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

Sponsored by:	National Kidney Foundation
Information provided by:	National Kidney Foundation
ClinicalTrials.gov Identifier:	NCT00496639

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

MedlinePlus related topics: Angioplasty

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Safety/Efficacy Study
Official Title:	Stent vs. Angioplasty for Treatment of Thrombosed AV Grfats: Long-Term Outcomes

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:

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

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

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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:

Maya ID, Allon M. Outcomes of thrombosed arteriovenous grafts: comparison of stents vs angioplasty. Kidney Int. 2006 Mar;69(5):934-7.

Maya ID, Saddekni S, Allon M. Treatment of refractory central vein stenosis in hemodialysis patients with stents. Semin Dial. 2007 Jan-Feb;20(1):78-82.

Maya ID, Oser R, Saddekni S, Barker J, Allon M. Vascular access stenosis: comparison of arteriovenous grafts and fistulas. Am J Kidney Dis. 2004 Nov;44(5):859-65.

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

Keywords provided by National Kidney Foundation:

hemodialysis
arterio-venous grafts
angioplasty
stents
mechanical thrombectomy

Study placed in the following topic categories:

Hyperplasia
Constriction, Pathologic
Thrombosis

Additional relevant MeSH terms:

Pathologic Processes

ClinicalTrials.gov processed this record on January 16, 2009