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In-Stent Restenosis Post-Approval Study

Primary Purpose

Peripheral Artery Disease, Vascular Disease

Status

Completed

Phase

Not Applicable

Locations

International

Study Type

Interventional

Intervention

Gore VIABAHN Endoprosthesis

About this trial

This is an interventional treatment trial for Peripheral Artery Disease focused on measuring Bare Metal Stent, In-Stent Restenosis

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Arms of the Study

Arm 1

Arm Type

Other

Arm Label

Gore VIABAHN Endoprosthesis

Arm Description

Gore VIABAHN Endoprosthesis deployed to treat failed non-covered stent(s) in the Superficial Femoral Artery

Outcomes

Primary Outcome Measures

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.

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

Secondary Outcome Measures

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.

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.

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.

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.

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.

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.

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.

Change in Ankle Brachial Index at 1 Year

Change in Ankle Brachial Index at 2 Years

Change in Ankle Brachial Index at 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.

Change in Rutherford Category at 1 Year

Change in Rutherford Category at 2 Years

Change in Rutherford Category at 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.

Full Information

NCT ID

NCT02542267

First Posted

August 19, 2015

Last Updated

October 10, 2023

Sponsor

W.L.Gore & Associates

1. Study Identification

Unique Protocol Identification Number

NCT02542267

Brief Title

In-Stent Restenosis Post-Approval 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)

Study Type

Interventional

2. Study Status

Record Verification Date

October 2023

Overall Recruitment Status

Completed

Study Start Date

September 2015 (undefined)

Primary Completion Date

July 2019 (Actual)

Study Completion Date

July 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

W.L.Gore & Associates

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Peripheral Artery Disease, Vascular Disease

Keywords

Bare Metal Stent, In-Stent Restenosis

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

108 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Gore VIABAHN Endoprosthesis

Arm Type

Other

Arm Description

Gore VIABAHN Endoprosthesis deployed to treat failed non-covered stent(s) in the Superficial Femoral Artery

Intervention Type

Device

Intervention Name(s)

Gore VIABAHN Endoprosthesis

Primary Outcome Measure Information:

Title

Primary Effectiveness

Description

Time Frame

12 Months

Title

Number of Subjects Free From Procedure and Device-Related Serious Adverse Events Within 30 Days of Index Procedure

Description

Primary Safety is defined as freedom from procedure and device-related serious adverse events within 30 days of index procedure

Time Frame

30 Days

Secondary Outcome Measure Information:

Title

Number of Subjects With Acute Procedural Success

Description

Time Frame

During hospitalization, approximately 1-2 days

Title

Primary Patency at 30 Days and 12, 24, and 36 Months

Description

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