Distal Evaluation of Functional Performance with Intravascular Sensors to Assess the Narrowing Effect: Guided Physiologic Stenting

Enrolling by invitation · Not applicable

Conditions studied: Coronary Artery Disease, Ischemic Heart Disease

In brief

Multi-center, prospective, randomized controlled study comparing PCI guided by angiography versus iFR Co-Registration using commercially available Philips pressure guidewires and the SyncVision co-registration system, employing an adaptive design study for interim sample size re-estimation.

Key facts

Study ID

NCT04451044

Run by

Philips Clinical & Medical Affairs Global

People needed

3212

Starts

2021-06-17

Expected to finish

2028-06-01

Last updated by the study team

2025-01-20

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 1. Adult men and women (local age of consent) who present with stable or unstable angina, or NSTEMI.
• 2. Undergoing cardiac catheterization with planned PCI 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:
• Presenting with NSTE-ACS (unstable angina with ECG changes or cardiac enzyme-positive NSTEMI) with an identified culprit lesion with DS ≥50%;
• One or more angiographic stenoses present with ≥80% stenosis severity by visual estimation;
• 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;
• One or more angiographic stenoses are present with ≥50% to <80% stenosis severity by visual estimation and a spot iFR measure ≤0.89 or FFR≤0.80 for borderline iFR..
• 4 Subject is willing to comply with all scheduled visits and tests and has provided informed written consent

You may not qualify if…

• 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 (other than a CTO supplying non-viable myocardium - see exclusion #11)
• 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, and persons kept in detention.

Where it is running

• Pima Heart & Vascular — Tucson, Arizona, United States
• Central Arkansas Veterans Healthcare System (CAVHS) — Little Rock, Arkansas, United States
• Glendale Adventist — Glendale, California, United States
• Colorado Heart and Vascular — Lakewood, Colorado, United States
• Yale University — New Haven, Connecticut, United States
• MedStar Washington Hospital Center — Washington D.C., District of Columbia, United States
• Memorial Healthcare — Hollywood, Florida, United States
• Tampa Cardiovascular Innovations and Research — Tampa, Florida, United States
• Emory University Hospital — Atlanta, Georgia, United States
• Northeast Georgia Medical Center — Gainesville, Georgia, United States
• Straub Medical Center — Honolulu, Hawaii, United States
• Carle Foundation Hospital — Urbana, Illinois, United States
• Community Healthcare System — Munster, Indiana, United States
• University of Kansas Medical Center — Kansas City, Kansas, United States
• Mass General — Boston, Massachusetts, United States
• Brigham and Women's Hospital — Boston, Massachusetts, United States
• Metro Cardiology Consultants — Coon Rapids, Minnesota, United States
• Fairview Health Services — Edina, Minnesota, United States
• Washington University School of Medicine — St Louis, Missouri, United States
• University of Nebraska Medical Center — Omaha, Nebraska, United States
• Dartmouth-Hitchcock Medical Center — Lebanon, New Hampshire, United States
• Gates Vascular Institute — Buffalo, New York, United States
• Northwell Health — Lake Success, New York, United States
• Columbia University Medical Center — New York, New York, United States
• University of Alabama Birmingham — Birmingham, Alabama, United States

Full record on ClinicalTrials.gov

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