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

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ClinicalTrials.gov Identifier: NCT04451044
Recruitment Status : Enrolling by invitation
First Posted : June 30, 2020
Last Update Posted : May 31, 2023
Sponsor:
Information provided by (Responsible Party):
Philips Clinical & Medical Affairs Global

Study Description
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Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Coronary Artery Disease Ischemic Heart Disease Device: Philips SyncVision system with Philips pressure wires Procedure: standard of care angiographically-guided PCI Not Applicable

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 3212 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Distal Evaluation of Functional Performance With Intravascular Sensors to Assess the Narrowing Effect: Guided Physiologic Stenting
Actual Study Start Date : June 17, 2021
Estimated Primary Completion Date : June 2026
Estimated Study Completion Date : June 2026
Arms and Interventions
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Arm Intervention/treatment
Experimental: physiologically-guided arm
Physiologically-guided PCI using the Philips SyncVision system for determining the PCI strategy
 Device: Philips SyncVision system with Philips pressure wires
Intent to use physiologically-guided PCI using the Philips SyncVision system for determining the PCI strategy
Active Comparator: angiographically-guided arm
Standard of care angiographically-guided PCI for determining the PCI strategy
 Procedure: standard of care angiographically-guided PCI
Intent to use PCI standard of care angiographically-guided PCI for determining the PCI strategy


Outcome Measures
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Primary Outcome Measures :
  1. Major Adverse Cardiac Events (MACE; composite of cardiac death, MI, or ischemia-driven revascularization) or hospitalization for progressive or unstable angina at 2 years [ Time Frame: 2 years ]

Secondary Outcome Measures :
  1. Major Adverse Cardiac Events (MACE; composite of cardiac death, MI, or ischemia-driven revascularization) or hospitalization for progressive or unstable angina [ Time Frame: 30 days, 1 year ]
  2. All-cause, cardiac and non-cardiac mortality [ Time Frame: 30 days, 1 year and 2 years ]
  3. All MI, target vessel MI, non-target vessel MI, procedural MI, non-procedural MI [ Time Frame: 30 days, 1 year and 2 years ]
  4. Ischemia-driven revascularization, including all revascularization, TVR, TLR, non-TLR TVR, and non-TVR [ Time Frame: 30 days, 1 year and 2 years ]
  5. Hospitalization for progressive or unstable ischemia [ Time Frame: 30 days, 1 year and 2 years ]
  6. Stent thrombosis (definite, probable and definite/probable) [ Time Frame: 30 days, 1 year and 2 years ]
  7. Angina-related Quality of Life [ Time Frame: 30 days, 1 year and 2 years ]
    Change from baseline in the Seattle Angina Questionnaire (SAQ-7) summary score

  8. Resource utilization [ Time Frame: 30 days, 1 year and 2 years ]
    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

  9. Cost effectiveness [ Time Frame: 30 days, 1 year and 2 years ]
    Cost per quality-adjusted life years gained


Eligibility Criteria
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Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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 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:

    1. Presenting with NSTE-ACS (unstable angina with ECG changes or cardiac enzyme-positive NSTEMI) with an identified culprit lesion with DS ≥50%;
    2. One or more angiographic stenoses present with ≥80% stenosis severity by visual estimation;
    3. 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;
    4. 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.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04451044


Locations
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Sponsors and Collaborators
Philips Clinical & Medical Affairs Global
Investigators
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Principal Investigator: Allen Jeremias, MD MSC FACC FSCAI Saint Francis Memorial Hospital
Study Chair: Gregg W Stone, MD The Zena and Michael A. Wiener Cardiovascular Institute, Icahn School of Medicine at Mount Sinai
More Information
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Responsible Party: Philips Clinical & Medical Affairs Global
ClinicalTrials.gov Identifier: NCT04451044    
Other Study ID Numbers: 190103
First Posted: June 30, 2020    Key Record Dates
Last Update Posted: May 31, 2023
Last Verified: May 2023
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Product Manufactured in and Exported from the U.S.: Yes
Additional relevant MeSH terms:
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Coronary Artery Disease
Myocardial Ischemia
Heart Diseases
Coronary Disease
 Cardiovascular Diseases
Arteriosclerosis
Arterial Occlusive Diseases
Vascular Diseases