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

Study Overview
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Brief Summary
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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.

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

Conditions
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Coronary Artery Disease, Ischemic Heart Disease

Intervention / Treatment
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* Device: Philips SyncVision system with Philips pressure wires
* Procedure: standard of care angiographically-guided PCI


Participation Criteria
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Eligibility Criteria
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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 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 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 (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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: physiologically-guided arm<br>Physiologically-guided PCI using the Philips SyncVision system for determining the PCI strategy | Device: Philips SyncVision system with Philips pressure wires<br>* Intent to use physiologically-guided PCI using the Philips SyncVision system for determining the PCI strategy<br>|
| Active Comparator: angiographically-guided arm<br>Standard of care angiographically-guided PCI for determining the PCI strategy | Procedure: standard of care angiographically-guided PCI<br>* Intent to use PCI standard of care angiographically-guided PCI for determining the PCI strategy<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Major Adverse Cardiac Events (MACE; composite of cardiac death, MI, or ischemia-driven revascularization) or hospitalization for progressive or unstable angina at 2 years |  | 2 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Major Adverse Cardiac Events (MACE; composite of cardiac death, MI, or ischemia-driven revascularization) or hospitalization for progressive or unstable angina |  | 30 days, 1 year | 
| All-cause, cardiac and non-cardiac mortality |  | 30 days, 1 year and 2 years | 
| All MI, target vessel MI, non-target vessel MI, procedural MI, non-procedural MI |  | 30 days, 1 year and 2 years | 
| Ischemia-driven revascularization, including all revascularization, TVR, TLR, non-TLR TVR, and non-TVR |  | 30 days, 1 year and 2 years | 
| Hospitalization for progressive or unstable ischemia |  | 30 days, 1 year and 2 years | 
| Stent thrombosis (definite, probable and definite/probable) |  | 30 days, 1 year and 2 years | 
| Angina-related Quality of Life | Change from baseline in the Seattle Angina Questionnaire (SAQ-7) summary score | 30 days, 1 year and 2 years | 
| Resource utilization | The [US-based] cost of all health care resources associated with the index procedure and pre-specified event costs throughout the two-year follow up period | 30 days, 1 year and 2 years | 
| Cost effectiveness | Cost per quality-adjusted life years gained | 30 days, 1 year and 2 years |