Plaque stabilization and restoration of vascular function by bioresorbable vascular scaffold in acute coronary syndrome prone patients

Phase 2

Completed

• Conditions: atherosclerosis; plaque; 10011082

• Registration Number: NL-OMON38540
• Lead Sponsor: Canisius Wilhelmina Ziekenhuis

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Last Update Posted: 29 April 2024

Recruitment & Eligibility

• Status: Completed
• Sex: Not specified
• Target Recruitment: 40

Inclusion Criteria

- Symptomatic patients between the age of 18 and 80 years
- Morise Risk score of *9 (intermediate or high risk) but no proven ischemia (no positive troponin or ST-elevation)
- Intermediate coronary lesion on CT scan (50-70% based on CT estimate) and a plaque with at least two of the following vulnerability criteria: Napkin ring sign, positive remodeling, low attenuation and spotty calcification
- FFR negative lesion at coronary angiogram
- Vessel diameter *2.5 mm on visual estimate

Exclusion Criteria

- High calcium score on CT scan preventing adequate evaluation of the coronary lesion.
- Lesions located in a coronary vessels previously stented.
- Left main (>50%) or known three vessel disease.
- Intolerance to Aspirin, Clopidogrel, Prasugrel, Ticagrelor, Heparine or Everolimus and known true anaphylaxis to prior contrast media or known bleeding diathesis or known coagulopathy.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>Composite endpoint of change in plaque cumulative score of signs of<br /><br>vulnerability on CT and nominal change in percent necrotic core and thin-cap<br /><br>fibroatheroma at VH-IVUS at 24 months</p><br>