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In-Stent Restenosis Post-Approval Study

NCT02542267 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 108

Last updated 2023-10-16

Study results available
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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.

Conditions

Interventions

DEVICE

Gore VIABAHN Endoprosthesis

Sponsors & Collaborators

  • W.L.Gore & Associates

    lead INDUSTRY

Principal Investigators

  • Peter Soukas, MD · Miriam Hospital, Providence, RI

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2015-09-30
Primary Completion
2019-07-31
Completion
2021-07-31

Countries

  • United States
  • Germany
  • Italy
  • Sweden

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02542267 on ClinicalTrials.gov