In-Stent Restenosis Post-Approval Study

October 10, 2023 updated by: W.L.Gore & Associates

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

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
108

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

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

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Primary Effectiveness
Time Frame: 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.
12 Months
Number of Subjects Free From Procedure and Device-Related Serious Adverse Events Within 30 Days of Index Procedure
Time Frame: 30 Days
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

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Number of Subjects With Acute Procedural Success
Time Frame: 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.
During hospitalization, approximately 1-2 days
Primary Patency at 30 Days and 12, 24, and 36 Months
Time Frame: 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
Time Frame: 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
Time Frame: 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
Time Frame: 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
Time Frame: 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
Time Frame: 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.
Pre-procedure and 30 Days
Change in Ankle Brachial Index at 1 Year
Time Frame: 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.
Pre-procedure and 1 Year
Change in Ankle Brachial Index at 2 Years
Time Frame: 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.
Pre-procedure and 2 Years
Change in Ankle Brachial Index at 3 Years
Time Frame: 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.
Pre-procedure and 3 Years
Change in Rutherford Category at 30 Days
Time Frame: 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.
Pre-procedure and 30 Days
Change in Rutherford Category at 1 Year
Time Frame: 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.
Pre-procedure and 1 Year
Change in Rutherford Category at 2 Years
Time Frame: 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.
Pre-procedure and 2 Years
Change in Rutherford Category at 3 Years
Time Frame: 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.
Pre-procedure and 3 Years
Stent Fracture at 12, 24, and 36 Months
Time Frame: 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

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
W.L.Gore & Associates

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Peter Soukas, MD, Miriam Hospital, Providence, RI

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
September 1, 2015

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
July 1, 2019

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
July 1, 2021

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
August 19, 2015

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
September 3, 2015

First Posted (Estimated)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
September 4, 2015

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
October 16, 2023

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
October 10, 2023

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
October 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • ISR 14-04

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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