Stent vs. Angioplasty for Treatment of Thrombosed AV Grafts: Long-Term Outcomes (NCT00496639) | Clinical Trial Compass
UnknownNot Applicable
Stent vs. Angioplasty for Treatment of Thrombosed AV Grafts: Long-Term Outcomes
United States130 participantsStarted 2006-10
Plain-language 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.
Who can participate
Age range
19 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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%
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Primary patency of arterial-venous graft (time from initial thrombectomy to next graft intervention either: angioplasty, thrombectomy or surgical revision)
Timeframe: time from initial thrombectomy to next graft intervention