NCT01220245已完成不适用
Heparin-bonded Endoluminal Versus Surgical Femoropopliteal Bypass; a Multicentre Randomized Controlled Trial
Rijnstate Hospital6 个研究点 分布在 1 个国家目标入组 129 人开始时间: 2010年10月1日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 129
- 试验地点
- 6
- 主要终点
- Primary (and -assisted) patency
研究概览
简要总结
In this multicentre Randomized Clinical Trial, the heparin-bonded endoluminal bypass will be compared to the surgical venous femoro-popliteal bypass, based on the non-inferiority principle for the patency. Besides equal patency, an improved quality of life is expected. Recruitment will take the first two years and patients will be followed during five years. Patients with an indication for surgical bypass, classified category 3-6 with a >50% stenosis or occlusion of the SFA over >/=10 cm in length will be included. At least one crural artery should be patent without significant lesions.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 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
- •Age over 18 years
- •Informed consent
- •Novo stenosis, restenosis >50% or occlusion of the native SFA, all > 10cm in length
- •Patent popliteal artery at the upper margin of the patella to the trifurcation
- •Diameter native SFA and popliteal artery are 5.0-7.5 mm
- •Indication for surgical bypass
- •Distal run-off at least one crural artery without significant stenosis
- •Ankle-brachial index (ABI) at rest < 0.8 in the study limb prior to procedure
排除标准
- •Patient unsuitable for administration of contrast agent
- •Pregnancy
- •Dementia or altered mental status that would prohibit giving conscious informed consent
- •Need for adjunctive major surgical or vascular procedures within one month
- •Untreated flow-limiting aortoiliac occlusive disease
- •Perioperative unsuccessful ipsilateral percutaneous vascular procedure to treat inflow disease just prior to enrollment
- •Femoral or popliteal aneurysm of target vessel
- •Non-arthrotic disease resulting in occlusion (e.g. embolism, Buerger's disease, vasculitis)
- •Severe medical comorbidities (untreated CAD/CHF, severe COPD, metastatic malignancies, dementia etc.) or other medical condition that would preclude compliance with study protocol
- •Major distal amputation (above the transmetatarsal) in the study limb
- •Any previously known coagulation disorder, including hypercoagulability
- •Contraindication to anticoagulation or antiplatelet therapy
- •Known allergies to stent/stent-graft components
- •History of prior life-threatening reaction to contrast agent
- •Patients with known hypersensitivity to heparin, including those patients who have had a previous incidence of heparin-induced thrombocytopenia (HIT) type II
- •Planned surgical procedure or major amputation to occur after enrollment of the patient
结局指标
主要结局
Primary (and -assisted) patency
时间窗: 5 years
Quality of life
时间窗: 5 years
次要结局
- Re-intervention(5 years)
- Secondary patency(5 years)
- Clinical improvement(5 years)
- Target lesion revascularisation(5 years)
- Complications(5 years)
研究者
Michel Reijnen
Principal Investigator
Rijnstate Hospital
研究点 (6)
Loading locations...
相似试验
终止
不适用
Prime Time for Superficial Femoral Artery (SFA) - The SFA StudyPeripheral Vascular DiseaseNCT00902317Arizona Heart Institute130
终止
不适用
Bypass or Thurpass for Superficial Femoral Artery Occlusion? Scandinavian Thurpass StudyFemoral Artery OcclusionNCT00810134University of Helsinki44
已完成
不适用
Ruptured Aorta-iliac Aneurysms: Endo vs. SurgeryRuptured Aorta-iliac AneurysmsNCT00577616Assistance Publique - Hôpitaux de Paris107
尚未招募
不适用
The Efficacy of Heparin-boned Viabahn Endoprosthesis and Paclitaxel-coated Balloons for Complex Femoropopliteal LesionsPeripheral Arterial DiseaseNCT06124755RenJi Hospital60
已完成
不适用
Comparison of Lower Limb Endovascular Interventions With and Without the EndoNaut WorkstationPeripheral Arterial DiseaseNCT04709991Therenva200