Stent vs. Angioplasty for Treatment of Thrombosed AV Grfats: Long-Term Outcomes
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 130
- 试验地点
- 2
- 主要终点
- Primary patency of arterial-venous graft (time from initial thrombectomy to next graft intervention either: angioplasty, thrombectomy or surgical revision)
研究概览
简要总结
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.
详细描述
HYPOTHESES
- The primary patency of grafts following thrombectomy and angioplasty is limited by the high re-stenosis rate.
- Stent deployment reduces the likelihood of re-stenosis at the site of the stenotic lesion, thereby prolonging primary graft patency following thrombectomy, and decreasing or delaying the need for future interventions.
- The cost savings arising from stent deployment (decrease in subsequent access procedures) outweigh the additional cost of the stent itself.
AIMS
- To evaluate whether stent placement in thrombosed grafts with underlying stenosis at the venous anastomosis results in longer primary graft patency, as compared with angioplasty alone.
- To determine whether stent placement in thrombosed grafts with underlying stenosis at the venous anastomosis reduces the subsequent cost of access procedures in excess of the cost of the stent.
To accomplish these goals, we will conduct a randomized clinical trial of hemodialysis patients who are referred for treatment of thrombosed A-V grafts. The patients will be randomized to be treated with thrombectomy + stent deployment or thrombectomy + angioplasty. The primary outcomes will be primary (unassisted) graft patency. The secondary outcomes will be secondary (assisted) graft patency and the cumulative cost of all access-related procedures, hospitalizations, and complications.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 19 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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%
结局指标
主要结局
Primary patency of arterial-venous graft (time from initial thrombectomy to next graft intervention either: angioplasty, thrombectomy or surgical revision)
时间窗: time from initial thrombectomy to next graft intervention
次要结局
- Total cost of access procedures and access complication per year of follow-up(per year follow-up)