Bifurcation ABSORB OCT Trial

Completed

• Conditions: Coronary Artery Disease; Coronary Atherosclerosis; 10011082

• Registration Number: NL-OMON44338
• Lead Sponsor: Academisch Medisch Centrum

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Last Update Posted: 23 April 2024

Recruitment & Eligibility

• Status: Completed
• Sex: Not specified
• Target Recruitment: 26

Inclusion Criteria

o Subject has a bifurcation lesion involving a side-branch larger than 2 mm and having main branch involvement (Medina 0,0,1 lesions are excluded)
o Subject must agree to undergo all clinical investigation plan-required follow-up visits and to undergo follow-up angiography and optical coherence tomography
o 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.

Exclusion Criteria

o Subject is younger than 18 years of age
o Subject is presenting with a STEMI
o Subject has a true bifurcation lesion where a priori two scaffold/stent strategy is planned.
o Subject has known hypersensitivity or contraindication to 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.
o Known renal insufficiency (eg. estimated Glomerular Filtration Rate (eGFR) <60mL/min/1.73m2 or serum creatinine level of >2.5mg/dL or subject on dialysis)
o Subject with a limited life expectancy less than one year.
o Subject is belonging to a vulnerable population (per investigator*s , e.g., subordinate hospital staff) or subject unable to read or write.

Study & Design

• Study Type: Interventional
• Study Design: Not specified