Physiologic Assessment of Coronary Stenosis Following PCI

Completed

• Conditions: blockage in heart artery; coronary stenosis; 10011082

• Registration Number: NL-OMON45522
• Lead Sponsor: Philips Volcano

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

1.Subject must be > 18 years old
2.Subjects presenting with stable angina, silent ischemia or non-ST-elevation ACS (unstable angina or biomarker positive)
3.Single vessel CAD with at least 2 separate lesions (*10 mm apart) of *40% stenosis or a single long lesion of *20mm OR multi-vessel CAD, defined as at least 2 vessels with *40% stenosis
4.Pre-PCI iFR performed in all vessels intended for PCI
5.Pre-PCI iFR of <0.90 of at least 1 stenosis
6.Subjects are able and willing to comply with scheduled visits and tests and to provide informed consent.

Exclusion Criteria

1.Pregnant or planning to become pregnant for the duration of the study
2.Acute STEMI within the past 7 days
3.Cardiogenic shock (sustained (>10 min) systolic blood pressure < 90 mmHg in absence of inotropic support or the presence of an intra-aortic balloon pump).
4.Ionotropic or temporary pacing requirement
5.Sustained ventricular arrhythmias
6.Prior CABG
7.Known ejection fraction *30%
8.Chronic Total Occlusion (CTO)
9.Known severe mitral or aortic stenosis.
10.Any known medical comorbidity resulting in life expectancy < 12 months.
11.Participation in any investigational study that has not yet reached its primary endpoint.
12.Known severe renal insufficiency (eGFR <30 ml/min/1.72 m2).
13.TIMI flow <3 at baseline
14.Intra-coronary thrombus on baseline angiography

Study & Design

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

Primary Outcome Measures

Name	Time	Method
<p>Rate of residual ischemia defined as iFR <0.90 after operator-assessed<br /><br>angiographically successful PCI (residual diameter stenosis <50% in any treated<br /><br>lesion in the target vessel)</p><br>