In-Stent Restenosis Post-Approval Study

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.

Study Overview

• Status: Completed
• Conditions: Peripheral Artery Disease; Vascular Disease
• Intervention / Treatment: Device: Gore VIABAHN Endoprosthesis

• Study Type: Interventional
• Enrollment (Actual): 108
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Germany
  • Rosenheim, Germany
    • Klinikum Rosenheim
• Italy
  • Reggio Emilia, Italy
    • Azienda Ospedaliera Santa Maria Nuova di Reggio Emilia
• Sweden
  • Malmo, Sweden
    • Skånes universitetssjukhus
• United States
  • Florida
    • Miami, Florida, United States, 33140
      • Mount Sinai Medical Center
  • Hawaii
    • Honolulu, Hawaii, United States, 96819
      • Kaiser Foundation Hospital
  • Illinois
    • Rockford, Illinois, United States, 61107
      • Rockford CardioVascular Associates
  • Iowa
    • Iowa City, Iowa, United States, 52242
      • University of Iowa Hospitals and Clinics
  • Louisiana
    • Houma, Louisiana, United States, 70360
      • Cardiovascular Institute of the South
  • Michigan
    • Saginaw, Michigan, United States, 48602
      • Covenant Medical Center, INC.
    • Traverse City, Michigan, United States, 49684
      • Munson Medical Center
  • Missouri
    • North Kansas City, Missouri, United States, 64116
      • Midwest Aortic and Vascular Institute (MAVI)
  • New York
    • New York, New York, United States, 10016
      • New York University Langone Medical Center
    • New York, New York, United States, 10065
      • New York Presbyterian Hospital/Weill Cornell Medical Center
  • North Carolina
    • Raleigh, North Carolina, United States, 27607
      • North Carolina Heart and Vascular
  • North Dakota
    • Fargo, North Dakota, United States, 58122
      • Sanford Health
  • Oregon
    • Portland, Oregon, United States, 97225
      • Providence Heart Clinic
  • Pennsylvania
    • Erie, Pennsylvania, United States, 16502
      • St. Vincent's Consultants in Cardiovascular Disease
  • Rhode Island
    • Providence, Rhode Island, United States, 02906
      • The Miriam Hospital
  • South Carolina
    • Greenville, South Carolina, United States, 29615
      • Greenville Hospital System
  • Texas
    • Dallas, Texas, United States, 75231
      • Texas Health Research - Presbyterian Heart and Vascular
    • Plano, Texas, United States, 75093
      • Texas Health Research - Presbyterian Hospital of Plano
  • Washington
    • Seattle, Washington, United States, 98122
      • Swedish Medical Center - Heart and Vascular Research
  • West Virginia
    • Charleston, West Virginia, United States, 25304
      • Charleston Area Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• 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

Exclusion Criteria:

• 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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: Gore VIABAHN Endoprosthesis; Gore VIABAHN Endoprosthesis deployed to treat failed non-covered stent(s) in the Superficial Femoral Artery	Device: Gore VIABAHN Endoprosthesis

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	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	30 Days

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	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.	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.	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.	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.	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.	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.	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.	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.	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.	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.	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.	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.	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.	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.	12, 24, and 36 months

Collaborators and Investigators

• Sponsor: W.L.Gore & Associates
• Investigators: Principal Investigator: Peter Soukas, MD, Miriam Hospital, Providence, RI

Study record dates

Study Major Dates

• Study Start: September 1, 2015
• Primary Completion (Actual): July 1, 2019
• Study Completion (Actual): July 1, 2021

Study Registration Dates

• First Submitted: August 19, 2015
• First Submitted That Met QC Criteria: September 3, 2015
• First Posted (Estimated): September 4, 2015

Study Record Updates

• Last Update Posted (Actual): October 16, 2023
• Last Update Submitted That Met QC Criteria: October 10, 2023
• Last Verified: October 1, 2023

More Information

Terms related to this study

• Keywords: Bare Metal Stent; In-Stent Restenosis
• Additional Relevant MeSH Terms: Cardiovascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Atherosclerosis; Peripheral Vascular Diseases; Vascular Diseases; Peripheral Arterial Disease
• Other Study ID Numbers: ISR 14-04