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临床试验/NCT07406308
NCT07406308尚未招募1 期

A Comparative Analysis of Mid- to Long-Term Outcomes of Paclitaxel-Coated Balloon Angioplasty With Adjunctive Debulking Versus Paclitaxel-Coated Balloon Angioplasty Alone for the Treatment of Chronic Femoropopliteal Artery Occlusions

Peking Union Medical College Hospital1 个研究点 分布在 1 个国家目标入组 408 人开始时间: 2026年4月20日最近更新:
干预措施

试验速览

阶段
1 期
状态
尚未招募
入组人数
408
试验地点
1
主要终点
1-year primary patency rate

研究概览

简要总结

This study aims to compare mid-to long-term outcomes of paclitaxel-coated balloon angioplasty with adjunctive debulking versus paclitaxel-coated balloon angioplasty alone for the treatment of chronic femoropopliteal artery diseases.

详细描述

Chronic femoropopliteal artery occlusion, particularly in long lesions, remains a significant challenge in endovascular treatment of lower extremity arterial disease due to its high occlusion burden and severe vascular calcification. In recent years, with the continuous advancement of endovascular techniques and devices, especially the emergence of the "leave nothing behind" concept, Drug-Coated Balloon (DCB) angioplasty has become a mainstream approach for treating femoropopliteal occlusions. While DCB offers excellent long-term patency and preserves future treatment options, adjunctive debulking procedures-a category of techniques that physically remove or ablate plaque prior to DCB dilation to achieve a larger, smoother lumen-have gained attention. These techniques primarily include atherectomy, laser ablation, and directional atherectomy. They can address more complex lesions and offer potential benefits such as enhanced drug absorption, reduced elastic recoil, and decreased need for bailout stenting. However, they also carry risks, including distal embolism and perforation. Consequently, the comparative efficacy between DCB alone and DCB combined with debulking measures remains uncertain, and the choice of treatment strategy still largely depends on operator experience. Therefore, an in-depth investigation is necessary to compare the efficacy and safety of these two approaches to inform and guide optimal clinical decision-making.

研究设计

研究类型
Interventional
分配方式
Non Randomized
干预模型
Parallel
主要目的
Treatment
盲法
None

盲法说明

Masking Description

入排标准

年龄范围
18 Years 至 85 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Subject age 18-85yrs.
  • Subject has been informed of the nature of the study, agrees to participate, and has signed a Medical Ethics Committee approved consent form.
  • Subject understands the duration of the study, agrees to attend follow-up visits, and agrees to complete the required testing.
  • Rutherford category 2-
  • Subject has atherosclerotic de novo, non-stented restenotic, or in-stent restenotic/occlusive lesions in the superficial femoral artery (SFA) and/or popliteal artery (P1 segment).
  • Patent inflow artery with stenosis <30% by visual estimation (or by core lab assessment if available) and at least 1 infrapopliteal artery to the ankle (<50% diameter stenosis).
  • A guidewire has successfully traversed the target treatment segment.

排除标准

  • Subject presents with acute arterial embolism or thrombosis requiring thrombectomy or thrombolysis for limb ischemia.
  • Subject has arterial occlusion caused by thromboangiitis obliterans (Buerger's disease) or other forms of immune-mediated vasculitis.
  • Subject has undergone surgery on the target vessel within the past 3 months, or has experienced repeated failures of endovascular therapy and is deemed unsuitable for further endovascular intervention.
  • Subject has an uncontrolled thrombophilia or hypercoagulable state.
  • Subject has a severe systemic disease (e.g., malignancy) with a life expectancy of less than 1 year.
  • Subject has contraindications or intolerance to antiplatelet/anticoagulant medications, such as aspirin, clopidogrel, or heparin.
  • Subject is pregnant or breastfeeding.
  • Subject meets one or more of the following conditions: chronic renal insufficiency (SCr ≥ 2.5 mg/dL) or on regular dialysis; cardiovascular or cerebrovascular surgery within the past 1 month; or severe sequelae from a major stroke.
  • Subject has a known allergy to nitinol alloy, paclitaxel, or contrast agents.

研究组 & 干预措施

DCB

Active Comparator

Participants in this group will be received drug-coated balloon angioplasty

干预措施: paclitaxel-coated balloon angioplasty (Device)

DCB+DP

Experimental

Participants in this group will be received drug-coated balloon angioplasty with debulking procedures.

干预措施: paclitaxel-coated balloon angioplasty with debulking procedures (Device)

结局指标

主要结局

1-year primary patency rate

时间窗: 1 year

次要结局

  • free from clinical-driven target lesion revascularization(1 year)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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