NCT03744572已完成不适用
Prestige Pilot - Phoenix Atherectomy and Stellarex DCB Clinical Investigation in Infrapopliteal Interventions
Michael Lichtenberg, MD5 个研究点 分布在 1 个国家目标入组 56 人开始时间: 2018年10月17日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 56
- 试验地点
- 5
- 主要终点
- Number of target lesions with patency at 6 months
研究概览
简要总结
This pilot study is to investigate if a lesion preparation strategy with Phoenix atherectomy before DCB (drug coated balloon) usage in patients with PAD (peripheral artery disease) Rutherford Stage 4-5 and mild/moderate/severe calcium can improve outcomes including patency and limb salvage and evaluate safety and performance of the combination therapy
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
- •Patients must be ≥ 18 years of age.
- •Patients are male or, if female, are either not of childbearing potential or must have a negative pregnancy test done within 7 days prior-index procedure and effective contraception must be used during participation in the Clinical Investigation.
- •Patients who are mentally and linguistically able to understand the aim of the Clinical Investigation and to show sufficient compliance in following the Clinical Investigation Plan.
- •Patients must agree to return for all required post-index procedure follow-up visits.
- •Patients are able to verbally acknowledge an understanding of the associated risks, benefits, and treatment alternatives to therapeutic options of the Clinical Investigation. Patients, by providing their informed consent, agree to these risks and benefits as stated in the patient informed consent document.
- •Rutherford Class 4-5
- •≥ 70% stenosis infrapopliteal lesion by angio visual assessment (later correlated with IVUS)
- •Target vessel(s) reconstitute(s) at or above the ankle with inline flow to at least one patent pedal vessel (includes perforating peroneal branches to dorsalis pedis and plantar artery).
- •The target lesion must either be de-novo or restenotic (stenosis ≥ 70% or occlusion by visual estimate). If the target lesion is restenotic, the prior PTA must have been done > 30 days prior-index procedure.
- •Treatment of multiple target lesions is allowed, as long as the composite target lesion length is ≤ 27 cm and the target lesions can be treated with a maximum of 2 overlapping Investigational Devices.
- •Presence of clearly visible calcification in two views (both sides of vessel at the same location) evaluated angiographically- [OPTIONAL: Computerized tomography (CT) angio images may substitute to confirm distribution of calcium, if available as standard of care]
- •Length of calcium ≥ 25 % of total lesion length or ≥ 2 cm total length by angio visual assessment (later correlated with IVUS)
- •At least one target lesion that is ≥ 2cm in length
排除标准
- •Patients with a known hypersensitivity or contraindication to aspirin, heparin, clopidogrel, or other anticoagulant/anti-platelet therapies, Paclitaxel (or analogs) or sensitivity to contrast media that cannot be adequately premedicated.
- •Patients with any contraindications as mentioned in the Instructions for Use (IFU) of the Investigational Device.
- •Patients with a life expectancy, from the Investigator's opinion, of less than 2 years.
- •Patients that are currently participating in other clinical investigations involving any investigational drug or device that may potentially confound the results of the Clinical Investigation, or that would limit the patient's compliance with the follow-up requirements of the Clinical Investigation.
- •Patients with a history of Myocardial Infarction (MI), thrombolysis or angina within 30 days prior-index procedure.
- •Patients with a history of major disabling stroke within 3 months prior index procedure.
- •Patients with any type of previous or planned surgical or interventional procedure within 15 days prior- and/or within 30 days post-index procedure.
- •Patients with a presence or history of severe renal failure (Glomerular Filtration Rate (GFR) ≤ 30 ml/min).
- •Patients who have undergone prior vascular surgery of the index limb to treat atherosclerotic disease.
- •Patients with clinically significant aneurysmal disease of the iliac, femoral or popliteal artery and patients with a history of clinically significant abdominal aortic aneurysm.
- •Treatment of the contralateral limb during the same index procedure or within 30 days post-index procedure in order to avoid confounding complications.
- •Target vessel(s) reconstitute(s) below the ankle with no inline flow to at least one patent pedal vessel.
- •Subjects scheduled to undergo a planned major amputation
- •Prior stent placement in the target lesion(s)
- •Unsuccessful guidewire crossing
- •Subintimal guidewire placement (confirmed by IVUS, no subintimal placement is allowed)
- •Persistent inflow disease left untreated or unsuccessfully treated
- •Non ischemic ulcers and/or ulcers at or above the ankle
结局指标
主要结局
Number of target lesions with patency at 6 months
时间窗: 6 months
Patency defined as freedom from occluded target lesions (flow) verified by duplex ultrasound without re-intervention
Composite Safety; Number of patients with freedom from BTK major adverse limb events (MALE) and/or perioperative death (POD)
时间窗: 30-days
Freedom from BTK major adverse limb events (MALE) and/or perioperative death (POD)
次要结局
- Number of target lesions with patency as indicated by PSVR measurement(6,12, and 24 months)
- correlation between IVUS metrics and angiographic core lab assessment(pre- and at end of percutaneous revascularization index procedure)
- Number of target lesions with secondary patency(6, 12 and 24 months)
- Number of target lesions with technical success(at end of percutaneous revascularization index procedure)
- Pain rating scale scores compared to Baseline(1, 6, 12 or 24 months)
- Walking Impairment Questionnaire (WIQ) score compared to Baseline(1, 6, 12 or 24 months)
- Percentage of complete wound healing (complete epithelialization)(1, 6, 12 or 24 months)
- Number of target lesions with procedural success(at end of percutaneous revascularization index procedure)
- Number of target lesions with device success for Phoenix atherectomy(during percutaneous revascularization index procedure post-Phoenix and before DCB treatment)
- Clinical success at follow-up,(1, 6, 12 or 24 months)
- Number of patients without Major Adverse Event (MAE)(6, 12, or 24 months)
- Wound, Ischemia, foot Infection (WIfI) Classification on target limb(1, 6,12 and 24 months)
- Ankle-Brachial Index (ABI)(1, 6,12 and 24 months)
- Number of patients with limb salvage(6, 12, and 24 months)
研究者
Michael Lichtenberg, MD
Chief medical officer Vascular Center
Klinikum Arnsberg
研究点 (5)
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