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Safety and Efficacy of Angiotech Vascular Wrap Paclitaxel-Eluting Mesh for Hemodialysis Vascular Access

NCT00448708 · Status: TERMINATED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 222

Last updated 2011-11-17

Study results available
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Summary

This is a multi-center clinical study in subjects requiring arteriovenous grafts in the upper extremity for hemodialysis access. All subjects will provide informed consent before undergoing any study procedures. The study will consist of multiple subject visits and telephone contacts during the 52 week study period. During the study period subjects must also maintain an appropriate hemodialysis schedule.

IDE Number: G060250

Conditions

Interventions

DEVICE

Vascular Wrap Paclitaxel-Eluting Mesh

0.9 µg/mm\^2 paclitaxel

DEVICE

Lifespan® ePTFE Vascular Graft

vascular graft

DEVICE

Lifespan® ePTFE Vascular Graft

vascular graft

Sponsors & Collaborators

  • Angiotech Pharmaceuticals

    lead INDUSTRY

Principal Investigators

  • Rui Avelar, MD · 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
2007-03-31
Primary Completion
2009-04-30
Completion
2009-04-30

Countries

  • United States

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 NCT00448708 on ClinicalTrials.gov