Qvanteq Bioactive Coronary Stent System First in Man (FIM) Clinical Investigation - QUEST I

QVANTEQ0 个研究点目标入组 14 人开始时间: 待定最近更新: 2024年4月23日

适应症

试验速览

暂无简介。

•Subjects must be at least 18 years of age
•Evidence of myocardial ischemia without elevated cardiac biomarkers (e.g. stable or unstable angina with stable haemodynamic condition, or silent ischemia demonstrated by positive territorial functional study)
•The patient has a planned intervention of one single de novo lesion in one or two separate major epicardial territories (LAD, LCX, or RCA)
•Lesion must have a visually estimated diameter stenosis of >=50% and <100%
•Lesion length must be <=16 mm
•Vessel size must be between 2.5 mm and 3.5 mm
•Written informed consent
•The patient agrees to the follow-up visits including angiographic follow-up and OCT control at 6 months

•Evidence of ongoing acute myocardial infarction (AMI) in ECG and/or elevated cardiac biomarkers (according to local standard hospital practice) have not returned within normal limits at the time of procedure.
•Patient suffered from stroke/TIA or myocardial infarction during the last 6 months
•Left ventricle ejection fraction (LVEF) <30%
•Platelet count <100,000 cells/mm3 or >400,000 cells/mm3, a WBC of <3,000 cells/mm3, or documented or suspected liver disease (including laboratory evidence of hepatitis)
•Known renal insufficiency, or subject on dialysis, or acute kidney failure.
•Patient undergoing planned surgery within 6 months with the necessity to stop ASA
•Patient requiring prolonged DAPT for other diagnoses (>1 month)
•History of bleeding diathesis or coagulopathy
•Patient requiring oral anticoagulation (Coumadin, NOAC)
•The patient is a recipient of a heart transplant
•Known hypersensitivity or contraindication to aspirin, heparin, clopidogrel or cobalt-chromium
•Other medical illness (e.g. cancer, stroke with neurological deficiency) or known history of substance abuse (alcohol, cocaine, heroin etc.) as per physician judgment that may cause non-compliance with the protocol or confound the data interpretation or is associated with a limited life expectancy
•Female of child bearing potential (age <50 years and last menstruation within the last 12 months), who did not underwent tubal ligation, ovariectomy or hysterectomy.

发起方

QVANTEQ