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 Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
108
Mount Sinai Medical Center
Miami, Florida, United States
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.
Time frame: 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
Time frame: 30 Days
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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Kaiser Foundation Hospital
Honolulu, Hawaii, 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
Covenant Medical Center, Inc.
Saginaw, Michigan, United States
Munson Medical Center
Traverse City, Michigan, 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
...and 13 more locations
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 12, 24, and 36 months