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

Sponsor
Philips Clinical & Medical Affairs Global (Industry)
Overall Status
Enrolling by invitation
CT.gov ID
NCT04451044
Collaborator
(none)
3,212
Enrollment
41
Locations
2
Arms
47.5
Anticipated Duration (Months)
78.3
Patients Per Site
1.7
Patients Per Site Per Month

Study Details

Study Description

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
  • Device: Philips SyncVision system with Philips pressure wires
  • Procedure: standard of care angiographically-guided PCI
 N/A

Study Design

Study Type:
Interventional
Anticipated 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 :
Jun 17, 2021
Anticipated Primary Completion Date :
Jun 1, 2025
Anticipated Study Completion Date :
Jun 1, 2025

Arms and Interventions

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

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 [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 [30 days, 1 year]

  2. All-cause, cardiac and non-cardiac mortality [30 days, 1 year and 2 years]

  3. All MI, target vessel MI, non-target vessel MI, procedural MI, non-procedural MI [30 days, 1 year and 2 years]

  4. Ischemia-driven revascularization, including all revascularization, TVR, TLR, non-TLR TVR, and non-TVR [30 days, 1 year and 2 years]

  5. Hospitalization for progressive or unstable ischemia [30 days, 1 year and 2 years]

  6. Stent thrombosis (definite, probable and definite/probable) [30 days, 1 year and 2 years]

  7. Angina-related Quality of Life [30 days, 1 year and 2 years]

    Change from baseline in the Seattle Angina Questionnaire (SAQ-7) summary score

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

    Cost per quality-adjusted life years gained

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
Inclusion Criteria:
    1. Adult men and women (local age of consent) who present with stable or unstable angina, or NSTEMI.
    1. Undergoing cardiac catheterization with planned PCI or possible ad hoc PCI
    1. 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
    1. 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)
    1. Prior CABG anytime
    1. Silent ischemia only (i.e. no cardiac symptoms related to coronary artery disease) within the prior 4 weeks
    1. Documented prior iFR pullback performed in any coronary artery including during the qualifying diagnostic angiogram
    1. Any vessel with in-stent restenosis (ISR) requiring treatment
    1. 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
    1. Presence of unstable ventricular arrhythmias
    1. Heart rate > 110, including uncontrolled atrial fibrillation (AF)
    1. Decompensated congestive heart failure (NYHA Class IV or Killip Class III or IV)
    1. 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)
    1. 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
    1. Any angiographic giant thrombus (i.e., thrombus length > 3x RVD at lesion)
    1. Any target vessel with < TIMI III flow
    1. Any target lesion with a reference vessel diameter (RVD) less than 2.25mm except for within the side branch of a bifurcation lesion
    1. 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)
    1. Known severe aortic or mitral valve stenosis/insufficiency
    1. Known non-cardiovascular comorbidity resulting in lifespan <24 months
    1. Known left ventricular ejection fraction ≤30%
    1. Estimated creatinine clearance (MDRD formula) <30 mL/min/1.73m2 or on dialysis
    1. 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
    1. Known pregnancy or planning to become pregnant (women of child-bearing potential must have a negative pregnancy test within 1 week of enrollment)
    1. Participating in another investigational drug or device study that has not reached its primary endpoint
    1. 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
    1. 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

Locations

Site City State Country Postal Code
1 Pima Heart & Vascular Tucson Arizona United States 85716
2 Central Arkansas Veterans Healthcare System (CAVHS) Little Rock Arkansas United States 72205
3 Colorado Heart and Vascular Lakewood Colorado United States 80228
4 MedStar Washington Hospital Center Washington District of Columbia United States 20010
5 Memorial Healthcare Hollywood Florida United States 33201
6 Tampa Cardiovascular Innovations and Research Tampa Florida United States 33607
7 Emory University Hospital Atlanta Georgia United States 30322
8 Northeast Georgia Medical Center Gainesville Georgia United States 30501
9 Northwest Community Hospital Arlington Heights Illinois United States 60005
10 Carle Foundation Hospital Urbana Illinois United States 61801
11 Mass General Boston Massachusetts United States 02114
12 Brigham and Women's Hospital Boston Massachusetts United States 02115
13 Fairview Health Services Edina Minnesota United States 55435
14 Washington University School of Medicine Saint Louis Missouri United States 63110
15 University of Nebraska Medical Center Omaha Nebraska United States 68198
16 AtlantiCare Regional Medical Center Pomona New Jersey United States 08240
17 Northwell Health Lake Success New York United States 11042
18 Columbia University Medical Center New York New York United States 10032
19 St. Francis Hospital Roslyn New York United States 11576
20 NC Heart and Vascular Research, LLC Raleigh North Carolina United States 27607
21 Summa Health System Akron Ohio United States 44304
22 Cleveland Clinic Cleveland Ohio United States 44195
23 Bryn Mawr Hospital Bryn Mawr Pennsylvania United States 19010
24 UPMC Presbyterian Pittsburgh Pennsylvania United States 15213
25 Lankenau Medical Center Wynnewood Pennsylvania United States 19096
26 North Central Heart Sioux Falls South Dakota United States 57108
27 Centennial Medical Center Nashville Tennessee United States 37203
28 Baylor Scott & White, The Heart Hospital Plano Plano Texas United States 75093
29 Akademisches Lehrkrankenhaus Feldkirch Feldkirch Austria
30 Royal Columbian Hospital New Westminster British Columbia Canada
31 CHU Lille, Institut Coeur Poumon Lille France
32 CHU Nimes Caremeau Nîmes France
33 Vivantes Klinikum im Friedrichshain Berlin Germany 10249
34 Albert Schweitzer Ziekenhuis / Hartcentum Dordrecht- Gorinchem Dordrecht Netherlands
35 Medisch Spectrum Twente Enschede Netherlands
36 Medisch Centrum Leeuwarden Leeuwarden Netherlands
37 Hospital Universitario Reina Sofía Córdoba Spain
38 Hospital Universitario Marqués de Valdecillas Santander Spain
39 Skane University Hospital Lund Sweden
40 Geneva University Hospital Geneva Switzerland
41 University Hospital Southampton Southampton Hampshire United Kingdom S016 6YD

Sponsors and Collaborators

  • Philips Clinical & Medical Affairs Global

Investigators

  • 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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Philips Clinical & Medical Affairs Global
ClinicalTrials.gov Identifier:
NCT04451044
Other Study ID Numbers:
  • 190103
First Posted:
Jun 30, 2020
Last Update Posted:
Jun 30, 2022
Last Verified:
Jun 1, 2022
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
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:
Coronary Artery Disease
Myocardial Ischemia
Heart Diseases

Study Results

No Results Posted as of Jun 30, 2022