MedTrace Logo

Safety Study of the Vascular Wrap Paclitaxel-Eluting Mesh for Hemodialysis Vascular Access

NCT01033357 · Status: TERMINATED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 222

Last updated 2013-02-11

No results posted yet for this study

Summary

The purpose of this study is to determine whether the long term use of the experimental Vascular Wrap(TM) Paclitaxel-Eluting Mesh is safe in the treatment of subjects needing hemodialysis access (via an expanded polytetrafluoroethylene (ePTFE) graft).

Conditions

  • End Stage Renal Failure on Dialysis
  • Hyperplasia

Interventions

DEVICE

Graft, Vascular Wrap

Lifespan® ePTFE Vascular Graft and Vascular Wrap Paclitaxel-Eluting Mesh (0.9 µg/mm2 paclitaxel)

DEVICE

Lifespan® ePTFE Vascular Graft Only

Vascular Graft only

Sponsors & Collaborators

  • Angiotech Pharmaceuticals

    lead INDUSTRY

Principal Investigators

  • Rui Avelar, M.D. · Angiotech Pharmaceuticals

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2008-03-31
Primary Completion
2010-03-31
Completion
2010-10-31

Countries

  • United States

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 NCT01033357 on ClinicalTrials.gov