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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04451044
Recruitment Status : Not yet recruiting
First Posted : June 30, 2020
Last Update Posted : June 30, 2020
Sponsor:
Information provided by (Responsible Party):
Philips Clinical & Medical Affairs Global

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

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 3212 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Distal Evaluation of Functional Performance With Intravascular Sensors to Assess the Narrowing Effect: Guided Physiologic Stenting
Estimated Study Start Date : January 2021
Estimated Primary Completion Date : March 2025
Estimated Study Completion Date : March 2025

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




Primary Outcome Measures :
  1. Target vessel failure (TVF; composite of cardiac death, target vessel-related myocardial infarction (MI), ischemia-driven target vessel revascularization (TVR)) or re-hospitalization for progressive or unstable ischemia [ Time Frame: 2 years ]

Secondary Outcome Measures :
  1. Target vessel failure (composite of cardiac death, target vessel-related MI, ischemia-driven TVR) or re-hospitalization for progressive or unstable ischemia [ Time Frame: 30 days, 1 year ]
  2. Cost effectiveness [ Time Frame: 30 days, 1 year and 2 years ]
    Cost per quality-adjusted life years gained

  3. All-cause, cardiac and non-cardiac mortality [ Time Frame: 30 days, 1 year and 2 years ]
  4. All MI, target vessel MI, non-target vessel MI, procedural MI, non-procedural MI [ Time Frame: 30 days, 1 year and 2 years ]
  5. Ischemia-driven revascularization, including all revascularization, TVR, TLR, non-TLR TVR, and non-TVR [ Time Frame: 30 days, 1 year and 2 years ]
  6. Repeat hospitalization for progressive or unstable ischemia [ Time Frame: 30 days, 1 year and 2 years ]
  7. Stent thrombosis (definite, probable and definite/probable) [ Time Frame: 30 days, 1 year and 2 years ]
  8. 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

  9. 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



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, NSTEMI, or STEMI ≥ 24 hours after symptom onset
  • 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 ACS (unstable angina with ECG changes or cardiac enzyme-positive NSTEMI) with an identified culprit lesion
    2. One or more angiographic stenoses are present with 90% stenosis severity by visual estimation;
    3. One or more angiographic stenoses are present with ≥40% to <90% stenosis severity by visual estimation and an abnormal non-invasive stress test in the distribution of the lesion(s)
    4. One or more angiographic stenoses are present with ≥40% to <90% stenosis severity by visual estimation and a spot iFR measure ≤0.89

Exclusion Criteria:

  • 1. STEMI within 24 hours
  • 2. PCI within the prior 12 months, or any PCI planned after the study procedure (other than planned staged procedures, which are allowed). Exception: Patients with STEMI within 30 days undergoing primary PCI of the index artery only in whom multivessel disease was present may be enrolled and the non-infarct vessels randomized.
  • 3. Silent ischemia
  • 4. Documented prior iFR pullback performed in any coronary artery including during the qualifying diagnostic angiogram
  • 5. Target lesion is in-stent restenosis (ISR)
  • 6. Prior CABG anytime
  • 7. Cardiogenic shock (sustained >20 min) defined as systolic blood pressure <90 mmHg not responding to fluid resuscitation, or need for inotropic, pressor, or device-based hemodynamic support)
  • 8. Presence of unstable ventricular arrhythmias
  • 9. Decompensated congestive heart failure
  • 10. Chronic total occlusion (CTO) of a target vessel (a CTO may be present in a non-target vessel if there is no intent to open the CTO during the index or later procedure)
  • 11. Known severe aortic or mitral valve stenosis/insufficiency
  • 12. Any known non-cardiovascular comorbidity resulting in lifespan <24 months
  • 13. Known left ventricular ejection fraction ≤30%
  • 14. Estimated creatinine clearance (MDRD formula) <30 mL/min or on dialysis
  • 15. Any cardiac or non-cardiac surgical procedure planned within 12 months after enrollment, or any procedure necessitating discontinuation of dual antiplatelet therapy planned within 6 months after enrollment
  • 16. Known pregnancy or planning to become pregnant (women of child-bearing potential must have a negative pregnancy test within 1 week of enrollment)
  • 17. Participating in another investigational drug or device study that has not reached its primary endpoint
  • 18.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
  • 19. 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.

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


Contacts
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Contact: Laura Menck, MA 763-218-0197 DefineGPS@Philips.com

Sponsors and Collaborators
Philips Clinical & Medical Affairs Global
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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: June 30, 2020
Last Verified: June 2020
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