinical success is defined as completion of the assigned procedure, the stented lesion having less than 30% residual stenosis determined by angiography immediately after stent placement and no MAEs within 30 days of the index procedure.
Measured: 30 days
Secondary Safety Assessment for Astron and Pulsar Stent: Adverse Event Rates
Evaluate the rates of all individual adverse event types that are not included in the primary endpoint analyses for the Astron stent and the Pulsar stent group. Please see the Serious Adverse Events and Other Adverse Events sections for event details.
Measured: 12 month
Comparison of Endpoints Results Between Occlusive and Non-occlusive Lesions for Astron and Pulsar Stent - 30 Day MAE Rate
Compare the 30 day MAE rate results between evaluable subjects treated for occlusive lesions (100% stenosis) and evaluable subjects treated for non-occlusive lesions (70% - 99% stenosis) for the Astron stent and the Pulsar stent group.
Measured: 30 days
Comparison of Endpoints Results Between Occlusive and Non-occlusive Lesions for Astron and Pulsar Stent - Primary Patency at 12-months
Compare the primary patency at 12-months results between evaluable subjects treated for occlusive lesions (100% stenosis) and evaluable subjects treated for non-occlusive lesions (70% - 99% stenosis) for the Astron stent and the Pulsar stent group.
Measured: 12 months
Comparison of Endpoints Results Between Occlusive and Non-occlusive Lesions for Astron and Pulsar Stent - Primary Assisted Patency at 12-Months
Compare the primary assisted patency (freedom from remote TVR) at 12-months results between evaluable subjects treated for occlusive lesions (100% stenosis) and evaluable subjects treated for non-occlusive lesions (70% - 99% stenosis) for the Astron stent and the Pulsar stent group.
Measured: 12 months
Comparison of Endpoints Results Between Occlusive and Non-occlusive Lesions for Astron and Pulsar Stent - Secondary Patency Rate at 12-Months
Compare the secondary patency (freedom from bypass and amputation of the target limb) at 12-months results between evaluable subjects treated for occlusive lesions (100% stenosis) and evaluable subjects treated for non-occlusive lesions (70% - 99% stenosis) for the Astron stent and the Pulsar stent group.
Measured: 12 months
Comparison of Endpoints Results Between Occlusive and Non-occlusive Lesions for Astron and Pulsar Stent - Acute Procedure Success
Compare the acute procedure success results between evaluable subjects treated for occlusive lesions (100% stenosis) and evaluable subjects treated for non-occlusive lesions (70% - 99% stenosis) for the Astron stent and the Pulsar stent group.
Measured: Acute / Date of Procedure
Comparison of Endpoints Results Between Occlusive and Non-occlusive Lesions for Astron and Pulsar Stent - 30-Day Clinical Success
Compare the 30-day clinical success results between evaluable subjects treated for occlusive lesions (100% stenosis) and evaluable subjects treated for non-occlusive lesions (70% - 99% stenosis) for the Astron stent and the Pulsar stent group.
Measured: 30 days
Comparison of Endpoint Results Between Standard and Long Lesions for the Pulsar Stent - MAE Rate
Compare the MAE rate results between evaluable subjects treated with standard length lesions (between 20 mm and 140 mm) and evaluable subjects treated for long lesions (between 141 mm and 190 mm) for the Pulsar stent group.
Measured: 12 months
Comparison of Endpoint Results Between Standard and Long Lesions for the Pulsar Stent - Primary Patency at 12 Months
Compare the primary patency rate at 12 months between evaluable subjects treated with standard length lesions (between 20 mm and 140 mm) and evaluable subjects treated for long lesions (between 141 mm and 190 mm) for the Pulsar stent group.
Measured: 12 months
Comparison of Endpoint Results Between Standard and Long Lesions for the Pulsar Stent - Stent Fracture Rate at 12 Months
Compare the stent fracture rate at 12 months between evaluable subjects treated with standard length lesions (between 20 mm and 140 mm) and evaluable subjects treated for long lesions (between 141 mm and 190 mm) for the Pulsar stent group.
Measured: 12 months
Comparison of Endpoint Results Between Standard and Long Lesions for the Pulsar Stent - Primary Assisted Patency at 12 Months
Compare the primary assisted patency rate at 12 months between evaluable subjects treated with standard length lesions (between 20 mm and 140 mm) and evaluable subjects treated for long lesions (between 141 mm and 190 mm) for the Pulsar stent group.
Measured: 12 months
Comparison of Endpoint Results Between Standard and Long Lesions for the Pulsar Stent - Secondary Patency Rate at 12 Months
Compare the secondary patency rate at 12 months between evaluable subjects treated with standard length lesions (between 20 mm and 140 mm) and evaluable subjects treated for long lesions (between 141 mm and 190 mm) for the Pulsar stent group.
Measured: 12 months
Comparison of Endpoint Results Between Standard and Long Lesions for the Pulsar Stent - Acute Procedure Success
Compare the acute procedure success results between evaluable subjects treated with standard length lesions (between 20 mm and 140 mm) and evaluable subjects treated for long lesions (between 141 mm and 190 mm) for the Pulsar stent group.
Measured: Acute / Date of Procedure
Comparison of Endpoint Results Between Standard and Long Lesions for the Pulsar Stent - 30-day Clinical Success
Compare the 30-day clinical success results between evaluable subjects treated with standard length lesions (between 20 mm and 140 mm) and evaluable subjects treated for long lesions (between 141 mm and 190 mm) for the Pulsar stent group.
Measured: 30 days
Number of Participants With Freedom From Clinically-driven TLR and Index Limb Amputation at 24 Months (Post Approval)
Evaluate the rate of freedom from target lesion revascularization (TLR) and/or index limb amputation for the Pulsar stent.
Measured: 24 Months
Safety Assessment for the Pulsar Stent: Percentage of Participants With Mortality, TLR, and Index Limb Amputation (Post Approval)
Evaluate the contribution of the individual rates of mortality, target lesion revascularization (TLR) and index limb amputation at 30 days post-index procedure to the primary safety endpoint for the Pulsar stent.
Measured: 24 Months
Percentage of Participants for the Pulsar Stent Group With MAE (30-day Mortality, Clinically-driven TLR, and Index Limb Amputation) and Their Components at 36 Months (Post Approval).
Evaluate the MAE rate and the individual component rates of mortality at 30 days post-index procedure, target lesion revascularization (TLR) and index limb amputation for the Pulsar stent.
Measured: 36 Months
Percentage of Participants With Target Lesion Revascularization (TLR) at 24 Months (Post Approval) (Pulsar Stent Group)
Measured: 24 Months
Percentage of Participants With Target Lesion Revascularization (TLR) at 36 Months (Post Approval) (Pulsar Stent Group)
Measured: 36 Months
Number of Participants With Stent Fracture at 24 Months (Post Approval).
Measured: 24 Months
Number of Participants With Stent Fracture at 36 Months (Post Approval) (Pulsar Stent Group).
Measured: 36 Months
Percentage of Subjects With Serious Adverse Events at 36 Months (Post Approval) (Pulsar Stent Group).
Summary of serious adverse event rates at 36 months. Refer to SAE section.
Measured: 36 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Mar 2011 (estimated)
- Study startJul 2011
- Primary completionSep 2015
- Study completion7 Sep 2017
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.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Peripheral Artery DiseaseStudies of the same condition, open and under way.
- 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 2
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 463 participants (actual)
Sponsor and investigators
- Lead sponsor
- Biotronik, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Mark Burket, MD, Principal investigator, University of Toledo
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01319812
- Sponsor's protocol ID
- BIOFLEX-I
- Acronym
- BIOFLEX-I
- Status last verified
- Mar 2019
- First submitted
- 18 Mar 2011
- Last updated
- 21 Mar 2019
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- Individual data sharing
- No: There is no plan to share IPD.
Publications
Burket MW, Brodmann M, Metzger C, Tan K, Jaff MR. Twelve-Month Results of the Nitinol Astron Stent in Iliac Artery Lesions. J Vasc Interv Radiol. 2016 Nov;27(11):1650-1656.e1. doi: 10.1016/j.jvir.2016.06.008. Epub 2016 Aug 16.
PubMed 27542591
Study at a glance
From the registry record, last updated by the sponsor on 21 Mar 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Treatment of Iliac and Femoral Atherosclerotic Lesions Using the Self-expanding Astron and Pulsar Stents
- ClinicalTrials.gov ID
- NCT01319812
- Acronym / sponsor ID
- BIOFLEX-I / BIOFLEX-I
- Keywords
- Vascular intervention, Endovascular, Peripheral stent
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 463 participants (actual)
- Lead sponsor
- Biotronik, Inc.Industry (pharma, biotech, devices)
- Study start
- Jul 2011
- Primary completion
- Sep 2015 (actual)
- Study completion
- 7 Sep 2017 (actual)
- First posted
- 22 Mar 2011 (estimated)
- Results
- Posted 5 Jun 2017
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The objective of this study is to separately demonstrate the safety and efficacy of BIOTRONIK's Astron and Pulsar stents. The Pulsar stent will be used for the treatment of femoro-popliteal lesions, located in the native superficial femoral artery (SFA) or proximal popliteal artery (PPA), while the Astron stent will be used for the treatment of the common or external iliac artery lesions.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Astron Stent Group | Experimental | Device: Astron StentsParticipants indicated for stenting in iliac atherosclerotic lesions. Intervention: Device: Astron Stents |
| Pulsar Stent Group | Experimental | Device: Pulsar StentsParticipants indicated for stenting in superficial femoral or proximal popliteal atherosclerotic lesions. Intervention: Device: Pulsar Stents |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (19 listed)
- To support the objectives of this study, the following initial inclusion criteria must be met for a subject to be enrolled and considered for the index procedure:
- Age ≥ 18 years
- Willingness to comply with study follow-up requirements
- Candidate for PTA
- Life-style limiting claudication or rest pain with an ABI ≤ 0.9 (resting or exercise). Thigh brachial index (TBI) may be used / performed if ABI is inadequate.
Key exclusion criteria (27 listed)
- To support the objectives of this study, the following initial exclusion criteria must not be present for a subject to be enrolled:
- Subjects pregnant or planning to become pregnant during the course of the study
- Life expectancy of less than one year
- Rutherford-Becker category 5 or 6. Subjects with ulcers caused by venous disease may be enrolled in the study.
- Previously stented lesion(s) in the target vessel
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 |
|---|---|---|
| Astron StentsAlso: Astron StentImplantation of self-expanding, bare-metal, nitinol stents for treatment of peripheral artery disease affecting the iliac artery. | Device | Astron Stent Group |
| Pulsar StentsAlso: Astron Pulsar Stent, Pulsar-18 Stent, Pulsar StentImplantation of self-expanding, bare-metal, nitinol stents for treatment of peripheral artery disease affecting superficial femoral or proximal popliteal arteries. | Device | Pulsar Stent Group |
Primary outcome
Effectiveness Endpoint for the Pulsar Stent: Primary Patency
Time frame: 12 months
The primary effectiveness endpoint for the Pulsar stent group is the primary patency rate at 12 months post-index procedure. Primary patency is defined as freedom from more than 50% restenosis based on the duplex ultrasound peak systolic velocity ratio, comparing data within the treated segment to the proximal normal segment or based on a clinically-indicated TLR with angiographic evidence of > 50% stenosis.
Safety Endpoint for the Pulsar Stent: Freedom From Procedure- or Stent-related Major Adverse Events
Time frame: 30 days
The primary safety endpoint for the Pulsar stent is the freedom from procedure- or stent-related major adverse events at 30 days post-index procedure. The major adverse event rate includes mortality, target lesion revascularization and index limb amputation.
Safety and Effectiveness Endpoint for the Astron Stent - Percentage of Participants With Major Adverse Events (MAE)
Time frame: 12 months
The primary endpoint for the Astron stent is a composite of the rate of procedure- or stent-related major adverse events at 12 months post-index procedure. The major adverse event rate includes 30-day mortality, along with 12-month rates of target lesion revascularization and index limb amputation. Success was measured against a performance goal of 15%, given a 7.5% expected 12-month MAE rate, with an assumed delta value of 7.5%.
Percentage of Participants With Primary Safety Endpoint (Post Market Analysis)
Time frame: 36 Months
Freedom from a composite of clinically-driven target lesion revascularization (TLR) and index limb amputation at 36 months.
37 secondary outcomes
Secondary Safety Assessment for the Pulsar Stent: Individual Rates of Mortality, TLR, and Index Limb Amputation
Time frame: 30 days
Long-Term Safety Assessment for the Pulsar Stent: Major Adverse Event Rate
Time frame: 12 months
Stent Integrity Assessment for the Pulsar Stent: Stent Fracture Rate
Time frame: 12 months
Secondary Safety Assessment for the Astron Stent - Distribution of MAE Rate
Time frame: 12 months
Secondary Effectiveness Assessment for the Astron Stent - Primary Patency Rate
Time frame: 12 months
Secondary Effectiveness Assessment for the Astron and Pulsar Stents - Primary Assisted Patency
Time frame: 12 months
Secondary Effectiveness Assessment for the Astron and Pulsar Stents - Secondary Patency
Time frame: 12 months
Functional Assessments for Subjects With the Astron and Pulsar Stents - Ankle - Brachial Index (ABI) Measurement
Time frame: 12 months
Functional Assessments for Subjects With the Astron and Pulsar Stents - Six-Minute Walk Test
Time frame: 12 months
Functional Assessments for Subjects With the Astron and Pulsar Stents - Walking Impairment Questionnaire PAD Specific Score
Time frame: 12 months
Functional Assessments for Subjects With the Astron and Pulsar Stents - Walking Impairment Questionnaire Walking Distance Score
Time frame: 12 months
Functional Assessments for Subjects With the Astron and Pulsar Stents - Walking Impairment Questionnaire Walking Speed Score
Time frame: 12 months
Functional Assessments for Subjects With the Astron and Pulsar Stents - Walking Impairment Questionnaire Stair Climbing Score
Time frame: 12 months
Acute Procedural Success for Astron and Pulsar Stent
Time frame: 30 days
Clinical Success
Time frame: 30 days
Secondary Safety Assessment for Astron and Pulsar Stent: Adverse Event Rates
Time frame: 12 month
Comparison of Endpoints Results Between Occlusive and Non-occlusive Lesions for Astron and Pulsar Stent - 30 Day MAE Rate
Time frame: 30 days
Comparison of Endpoints Results Between Occlusive and Non-occlusive Lesions for Astron and Pulsar Stent - Primary Patency at 12-months
Time frame: 12 months
Comparison of Endpoints Results Between Occlusive and Non-occlusive Lesions for Astron and Pulsar Stent - Primary Assisted Patency at 12-Months
Time frame: 12 months
Comparison of Endpoints Results Between Occlusive and Non-occlusive Lesions for Astron and Pulsar Stent - Secondary Patency Rate at 12-Months
Time frame: 12 months
Comparison of Endpoints Results Between Occlusive and Non-occlusive Lesions for Astron and Pulsar Stent - Acute Procedure Success
Time frame: Acute / Date of Procedure
Comparison of Endpoints Results Between Occlusive and Non-occlusive Lesions for Astron and Pulsar Stent - 30-Day Clinical Success
Time frame: 30 days
Comparison of Endpoint Results Between Standard and Long Lesions for the Pulsar Stent - MAE Rate
Time frame: 12 months
Comparison of Endpoint Results Between Standard and Long Lesions for the Pulsar Stent - Primary Patency at 12 Months
Time frame: 12 months
Comparison of Endpoint Results Between Standard and Long Lesions for the Pulsar Stent - Stent Fracture Rate at 12 Months
Time frame: 12 months
Comparison of Endpoint Results Between Standard and Long Lesions for the Pulsar Stent - Primary Assisted Patency at 12 Months
Time frame: 12 months
Comparison of Endpoint Results Between Standard and Long Lesions for the Pulsar Stent - Secondary Patency Rate at 12 Months
Time frame: 12 months
Comparison of Endpoint Results Between Standard and Long Lesions for the Pulsar Stent - Acute Procedure Success
Time frame: Acute / Date of Procedure
Comparison of Endpoint Results Between Standard and Long Lesions for the Pulsar Stent - 30-day Clinical Success
Time frame: 30 days
Number of Participants With Freedom From Clinically-driven TLR and Index Limb Amputation at 24 Months (Post Approval)
Time frame: 24 Months
Safety Assessment for the Pulsar Stent: Percentage of Participants With Mortality, TLR, and Index Limb Amputation (Post Approval)
Time frame: 24 Months
Percentage of Participants for the Pulsar Stent Group With MAE (30-day Mortality, Clinically-driven TLR, and Index Limb Amputation) and Their Components at 36 Months (Post Approval).
Time frame: 36 Months
Percentage of Participants With Target Lesion Revascularization (TLR) at 24 Months (Post Approval) (Pulsar Stent Group)
Time frame: 24 Months
Percentage of Participants With Target Lesion Revascularization (TLR) at 36 Months (Post Approval) (Pulsar Stent Group)
Time frame: 36 Months
Number of Participants With Stent Fracture at 24 Months (Post Approval).
Time frame: 24 Months
Number of Participants With Stent Fracture at 36 Months (Post Approval) (Pulsar Stent Group).
Time frame: 36 Months
Percentage of Subjects With Serious Adverse Events at 36 Months (Post Approval) (Pulsar Stent Group).
Time frame: 36 months
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Mar 2019.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 27542591Burket MW, Brodmann M, Metzger C, Tan K, Jaff MR. Twelve-Month Results of the Nitinol Astron Stent in Iliac Artery Lesions. J Vasc Interv Radiol. 2016 Nov;27(11):1650-1656.e1. doi: 10.1016/j.jvir.2016.06.008. Epub 2016 Aug 16.
- Twelve-Month Results of the Nitinol Astron Stent in Iliac Artery LesionsLink provided by the sponsor.
- Individual participant dataSharing planned: No. There is no plan to share IPD.
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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.
Mark Burket, MD principal investigator
University of Toledo
35 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Astron Stents and Pulsar Stents in people with Peripheral Artery Disease and Peripheral Vascular Disease, run by Biotronik, Inc. at 35 sites in 2 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 19 inclusion and 27 exclusion criteria. 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 21 Mar 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 35 sites in United States, Canada. 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.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 5 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?
Effectiveness Endpoint for the Pulsar Stent: Primary Patency (time frame: 12 months). The study lists 4 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 NCT01319812, which also lists 1 linked publication.
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 21 Mar 2019.