The Acute and Long-term Clinical Outcome of Self- Expandable Stent in Complex Proximal Superficial Femoral Artery Lesions Involving the Femoral Bifurcation

Qingdao Hiser Medical Group0 个研究点目标入组 300 人开始时间: 2021年8月18日最近更新: 2021年8月19日

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: 300
主要终点: Major adverse events and freedom from target lesion revascularization

研究概览研究设计入排标准结局指标研究者记录与标识符相似试验

研究概览

简要总结

The stent-FP study investigates the impact of coverage of profound femoral artery (PFA) by bare metal stent deployed in proximal superficial femoral artery (SFA) lesions. 300 patients with femoral bifurcation lesions will be included and divided into 3 groups according to the location of proximal stent edge. The primary endpoint of the study is major adverse events and freedom from target lesion revascularization at 48 months. Secondary endpoints include primary patency of PFA and bare metal stent at 1,6, 12,24,36and 48 month, MAE and F -TLR at 1,6, 12,24,36 month.

研究设计

研究类型: Observational
观察模型: Case Crossover
时间视角: Prospective

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

•Patients with chronic atherosclerosis obliterans aged over 18 years
•Patients presenting Rutherford classification from 2-5
•Patients is willing to follow-up on time
•Patient has a life expectancy of at least 24 months
•Prior to enrolment, the guidewire has crossed target lesion
•De novo lesions located in the femoral artery bifurcation (5mm between distal CFA and proximal SFA), need for primary bare metal stent implantation
•There is a patent deep femoral artery demonstrated by angiography
•If the first-time endovascular treatment is failure, patients undergo endovascular treatment successfully at the second time, the patients can still be enrolled （9）For patients with aortoiliac artery lesions, they can be enrolled after the successful reconstruction of aortoiliac artery .
•(10) The lower extremity artery needs to have a healthy runoff of no less than 10 cm above the ankle, and at least one healthy dorsalis pedis artery, medial or lateral plantar artery connected with the digital artery below the ankle (11) Informed consent signed by patients

排除标准

•Patients who are known to be allergic to heparin, low molecular weight heparin, contrast agents, etc.
•In the past 3 months, they have participated in other drugs that interfere with this clinical trial or patients in clinical trials of medical devices
•Pregnant and lactating women
•Patients with other diseases that may make the trial difficult or significantly shorten the patient's life expectancy (<2 years), such as tumors, severe liver disease, cardiac insufficiency, etc or patients whose life expectancy is less than 24 months (24 months of follow-up are required)
•Patients with acute arterial thrombosis or embolism at the target lesion site.
•Patients who underwent stent implantation in common femoral artery previously
•(8) Use of thrombectomy, atherectomy or laser devices during procedure (9) Previous open surgery in the same limb . (10) Patients with deep femoral artery totally occlusion

结局指标

主要结局

Major adverse events and freedom from target lesion revascularization

时间窗: post-interventional 48 months

Major adverse events and freedom from target lesion revascularization at 48 months

次要结局

primary patency of PFA and bare metal stent(post-interventional 1,6, 12,24,36 and 48 month)
MAE(post-interventional 1,6, 12,24,36 month)
F -TLR(post-interventional 1,6, 12,24,36 month)

研究者

发起方

Qingdao Hiser Medical Group

申办方类型

Other

责任方

Sponsor

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