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Stent vs. Angioplasty for Treatment of Thrombosed AV Grafts: Long-Term Outcomes

NCT00496639 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 130

Last updated 2008-05-22

No results posted yet for this study

Summary

Arteriovenous grafts are used as the vascular access in 40-50% of hemodialysis patients. Grafts are prone to recurrent stenosis (narrowing) and thrombosis (clotting). Graft clotting is usually due to a narrowing at the site where the graft joins the vein. The standard treatment is to remove the clot and angioplasty the narrowed area. The long-term outcome is not good, lasting only about 1 month. Placing a stent (a small metallic, PTFE covered, spring) at the narrowed site may keep the graft open longer. Principal investigator's preliminary research data suggest that placing a stent at the stenotic site prolongs graft patency following thrombectomy, as compared to conventional angioplasty.

This is a single-center, randomized clinical trial, in which patients with a clotted graft with underlying stenosis at the venous anastomosis of the graft will be allocated to thrombectomy + angioplasty (control group) or to thrombectomy + stent placement (study group). The primary endpoint will be primary (unassisted) graft patency. The secondary endpoints will be secondary (assisted) graft patency and overall access-related costs.

Conditions

  • Hyperplasia
  • Stenosis

Interventions

PROCEDURE

angioplasty

Balloonplasty of the stenotic lesion at the venous anastomosis of the thrombosed AV graft.

PROCEDURE

stent placement

Balloonplasty plus stent deployment at the stenotic lesion at the venous anastomosis of the thrombosed AV graft

Sponsors & Collaborators

  • National Kidney Foundation, United States

    lead OTHER

Principal Investigators

  • Ivan D Maya, MD · University of Alabama at Birmingham

  • Michael Allon, MD · University of Alabama at Birmingham

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
19 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2006-10-31
Primary Completion
2009-12-31
Completion
2010-12-31

Countries

  • United States

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 NCT00496639 on ClinicalTrials.gov