Observational, Prospective, Single-arm Multicentric Study of Shockwave ®S4 Catheter IVL (Intravascular Lithotripsy) Balloon for the Treatment of Infrapopliteal Calcified Stenoses and/or Occlusions in Patients With Critical Limb Ischaemia
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 发起方
- 入组人数
- 9
- 试验地点
- 6
- 主要终点
- Composite of Acute Gain Index and freedom from clinically driven target lesion revascularization (CD-TLR) through 6 months post procedure
研究概览
简要总结
The study will evaluate the safety and efficacy of Peripheral Intravascular Lithotripsy system with Shockwave S4 catheter® for the treatment of de novo, re-stenosis or re-occlusive,calcified chronic total occlusion (CTOs) lesions in patients with Critical Limb Threatening Ischemia (CLTI).
详细描述
The present study is designed as a multicentre, prospective, single-arm, observational study.
All eligible subjects for undergoing intervention with Shockwave S4 catheter® Peripheral Intravascular Lithotripsy (IVL) at sites participating in the study will be considered for enrolment and will be asked to give consent prior to participating.
Subjects will be considered enrolled in the study at the time written informed consent is given to the use of their personal data. Once patients are enrolled, their demographics, medical history, disease-relevant conditions, treatment details and outcomes will be collected for up to 12 months from the procedure.
The study will collect information about the medical care patients receive during their planned procedure. No additional testing or procedures will be done.
The procedure with Shockwave S4 catheter® Peripheral Intravascular Lithotripsy (IVL) will be performed as per the current instructions for use.
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
- •Patient has signed an approved informed consent form
- •Patient with Critical Limb Ischaemia, Rutherford category 4 (ischaemic rest pain), 5(minor tissue loss) or 6 (major tissue loss)
- •Patient with Stenotic (>50% luminal loss) or occluded infrapopliteal artery, including the tibiofibular trunk, the anterior tibial artery, the posterior tibial artery and the peroneal artery
- •The vascular lesion length will be no longer than 150 mm.
- •Patient with no significant disease at the inflow: common iliac, external iliac, superficial femoral and popliteal artery on the ipsilateral side prior to enrollment, and patient with no significant disease at the outflow - runoff to ankle level: plantar for posterior tibial, pedal for anterior tibial, anterior and posterior perforant branches for peroneal vessels or previous successful revascularization of the disease segments (inflow-outflow)
- •Live expectancy > 1 year.
- •Presence at least ≥1 filling pedal vessel on the target limb.
排除标准
- •Subject pregnant or planning to become pregnant during the study
- •Subject no able to perform the follow up or other factors making clinical follow-up difficult
- •Acute or Subacute limb ischaemia which requires thrombolysis as first treatment modality or previous thrombolytic therapy in the last 48-72 hours.
- •Known allergy to concomitant medication, antiplatelet anti-coagulant or thrombolytic medication
- •Poor inflow due to ipsilateral stenoses or occlusions of the iliac or femoropopliteal arteries
- •Significant stenoses (> 50%) distal to the target lesion that might require revascularization or impede run-off
- •Desert foot condition. No Patent foot main arteries
- •Subject enrolled in another investigational study that has not reached its primary endpoint
结局指标
主要结局
Composite of Acute Gain Index and freedom from clinically driven target lesion revascularization (CD-TLR) through 6 months post procedure
时间窗: 30 days, 6 months
Acute Gain Index defined as the Acute Gain (difference between the vessel diameter before and after IVL) divided by the Reference Vessel Diameter CD-TLR defined as as repeat percutaneous intervention or surgical bypass graft to treat an angiographic significant restenosis (\>50%) at the level of the treated lesion ±10 mm (proximally and/or distally) in the presence of at least 1 of the following criteria: * recurrence of pain in the foot at rest that increases in the supine position * recurrence of pedal ulceration, evidence of halted healing * appearance of a new foot lesion * target vessel occlusion (by either angiography or DUS).
次要结局
- Composite of Freedom from device and procedure-related death and freedom from target limb major amputation and clinically-driven and mechanical target lesion revascularization (CD-MTLR)(30 days, 6 months)
- Rutherford class shift(Baseline, 30 days, 6 months, 12 months)
- Amputation rate(30 days, 6 months, 12 months)
- CD-TLR(30 days, 6 months)
- Major adverse event (MAE) rates(30 days, 6 months, 12 months)
- Technical success(Day 1)
- Clinical Success(Day 1)
- Late Lumen Loss Index(6 months)
- Procedural Success(Day 1)
- Ankle-brachial index (ABI) or trans-cutaneous oximetry (TcPO2) improvements(Baseline,30 days, 6 months, 12 months)