Multicenter, Clinical Pilot-Study of ProEndoTecc Vascular Grafts (6, 7 or 8 mm Diameter) as Superficial Femoral Artery Bypass/Interponate
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 发起方
- 入组人数
- 33
- 试验地点
- 24
- 主要终点
- Primary patency of device
研究概览
简要总结
This is a multi-center, clinical pilot-study of ProEndoTecc Vascular Grafts (6, 7 or 8 mm Diameter) as superficial femoral artery bypass/interponate.
The aim of this study is to demonstrate safety of implantation, patency and durability of a new type of vascular graft.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 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 89 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Female or male patient from 18 to 89 years of age
- •Superficial femoral artery occlusion from 5 to 40 cm in length (above the knee joint),
- •Patient must present with intermittent claudication, with resistance to medical therapy and exercise or critical ischemia,
- •Patient has Rutherford grade 3, 4, or 5 occlusive vascular disease,
- •Women of childbearing age must have negative pregnancy test prior to inclusion
排除标准
- •Bleeding diathesis
- •Patient has known coagulation disorders including hypercoagulability
- •Presence of one or several previously placed endo-prosthesis or grafts in the diseased extremity (below iliacs)
- •Other than 6-8 mm diameter graft is needed.
- •Patients PAD state is in Fontaine Grade IV, Rutherford Grade 6 (Patient has active infection or pronounced necrosis in the region of graft placement)
- •Patient has an acute embolic arterial occlusion
- •Life-expectancy less than 6 month due to co-morbidity or other situation that would make the patient an unlikely candidate for follow-up visits
- •Patient had percutaneous transluminal angioplasty at the implant site within the previous 30 days
- •Participation in another clinical study less than 30 days prior to inclusion
- •Patient is in need of, or is scheduled for, a cardiac surgical procedure or a different vascular surgical procedure
- •Pregnant or breast feeding female patients
- •Multiple graft (implant) needed
- •Patients unable to understand the full meaning of the informed consent
- •Subjects who, in the opinion of the investigator, will be inappropriate for inclusion into this trial or will not comply with requirements of the study
- •Subjects who are imprisoned (according to MPG §20.3)
- •Patients who are lawfully kept in an institution
- •Participation in this trial at an earlier stage
- •Current participation in another clinical trial
结局指标
主要结局
Primary patency of device
时间窗: 6, 12, 24 months after implatation
Primary Patency of treated arterial segment at 6 month after intervention. Primary Patency is defined by objective demonstration via colour-coded Doppler sonography or angiography that the entire length of the graft remain patent with no further intervention required for symptomatic recurrent disease. In case this information is not available, primary patency might be declared, if any the following criteria are fulfilled: Present ABI increased of ≥0.1 compared to preoperative status Present PAD-Grade according to Rutherford increased by one degree Palpable pulse distal of prosthesis.
次要结局
- Guarding Safety variables(6,12, 24 months after implantation)