Dutch BifUrcaTion Study Evaluating CHaracteristics of the Side Branch OPening with Optical Coherence Tomography after Side Branch FENestration in Patients Treated with COMBO or XIENCE Stent.

Orbus Neich0 个研究点目标入组 30 人开始时间: 待定最近更新: 2024年2月28日

适应症

试验速览

暂无简介。

•Subject has a bifurcation lesion involving a side-branch larger than 2 mm (after pre-dilatation) and having main branch involvement (Medina 0,0,1 lesions are excluded)
•Subject must agree to undergo all clinical investigation plan-required follow-up visits
•Subject is able to verbally confirm understanding and he/she or his/her legally authorized representative provides written informed consent prior to any Clinical Investigation related procedure, as approved by the appropriate Ethics Committee.

•Subject is younger than 18 years of age
•oSubject is presenting with a STEMI
•oSubject has a true bifurcation lesion where a priori two stent strategy is planned.
•oSubject has known hypersensitivity or contraindication to contrast, aspirin, both heparin and bivalirudin, antiplatelet medication specified for use in the study (clopidogrel, prasugrel and ticagrelor, inclusive), everolimus, poly (L-lactide), poly (DL-lactide), cobalt, chromium, nickel, tungsten, acrylic and fluoro polymers or contrast sensitivity that cannot be adequately pre-medicated.
•oKnown renal insufficiency (eg. estimated Glomerular Filtration Rate (eGFR) <60mL/min/1.73m2 or serum creatinine level of >2.5mg/dL or subject on dialysis)
•oSubject with a limited life expectancy less than one year.
•oSubject is belonging to a vulnerable population (per investigator’s judgment, e.g., subordinate hospital staff) or subject unable to read or write.

发起方

Orbus Neich