Shockwave™ vs Surgical Endarterectomy for Calcified Severe Common Femoral Artery Stenosis: Comparison of Efficacy, Safety and Long-Term Outcomes
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 60
- 试验地点
- 2
- 主要终点
- Clinically driven target lesion revascularization (cdTLR (symptom-driven repeat revascularization of the index lesion))
研究概览
简要总结
The investigators hypothesize that Shockwave with DCB is non-inferior to surgical endarterectomy for common femoral artery (CFA) stenosis with regard to primary efficacy and safety endpoints. The study will challenge the current guideline that recommends common femoral endarterectomy (CFE) as the primary treatment for symptomatic CFA stenosis.
详细描述
This is a pilot, prospective, randomized clinical trial. This trial compares patients with severe symptomatic moderate to severe calcified CFA stenosis undergoing traditional gold standard CFA endarterectomy to innovative technique of endovascular treatment using Shockwave™ Intra vascular Lithotripsy (IVL) using M5+ balloon with Drug coated balloon to achieve removal and debulking of plaque and achieve luminal gain. Patients who meet inclusion criteria will be informed and consented by a clinical coordinator if they wish to participate in the trial. If participants are candidates for surgery, they will then be randomized into one of two cohorts, receiving either Shockwave™ IVL + DCB (drug-coated balloon) procedure or a standard surgical endarterectomy. The study compares the 1-year efficacy and 6-month safety outcomes post-procedure for patients with severe, symptomatic CFA stenosis receiving Shockwave™ IVL with DCB versus surgical endarterectomy.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 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
- •A patient will be eligible for inclusion in this study if he or she meets all of the following criteria (confirmed by core lab):
- •CFA atherosclerotic stenosis 60-100%
- •Moderate to severe calcification reported on imaging
- •Lifestyle-limiting intermittent claudication (IC) or chronic limb-threatening ischemia (CLTI) as described by Rutherford chronic limb ischemia (CLI) category 2-5
- •Failing conservative therapy
- •Operative candidate for CFE prior to enrollment
- •≥18 years of age
排除标准
- •A patient will be ineligible for inclusion in this study if he or she meets any of the following criteria:
- •History of CFE or bypass in affected limb
- •Thrombosis of affected CFA
- •Aneurysm in the common femoral artery of target limb
- •Known target lesion restenosis (re-narrowing of the artery to ≥50% following the alleviation of a previous narrowing within 3 months)
- •Any preceding percutaneous cardiovascular intervention within 2 weeks
- •Inability to tolerate DAPT
- •Known coagulopathy or bleeding diathesis, thrombocytopenia with platelet count <100,000/µL
- •Uncontrolled diabetes (HbA1c ≥10.0%)
- •Non-ambulatory
- •Extensive tissue loss requiring amputation or salvageable only with complex foot reconstruction or non-traditional transmetatarsal amputations
- •MI within 6 weeks (defined as presumed ischemic symptoms (chest pain, ST-segment deviation and troponin higher than 2 times the upper limit of normal))
- •Stroke within 3 months (defined as sudden transient or irreversible focal neurological deficit resulting from a cerebrovascular cause)
研究组 & 干预措施
Shockwave Catheter
Shockwave™ Intravenous Lithotripsy (IVL)+ DCB (Drug Coated Balloon)
干预措施: Shockwave Catheter (Device)
surgical endarterectomy
Surgery should be performed with patch angioplasty, with or without profunda femoris endarterectomy.
干预措施: CFA Endarterectomy (Procedure)
结局指标
主要结局
Clinically driven target lesion revascularization (cdTLR (symptom-driven repeat revascularization of the index lesion))
时间窗: Procedure date through 1-year post-op
Restenosis to ≥ 50% of the target lesion on angiography or follow-up ultrasound
时间窗: Procedure date through 1-year post-op
Freedom from perioperative death
时间窗: Procedure date through 30 days post-op
Freedom from major adverse cardiovascular events (MACE (stroke, myocardial infarction (MI), cardiovascular death))
时间窗: Procedure date through 30 days post-op
Freedom from major adverse events
时间窗: Procedure date through 6 months post-op
1. Acute occlusion of the target lesion 2. Flow-limiting dissection of the target lesion 3. Symptomatic thrombus or embolus in treated limb requiring treatment 4. Unplanned percutaneous/surgical revascularization or amputation above the ankle of the treated limb 5. Access/surgical site complications 1. Bleeding events (specify Bleeding Academic Research Consortium (BARC) type - see Appendix 18.2) 2. Surgical site infection requiring medication or surgery, wound dehiscence, patch/arterial infection, lymphatic leak requiring surgery
次要结局
- Mortality(Procedure date through 1-year post-op)
- Rutherford Chronic Limb Ischemia (CLI) Category(30 days post-op, 3 months post-op, 6 months post-op, 1 year post-op)
- Treatment satisfaction and quality of life (PAQ)(Pre-op, 30 days post-op, 6 months post-op, 1 year post-op)
- Intraoperative blood transfusion > 4 minutes(Intra-op)
- Procedural duration (minutes)(Intra-op)
- Length of stay (days)(Procedure date through 1 year post-op)
- Postoperative anemia requiring blood transfusion(Procedure date through 30 days post-op)
- Readmissions(30 days post-op, 30 days post-discharge)
- Return to the operating room / angiography suite(30 days post-op)
- Access/surgical site complications(30 days post-op, 6 months post-op)
- Pneumonia (number of cases)(Procedure date through 30 days post-op)
- Prolonged intubation(Procedure date through 30 days post-op)
- Urinary tract infection(Procedure date through 30 days post-op)
- Sepsis(Procedure date through 30 days post-op)
- Septic shock(Procedure date through 30 days post-op)
- Graft failure(Procedure date through 30 days post-op)
- Cardiac arrest(Procedure date through 30 days post-op)
- Myocardial infarction(Procedure date through 30 days post-op)
- Acute kidney injury(Procedure date through 30 days post-op)
- Dialysis(Procedure date through 30 days post-op)
- Deep vein thrombosis(Procedure date through 30 days post-op)
- Pulmonary embolism(Procedure date through 30 days post-op)