MedTrace Logo

Clinical Study of the BARD® COVERA™ Arteriovenous (AV) Stent Graft

NCT02649946 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 280

Last updated 2021-12-21

Study results available
· View outcomes & findings →

Summary

The objective of this study is to assess the safety and effectiveness of the COVERA™ Vascular Covered Stent for the treatment of stenotic lesions in the upper extremity venous outflow of the Arteriovenous (AV) access circuit.

Conditions

  • Stenosis
  • Restenosis

Interventions

DEVICE

Covera Vascular Covered Stent following PTA

Treatment of stenoses with primary percutaneous transluminal angioplasty (PTA) and placement of the Covera Vascular Covered Stent.

PROCEDURE

Percutaneous Transluminal Angioplasty (PTA) with Uncoated PTA Balloon

Treatment of stenoses with PTA only

Sponsors & Collaborators

  • C. R. Bard

    lead INDUSTRY

Principal Investigators

  • Bart Dolmatch, M.D. · The Palo Alto Medical Foundation

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
21 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2016-06-30
Primary Completion
2018-08-31
Completion
2021-02-28

Countries

  • United States
  • Australia
  • Austria
  • Belgium
  • Germany
  • Netherlands
  • New Zealand
  • Switzerland

Study Locations

More Related Trials

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 NCT02649946 on ClinicalTrials.gov