Pre-emptive, OCT guided angioplasty of vulnerable, intermediate coronary lesions: a randomized trial

Phase 3

Completed

• Conditions: Atherosclerosis; 10011082; vulnerable plaque; 10003216

• Registration Number: NL-OMON43561
• Lead Sponsor: Vrije Universiteit 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: 1000

Inclusion Criteria

- patients with acute myocardial infarction and residual, non-obstructive CAD, with the possibility of plaque vulnerability.
- the coronary lesion must be suitable for PCI with a commercially available BVS.

Exclusion Criteria

- Refusal or inability to provide informed consent.
- < 18 years of age
- Previous CABG.
- Indication for revascularization by CABG.
- Target vessel diameter < 2,5 mm or >4.0 mm
- Anatomy or lesions unsuitable for OCT catheter crossing or imaging (aorta-ostial lesions, small diameter segment, severe calcifications)
- Anatomy unsuitable for BVS placement (left main, bifurcation stenting, sidebranch (> 2 mm) involvement).
- Target lesion is instent restenosis
- Target lesion is chronic total occlusion
- Severe kidney disease defined as an eGFR < 30 ml/min.
- Target lesion in the same vessel as the treated culprit lesion
- Target lesion in the same segment as a previously implanted stent/scaffold
- Estimated life expectancy < 1 year

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>a composite of major adverse cardiovascular events (all cause mortality,<br /><br>non-fatal myocardial infarction (STEMI or NSTEMI), or unplanned<br /><br>revascularization) at one year follow-up.</p><br>

Secondary Outcome Measures

Name	Time	Method
<p>The primary outcome at 2 and 5 year follow up</p><br>