NCT03638115Unknown不适用
Clinical Investigation of the Safety & Effectiveness of the VaSecure 018 Drug Coated PTA Balloon Catheter in the Treatment of Patients With Chronic Limb Threatening Ischemia (CLTI) Involving Below-the-Knee (BTK) Arteries
Vascuros Medical Pte Ltd7 个研究点 分布在 3 个国家目标入组 46 人开始时间: 2018年10月30日最近更新:
适应症
干预措施
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 46
- 试验地点
- 7
- 主要终点
- Freedom from a composite endpoint of Major adverse limb event (MALE) and procedure-related mortality.
研究概览
简要总结
To assess the safety and performance of the VaSecure drug-coated PTA balloon catheter in the treatment of patients with Chronic Limb Threatening Ischemia (CLTI) of the lower limb below the knee (BTK)
详细描述
The VaSecure Drug Coated PTA Balloon Catheter is indicated for percutaneous transluminal angioplasty (PTA), after predilatation, of de novo lesions in the peripheral vasculature of the lower limb with reference vessel diameters of 2-4 mm.
The study will include patients with lesions located in the infrapopliteal arteries diagnosed with CLTI of Rutherford categories 3-5. A maximum number of 46 patients will be enrolled in this clinical investigation in 7 sites in Europe and 2 in Singapore.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 21 Years 至 90 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Able to provide written informed consent prior to participating in the clinical investigation, e.g. patients are mentally able to understand the aim of the clinical investigation.
- •Has a documented diagnosis of CLTI of Rutherford category 3-
- •The target lesion must be de novo.
- •Life expectancy is >1 year, in the investigator's opinion.
- •For women: menopausal or under active birth control.
- •Patient must agree not to participate in any other clinical trial during 12 month follow-up period.
- •Visual angiographic inclusion criteria
- •Reference vessel(s) diameter is between 2mm-4mm. Each lesion in one or maximum two of the infrapopliteal arteries NOT extending beyond the ankle joint. Target lesion(s) consisting of a single solitary or series of multiple adjacent lesions (all less than 30 mm apart) in a single tibial vessel with a diameter stenosis ≥70% and a cumulative length of ≥50 mm to ≤250 mm. If there are two target lesions they will be separated for ≥3 cm and will be named from proximal to distal. Target lesion must be a tibial vessel (excluding popliteal artery) branching from popliteal artery.
排除标准
- •Breastfeeding or pregnant woman.
- •Severe concentric calcification, documented by angiography using the COMPLIANCE360-Score (This scoring system takes into account both the arc of calcium (< or > 180º) and percent of lesion length (< or > 50%) as judged by fluoroscopy.) that could not be fully expanded by predilatation balloon and documented by angiography. Valid record up to 30 days before screening.
- •Patients with major amputations that have already been performed or are planned, either on the target leg or on the contralateral side. .
- •History of stroke within 3 months.
- •History of myocardial infarction, thrombolysis or angina within 30 days prior to index procedure.
- •Renal failure or chronic kidney disease with estimated Glomerular Filtration Rate (eGFR) ≤30 mL/min per 1.73 m2 (or serum creatinine ≥2.5 mg/dL within 30 days of index procedure or treated with dialysis).
- •Diagnosed active untreated systemic infection or uncontrolled coagulopathy within 14 days prior to index procedure.
- •Co-morbid conditions limiting life expectancy to <12 months.
- •Hemorrhagic diathesis or another disorder such as gastrointestinal ulceration or cerebral circulatory disorders which restrict the use of platelet aggregation inhibitor therapy and anticoagulation therapy.
- •Known allergy to paclitaxel or paclitaxel-related compounds or contrast media that cannot be adequately managed with pre- and post-procedure medication.
- •Is currently participating in an investigational drug or other investigational device study or previously enrolled in this study.
- •Is unlikely to comply with the follow up schedule.
- •Has uncontrolled ulcer wound infection.
- •Is unwilling to comply with a concurrent ulcer wound therapy.
- •Has an allergy to acetylsalicylic acid, prasugrel, ticagrelol, and clopidogrel (Plavix®).
- •Use of atherectomy in proximal vessels or TL. However, the use of scoring/cutting balloons in the TL is allowed.
- •Angiographic exclusion criteria
- •Lesions that cannot be successfully predilated to achieve a residual stenosis of <50% by visual estimate.
- •Severe dissection post dilatation resulting in a flow limiting lesion.
- •Thrombus in the target vessel documented by angiography.
- •Aneurysm in the target vessel(s).
- •Treatment of the contralateral limb during the same index procedure or within 30 days post-index procedure in order to avoid confounding complications.
研究组 & 干预措施
VaSecure™ Drug Coated PTA Balloon Catheter
Experimental
干预措施: VaSecure™ (Device)
结局指标
主要结局
Freedom from a composite endpoint of Major adverse limb event (MALE) and procedure-related mortality.
时间窗: 30 days
Major adverse limb event is defined as the composite of either major amputation or major re-intervention through 30 days of the index procedure.
次要结局
- Procedure success rate(Index procedure or 1 day post index procedure)
- Freedom from clinically-driven target lesion revascularization (cd-TLR) and target vessel revascularization (TVR)(3, 6, 9 and 12 months)
- Incidence of all Adverse Events (AEs)(30 days, and 3, 6, 9 and 12 months)
- Freedom from major target limb amputation(3, 6, 9 and 12 months)
- Late Lumen Loss (LLL) of the target lesion(6 months)
- Haemodynamic microvascular performance(Baseline, 6 and 12 months)
- Clinical Improvement (combined endpoint) in amputation free, cd-TLR free, surviving patients(3, 6, 9 and 12 months)
- Limb salvage(6 and 12 months)
- Amputation-free survival(6 and 12 months)
- Angiographic Restenosis(6 months)
- Angiographic Restenotic Burden(6 months)
- Freedom from occlusion (FFO) without cd-TLR on Duplex ultrasound(3, 6 and 9 months)
- Wound healing rate(30 days, 3, 6, 9 and 12 months.)
- Rutherford status(3, 6, 9 and 12 months)
研究者
研究点 (7)
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