Physiology and Imaging Pre- and Post Stenting

Completed

• Conditions: atherosclerosis; coronary artery disease; 10011082

• Registration Number: NL-OMON38867
• Lead Sponsor: Catharina-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

- Patients 18 years or older
- Signed informed consent
- Stable angina or medically stabilized unstable angina, scheduled for PCI
of 1- or 2-vessel disease
- Vessel reference diameter of at least 2.5mm

Exclusion Criteria

- Severely tortuous and/or heavily calcified coronary arteries
- Chronically occluded coronary arteries
- Participation in other study
- Pregnancy

Study & Design

• Study Type: Observational invasive
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>Endpoints<br /><br><br /><br>Primary endpoint<br /><br><br /><br>Percentage of lesions with treatment change (post-dilatation, extra stent, 2B3A<br /><br>etc.) based on OCT/FFR post-PCI versus based on angiography.<br /><br><br /><br><br /><br><br /><br>Statistical analysis<br /><br>- Primary endpoint: Estimated % of lesions treated additionally after stenting<br /><br>based on angiography: <5%. Estimated % of lesions treated additionally after<br /><br>stenting based on OCT/FFR: 10-20%. An absolute difference of 15% between<br /><br>post-angiography and post-OCT/FFR additional treatment will be defined as<br /><br>clinically relevant. An estimated 40 patients is needed in order to detect a<br /><br>clinically relevant difference.</p><br>

Secondary Outcome Measures

Name	Time	Method
<p>Secondary endpoints<br /><br><br /><br>Percentage of lesions with change in stent length and/or diameter pre-PCI,<br /><br>based on OCT/FFR pre-PCI versus based on angiography.</p><br>