Amsterdam Investigator-initiateD ABSORB trial- AIDA CTO Physiology <br>

Completed

• Conditions: coronary artery disease; coronary artherosclerosis; 10011082

• Registration Number: NL-OMON43582
• Lead Sponsor: Academisch Medisch Centrum

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Last Update Posted: 28 February 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 chronic total occlusion
o Subject must agree to undergo all clinical investigation plan-required follow-up visits and to undergo follow-up angiography and intracoronary measurements
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 has known hypersensitivity or contraindication to Acetylcholine, nitroglycerin, adenosine or 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>The endothelium-dependent and non-endothelium-dependent vasomotion and<br /><br>perfusion restoration in coronary vessels treated with ABSORB BVS or Xience DES<br /><br>in CTO coronary lesions </p><br>