Recruiting

Stent vs. Angioplasty

Sponsor:

National Kidney Foundation, United States

Code:

NCT00496639

Conditions

Hyperplasia

Stenosis

Eligibility Criteria

Sex: All

Age: 19+

Healthy Volunteers: Not accepted

Interventions

angioplasty

stent placement

Study Details

Brief 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

Study ID

NCT00496639

Start date

Oct, 2006

Status verified date

May, 2008

Completion date

Dec, 2010

Anticipated

Primary completion date

Dec, 2009

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 19+

Healthy Volunteers: Not accepted

Inclusion Criteria:

  • Established dialysis patient with a recent thrombosed AV graft (less than 48 hours).
  • AV grafts can be located at the forearm, upper arm or thigh.
  • Either first or second episode of thrombosis of the AV graft.
  • Stenotic lesion at the venous anastomosis greater than 50% at time of initial intervention.

Exclusion Criteria:

  • Established ESRD patients with a recent thrombosed AV fistula.
  • Prior participation in this study.
  • Prior Stent placement at the venous anastomosis.
  • Inability to restore blood flow after mechanical thrombectomy.
  • Stenotic lesion at other venous site (i.e. venous outlet or central vessels)
  • Three or more prior mechanical thrombectomies and angioplasties of the same graft.
  • Stenotic lesion at the venous anastomosis less than 50%

Study Design

Enrollment

130 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Interventions

angioplasty

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

stent placement

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

Primary outcome measure

  • Primary patency of arterial-venous graft (time from initial thrombectomy to next graft intervention either: angioplasty, thrombectomy or surgical revision) [ Time Frame: time from initial thrombectomy to next graft intervention ]

Central Contacts and Locations

Central contacts

Ivan D Maya, MD

205-996-2186imaya@uab.edu

Michael Allon, MD

205-996-2186mallon@uab.edu

Locations

University of Alabama Hospitals

Recruiting

Birmingham, Alabama, United States, 35294

Contacts

Ivan D Maya, MD

205-996-2186imaya@uab.edu

Principal Investigator:

Ivan D Maya, MD

More Information

Sponsor

National Kidney Foundation, United States

Last update posted

May 22, 2008

Last verified

May, 2008

Keywords

  • hemodialysis
  • arterio-venous grafts
  • angioplasty
  • stents
  • mechanical thrombectomy

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by National Kidney Foundation, United States on 2008-05-22.