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临床试验/NCT05617053
NCT05617053已完成不适用

DIRECTIONAL ATHERECTOMY WITH ANTIRESTENOTIC THERAPY vs PTA/SUPERA STENTING FOR POPLITEAL ARTERY ATHEROSCLEROTIC LESIONS: A CASE-MATCH PROPENSITY STUDY

Vascular Investigation Network Spanish Society for Angiology and Vascular Surgery0 个研究点目标入组 143 人开始时间: 2016年1月1日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
143
主要终点
Primary latency 12-months

研究概览

简要总结

The purpose of this study was to compare the results of directional atherectomy with antirestenotic therapy (DAART technique) and angioplasty/Supera stenting for the treatment of popliteal atherectomy lesions.

详细描述

Atherectomy offers a way to improve the chances to avoid stent placement, although it did not show superiority in terms of vessel patency or limb salvage compared with POBA. Nevertheless, atherectomy can modify the plaque morphology and the mechanical properties of the baseline disease, which allows better drug penetration and diffusion into the vessel wall.

Moreover, the combination of directional atherectomy devices and drug coated balloons (directional atherectomy with antirestenotic therapy, DAART), theoretically might further improve the clinical outcomes of drug coated angioplasty. The "leave nothing behind" strategies have gained support among interventionalist. Many studies claim that atherectomy improves results when combined with adjunctive DCB.

The Supera stent, when compared with other self-expanding nitinol stents, has proven to deforms less with knee flexion and exhibits less strain. It mimics the natura structure and movement of the anatomy and optimizes luminal gain maintaining a round open lumen in challenging anatomies, as the popliteal artery. Mechanical scaffolding is often required owing to elastic recoil and flow-limiting dissections in complex popliteal lesions.

The purpose to this study was to retrospectively evaluate the efficacy of both techniques for endovascular treatment of atherosclerotic lesions of the popliteal artery.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Retrospective

入排标准

年龄范围
18 Years 至 99 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • patients with lifestyle limiting intermittent claudication ischemic rest pain, ischemic ulcers or gangrene (Rutherford class 3 to 6) who presented atherosclerotic lesions in the popliteal artery undergoing endovascular treatment by DAART of PTA/Supera stenting and at least a 12-months of follow-up

排除标准

  • Exclusion criteria were patients who could not receive antiplatelet or anticoagulation therapies. Other exclusion criteria were patients with aneurysm of the ipsilateral superficial femoral artery or popliteal artery, acute thrombus, unsalvageable limb, very limited life-expectancy or with doubts in their willingness or capability to allow follow-up examinations.

结局指标

主要结局

Primary latency 12-months

时间窗: 12 months

primary patency at 12-months follow-up, defined as absence of binary restenosis or reocclusion on duplex ultrasound examination without repeat target lesion interventions

次要结局

  • Amputation rate(12-months)
  • Secondary Patency(12-months)
  • Stent fracture(12-months)
  • Clinical status(12-months)
  • Mortality(12-months)
  • ABI measurement(12-months)
  • Primary-assisted patency(12-months)

研究者

发起方
Vascular Investigation Network Spanish Society for Angiology and Vascular Surgery
申办方类型
Network
责任方
Principal Investigator
主要研究者

Enrique M. San Norberto

MD, PhD, MSc, MPGCert

Vascular Investigation Network Spanish Society for Angiology and Vascular Surgery

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