NCT06434779尚未招募不适用
Single Arm, Multicenter, Prospective Registry Investigating Efficacy and Safety of Mechanical Thrombectomy (JETi®) in Acute and Acute-on-Chronic Arterial Occlusions in Femoro-popliteal and Proximal BTK-Lesions (JETART)
Vascular Science LP GmbH0 个研究点目标入组 200 人开始时间: 2024年7月1日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 200
- 主要终点
- Primary Efficacy Endpoint
研究概览
简要总结
To demonstrate the efficacy and safety of the mechanical thrombectomy device (JETi 6F and 8F) for treatment of patients with symptomatic peripheral artery disease (PAD) due to acute or acute on chronic occlusions of the femoral and/or popliteal arteries and the first 10 cm of the below-the -knee arteries.
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
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Patient is ≥18 years
- •Patient has Rutherford Classification 2,3 or
- •Patient has provided written informed consent and is willing to comply with study follow-up requirements.
- •Angiographic inclusion criteria
- •De novo thrombotic occlusive lesion(s) or thrombotic re-occlusion or in-stent thrombotic occlusive lesion(s) or thrombotic occlusion of a bypass (autolog or prosthetic) occurring acute or subacute with onset of complains within <30 days prior to first seen by investigating physician.
- •Target lesion is located between the ostium of the SFA and the end of the P3 segment of the popliteal artery, tibioperoneal trunk, respectively the first 10 cm of the below the knee vessels
- •Target vessel diameter ≥ 3 mm and ≤ 8 mm and irrespective of lesion length
- •Target lesion must be occlusive lesion Note: there is no limitation in lesion length
- •Successful, uncomplicated crossing of the target lesion occurs when the tip of the guidewire is distal to the target lesion without the occurrence of flow-limiting dissection of perforation and is judged by visual inspection to be within the true lumen.
- •A patent inflow artery free from significant stenosis (≥50% stenosis) as confirmed by angiography.
- •At least one patent native distal outflow artery to the ankle or foot, free from significant stenosis (≥ 50 % stenosis) as confirmed by angiography.
排除标准
- •Patients meets any contraindication for JETi mechanical thrombectomy use per IFU
- •Lesion crossing is difficult and the lesion is not suspicious for fresh thrombus containment
- •Pregnant women or female patients of childbearing potential that do not use adequate contraceptive methods
- •Patient has a life expectancy of less than 1 year
- •Patient has a known allergy to contrast medium that cannot be adequately pre-medicated.
- •Patient is allergic to all anti-platelet treatments
- •Patient has platelet count <100.000/mm3 or >700.000/mm
- •Patient has history of gastrointestinal hemorrhage requiring a transfusion within 3 months prior to the study procedure
- •Patient is diagnosed with coagulopathy that bares the risk of increased bleeding risk
- •Patient has history of stroke within past 90 days
- •Patient is participating in an investigational drug or medical device study that has not completed primary endpoint(s) evaluation or that clinically interferes with the endpoints from this study.
- •Patient has had any major (e.g. cardiac, peripheral, abdominal) surgical procedure or intervention unrelated to this study within 30 days prior to the index procedure or has planned major surgical procedure or intervention within 30 days of the index procedure
- •Patient is unwilling or unable to comply with procedures specified in the protocol or has difficulty or inability to return for follow-up visits as specified by the protocol
- •Patient suffering from HIT II
- •Angiographic Exclusion Criteria:
- •Target lesion is larger than 8 mm, respectively smaller than 3 mm
- •Significant target vessel tortuosity or other parameters prohibiting access to the target lesion
- •Absence of thrombus in the target vessel
- •Iliac inflow disease requiring treatment, unless the iliac artery disease is successfully treated first during the index procedure. Success is defined as ≤ 30 % residual diameter stenosis without death or major complications.
- •No patent outflow vessels on the level of 10 cm below the origin of below the-knee arteries to the level of the foot or ankle.
结局指标
主要结局
Primary Efficacy Endpoint
时间窗: During index procedure
The primary efficacy endpoint is technical procedural success (post Jeti) defined as restoration of impaired flow to a straight-line orthograde flow in the target vessel/bypass with near complete or complete recanalization of occluded vessel by using the JETI system prior to further additional endovascular therapy.
Primary Safety Endpoint
时间窗: Up to 30 days post-index procedure
The primary safety endpoint is a composite of 1. freedom from device- and procedure-related death through 30 days post-index procedure; 2. freedom from major target limb amputation (above-the-ankle (ATA)) through 30 days post-procedure and 3. freedom from clinically-driven target vessel revascularization (CD-TVR) through 30 days post-index procedure
次要结局
- Acute device success(During index procedure)
- Change of life quality according to the Walking Impairment Questionnaire (WIQ) from baseline to 30 days post-index procedure(Up to 30 days)
- Sustained clinical improvement at discharge and at 30- days post-index procedure(Hospital admission to discharge up to 30 days and at 30 days)
- Primary Patency at discharge and at 30 days post-index procedure(Hospital admission to discharge up to 30 days and at 30 days)
- Secondary safety endpoint at discharge up to 30 days post index procedure(Up to 30 days)
- Freedom from TLR at discharge and at 30 days post-index procedure(Hospital admission to discharge up to 30 days and at 30 days)
- Change in target limb Rutherford Classification from baseline to 30 days post-index procedure(Up to 30 days)
- Change of life quality according to the EQ-5D questionnaire from baseline to 30 days post-index procedure(Up to 30 days)
- Duration of hospital stay(Hospital admission to discharge up to 30 days)
- Change in target limb resting ABI from baseline to discharge and at 30 days post-index procedure(Up to 30 days)
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