In-Stent Restenosis Post-Approval Study

Peripheral Artery Disease Clinical Trial

Official title:

Post-Approval Study of the GORE® VIABAHN® Endoprosthesis for the Treatment of In-Stent Restenosis (ISR) in the Superficial Femoral Artery (SFA)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02542267
• Other study ID #: ISR 14-04
• Status: Completed
• Phase: N/A
• Start date: September 2015
• Est. completion date: July 2021

Study information

• Verified date: October 2023
• Source: W.L.Gore & Associates
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 108
• Est. completion date: July 2021
• Est. primary completion date: July 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Peripheral Arterial Disease
• Peripheral Artery Disease
• Vascular Disease
• Vascular Diseases

Intervention

Device:
• Gore VIABAHN Endoprosthesis

Locations

Country	Name	City	State
Germany	Klinikum Rosenheim	Rosenheim
Italy	Azienda Ospedaliera Santa Maria Nuova di Reggio Emilia	Reggio Emilia
Sweden	Skånes Universitetssjukhus	Malmo
United States	Charleston Area Medical Center	Charleston	West Virginia
United States	Texas Health Research - Presbyterian Heart and Vascular	Dallas	Texas
United States	St. Vincent's Consultants in Cardiovascular Disease	Erie	Pennsylvania
United States	Sanford Health	Fargo	North Dakota
United States	Greenville Hospital System	Greenville	South Carolina
United States	Kaiser Foundation Hospital	Honolulu	Hawaii
United States	Cardiovascular Institute of the South	Houma	Louisiana
United States	University of Iowa Hospitals and Clinics	Iowa City	Iowa
United States	Mount Sinai Medical Center	Miami	Florida
United States	New York Presbyterian Hospital/Weill Cornell Medical Center	New York	New York
United States	New York University Langone Medical Center	New York	New York
United States	Midwest Aortic and Vascular Institute (MAVI)	North Kansas City	Missouri
United States	Texas Health Research - Presbyterian Hospital of Plano	Plano	Texas
United States	Providence Heart Clinic	Portland	Oregon
United States	The Miriam Hospital	Providence	Rhode Island
United States	North Carolina Heart and Vascular	Raleigh	North Carolina
United States	Rockford CardioVascular Associates	Rockford	Illinois
United States	Covenant Medical Center, Inc.	Saginaw	Michigan
United States	Swedish Medical Center - Heart and Vascular Research	Seattle	Washington
United States	Munson Medical Center	Traverse City	Michigan

Sponsors (1)

Lead Sponsor	Collaborator
W.L.Gore & Associates

Countries where clinical trial is conducted

United States,  Germany,  Italy,  Sweden, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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	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
Secondary	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
Secondary	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	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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