Peripheral Artery DiseaseNCT02542267
In-Stent Restenosis Post-Approval Study
A study testing Gore VIABAHN Endoprosthesis in people with Peripheral Artery Disease and Vascular Disease, run by W.L.Gore & Associates at 23 sites in 4 countries.
Trial summary
The objective of the ISR 14-04 study is to evaluate post-market safety and effectiveness of GORE® VIABAHN® Endoprosthesis for treatment of In-Stent Restenosis of the Superficial Femoral Artery. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Peripheral Artery Disease, Vascular Disease
- What is being tested?
- Gore VIABAHN Endoprosthesis
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 108 participants
- Where
- 23 sitesin 4 countries
- Study dates
- Sep 2015to Jul 2021
- 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 has a previously implanted (> 30 days) non-covered stent(s) located in the SFA
- Patient has life-style limiting claudication, resting leg pain or minor tissue loss (Rutherford Category 2 - 5)
- Patient demonstrates an Ankle Brachial Index (ABI) <=0.9. If ABI >0.9 or not measurable, patient is eligible for study if Toe Brachial Index is <=0.5
- Patient has >=50% in-stent restenosis and / or an occlusion in a previously implanted (>30 days) non-covered stent(s) located in the superficial femoral artery defined as beginning at least 1cm below the origin of the profunda femoris artery and ending at least 1cm above the intercondylar notch.
- Patient has a maximum total lesion length of 270mm, consisting of in-stent and adjacent occlusive disease
- Patient has a reference vessel diameter between 4.0 and 6.5mm
- Patient has at least one patent infrapopliteal runoff vessel (<50% stenosis) not requiring reintervention
- Note: Additional Inclusion Criteria may apply
Who cannot join
- Patient has a known allergy to stent graft components (nickel-titanium or expanded-polytetrafluoroethylene)
- Patient has a known intolerance to anticoagulation or antiplatelet therapy
- Patient has known coagulation disorder, including hypercoagulability.
- Patient has major distal amputation (above the transmetatarsal)
- Patient has any previous surgery in the target vessel
- Patient has had previous target vessel in-stent restenosis treated by relining with another stent
- Patient has untreated flow-limiting aortoiliac stenotic disease
- Note: Additional Exclusion Criteria may apply
Trial locations and contacts
23 sites in 4 countries.
23 sites in 4 countries
United States20 sites
Charleston Area Medical Center
Charleston, West Virginia, 25304
Texas Health Research - Presbyterian Heart and Vascular
Dallas, Texas, 75231
St. Vincent's Consultants in Cardiovascular Disease
Erie, Pennsylvania, 16502
Sanford Health
Fargo, North Dakota, 58122
Greenville Hospital System
Greenville, South Carolina, 29615
Kaiser Foundation Hospital
Honolulu, Hawaii, 96819
Cardiovascular Institute of the South
Houma, Louisiana, 70360
University of Iowa Hospitals and Clinics
Iowa City, Iowa, 52242
Mount Sinai Medical Center
Miami, Florida, 33140
New York University Langone Medical Center
New York, New York, 10016
New York Presbyterian Hospital/Weill Cornell Medical Center
New York, New York, 10065
Midwest Aortic and Vascular Institute (MAVI)
North Kansas City, Missouri, 64116
Texas Health Research - Presbyterian Hospital of Plano
Plano, Texas, 75093
Providence Heart Clinic
Portland, Oregon, 97225
The Miriam Hospital
Providence, Rhode Island, 02906
North Carolina Heart and Vascular
Raleigh, North Carolina, 27607
Rockford CardioVascular Associates
Rockford, Illinois, 61107
Covenant Medical Center, Inc.
Saginaw, Michigan, 48602
Swedish Medical Center - Heart and Vascular Research
Seattle, Washington, 98122
Munson Medical Center
Traverse City, Michigan, 49684
Italy1 site
Azienda Ospedaliera Santa Maria Nuova di Reggio Emilia
Reggio Emilia
About this study
Official title: Post-Approval Study of the GORE® VIABAHN® Endoprosthesis for the Treatment of In-Stent Restenosis (ISR) in the Superficial Femoral Artery (SFA)
The objective of the ISR 14-04 study is to evaluate post-market safety and effectiveness of GORE® VIABAHN® Endoprosthesis for treatment of In-Stent Restenosis of the Superficial Femoral Artery.
- Conditions
- Peripheral Artery Disease, Vascular Disease
- Being tested
- Gore VIABAHN Endoprosthesis
- Keywords
- Bare Metal Stent, In-Stent Restenosis
- Medical subject headings
- Peripheral Arterial Disease, Vascular Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Gore VIABAHN EndoprosthesisDevice
| Study group | Role | What they receive |
|---|---|---|
| Gore VIABAHN Endoprosthesis | Other | Gore VIABAHN Endoprosthesis deployed to treat failed non-covered stent(s) in the Superficial Femoral Artery Receives: Device: Gore VIABAHN Endoprosthesis |
What is being measured
The primary outcome is the main question the study is designed to answer.
Primary Effectiveness
Primary Effectiveness is Primary Patency defined as patent blood flow through the study device, which requires either a Peak Systolic Velocity Ratio measurement ≤ 2.5 or patent flow indicated by the Core Lab, and without repeat intervention measured at 12 months and assessed by Kaplan-Meier analysis.
Measured: 12 Months
Number of Subjects Free From Procedure and Device-Related Serious Adverse Events Within 30 Days of Index Procedure
Primary Safety is defined as freedom from procedure and device-related serious adverse events within 30 days of index procedure
Measured: 30 Days
Secondary outcomes (15)
Number of Subjects With Acute Procedural Success
Acute Procedural Success is defined as successful delivery of the study device and complete coverage of the target lesion without a procedure or device-related Serious Adverse Event prior to hospital discharge.
Measured: During hospitalization, approximately 1-2 days
Primary Patency at 30 Days and 12, 24, and 36 Months
Primary patency is defined as patent blood flow through the study device, which requires either a PSVR measurement ≤ 2.5 or patent flow indicated by the Core Lab, without repeat intervention.
Measured: 30 days and 12, 24, and 36 months
Primary Assisted Patency at 30 Days and 12, 24, and 36 Months
Primary assisted patency is defined as blood flow through the study device regardless of repeat interventions to maintain patency prior to occlusion.
Measured: 30 days and 12, 24, and 36 months
Secondary Patency at 30 Days and 12, 24, and 36 Months
Secondary patency is defined as blood flow through the study device regardless of repeat interventions to restore patency after occlusion.
Measured: 30 days and 12, 24, and 36 months
Freedom From Target Lesion Revascularization at 30 Days and 12, 24, and 36 Months
Target Lesion Revascularization is defined as a repeat intervention within the study device and 5 mm proximal or distal to the edge of the study device to maintain or re-establish patency.
Measured: 30 days and 12, 24, and 36 months
Freedom From Major Amputation at 30 Days and 12, 24, and 36 Months
Major Amputation is defined as removal of the study limb above the metatarsals, resulting from a vascular event.
Measured: 30 days and 12, 24, and 36 months
Change in Ankle Brachial Index at 30 Days
The Ankle Brachial Index (ABI) is the ankle systolic pressure in the study limb divided by the highest systolic pressure in either arm. ABI values <= 0.90 are considered abnormal, 0.91-0.99 borderline, 1.00-1.40 normal, and >1.40 noncompressible. The change in ABI was measured relative to that obtained pre-procedure.
Measured: Pre-procedure and 30 Days
Change in Ankle Brachial Index at 1 Year
The Ankle Brachial Index (ABI) is the ankle systolic pressure in the study limb divided by the highest systolic pressure in either arm. ABI values <= 0.90 are considered abnormal, 0.91-0.99 borderline, 1.00-1.40 normal, and >1.40 noncompressible. The change in ABI was measured relative to that obtained pre-procedure.
Measured: Pre-procedure and 1 Year
Change in Ankle Brachial Index at 2 Years
The Ankle Brachial Index (ABI) is the ankle systolic pressure in the study limb divided by the highest systolic pressure in either arm. ABI values <= 0.90 are considered abnormal, 0.91-0.99 borderline, 1.00-1.40 normal, and >1.40 noncompressible. The change in ABI was measured relative to that obtained pre-procedure.
Measured: Pre-procedure and 2 Years
Change in Ankle Brachial Index at 3 Years
The Ankle Brachial Index (ABI) is the ankle systolic pressure in the study limb divided by the highest systolic pressure in either arm. ABI values <= 0.90 are considered abnormal, 0.91-0.99 borderline, 1.00-1.40 normal, and >1.40 noncompressible. The change in ABI was measured relative to that obtained pre-procedure.
Measured: Pre-procedure and 3 Years
Change in Rutherford Category at 30 Days
The Rutherford Category is a lower limb ischemia classification with 7 categories ranging from least severe (category 0) to most severe (category 6): Category 0 - No claudication; Category 1 - Mild claudication; Category 2 - Moderate claudication; Category 3 - Severe claudication; Category 4 - Ischemic rest pain; Category 5 - Minor tissue loss, non-healing ulcer, focal gangrene with diffuse pedal ischemia; Category 6 - Major tissue loss, extending above transmetatarsal level, functional foot no longer salvageable. The change is Rutherford Category was measured relative to that obtained pre-procedure and a negative change corresponds to improved outcome.
Measured: Pre-procedure and 30 Days
Change in Rutherford Category at 1 Year
The Rutherford Category is a lower limb ischemia classification with 7 categories ranging from least severe (category 0) to most severe (category 6): Category 0 - No claudication; Category 1 - Mild claudication; Category 2 - Moderate claudication; Category 3 - Severe claudication; Category 4 - Ischemic rest pain; Category 5 - Minor tissue loss, non-healing ulcer, focal gangrene with diffuse pedal ischemia; Category 6 - Major tissue loss, extending above transmetatarsal level, functional foot no longer salvageable. The change is Rutherford Category was measured relative to that obtained pre-procedure and a negative change corresponds to improved outcome.
Measured: Pre-procedure and 1 Year
Change in Rutherford Category at 2 Years
The Rutherford Category is a lower limb ischemia classification with 7 categories ranging from least severe (category 0) to most severe (category 6): Category 0 - No claudication; Category 1 - Mild claudication; Category 2 - Moderate claudication; Category 3 - Severe claudication; Category 4 - Ischemic rest pain; Category 5 - Minor tissue loss, non-healing ulcer, focal gangrene with diffuse pedal ischemia; Category 6 - Major tissue loss, extending above transmetatarsal level, functional foot no longer salvageable. The change is Rutherford Category was measured relative to that obtained pre-procedure and a negative change corresponds to improved outcome.
Measured: Pre-procedure and 2 Years
Change in Rutherford Category at 3 Years
The Rutherford Category is a lower limb ischemia classification with 7 categories ranging from least severe (category 0) to most severe (category 6): Category 0 - No claudication; Category 1 - Mild claudication; Category 2 - Moderate claudication; Category 3 - Severe claudication; Category 4 - Ischemic rest pain; Category 5 - Minor tissue loss, non-healing ulcer, focal gangrene with diffuse pedal ischemia; Category 6 - Major tissue loss, extending above transmetatarsal level, functional foot no longer salvageable. The change is Rutherford Category was measured relative to that obtained pre-procedure and a negative change corresponds to improved outcome.
Measured: Pre-procedure and 3 Years
Stent Fracture at 12, 24, and 36 Months
Device stent fractures that are clearly distinguishable from previously implanted stents will be assessed by the study core lab through x-ray images.
Measured: 12, 24, and 36 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Sep 2015 (estimated)
- Study startSep 2015
- Primary completionJul 2019
- Study completionJul 2021
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 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
- Masking
- None (open label)
- Enrolment
- 108 participants (actual)
Sponsor and investigators
- Lead sponsor
- W.L.Gore & Associates
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Peter Soukas, MD, Principal investigator, Miriam Hospital, Providence, RI
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02542267
- Sponsor's protocol ID
- ISR 14-04
- Status last verified
- Oct 2023
- First submitted
- 19 Aug 2015
- Last updated
- 16 Oct 2023
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 16 Oct 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Post-Approval Study of the GORE® VIABAHN® Endoprosthesis for the Treatment of In-Stent Restenosis (ISR) in the Superficial Femoral Artery (SFA)
- ClinicalTrials.gov ID
- NCT02542267
- Acronym / sponsor ID
- ISR 14-04
- Conditions
- Peripheral Artery Disease, Vascular Disease
- Keywords
- Bare Metal Stent, In-Stent Restenosis
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 108 participants (actual)
- Lead sponsor
- W.L.Gore & AssociatesIndustry (pharma, biotech, devices)
- Study start
- Sep 2015
- Primary completion
- Jul 2019 (actual)
- Study completion
- Jul 2021 (actual)
- First posted
- 4 Sep 2015 (estimated)
- Results
- Posted 21 Aug 2020
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 the ISR 14-04 study is to evaluate post-market safety and effectiveness of GORE® VIABAHN® Endoprosthesis for treatment of In-Stent Restenosis of the Superficial Femoral Artery.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Gore VIABAHN Endoprosthesis | Other | Device: Gore VIABAHN EndoprosthesisGore VIABAHN Endoprosthesis deployed to treat failed non-covered stent(s) in the Superficial Femoral Artery |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Patient has a previously implanted (> 30 days) non-covered stent(s) located in the SFA
- Patient has life-style limiting claudication, resting leg pain or minor tissue loss (Rutherford Category 2 - 5)
- Patient demonstrates an Ankle Brachial Index (ABI) <=0.9. If ABI >0.9 or not measurable, patient is eligible for study if Toe Brachial Index is <=0.5
- Patient has >=50% in-stent restenosis and / or an occlusion in a previously implanted (>30 days) non-covered stent(s) located in the superficial femoral artery defined as beginning at least 1cm below the origin of the profunda femoris artery and ending at least 1cm above the intercondylar notch.
- Patient has a maximum total lesion length of 270mm, consisting of in-stent and adjacent occlusive disease
Key exclusion criteria (8 listed)
- Patient has a known allergy to stent graft components (nickel-titanium or expanded-polytetrafluoroethylene)
- Patient has a known intolerance to anticoagulation or antiplatelet therapy
- Patient has known coagulation disorder, including hypercoagulability.
- Patient has major distal amputation (above the transmetatarsal)
- Patient has any previous surgery 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 |
|---|---|---|
| Gore VIABAHN Endoprosthesis | Device | Gore VIABAHN Endoprosthesis |
Primary outcome
Primary Effectiveness
Time frame: 12 Months
Primary Effectiveness is Primary Patency defined as patent blood flow through the study device, which requires either a Peak Systolic Velocity Ratio measurement ≤ 2.5 or patent flow indicated by the Core Lab, and without repeat intervention measured at 12 months and assessed by Kaplan-Meier analysis.
Number of Subjects Free From Procedure and Device-Related Serious Adverse Events Within 30 Days of Index Procedure
Time frame: 30 Days
Primary Safety is defined as freedom from procedure and device-related serious adverse events within 30 days of index procedure
15 secondary outcomes
Number of Subjects With Acute Procedural Success
Time frame: During hospitalization, approximately 1-2 days
Primary Patency at 30 Days and 12, 24, and 36 Months
Time frame: 30 days and 12, 24, and 36 months
Primary Assisted Patency at 30 Days and 12, 24, and 36 Months
Time frame: 30 days and 12, 24, and 36 months
Secondary Patency at 30 Days and 12, 24, and 36 Months
Time frame: 30 days and 12, 24, and 36 months
Freedom From Target Lesion Revascularization at 30 Days and 12, 24, and 36 Months
Time frame: 30 days and 12, 24, and 36 months
Freedom From Major Amputation at 30 Days and 12, 24, and 36 Months
Time frame: 30 days and 12, 24, and 36 months
Change in Ankle Brachial Index at 30 Days
Time frame: Pre-procedure and 30 Days
Change in Ankle Brachial Index at 1 Year
Time frame: Pre-procedure and 1 Year
Change in Ankle Brachial Index at 2 Years
Time frame: Pre-procedure and 2 Years
Change in Ankle Brachial Index at 3 Years
Time frame: Pre-procedure and 3 Years
Change in Rutherford Category at 30 Days
Time frame: Pre-procedure and 30 Days
Change in Rutherford Category at 1 Year
Time frame: Pre-procedure and 1 Year
Change in Rutherford Category at 2 Years
Time frame: Pre-procedure and 2 Years
Change in Rutherford Category at 3 Years
Time frame: Pre-procedure and 3 Years
Stent Fracture at 12, 24, and 36 Months
Time frame: 12, 24, and 36 months
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Oct 2023.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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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.
Peter Soukas, MD principal investigator
Miriam Hospital, Providence, RI
23 sites in 4 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Gore VIABAHN Endoprosthesis in people with Peripheral Artery Disease and Vascular Disease, run by W.L.Gore & Associates at 23 sites in 4 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 8 inclusion and 8 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 16 Oct 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 23 sites in United States, Germany, Italy, Sweden. 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 21 Aug 2020). 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?
Primary Effectiveness (time frame: 12 Months). 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?
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 16 Oct 2023.