Stent vs. Angioplasty for Treatment of Thrombosed AV Grafts: Long-Term Outcomes
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|ClinicalTrials.gov Identifier: NCT00496639|
Recruitment Status : Unknown
Verified May 2008 by National Kidney Foundation.
Recruitment status was: Recruiting
First Posted : July 4, 2007
Last Update Posted : May 22, 2008
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 or disease||Intervention/treatment||Phase|
|Hyperplasia Stenosis||Procedure: angioplasty Procedure: stent placement||Not Applicable|
Show Detailed Description
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||130 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||Stent vs. Angioplasty for Treatment of Thrombosed AV Grfats: Long-Term Outcomes|
|Study Start Date :||October 2006|
|Estimated Primary Completion Date :||December 2009|
|Estimated Study Completion Date :||December 2010|
- 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 graftOther Name: Stent deployment
- 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 ]
- Total cost of access procedures and access complication per year of follow-up [ Time Frame: per year follow-up ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00496639
|Contact: Ivan D Maya, MDemail@example.com|
|Contact: Michael Allon, MDfirstname.lastname@example.org|
|United States, Alabama|
|University of Alabama Hospitals||Recruiting|
|Birmingham, Alabama, United States, 35294|
|Contact: Ivan D Maya, MD 205-996-2186 email@example.com|
|Principal Investigator: Ivan D Maya, MD|
|Sub-Investigator: Michael Allon, MD|
|Sub-Investigator: Souheil Saddekni, MD|
|Sub-Investigator: Rachel Oser, MD|
|Principal Investigator:||Ivan D Maya, MD||University of Alabama at Birmingham|
|Study Director:||Michael Allon, MD||University of Alabama at Birmingham|