Ticagrelor vs. clopidogrel in patients undergoing implantation of paclitaxel-eluting stents in the femoropopliteal district: a randomized, nested pilot study using Frequency-Domain Optical Coherence Tomography (FD-OCT)

AUSL 80 个研究点目标入组 40 人开始时间: 2014年11月11日最近更新: 2018年3月5日

适应症

试验速览

暂无简介。

•age > 18 years, with clinical evidence of claudication or critical limb ischemia; angiographic evidence of > 50% stenosis or occlusion of the superficial femoral or popliteal artery for a length > 40mm; presence of at least 1 vessel with direct flow to the pedal circle; treated with drug eluting stent implantation
•Are the trial subjects under 18? no
•Number of subjects for this age range:
•F.1.2 Adults (18-64 years) yes
•F.1.2.1 Number of subjects for this age range 10
•F.1.3 Elderly (>=65 years) yes
•F.1.3.1 Number of subjects for this age range 30

•need of major limb amputation for irreversibility of the lesions (judged by diabetic foot specialist); hypersensitivity or known contraindications to aspirin, heparin, ticagrelor or paclitaxel or any of the excipients; known hypersensitivity to iodinated contrast media that cannot be adequately controlled by premedication; unwillingness to carry out clinical and angiographic controls; patients with a medical condition requiring treatment with cytostatic drugs or radiation therapy with a life expectancy of less than 1 year; active pathological bleeding, history of intracranial haemorrhage and severe hepatic failure;
•pregnancy or lactation; dialysis required.

发起方

AUSL 8