Amsterdam Investigator-initiated Absorb trial the bifurcation strategy

Completed

• Conditions: Coronary Artery Disease; Coronary Atherosclerosis; 10011082

• Registration Number: NL-OMON41341
• 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: 40

Inclusion Criteria

o Subject is enrolled in the Amsterdam Investigator-InitiateD Absorb strategy trial
o Subject has a bifurcation lesion involving a side-branch greater than 2 mm (excluding Medina class 0,0,1 where the is no main-branch involvement)
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 known hypersensitivity or contraindication to contrast 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 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
<p>o Incomplete strut apposition in the bifurcation region at 25 months</p><br>