In-Stent Restenosis Post-Approval Study
- Conditions
- Peripheral Artery DiseaseVascular Disease
- Interventions
- Device: Gore VIABAHN Endoprosthesis
- Registration Number
- NCT02542267
- Lead Sponsor
- W.L.Gore & Associates
- Brief 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 108
- 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
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Gore VIABAHN Endoprosthesis Gore VIABAHN Endoprosthesis Gore VIABAHN Endoprosthesis deployed to treat failed non-covered stent(s) in the Superficial Femoral Artery
- Primary Outcome Measures
Name Time Method Number of Subjects Free From Procedure and Device-Related Serious Adverse Events Within 30 Days of Index Procedure 30 Days Primary Safety is defined as freedom from procedure and device-related serious adverse events within 30 days of index procedure
Primary Effectiveness 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.
- Secondary Outcome Measures
Name Time Method Change in Ankle Brachial Index at 30 Days Pre-procedure and 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.
Primary Patency at 30 Days and 12, 24, and 36 Months 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.
Change in Rutherford Category at 30 Days Pre-procedure and 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.
Number of Subjects With Acute Procedural Success During hospitalization, approximately 1-2 days 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.
Change in Rutherford Category at 2 Years Pre-procedure and 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.
Change in Rutherford Category at 3 Years Pre-procedure and 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.
Primary Assisted Patency at 30 Days and 12, 24, and 36 Months 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.
Freedom From Target Lesion Revascularization at 30 Days and 12, 24, and 36 Months 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.
Change in Ankle Brachial Index at 1 Year Pre-procedure and 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.
Secondary Patency at 30 Days and 12, 24, and 36 Months 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.
Freedom From Major Amputation at 30 Days and 12, 24, and 36 Months 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.
Change in Ankle Brachial Index at 2 Years Pre-procedure and 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.
Change in Ankle Brachial Index at 3 Years Pre-procedure and 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.
Change in Rutherford Category at 1 Year Pre-procedure and 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.
Stent Fracture at 12, 24, and 36 Months 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.
Trial Locations
- Locations (23)
Munson Medical Center
🇺🇸Traverse City, Michigan, United States
North Carolina Heart and Vascular
🇺🇸Raleigh, North Carolina, United States
Sanford Health
🇺🇸Fargo, North Dakota, United States
Covenant Medical Center, Inc.
🇺🇸Saginaw, Michigan, United States
Rockford CardioVascular Associates
🇺🇸Rockford, Illinois, United States
University of Iowa Hospitals and Clinics
🇺🇸Iowa City, Iowa, United States
Cardiovascular Institute of the South
🇺🇸Houma, Louisiana, United States
Texas Health Research - Presbyterian Heart and Vascular
🇺🇸Dallas, Texas, United States
Texas Health Research - Presbyterian Hospital of Plano
🇺🇸Plano, Texas, United States
Midwest Aortic and Vascular Institute (MAVI)
🇺🇸North Kansas City, Missouri, United States
New York University Langone Medical Center
🇺🇸New York, New York, United States
New York Presbyterian Hospital/Weill Cornell Medical Center
🇺🇸New York, New York, United States
St. Vincent's Consultants in Cardiovascular Disease
🇺🇸Erie, Pennsylvania, United States
Greenville Hospital System
🇺🇸Greenville, South Carolina, United States
The Miriam Hospital
🇺🇸Providence, Rhode Island, United States
Azienda Ospedaliera Santa Maria Nuova di Reggio Emilia
🇮🇹Reggio Emilia, Italy
Skånes Universitetssjukhus
🇸🇪Malmo, Sweden
Klinikum Rosenheim
🇩🇪Rosenheim, Germany
Charleston Area Medical Center
🇺🇸Charleston, West Virginia, United States
Mount Sinai Medical Center
🇺🇸Miami, Florida, United States
Kaiser Foundation Hospital
🇺🇸Honolulu, Hawaii, United States
Swedish Medical Center - Heart and Vascular Research
🇺🇸Seattle, Washington, United States
Providence Heart Clinic
🇺🇸Portland, Oregon, United States