NL-OMON54360
Recruiting
Not Applicable
Distal Evaluation of Functional Performance With Intravascular Sensors to Assess the Narrowing Effect: Guided Physiologic Stenting;Substudy: Characterization of Intermediate Lesions - DEFINE GPS;Substudy: ChI
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Not specified
- Sponsor
- Philips
- Enrollment
- 521
- Status
- Recruiting
- Last Updated
- last year
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •1\. Adult men and women (local age of consent) who present with stable or
- •unstable angina, or NSTEMI.
- •2\. Undergoing cardiac catheterization with planned or possible ad hoc PCI
- •3\. Following angiography, PCI is indicated in at least one coronary artery\* on
- •the basis of one or more of the following:
- •a. Presenting with NSTE\-ACS (unstable angina with ECG changes or cardiac
- •enzyme\-positive NSTEMI) with an identified culprit lesion with DS \>\=50%;
- •b. One or more angiographic stenoses present with \>\=80% stenosis severity by
- •visual estimation;
- •c. One or more angiographic stenoses present with \>\=50% to \<80% stenosis
Exclusion Criteria
- •1\. STEMI within 30 days
- •2\. PCI within the prior 12 months, or any PCI planned after the study procedure
- •(other than planned staged procedures of randomized vessels which are allowed)
- •3\. Prior CABG anytime
- •4\. Silent ischemia only (i.e. no cardiac symptoms related to coronary artery
- •disease) within the prior 4 weeks
- •5\. Documented prior iFR pullback performed in any coronary artery including
- •during the qualifying diagnostic angiogram
- •6\. Any vessel with in\-stent restenosis (ISR) requiring treatment
- •7\. Cardiogenic shock defined as systolic blood pressure \<90 mmHg for \>20
Outcomes
Primary Outcomes
Not specified
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