All Comers Post Market Clinical Follow-up to Continue the Surveillance of the Acotec Drug Coated PTA Catheter Orchid, Tulip and Litos in Lower Limb Treatment
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 3,000
- 试验地点
- 6
- 主要终点
- Primary efficacy endpoint -CLI group
研究概览
简要总结
All-comers, prospective, multi-center, single-arm, non-interventional post market clinical follow-up (PMCF) Cohort 1 - Claudicants: Rutherford Clinical Category (RCC) 2-3 Cohort 2 - Critical Limb Ischemia: Rutherford Clinical Category (RCC) 4-6
详细描述
To prospectively collect and assess safety and efficacy data on the AcoArt drug-coated PTA balloon catheters carrying the CE Mark per current Instructions for Use in a real-world cohort of patients with symptomatic arterial disease undergoing endovascular lower limb revascularization per the institution's standard practice.
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
- •Patient is ≥ 18 years old at the time of consent.
- •Significant stenosis (≥70%) or occlusions of de-novo or restenotic lesion(s) located in iliac, superficial femoral, popliteal and/or infra-popliteal arteries suitable for angioplasty per operator visual assessment.
- •Lesion(s) can be treated with available AcoArt Orchid (0.035"), AcoArt Tulip (0.018") and AcoArt Litos (0.014") DCB device per current IFU.
- •Subject has provided written informed consent prior to participation in the PMCF, understands the purpose of this PMCF and agrees to comply with all protocol-specified examinations and follow-up appointments.
- •Rutherford Classification Category 2-6 Subjects with Rutherford Category 2 have gone through a conservative therapy without success.
- •Inflow lesion treated prior to target lesion treatment
排除标准
- •Rutherford Classification Category 0, 1
- •Patient already enrolled in other investigational (interventional) studies that would interfere with study endpoints
- •Inability to tolerate required antithrombotic or antiplatelet therapies.
- •Non-dilatable severely calcified lesion.
- •Known hypersensitivity/allergy to components of the investigational device
- •Un-treated acute or subacute thrombus in the target lesion.
- •Life expectancy < 1 year.
- •Pregnancy or female patient with child bearing potential not taking adequate contraceptives or currently lactating.
- •Other comorbidities, which in the opinion of the investigator limit longevity or likelihood of compliance with protocol follow up.
- •Myocardial infarction or stroke within 30 days prior to index procedure.
结局指标
主要结局
Primary efficacy endpoint -CLI group
时间窗: 6 Months
Freedom from clinically-driven TLR within 6 months after index procedure, which is defined as any re-intervention within the target lesion(s) due to delayed or worsening wound healing, new or recurrent wound, or worsening Rutherford class.
Primary safety endpoint- non-CLI group
时间窗: 30 days
A composite of freedom from major adverse limb events and perioperative death (MALE-POD) through 30 days after index procedure. A major adverse limb event is defined as above-ankle amputation or major reintervention (ie, new bypass graft, major surgical graft revision such as a jump graft or an interposition graft, or thrombectomy/thrombolysis) of the treated limb.
Primary efficacy endpoint - non-CLI group
时间窗: 12 Months
Freedom from clinically-driven target lesion revascularization (CD-TLR) within 12 months after index procedure, which is defined as any re-intervention within the target lesion(s) due to recurrent clinical symptoms of PAD (increase of one Rutherford class or more) and/or drop of ankle-brachial index (≥20% or \>0.15 when compared with maximum early post-procedural level).
Primary safety endpoint- CLI group
时间窗: 12 Months
A composite of freedom from device- and procedure-related mortality, freedom from major target limb amputation and TLR within 12 months post-index procedure
次要结局
- Rate of (Major) Amputation-free survival - CLI group(6 months,12 months,24 months, 36months,48 months,60 months)
- Rate of CD-TLR(6 months,12 months,24 months, 36months,48 months,60 months)
- Rate of All-cause mortality(6 months,12 months,24 months, 36months,48 months,60months)
- Rate of Major amputation(6 months,12 months,24 months, 36months,48 months,60 months)
- Rate of Wound healing - CLI group(60 months)
- Rate of Target vessel revascularization (TVR)(6 months,12 months,24 months, 36months,48 months,60 months)
- Rate of Target limb revascularization(6 months,12 months,24 months, 36months,48 months,60 months)
- Rate of Any TLR (including clinically-driven and incidental TLR)(6 months,12 months,24 months, 36months,48 months,60 months)
- Rate of Procedural success(Post procedure)
- Rate of primary sustained clinical improvement(6 months,12 months,24 months, 36months,48 months,60 months)
- Rate of Device- or procedure-related death(30 days, 6 months)
- Rate of Technical success(Post procedure)
- Change in Rutherford clinical category (target limb)(6 months,12 months,24 months, 36months,48 months,60 months)
- Rate of secondary sustained clinical improvement(6 months,12 months,24 months, 36months,48 months,60 months)
- Rate of Minor amputation - CLI group(6 months,12 months,24 months, 36months,48 months,60 months)
- New or recurrent wound of the target limb - CLI group(60 months)