NCT06951685招募中不适用
Prospective, Non-randomized, Early Feasibility Clinical Study to Assess the Feasibility of the Novel Xeltis Peripheral Artery Disease (XPAD) Bypass Conduit
Xeltis1 个研究点 分布在 1 个国家目标入组 6 人开始时间: 2025年5月2日最近更新:
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 6
- 试验地点
- 1
- 主要终点
- Primary patency rate
研究概览
简要总结
A prospective, single arm, non-randomized early feasibility study to evaluate the preliminary safety and performance of the XPAD conduit in patients with peripheral arterial occlusive disease (PAOD), scheduled to undergo elective above-knee femoral popliteal 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
- •Subjects with femoral artery occlusion who require elective above-knee femoral popliteal bypass surgery
- •Patient has Rutherford grade 3, 4, or 5 occlusive vascular disease and TASC C or D lesions. Rutherford grade 5 may be included with a wound, ischemia and foot infection (WiFi) classification of up to grade 2, provided there are two outflow vessels with at least one reaching the pedal arch
- •At least 18 years of age at screening
- •Suitable anatomy (assessed by a pre-procedural contrasted CT scan or previous angiogram assessed up to 90 days prior to baseline)
- •Patient has been informed of the nature of the study, agrees to its provisions, and has provided written informed consent
- •Patient 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
- •Subject requires, or is scheduled for, a cardiac surgical procedure or a different vascular surgical procedure within 30 days of study procedure.
- •Presence or history of bypass in the diseased limb
- •Subject requires sequential extremity revascularizations or other procedures that require use of additional vascular grafts
- •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
- •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 patient 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
- •Known active bleeding disorder and/or any coagulopathy or thromboembolic disease
- •Allergies to study device (nitinol) or agents/medication, such as contrast agents or aspirin, that can't be controlled medically
- •Previous enrolment in this study
- •Subject 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:
- •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
Primary patency: Defined as the interval between graft implantation and the first intervention to maintain or restore patency
Freedom from device-related SAE
时间窗: Day 1, 1, 6 and 12 months
次要结局
- Implantation success rate(Day 1)
- Freedom from Major Bleeding events(Day 1, 1 and 6 months)
- Patency (primary, primary assisted, and secondary) rates(6, 12, 24, and 36 months)
- Freedom from device-related SAE(24 and 36 months)
- Rate of wound/graft infections(1, 6, 12, 24, and 36 months)
- Freedom from Major Amputations(1, 6, 12, 24, and 36 months)
- Freedom from all-cause mortality(1, 6, 12, 24, and 36 months)
研究者
研究点 (1)
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