NCT05307263招募中不适用
Combination Therapy of Atherectomy Plus Drug-coated Balloon Versus Drug-coated Balloon for Complex Femoropopliteal Artery Disease (ARTEMIS Trial)
适应症
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 300
- 试验地点
- 1
- 主要终点
- Primary patency
研究概览
简要总结
- Prospective, multi-center, randomized, controlled comparison study
- A total of 300 subjects with complex femoropopliteal artery disease will be included according to inclusion and exclusion criteria. Complex lesions include long lesions (>150 mm), calcified lesions (PACSS grade 2-4) and in-stent lesions.
- Patients will be randomized in a 1:1 manner into atherectomy plus drug-coated balloon (DCB) or angiography-guided intervention group. • The randomization will be startified by the participating center and in-stent restenosis lesion. • For the DCB treatment, either IN.PACT (Medtronic) or Ranger (Boston Scientific) DCB will be used. • For the atherectomy, HawkOne (Medtronic), Jetstream (Boston scientific), or Rotarex (Straub Medical) will be used. • The primary endpoint is primary patency at 12 months based on Kaplan-Meier survival analysis. • Ankle-brachial index and Image study follow-up (Duplex US, CT angiography, or catheter angiography) will be performed at 1 year.
- Patients will be followed clinically for 2 years after the procedure.
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 85 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age 19 years or older
- •Symptomatic peripheral artery disease:
- •Moderate or severe claudication (Rutherford category 2 or 3)
- •Critical limb ischemia (Rutherford category 4 or 5)
- •Femoropopliteal artery disease (stenosis > 50%) with one of following complex lesion characteristics: - long lesion (>150 mm), in-stent restenosis, calcified lesion (PACCS grade 2-4)
- •Femoropopliteal artery lesions that operators consider appropriate for treatment with both atherectomy plus drug-coated balloons and drug-coated balloons alone
- •Patients with signed informed consent
排除标准
- •Acute critical limb ischemia
- •Severe critical limb ischemia (Rutherford category 6)
- •Contraindication to any of the following medications: heparin, aspirin, clopidogrel, or contrast agents due to severe hypersensitive reactions
- •Age > 85 years
- •Severe hepatic dysfunction (> 3 times normal reference values)
- •Significant thrombocytopenia, anemia, or known bleeding diathesis
- •LVEF < 35% or clinically overt congestive heart failure
- •Pregnant women or women with potential childbearing
- •Life expectancy <1 year due to comorbidity
- •Previous bypass surgery in the target femoropopliteal artery
- •Untreated inflow disease of the ipsilateral pelvic or femoropopliteal arteries (more than 50% stenosis or occlusion)
结局指标
主要结局
Primary patency
时间窗: 12 months post treatment
Primary patency is defined as absence of restenosis \>50% by Duplex ultrasound, CT angiography, or catheter-based angiography
次要结局
未报告次要终点
研究者
研究点 (1)
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