NCT07716020尚未招募不适用
Prospective, Non-randomized, European Feasibility Clinical Study to Assess the Safety and Performance of the Xeltis Peripheral Artery Disease (XPAD) Bypass Conduit.
Xeltis0 个研究点目标入组 15 人开始时间: 2026年12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
- 15
- 主要终点
- Primary patency rate
研究概览
简要总结
A prospective, single arm, non-randomized European feasibility study to evaluate the safety and performance of the XPAD conduit in patients with peripheral arterial occlusive disease (PAOD), scheduled to undergo elective lower-limb, above or below the knee, bypass surgery.
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
- 否
入选标准
- •Participants with peripheral artery occlusion who require elective lower-limb bypass surgery
- •Participant has Rutherford grade 3 or 4 occlusive vascular disease and TASC C or D lesions.
- •At least 18 years of age at screening
- •Suitable anatomy while avoiding joints (assessed by a pre-procedural contrasted CT scan or previous angiogram assessed up to 90 days prior to baseline)
- •Participant has been informed of the nature of the study, agrees to its provisions, and has provided written informed consent
- •Participant has been informed and agrees to pre- and post-procedure follow-up, including follow-up angiography
- •Life expectancy of at least 24 months
排除标准
- •Participant requires, or is scheduled for, a cardiac surgical procedure or a different vascular surgical procedure within 30 days of study procedure.
- •Stroke or myocardial infarction event within 6 weeks of the procedure or evidence of prior massive stroke (Modified Rankin Scale 3 or above)
- •History of acute arterial occlusion requiring an emergent intervention within the last 12 months
- •Severe chronic renal insufficiency (serum creatinine >2.5 mg/dL) or undergoing hemodialysis
- •Previous renal transplant
- •Uncontrolled arterial hypertension (BP >200 mmHg) at 2 successive readings
- •Uncontrolled or poorly controlled diabetes
- •Abnormal blood values that could influence participant recovery and or/ graft hemostasis
- •Reduced liver function, defined as: >2x the upper limit of normal for serum bilirubin, International Normalized Ratio (INR) >1.5 or prothrombin time (PT) >18 seconds
- •Any active local or systemic infection
- •Known heparin- induced thrombocytopenia, active bleeding disorder and/or any coagulopathy or thromboembolic disease
- •Allergies to study device (nitinol) or agents/medication, such as contrast agents, aspirin or NOACs, that can't be controlled medically
- •Previous enrolment in this study
- •Participant is participating in another study
- •Pregnant or breastfeeding woman or woman in fertile period not taking adequate contraceptives
- •Any other condition which, in the judgement of the investigator would preclude adequate evaluation for the safety and performance of the study conduit
- •Intra-operative exclusion criteria:
- •1. Unsuitable anatomy to implant the XPAD conduit (e.g. target vessel diameter smaller than anticipated; severe calcification)
结局指标
主要结局
Primary patency rate
时间窗: 12 months post-implant
Primary patency defined as the interval between conduit implantation and the first intervention to maintain or restore patency
Freedom from device-related SAE
时间窗: Day 1, 30 days, 6 months, and 12 months post-implant
次要结局
- Patency (primary, primary assisted, and secondary) rates(6, 12, 24, 36, 48 and 60 months post-implant)
- Freedom from device-related SAE(24, 36, 48 and 60 months post-implant)
- Rate of wound/conduit infections(30 days, 6, 12, 24, 36, 48 and 60 months post-implant)
- Freedom from Major Amputations(30 days, 6, 12, 24, 36, 48, and 60 months post-implant)
- Freedom from all-cause mortality(30 days, 6, 12, 24, 36, 48, and 60 months post-implant)
- Implantation success rate(Day 1)
- Freedom from Major Bleeding events(Day 1, 30 days and 6 months post-implant)
研究者
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