The LegDeb2 Global Registry for the Treatment of Superficial Femoral, Popliteal or Below-The-Knee Artery Lesions Using the Legflow DrugEluting Balloon
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 512
- 试验地点
- 7
- 主要终点
- Efficacy: Freedom from Clinically driven TLR
研究概览
简要总结
LEGDEB2 is a Global Registry for the Treatment of Superficial Femoral and/or Popliteal or Below-The-Knee or Iliac Artery Lesions Using the Legflow Drug-Eluting Balloon
详细描述
LEGDEB2 is a Global Registry aimed to prospectively collect and assess global safety and efficacy data on the Legflow Drug Eluting Balloon (DEB) in treatment of atherosclerotic disease of the superficial femoral and/or popliteal and/or below-the-knee and/or iliac arteries in "real world" patient population.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age ≥ 18 years or minimum age as required by local regulations.
- •Subject with documented diagnosis of lower extremities arterial disease (LEAD).
- •Angiographically documented single or multiple lesions/occlusions (de novo or re-stenotic lesion(s) or in-stent restenosis within the target vessels with a minimum lesion length of 2 cm including bilateral disease if both limbs are treated within 35 days.
- •Positive diagnostic indication for PTA with a DEB in accordance with the Instructions For Use (IFU) of the Legflow DEB.
- •Adequate distal run-off to the ankle (at least one native calf vessel [posterior tibial, anterior tibial, or peroneal arteries] is patent, defined as ≤ 50% diameter stenosis) either pre-existing or successfully re- established prior to target lesion treatment.
- •Adequate inflow (≤ 50% diameter stenosis) either pre-existing or successfully re-established prior to target lesion treatment.
- •Female subjects of childbearing potential must have a negative pregnancy test ≤ 7 days before enrollment.
- •Signed and dated Patient Informed Consent (PIC) form.
- •Ability and willingness to comply with the clinical investigation plan (CIP).
- •Life expectancy, in the Investigator's opinion, of at least 12 months
排除标准
- •High probability of non-adherence to CIP follow-up requirements.
- •Failure to successfully cross the target lesion with a guide wire (successful crossing means tip of the guide wire distal to the target lesion in the absence of flow limiting dissections or perforations).
- •Lesion within or adjacent to an aneurysm or presence of a popliteal aneurysm.
- •Acute or sub-acute thrombus in the target vessel.
- •Target lesion also requires treatment with alternative drug eluting technology-based therapy or other antiproliferative therapy (cryoplasty, brachytherapy).
- •Plan for surgical or interventional procedure within 30 days after the study procedure (except for bilateral target limb treatment).
- •Known allergies or sensitivities to heparin, aspirin, other anti- coagulant/anti-platelet therapies, and/or paclitaxel.
结局指标
主要结局
Efficacy: Freedom from Clinically driven TLR
时间窗: 12 Months
Freedom from clinically-driven target lesion revascularization (TLR) within 12 months post-index procedure, which is defined as: * Any re-intervention within the target lesion(s) due to symptoms
Safety: Freedom from MAE
时间窗: 30 days
A composite of freedom from device- and procedure-related mortality through 30 days, freedom from device or procedure related mortality, freedom from any cardiac or cardiovascular death, freedom from major target limb amputation
次要结局
- Freedom from MALE and MACCE(30 days, 6 Months, 12 Months, 24 Months, 36 Months)
- Freedom from all cause mortality(30 days, 6 Months, 12 Months, 24 Months, 36 Months)
- Freedom from CD-TVR(6 Months, 12 Months, 24 Months, 36 Months)
- Freedom from Major target limb amputation(30 days, 6 Months, 12 Months, 24 Months, 36 Months)
- Procedural Success(Day 1)
- Freedom from CD-TLR(24 Months, 36 Months)
- Device Success(Day 1)
- Clinical Success(Day 1)
- Primary sustained clinical improvement(6 Months, 12 Months, 24 Months, 36 Months)
研究者
Eugenio Stabile
Associate Professor of Cardiovascular Medicine
Federico II University