Distal Evaluation of Functional Performance With Intravascular Sensors to Assess the Narrowing Effect: Guided Physiologic Stenting;Substudy: Characterization of Intermediate Lesions

Recruiting

• Conditions: Coronary artery disease; 10011082

• Registration Number: NL-OMON54360
• Lead Sponsor: Philips

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Last Update Posted: 9 September 2024

Recruitment & Eligibility

• Status: Recruiting
• Sex: Not specified
• Target Recruitment: 521

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
severity by visual estimation and an abnormal non-invasive stress test in the
distribution of the lesion(s) within the past 60 days;
d. One or more angiographic stenoses are present with >=50% to <80% stenosis
severity by visual estimation and a spot iFR measure <=0.89.
Note: Multiple target vessels may be present. However, all must be qualified by
all inclusion and exclusion criteria prior to randomization, and all qualified
vessels must be treated per the randomization assignment (e.g. all with
standard angiographic guidance or all with physiologic guidance). Non-culprit
vessels in patients with NSTE-ACS must qualify by one of the criteria listed in
b-d above.
Staged procedures are permitted as detailed below.
4. Subject is willing to comply with all scheduled visits and tests and are
able and have provided informed written consent
*May or may not be known prior to consent. If patient is consented and
following angiography all inclusion criteria are not present or any exclusion
criteria are present, the patient will not be randomized

For the substudy ChIL:
1. Adult men and women (local age of consent) who present with stable angina
2. Undergoing cardiac catheterization with planned or possible ad hoc PCI
3. Following angiography, at least one epicardial vessel has one or more
angiographic stenoses with >=50% to <80% stenosis severity by visual estimation
and a spot iFR measure > 0.89 or FFR > 0.80.
4. Subject is willing to comply with all procedure steps and has provided
informed written consent

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
minutes not responding to fluid resuscitation, or need for inotropic, pressor,
or device-based hemodynamic support
8. Presence of unstable ventricular arrhythmias
9. Heart rate > 110, including uncontrolled atrial fibrillation (AF)
10. Decompensated congestive heart failure (NYHA Class IV or Killip Class III
or IV)
11. Chronic total occlusion (CTO) of a target vessel (exception: a CTO may be
present in a non-target vessel if it is supplying non-viable myocardium and
there is no intent to open the CTO during the index or later procedure)
12. Coronary anatomy not amenable to pressure wire manipulation due to extreme
tortuosity or complexity such that it is unlikely that a pressure wire could be
passed to the distal third of the three major epicardial coronary arteries
13. Any angiographic giant thrombus (i.e., thrombus length > 3x RVD at lesion)
14. Any target vessel with < TIMI III flow
15. Any target lesion with a reference vessel diameter (RVD) less than 2.25mm
except for within the side branch of a bifurcation lesion
16. Any non-target lesion with a reference vessel diameter (RVD) greater than
2.00mm that contains an >=80% stenosis and is not intended for treatment with PCI
17. Known severe aortic or mitral valve stenosis/insufficiency
18. Known non-cardiovascular comorbidity resulting in lifespan <24 months
19. Known left ventricular ejection fraction <=30%
20. Estimated creatinine clearance (MDRD formula) <30 mL/min/1.73m2 or on
dialysis
21. Any cardiac or non-cardiac surgical procedure planned within 12 months
after enrollment, or any procedure planned within 6 months after enrollment
that would necessitate discontinuation of dual antiplatelet therapy
22. Known pregnancy or planning to become pregnant (women of child-bearing
potential must have a negative pregnancy test within 1 week of enrollment)
23. Participating in another investigational drug or device study that has not
reached its primary endpoint
24. Any condition such as dementia or substance abuse that may impair the
patient*s ability to comply with all study procedures, including medication
compliance and follow-up visits
25. Patient is a member of a vulnerable population who, in the judgment of the
investigator, is unable to give Informed Consent for reasons of incapacity,
immaturity, adverse personal circumstances or lack of autonomy. This may
include individuals with mental disability, persons in nursing homes, children,
impoverished persons, persons in emergency situations, homeless persons,
nomads, refugees, and those permanently incapable of giving informed consent.
Vulnerable populations also include university students, subordinate hospital
and laboratory personnel, employees of the Sponsor, members of the armed
forces, a

Study & Design

• Study Type: Interventional
• Study Design: Not specified