Stent vs. Angioplasty for Treatment of Thrombosed AV Grafts: Long-Term Outcomes
Status unconfirmed · Not applicable
Conditions studied: Hyperplasia, Stenosis
In brief
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.
Key facts
- Study ID
- NCT00496639
- Run by
- National Kidney Foundation, United States
- People needed
- 130
- Starts
- 2006-10-01
- Expected to finish
- 2010-12-01
- Last updated by the study team
- 2008-05-22
Who can join
Age: 19 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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.
You may not qualify if…
- 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%
Where it is running
- University of Alabama Hospitals — Birmingham, Alabama, United States (enrolling)
Full record on ClinicalTrials.gov
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