NCT02542267

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.

Trial Health

90
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
108

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Sep 2015

Longer than P75 for not_applicable

Geographic Reach
4 countries

23 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

August 19, 2015

Completed
13 days until next milestone

Study Start

First participant enrolled

September 1, 2015

Completed
3 days until next milestone

First Posted

Study publicly available on registry

September 4, 2015

Completed
3.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2019

Completed
1.1 years until next milestone

Results Posted

Study results publicly available

August 21, 2020

Completed
10 months until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2021

Completed
Last Updated

October 16, 2023

Status Verified

October 1, 2023

Enrollment Period

3.8 years

First QC Date

August 19, 2015

Results QC Date

July 15, 2020

Last Update Submit

October 10, 2023

Conditions

Peripheral Artery DiseaseVascular Disease

Keywords

Bare Metal StentIn-Stent Restenosis

Outcome Measures

Primary Outcomes (2)

  • 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 Outcomes (15)

  • Number of Subjects With Acute Procedural Success

    During hospitalization, approximately 1-2 days

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

    30 days and 12, 24, and 36 months

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

    30 days and 12, 24, and 36 months

  • Secondary Patency at 30 Days and 12, 24, and 36 Months

    30 days and 12, 24, and 36 months

  • Freedom From Target Lesion Revascularization at 30 Days and 12, 24, and 36 Months

    30 days and 12, 24, and 36 months

  • +10 more secondary outcomes

Study Arms (1)

Gore VIABAHN Endoprosthesis

OTHER

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

Device: Gore VIABAHN Endoprosthesis

Interventions

Gore VIABAHN EndoprosthesisDEVICE
Gore VIABAHN Endoprosthesis

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (23)

Mount Sinai Medical Center

Miami, Florida, 33140, United States

Location

Kaiser Foundation Hospital

Honolulu, Hawaii, 96819, United States

Location

Rockford CardioVascular Associates

Rockford, Illinois, 61107, United States

Location

University of Iowa Hospitals and Clinics

Iowa City, Iowa, 52242, United States

Location

Cardiovascular Institute of the South

Houma, Louisiana, 70360, United States

Location

Covenant Medical Center, Inc.

Saginaw, Michigan, 48602, United States

Location

Munson Medical Center

Traverse City, Michigan, 49684, United States

Location

Midwest Aortic and Vascular Institute (MAVI)

North Kansas City, Missouri, 64116, United States

Location

New York University Langone Medical Center

New York, New York, 10016, United States

Location

New York Presbyterian Hospital/Weill Cornell Medical Center

New York, New York, 10065, United States

Location

North Carolina Heart and Vascular

Raleigh, North Carolina, 27607, United States

Location

Sanford Health

Fargo, North Dakota, 58122, United States

Location

Providence Heart Clinic

Portland, Oregon, 97225, United States

Location

St. Vincent's Consultants in Cardiovascular Disease

Erie, Pennsylvania, 16502, United States

Location

The Miriam Hospital

Providence, Rhode Island, 02906, United States

Location

Greenville Hospital System

Greenville, South Carolina, 29615, United States

Location

Texas Health Research - Presbyterian Heart and Vascular

Dallas, Texas, 75231, United States

Location

Texas Health Research - Presbyterian Hospital of Plano

Plano, Texas, 75093, United States

Location

Swedish Medical Center - Heart and Vascular Research

Seattle, Washington, 98122, United States

Location

Charleston Area Medical Center

Charleston, West Virginia, 25304, United States

Location

Klinikum Rosenheim

Rosenheim, Germany

Location

Azienda Ospedaliera Santa Maria Nuova di Reggio Emilia

Reggio Emilia, Italy

Location

Skånes Universitetssjukhus

Malmo, Sweden

Location

MeSH Terms

Conditions

Peripheral Arterial DiseaseVascular Diseases

Condition Hierarchy (Ancestors)

AtherosclerosisArteriosclerosisArterial Occlusive DiseasesCardiovascular DiseasesPeripheral Vascular Diseases

Results Point of Contact

Title
Eric Novak
Organization
W. L. Gore & Associates
enovak@wlgore.com
314-440-2119

Study Officials

  • Peter Soukas, MD

    Miriam Hospital, Providence, RI

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restriction Type
OTHER
Restrictive Agreement
Yes

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 19, 2015

First Posted

September 4, 2015

Study Start

September 1, 2015

Primary Completion

July 1, 2019

Study Completion

July 1, 2021

Last Updated

October 16, 2023

Results First Posted

August 21, 2020

Record last verified: 2023-10

Locations

IT(1)DE(1)US(20)SE(1)