A Prospective, Multicenter, Single Arm Real-World Registry Investigating the Clinical Use and Safety of the Lutonix Drug Coated Balloon Percutaneous Transluminal Angioplasty (PTA) Catheter for Treatment of Below-the-Knee (BTK) Arteries
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 371
- 试验地点
- 26
- 主要终点
- Freedom from major adverse limb related events below the knee and of perioperative death.
研究概览
简要总结
The study will enroll patients presenting with claudication, or critical limb ischemia (Rutherford Category 3- 5) and an angiographically significant (≥ 70%) native artery lesion appropriate for angioplasty that is below the knee. Subjects will be treated with the Lutonix Drug Coated Balloon (DCB) carrying the CE Mark per current IFU and followed clinically for a minimum of 2 years.
详细描述
Patients will be treated according to hospital routine with anticipated visits 30 days, 6 months, 12months and 24 months after the index procedure. Data on Rutherford grade, wound healing, patency of the target lesion, concomitant antiplatelet medication and Adverse Events will be collected.
研究设计
- 研究类型
- Observational
- 观察模型
- Other
- 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
- •Male or non-pregnant, non-breastfeeding female ≥18 years of age;
- •Rutherford Clinical Category 3-5;
- •Patient is willing to provide informed consent, and is willing to comply with the protocol-required follow up visits and recommended medication regimen;
- •Significant stenosis (≥70%) or occlusion of one or more native artery(s) below the tibial plateau and above the tibiotalar joint appropriate for angioplasty per operator visual assessment;
- •Lesion(s) can be treated with available Lutonix DCB device size matrix per current Instructions for Use (IFU); and
- •Target vessel(s) reconstitute(s) at or above the ankle with inline flow to at least one patent (<50% residual stenosis) inframalleolar outflow vessel (planned treatment below-the-ankle is not allowed).
- •NOTE: Outflow must be assessed AFTER pre-dilatation NOTE: More than one artery allowed, but each target vessel MUST demonstrate inline inframalleolar outflow.
排除标准
- •Patients will be excluded if ANY of the following conditions apply:
- •Patient is currently participating in an investigational drug or device study which has not yet reached its primary endpoint or was previously enrolled into this registry (i.e. Lutonix BTK registry);
- •Inability to take recommended medications as stated in the IFU or non-controllable allergy to contrast; or
- •Neurotrophic ulcer or heel pressure ulcer or ulcer potentially involving calcaneus (index limb).
结局指标
主要结局
Freedom from major adverse limb related events below the knee and of perioperative death.
时间窗: 30-days
Freedom from the composite of all-cause death, above-ankle amputation or major reintervention, i.e. new bypass graft, jump/interposition graft revision, or thrombectomy/thrombolysis, of the index limb involving a below-the-knee artery. All these events will be adjudicated by a Clinical Events Committee.
Rate of Target Lesion Revascularization (TLR)
时间窗: 6 months
Defined as clinically-driven target lesion reintervention. All re-interventions at the target limb are captured and adjudicated by a Clinical Events Committee.
次要结局
- Primary patency of the target lesion(6, 12 and 24 months)
- Freedom from clinically-driven Target Lesion Revascularization (TLR)(12 and 24 months)
- Rate of amputations above the ankle at the target limb(1, 6, 12 and 24 months)
- Rate of Target vessel reintervention (TVR)(1, 6, 12 and 24 months)
- Rate of unexpected device or drug-related adverse events(1, 6, 12 and 24 months)
- Rate of reintervention for treatment of thrombosis of the target vessel(s)(1, 6, 12 and 24 months)
- Rate of reintervention for embolization to its distal vasculature(1, 6, 12 and 24 months)
- Rate of death(1, 6, 12 and 24 months)
- Status of ischemic wounds at the target limb(6 and 12 months)
- Rate of new or recurrent artery lesions at the target limb(6 and 12 months)
- Change in Rutherford Class at the target limb(6 and 12 months)