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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified May 2008 by National Kidney Foundation.
Recruitment status was  Recruiting
Sponsor:
Information provided by:
National Kidney Foundation
ClinicalTrials.gov Identifier:
NCT00496639
First received: July 3, 2007
Last updated: May 21, 2008
Last verified: May 2008
History of Changes
  Purpose

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.


Condition Intervention
Hyperplasia
Stenosis
 Procedure: angioplasty
Procedure: stent placement

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Stent vs. Angioplasty for Treatment of Thrombosed AV Grfats: Long-Term Outcomes

Resource links provided by NLM:

MedlinePlus related topics: Angioplasty
U.S. FDA Resources

Further study details as provided by National Kidney Foundation:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Total cost of access procedures and access complication per year of follow-up [ Time Frame: per year follow-up ] [ Designated as safety issue: No ]

Estimated Enrollment: 130
Study Start Date: October 2006
Estimated Study Completion Date: December 2010
Estimated Primary Completion Date: December 2009 (Final data collection date for primary outcome measure)
Intervention Details:
    Procedure: angioplasty
    Balloonplasty of the stenotic lesion at the venous anastomosis of the thrombosed AV graft.
    Other Name: angioplasty
    Procedure: stent placement
    Balloonplasty plus stent deployment at the stenotic lesion at the venous anastomosis of the thrombosed AV graft
    Other Name: Stent deployment
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  Eligibility

Ages Eligible for Study:   19 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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%
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00496639

Contacts
Contact: Ivan D Maya, MD 205-996-2186 imaya@uab.edu
Contact: Michael Allon, MD 205-996-2186 mallon@uab.edu

Locations
United States, Alabama
University of Alabama Hospitals Recruiting
Birmingham, Alabama, United States, 35294
Contact: Ivan D Maya, MD     205-996-2186     imaya@uab.edu    
Principal Investigator: Ivan D Maya, MD            
Sub-Investigator: Michael Allon, MD            
Sub-Investigator: Souheil Saddekni, MD            
Sub-Investigator: Rachel Oser, MD            
Sponsors and Collaborators
National Kidney Foundation
Investigators
Principal Investigator: Ivan D Maya, MD University of Alabama at Birmingham
Study Director: Michael Allon, MD University of Alabama at Birmingham
  More Information

Publications:

Responsible Party: Dolph Chianchiano, JD, MPA., National Kidney Foundation
ClinicalTrials.gov Identifier: NCT00496639     History of Changes
Other Study ID Numbers: YIG482
Study First Received: July 3, 2007
Last Updated: May 21, 2008
Health Authority: United States: Institutional Review Board

Keywords provided by National Kidney Foundation:
hemodialysis
arterio-venous grafts
angioplasty
stents
mechanical thrombectomy

Additional relevant MeSH terms:
Constriction, Pathologic
Hyperplasia
Thrombosis
Pathological Conditions, Anatomical
 Pathologic Processes
Embolism and Thrombosis
Vascular Diseases
Cardiovascular Diseases

ClinicalTrials.gov processed this record on May 16, 2013