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.
- Conditions
- Coronary Artery Disease
- Registration Number
- NL-OMON25824
- Lead Sponsor
- Orbus Neich
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Pending
- Sex
- Not specified
- Target Recruitment
- 30
•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.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Appearance of overhanging struts in front of the side branch ostium on three-dimensional OCT post-implantation and post-procedure measured by cute-plane analysis
- Secondary Outcome Measures
Name Time Method umber of non-apposed side branch (NASB) struts post-implantation and post-procedure