Infrapopliteal Drug Eluting Angioplasty Versus Stenting for the Treatment of Long-segment Arterial Disease: The IDEAS-I Randomized Controlled Trial.
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 50
- 试验地点
- 2
- 主要终点
- Angiographic Binary Restenosis
研究概览
简要总结
In total 50 patients diagnosed with long-segment infrapopliteal arterial disease will be randomized in two groups. The patients randomized in the Drug coated balloons (DCB) study arm will undergo a percutaneous transluminal angioplasty (PTA) with the use of a paclitaxel-coated balloon, while the patients randomized in the drug-eluting stent (DES) study arm will undergo primary stenting using drug-eluting stent(s). The study's primary endpoints will be the 6-month angiographic binary restenosis rate. Secondary endpoints will include the immediate technical success,6-month primary patency, target lesion revascularization and limb salvage and complication rates.
详细描述
Patients programmed to undergo PTA due to angiographically-proven infrapopliteal arterial disease in our department will be randomized in the above mentioned study arms. The studies primary endpoint will be assessed with the use of intra-arterial digital subtracted angiography and subsequent Quantitative Vascular Analysis (QVA) analysis.Clinical follow-up is set at 1, 3 and 6 months. Patients' baseline demographics and procedural details will be recorded and analyzed.
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
- Single (Participant)
入排标准
- 年龄范围
- 18 Years 至 90 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Angiographically documented infrapopliteal disease.
- •Rutherford category of peripheral arterial disease between class 3 to 6
- •Lesion length between 70 to 220 mm
- •Lesions situated in the proximal, mid and mid to distal segments of the tibial vessels.
排除标准
- •Lesion length < 70 mm or > 220 mm.
- •Lesions situated in the distal third of the tibial vessels
研究组 & 干预措施
Drug Coated Balloon (DCB) Arm
Patients included in this arm will undergo PTA with the use of a paclitaxel coated balloon.
干预措施: Paclitaxel coated balloon angioplasty. (Procedure)
Drug Eluting Stents (DES) Arm
Patients in this arm will undergo primary infrapopliteal stenting of the target lesion using a drug-eluting stent.
干预措施: Infrapopliteal Primary Drug Eluting Stenting (Procedure)
结局指标
主要结局
Angiographic Binary Restenosis
时间窗: 6 months
Angiographic binary restenosis of the target lesion defined by quantitative vessel analysis at 6 months follow-up
次要结局
- Procedure related complication rates(up to 30 days)
- Limb salvage(6 months)
- Technical success rate(intra-procedural)
- Angiographic Primary Patency(6 months)
- Target lesion revascularization(6 months)
研究者
SIABLIS DIMITRIOS
Professor of RAdiology
University of Patras