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Tack Optimized Balloon Angioplasty Study of the Tack Endovascular System® in Below the Knee Arteries

NCT02942966 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 233

Last updated 2022-01-31

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 the Mid/Distal Popliteal, Tibial, and Peroneal Arteries ranging in diameter from 1.5mm to 4.5mm for the treatment of post percutaneous transluminal balloon angioplasty (PTA) dissection(s) requiring repair.

Conditions

  • Peripheral Arterial Disease

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

  • Patrick J. Geraghty, MD · Washington University School of Medicine in St. Louis

  • George Adams, MD · Rex Hospital

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2017-02-08
Primary Completion
2019-07-11
Completion
2022-01-10
FDA Device
Yes

Countries

  • United States
  • Austria
  • Czechia
  • Germany
  • Hungary
  • New Zealand

Study Locations

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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 NCT02942966 on ClinicalTrials.gov