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Tack Optimized Balloon Angioplasty Study of the Tack Endovascular System™ in Femoropoliteal Arteries

NCT02522884 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 213

Last updated 2021-04-27

Study results available
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Summary

This is a prospective, multi-center, single-arm, non-blinded study designed to investigate the safety and efficacy of the Tack Endovascular System in subjects with post-balloon angioplasty (post-PTA) dissection(s) type(s) A through F in the superficial femoral and proximal popliteal arteries ranging in diameter from 2.5mm to 6.0mm.

Conditions

Interventions

DEVICE

Tack Endovascular System

Repair of post-PTA dissections using the Intact Vascular Tack Endovascular System.

Sponsors & Collaborators

  • Philips Clinical & Medical Affairs Global

    lead INDUSTRY

Principal Investigators

  • William A. Gray, MD · Main Line Health/Lankenau Heart Institute

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
2018-05-31
Completion
2020-03-31

Countries

  • United States
  • Austria
  • Netherlands

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 NCT02522884 on ClinicalTrials.gov