Common Iliac Artery Occlusive DiseaseNCT01961167
Evaluation of the GORE® VIABAHN® BALLOON EXPANDABLE ENDOPROSTHESIS (VIABAHN BX)
A study testing Stenting of common and/or external iliacs in people with Common Iliac Artery Occlusive Disease and External Iliac Artery Occlusive Disease, run by W.L.Gore & Associates at 1 site in New Zealand.
Trial summary
The primary objective of the VBX13-05 clinical study is to evaluate the safety and efficacy of VIABAHN BX for the treatment of arterial occlusive disease in patients with de novo or restenotic lesions in the common and/or external iliac arteries. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Common Iliac Artery Occlusive Disease, External Iliac Artery Occlusive Disease, Peripheral Arterial Disease
- What is being tested?
- Stenting of common and/or external iliacs
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 27 participants
- Where
- 1 siteNew Zealand
- Study dates
- Dec 2013to 14 Dec 2017
- 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
Who may be able to join
- Patient is at least 18 years old;
- Patient is male, infertile female, or female of childbearing potential practicing an acceptable method of preventing pregnancy;
- Patient or legal representative is willing to give written informed consent;
- Patient is capable of complying with protocol requirements, including all follow-up visits;
- Patient has symptomatic claudication or rest pain without tissue loss (Rutherford Categories 2-4).
- Patient has de novo or restenotic target lesion(s) in the common and/or external iliac artery
Who cannot join
- Patient has a life expectancy of less than 1 year;
- Patient has a known allergy to stent graft components, including stainless steel or heparin;
- Patient has a known intolerance to antiplatelet, anticoagulant, or thrombolytic medications that would prevent compliance with the protocol;
- Patient has a condition (unrelated to the study) that is expected to require indefinite, or lifelong, anticoagulation
- Patient has had vascular access / catheterization in the lower extremity within 30 days of study enrollment;
- Patient has had a previous or planned coronary intervention within 30 days prior to enrollment in this study or required at time of study procedure; Patient has had a previous or planned bypass surgery in the target leg, or a bypass that occurs at the time of the study procedure;
Show all 11Show fewer
- Patient is currently participating in this or another investigative clinical study.
- Patient has evidence of angiographically visible thrombus within or adjacent to the target lesion(s);
- Patient has aneurysmal dilation proximal or distal to the target lesion(s) that would interfere with the placement of the device;
- Patient has a target lesion requiring atherectomy or any ablative device to facilitate stent delivery;
- Patient has a target lesion situated in such a way that an implanted device will prevent blood flow or perfusion to the internal iliac artery if patent
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Evaluation of the GORE® VIABAHN® BALLOON EXPANDABLE ENDOPROSTHESIS (VIABAHN BX) for the Treatment of Occlusive Disease in the Common and External Iliac Arteries
The primary objective of the VBX13-05 clinical study is to evaluate the safety and efficacy of VIABAHN BX for the treatment of arterial occlusive disease in patients with de novo or restenotic lesions in the common and/or external iliac arteries.
- Conditions
- Common Iliac Artery Occlusive Disease, External Iliac Artery Occlusive Disease, Peripheral Arterial Disease
- Being tested
- Stenting of common and/or external iliacs
- Keywords
- PAD, Stent, Claudication, VIABAHN, Gore, Endoprosthesis, Vascular Diseases, Cardiovascular Diseases, Iliac Occlusive Disease, Balloon Expandable, Stent Graft, VBX
- Medical subject headings
- Peripheral Arterial Disease, Intermittent Claudication, Vascular Diseases, Cardiovascular Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Stenting of common and/or external iliacsDevice
Balloon expandable stenting of iliac occlusive disease
| Study group | Role | What they receive |
|---|---|---|
| Gore VIABAHN BX | Experimental | Balloon expandable stenting of iliac occlusive disease Receives: Device: Stenting of common and/or external iliacs |
What is being measured
The primary outcome is the main question the study is designed to answer.
Composite of Major Adverse Events (MAEs)
Percentage of study subjects experiencing a major adverse event (MAE) defined as:
- Device- or procedure-related death within 30 days of the index procedure; and
- Myocardial Infarction (MI) occurring within 30 days of the index procedure; and
- Amputation above the metatarsals in the treated leg, resulting from a vascular event, occurring within 30 days of the index procedure.
Measured: 30 days
Secondary outcomes (31)
Acute Procedural Success
Number of subjects who experience acute procedural success defined as less than or equal to 30% residual stenosis prior to procedure completion and no device- or procedure-related SAEs before discharge at day 1.
Measured: Discharge
Thirty-day Clinical Success
Number of subjects who experienced 30-day clinical success defined as an improvement of at least one Rutherford Category at the 30-day visit as compared to pre-procedure and no device- or procedure-related serious adverse events (SAEs) within 30 days of the index procedure.
Rutherford categories include:
Stage 0 - Asymptomatic Stage 1 - Mild claudication Stage 2 - Moderate claudication - The distance that delineates mild, moderate and severe claudication is not specified in the Rutherford classification, but is mentioned in the Fontaine classification as 200 meters.
Stage 3 - Severe claudication Stage 4 - Rest pain Stage 5 - Ischemic ulceration not exceeding ulcer of the digits of the foot Stage 6 - Severe ischemic ulcers or frank gangrene
Measured: 30 Days
Primary Patency
Kaplan-Meier estimate of primary patency at 30 days. Primary patency is defined as blood flow in the treated segment(s), without reintervention.
Measured: 30 Days
Primary Patency
Kaplan-Meier estimate of primary patency at 6 months. Primary patency is defined as blood flow in the treated segment(s), without reintervention.
Measured: 6 Months
Primary Assisted Patency
Kaplan-Meier estimate of primary assisted patency at 30 days. Primary assisted patency is defined as blood flow maintained with or without reintervention in the originally treated segment(s), including the proximal and distal margins.
Measured: 30 Days
Primary Assisted Patency
Kaplan-Meier estimate of primary assisted patency at 6 Months. Primary assisted patency is defined as blood flow maintained with or without reintervention in the originally treated segment(s), including the proximal and distal margins.
Measured: 6 Months
Secondary Patency
Kaplan-Meier estimate of secondary patency at 30 days. Secondary patency is defined as presence of blood flow, with or without reintervention, in the originally treated segment(s), including the proximal and distal margins.
Measured: 30 Days
Secondary Patency
Kaplan-Meier estimate of secondary patency at 6 months. Secondary patency is defined as presence of blood flow, with or without reintervention, in the originally treated segment(s), including the proximal and distal margins.
Measured: 6 Months
Freedom From Target Lesion(s) Revascularization (TLR)
Kaplan-Meier estimate of freedom from target lesion revascularization (TLR) at 30 days. TLR is defined as revascularization occurring within the treated segment(s) by means of a percutaneous vascular intervention, surgical bypass, thrombolysis, or other invasive means.
Measured: 30 Days
Freedom From Target Lesion(s) Revascularization (TLR)
Kaplan-Meier estimate of freedom from target lesion revascularization (TLR) at 6 months. TLR is defined as revascularization occurring within the treated segment(s) by means of a percutaneous vascular intervention, surgical bypass, thrombolysis, or other invasive means.
Measured: 6 Months
Freedom From Target Vessel Revascularization (TVR)
Kaplan-Meier estimate of freedom from target vessel revascularization (TVR) at 30 days. TVR is defined as revascularization of the vessel treated at the time of the index procedure by means of a percutaneous vascular intervention, surgical bypass, thrombolysis, or other invasive means.
Measured: 30 Days
Freedom From Target Vessel Revascularization (TVR)
Kaplan-Meier estimate of freedom from target vessel revascularization (TVR) at 6 months. TVR is defined as revascularization of the vessel treated at the time of the index procedure by means of a percutaneous vascular intervention, surgical bypass, thrombolysis, or other invasive means.
Measured: 6 Months
Number of Participants With a Change in Rutherford Category
Change in Rutherford Category from pre-procedure at 30 days.
Rutherford categories include:
Stage 0 - Asymptomatic Stage 1 - Mild claudication Stage 2 - Moderate claudication - The distance that delineates mild, moderate and severe claudication is not specified in the Rutherford classification, but is mentioned in the Fontaine classification as 200 meters.
Stage 3 - Severe claudication Stage 4 - Rest pain Stage 5 - Ischemic ulceration not exceeding ulcer of the digits of the foot Stage 6 - Severe ischemic ulcers or frank gangrene
Measured: 30 Days
Number of Participants With Change in Rutherford Category
Change in Rutherford Category from pre-procedure at 6 months.
Rutherford categories include:
Stage 0 - Asymptomatic Stage 1 - Mild claudication Stage 2 - Moderate claudication - The distance that delineates mild, moderate and severe claudication is not specified in the Rutherford classification, but is mentioned in the Fontaine classification as 200 meters.
Stage 3 - Severe claudication Stage 4 - Rest pain Stage 5 - Ischemic ulceration not exceeding ulcer of the digits of the foot Stage 6 - Severe ischemic ulcers or frank gangrene
Measured: 6 Months
Change in Ankle Brachial Index (ABI)
Change in Ankle Brachial Index (ABI) from pre-procedure at 30 days. Larger values indicate a better outcome. The ABI is the systolic pressure at the ankle, divided by the systolic pressure at the arm
Measured: 30 Days
Change in Ankle Brachial Index (ABI)
Change in Ankle Brachial Index(ABI) from pre-procedure at 6 months. Larger values indicate a better outcome.The ABI is the systolic pressure at the ankle, divided by the systolic pressure at the arm
Measured: 6 Months
Freedom From Major Adverse Events (MAEs)
Number of subjects experiencing freedom from procedure- or device-related events causing death, occurring within 30 days of the index procedure; and myocardial infarction (MI) occurring within 30 days of the index procedure; and target lesion revascularization (TLR) occurring within 6 months of the index procedure; and major amputation of the treated leg(s), resulting from a vascular event, occurring within 6 months of the index procedure.
Measured: 6 months
Change in Functional Status - EQ5D- Mobility
Change in functional status (EQ5D - Mobility) from pre-procedure at 30 days. EQ5D is a standard instrument for use as a measure of health outcome.
Measured: 30 days
Change in Functional Status - EQ5D- Mobility
Change in functional status (EQ5D - Mobility) from pre-procedure at 6 months. EQ5D is a standard instrument for use as a measure of health outcome.
Measured: 6 Months
Change in Functional Status - EQ5D - Self Care
Change in functional status (EQ5D - Self Care) from pre-procedure at 30 days. EQ5D is a standard instrument for use as a measure of health outcome.
Measured: 30 days
Change in Functional Status - EQ5D - Self Care
Change in functional status (EQ5D - Self Care) from pre-procedure at 6 months. EQ5D is a standard instrument for use as a measure of health outcome.
Measured: 6 Months
Change in Functional Status - EQ5D - Usual Activities
Change in functional status (EQ5D - Usual Activities) from pre-procedure at 30 days. EQ5D is a standard instrument for use as a measure of health outcome.
Measured: 30 days
Change in Functional Status - EQ5D - Usual Activities
Change in functional status (EQ5D - Usual Activities) from pre-procedure at 6 months. EQ5D is a standard instrument for use as a measure of health outcome.
Measured: 6 Months
Change in Functional Status - EQ5D - Pain/Discomfort
Change in functional status (EQ5D - Pain/Discomfort) from pre-procedure at 30 days. EQ5D is a standard instrument for use as a measure of health outcome.
Measured: 30 Days
Change in Functional Status - EQ5D - Pain/Discomfort
Change in functional status (EQ5D - Pain/Discomfort) from pre-procedure at 6 months. EQ5D is a standard instrument for use as a measure of health outcome.
Measured: 6 Months
Change in Functional Status - EQ5D - Anxiety/Depression
Change in functional status (EQ5D - Anxiety/Depression) from pre-procedure at 30 days. EQ5D is a standard instrument for use as a measure of health outcome.
Measured: 30 Days
Change in Functional Status - EQ5D - Anxiety/Depression
Change in functional status (EQ5D - Anxiety/Depression) from pre-procedure at 6 months. EQ5D is a standard instrument for use as a measure of health outcome.
Measured: 6 Months
Change in Functional Status - EQ5D- Own Health State
Change in functional status (EQ5D - Own Health State) from pre-procedure at 30 days. EQ5D is a standard instrument for use as a measure of health outcome.
Measured: 30 Days
Change in Functional Status - EQ5D- Own Health State
Change in functional status (EQ5D - Own Health State) from pre-procedure at 6 months. EQ5D is a standard instrument for use as a measure of health outcome.
Measured: 6 Months
Number of Participants With Improvement in Differential Diagnoses at 30 Days - Walking Impairment Questionnaire (WIQ)
Patient reported outcome based on study questionnaire. Percentage of subjects with improvement on WIQ from pre-procedure at 30 days.
Measured: 30 day
Number of Participants With Improvement in Differential Diagnoses at 180 Days - Walking Impairment Questionnaire (WIQ)
Patient reported outcome based on study questionnaire. Percentage of subjects with improvement on WIQ from pre-procedure at 180 days.
Measured: 6 Months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Oct 2013 (estimated)
- Study startDec 2013
- Primary completionJan 2015
- Study completion14 Dec 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.
- Other trials for Common Iliac Artery Occlusive DiseaseStudies of the same condition, open and under way.
- More trials run by W.L.Gore & AssociatesThe 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
- Model description
- Single group assignment
- Masking
- None (open label)
- Enrolment
- 27 participants (actual)
Sponsor and investigators
- Lead sponsor
- W.L.Gore & Associates
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Andrew Holden, MB ChB, Principal investigator, Auckland City Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01961167
- Sponsor's protocol ID
- VBX 13-05
- Status last verified
- Nov 2019
- First submitted
- 8 Oct 2013
- Last updated
- 19 Nov 2019
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 19 Nov 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the GORE® VIABAHN® BALLOON EXPANDABLE ENDOPROSTHESIS (VIABAHN BX) for the Treatment of Occlusive Disease in the Common and External Iliac Arteries
- ClinicalTrials.gov ID
- NCT01961167
- Acronym / sponsor ID
- VBX 13-05
- Conditions
- Common Iliac Artery Occlusive Disease, External Iliac Artery Occlusive Disease, Peripheral Arterial Disease
- Keywords
- PAD, Stent, Claudication, VIABAHN, Gore, Endoprosthesis, Vascular Diseases, Cardiovascular Diseases
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 27 participants (actual)
- Lead sponsor
- W.L.Gore & AssociatesIndustry (pharma, biotech, devices)
- Study start
- Dec 2013 (actual)
- Primary completion
- Jan 2015 (actual)
- Study completion
- 14 Dec 2017 (actual)
- First posted
- 11 Oct 2013 (estimated)
- Results
- Posted 6 Nov 2019
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The primary objective of the VBX13-05 clinical study is to evaluate the safety and efficacy of VIABAHN BX for the treatment of arterial occlusive disease in patients with de novo or restenotic lesions in the common and/or external iliac arteries.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Single group assignment
| Arm | Type | Receives |
|---|---|---|
| Gore VIABAHN BX | Experimental | Device: Stenting of common and/or external iliacsBalloon expandable stenting of iliac occlusive disease |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Patient is at least 18 years old;
- Patient is male, infertile female, or female of childbearing potential practicing an acceptable method of preventing pregnancy;
- Patient or legal representative is willing to give written informed consent;
- Patient is capable of complying with protocol requirements, including all follow-up visits;
- Patient has symptomatic claudication or rest pain without tissue loss (Rutherford Categories 2-4).
Key exclusion criteria (11 listed)
- Patient has a life expectancy of less than 1 year;
- Patient has a known allergy to stent graft components, including stainless steel or heparin;
- Patient has a known intolerance to antiplatelet, anticoagulant, or thrombolytic medications that would prevent compliance with the protocol;
- Patient has a condition (unrelated to the study) that is expected to require indefinite, or lifelong, anticoagulation
- Patient has had vascular access / catheterization in the lower extremity within 30 days of study enrollment;
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 of common and/or external iliacsBalloon expandable stenting of iliac occlusive disease | Device | Gore VIABAHN BX |
Primary outcome
Composite of Major Adverse Events (MAEs)
Time frame: 30 days
Percentage of study subjects experiencing a major adverse event (MAE) defined as: * Device- or procedure-related death within 30 days of the index procedure; and * Myocardial Infarction (MI) occurring within 30 days of the index procedure; and * Amputation above the metatarsals in the treated leg, resulting from a vascular event, occurring within 30 days of the index procedure.
31 secondary outcomes
Acute Procedural Success
Time frame: Discharge
Thirty-day Clinical Success
Time frame: 30 Days
Primary Patency
Time frame: 30 Days
Primary Patency
Time frame: 6 Months
Primary Assisted Patency
Time frame: 30 Days
Primary Assisted Patency
Time frame: 6 Months
Secondary Patency
Time frame: 30 Days
Secondary Patency
Time frame: 6 Months
Freedom From Target Lesion(s) Revascularization (TLR)
Time frame: 30 Days
Freedom From Target Lesion(s) Revascularization (TLR)
Time frame: 6 Months
Freedom From Target Vessel Revascularization (TVR)
Time frame: 30 Days
Freedom From Target Vessel Revascularization (TVR)
Time frame: 6 Months
Number of Participants With a Change in Rutherford Category
Time frame: 30 Days
Number of Participants With Change in Rutherford Category
Time frame: 6 Months
Change in Ankle Brachial Index (ABI)
Time frame: 30 Days
Change in Ankle Brachial Index (ABI)
Time frame: 6 Months
Freedom From Major Adverse Events (MAEs)
Time frame: 6 months
Change in Functional Status - EQ5D- Mobility
Time frame: 30 days
Change in Functional Status - EQ5D- Mobility
Time frame: 6 Months
Change in Functional Status - EQ5D - Self Care
Time frame: 30 days
Change in Functional Status - EQ5D - Self Care
Time frame: 6 Months
Change in Functional Status - EQ5D - Usual Activities
Time frame: 30 days
Change in Functional Status - EQ5D - Usual Activities
Time frame: 6 Months
Change in Functional Status - EQ5D - Pain/Discomfort
Time frame: 30 Days
Change in Functional Status - EQ5D - Pain/Discomfort
Time frame: 6 Months
Change in Functional Status - EQ5D - Anxiety/Depression
Time frame: 30 Days
Change in Functional Status - EQ5D - Anxiety/Depression
Time frame: 6 Months
Change in Functional Status - EQ5D- Own Health State
Time frame: 30 Days
Change in Functional Status - EQ5D- Own Health State
Time frame: 6 Months
Number of Participants With Improvement in Differential Diagnoses at 30 Days - Walking Impairment Questionnaire (WIQ)
Time frame: 30 day
Number of Participants With Improvement in Differential Diagnoses at 180 Days - Walking Impairment Questionnaire (WIQ)
Time frame: 6 Months
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Nov 2019.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: Undecided
Related trials for Common Iliac Artery Occlusive Disease
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Endovascular Modalites for Contralateral Common Iliac Artery in Patients With Symptomatic Unilateral Common Iliac Artery Occlusive Disease
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Safety and Effectiveness of the Peripheral Balloon-Expandable Covered Stent System for Iliac Artery Stenosis/Occlusion. (SELECT)
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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.
Andrew Holden, MB ChB principal investigator
Auckland City Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Stenting of common and/or external iliacs in people with Common Iliac Artery Occlusive Disease and External Iliac Artery Occlusive Disease, run by W.L.Gore & Associates at 1 site in New Zealand.
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 6 inclusion and 11 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 19 Nov 2019. 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 New Zealand. 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 Nov 2019). 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?
Composite of Major Adverse Events (MAEs) (time frame: 30 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 19 Nov 2019.