The purpose of this study is to evaluate the efficacy and safety of successful interventional therapy and unblocked blood vessel maintaining in the treatment of coronary in-stent restenosis by paclitaxel -eluting PTCA- balloon catheter (3μg/mm2 balloon surface area) versus paclitaxel-eluting stent Taxus® Liberte, and the reference diameter of coronary artery stenosis is 2.5mm-4.0mm and the length ≤30mm.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
220
SeQuent® Please with a length of 10mm,15mm,17mm,20mm and 26mm and diameter of 2.5 mm, 2.75 mm, 3.0mm, 3.5mm and 4.0mm are to be used in the trial
Taxus Liberte with a length of 8mm,12mm,16mm,20mm and 24mm and diameter of 2.5 mm, 2.75 mm, 3.0mm, 3.5mm and 4.0mm are to be used in the trial
Fuwai CVD Hospital of Chinese Academy of Medical Sciences
Beijing, China
Late lumen loss in segment section at M9
To measure the diameter loss in segment restenosis of the target lesion vessel by using angiography
Time frame: One year
Success rate of the interventional therapy
To compare the successful treatment of coronary artery stent restenosis intervention between Paclitaxel release PTCA balloon and Taxus® Liberte, including apparatus success, lesion success and clinical success
Time frame: Two year
Outcomes of clinical follow-up visits for drug stent versus drug balloon
* Binary restenosis rate in lesion section at M9 * Cardiovascular clinical composite endpoints related to apparatus at D30, M6, M9, M12 and M24, including cardiac death, target blood vessel myocardial infarction and target lesion vessel revascularization driven by clinical symptoms, briefed as target lesion failure * Cardiovascular clinical composite endpoints related to patients at D30, M6, M9, M12 and M24, including all-cause death, all myocardial infarction and any vessel revascularization * Thrombus event rate defined by ARC
Time frame: Two year
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