Performance of the Shockwave Medical Peripheral Lithotripsy System vs Standard Balloon Angioplasty for Lesion Preparation Prior to Supera Stent Implantation in the Treatment of Symptomatic Severely Calcified Femoropopliteal Lesions in PAD
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 120
- 试验地点
- 2
- 主要终点
- Primary efficacy
研究概览
简要总结
This study is an investigator-initiated, prospective, single-center, 1:1 randomized pilot study.
The trial evaluates the safety and efficacy of intravascular lithotripsy in comparison to standard lesion preparation using standard and/or high-pressure balloon angioplasty in patients with femoropopliteal artery disease. All patients will receive subsequent Supera stent implantation at the operator's discretion. Additional standard nitinol bare metal stent (BMS), drug-eluting stent or covered stent implantation is at the operator's discretion.
Patients will be stratified for total occlusions.
详细描述
All enrolled subjects will be followed up through 60 months. At 6, 12, 24, 36 MFU after index procedure the incidence of restenosis will be assessed by DUS.
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
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Subject age ≥ 18
- •Subject has been informed of the nature of the study, agrees to participate, and has signed a Medical Ethics Committee approved inform consent form
- •Subject understands the duration of the study, agrees to attend follow-up visits, and agrees to complete the required testing
- •Rutherford Classification 2-5
- •Subject has a de novo or restenotic lesion in SFA and/or PPA not exceeding the medial femoral epicondyle with ≥ 70% stenosis documented angiographically
- •No previous stent in the target lesion, if target vessel was previously stented the stent should be at least 3cm apart
- •Target lesion length is ≥ 10cm, no maximum lesion length limit
- •Severe calcification on fluoroscopy defined by PACSS Grade 4: 1) bilateral calcification and 2) extending ≥50mm in length
- •Multiple lesions with max. 3cm healthy vessel segment in between lesions can be considered at the discretion of the operator as one lesion
- •Reference vessel diameter (RVD) ≥ 4 mm and ≤ 6.5 mm by visual estimation
- •Patency of at least one infrapopliteal artery to the ankle (< 50% diameter stenosis) in continuity with the native femoropopliteal artery
- •A guidewire has successfully traversed the target treatment segment (both intraluminal and subintimal crossing allowed)
排除标准
- •Failure to successfully cross the target lesion
- •Presence of fresh thrombus in the lesion
- •Presence of aneurysm in the target vessel/s
- •Presence of a stent in the target lesion, at least 3cm from any previously stent in target vessel
- •Prior vascular surgery of the target lesion
- •Stroke or heart attack within 3 months prior to enrollment
- •Enrolled in another investigational drug, device or biologic study that has not reached the primary endpoint
- •Life expectancy of less than one year
- •Known allergies or sensitivity to heparin, aspirin, other anticoagulant/ antiplatelet therapies or contrast media that cannot be adequately pre-treated prior to index procedure
- •Rutherford Classification of 0, 1, or 6
- •Significant gastrointestinal bleeding or any coagulopathy that would contraindicate the use of anti-platelet therapy
- •Receiving immunosuppressant therapy
- •Pregnant or breast-feeding females
- •History of major amputation (defined as amputation above ankle joint) in the same limb as the target lesion
研究组 & 干预措施
Intravascular lithotripsy arm
Treatment with Lithotripsy system followed by Supera stent implantation in lesion segments with severe calcification.
干预措施: Intravascular lithotripsy (Procedure)
Standard lesion preparation arm
Treatment with Balloon angioplasty with a conventional and/or high-pressure balloon angioplasty followed by Supera stent implantation in lesion segments with severe calcification.
干预措施: Standard lesion preparation (Procedure)
结局指标
主要结局
Primary efficacy
时间窗: During the Procedure
Procedural success defined as residual stenosis ≤ 30% without flow-limiting dissection (≥Grade D) in the final angiogram and without the need of additional stent implantation.
Rate of primary outcome events
时间窗: 12 month
Composite endpoint defined as freedom from device and procedure-related death, freedom from both target limb major amputation and clinically-driven target lesion revascularization
次要结局
- Rate of vessel rupture(During the Procedure)
- Fluoroscopy Duration (min)(During the Procedure)
- Rate of any dissections after lesion preparation and in the final angiogram(During the Procedure)
- Need of additional stent implantation(During the Procedure)
- Procedure Time (min)(During the Procedure)
- Walking Impairment Questionnaire (WIQ)(6, 12, 24 and 36 months)
- Rate of primary patency(6, 12, 24 and 36 months)
- Rate of Duplex-defined binary restenosis (PVR >2.4) of the target lesion(post-procedure until discharge from hospital (up to 48 hours) and at 6, 12, 24 and 36 months or at any time of re-intervention)
- Rate of Clinically-driven Target lesion revascularization(30 days, 6, 12, 24, 36, 48 and 60 months)
- Rate of Freedom from Major Adverse Event (defined as death, Target lesion revascularization, Target vessel revascularization and target limb major amputation)(30 days, 6, 12, 24, 36, 48 and 60 months)
- Ankle-brachial index (ABI)(6, 12, 24 and 36 months)
- EQ VAS(6, 12, 24 and 36 months)
- EQ-5D-5L questionnaire(6, 12, 24 and 36 months)
- Radiation dose area product(During the Procedure)
- Additional need of intra-procedural pain medication(During the Procedure)
- Perception of procedural pain evaluated using a numerical rating scale from 0 (no pain) to 10 (severest pain)(During the Procedure)
- Rate of All-cause mortality(30 days, 6, 12, 24, 36, 48 and 60 months)
- Rutherford Classification(6, 12, 24 and 36 months)