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

Coronary Artery Disease Clinical Trial

— DEFINE GPS  

Official title:

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

Clinical Trial Details — Status: Enrolling by invitation

Administrative data

• NCT number: NCT04451044
• Other study ID #: 190103
• Status: Enrolling by invitation
• Phase: N/A
• Start date: June 17, 2021
• Est. completion date: June 2026

Study information

• Verified date: December 2023
• Source: Philips Clinical & Medical Affairs Global
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Enrolling by invitation
• Enrollment: 3212
• Est. completion date: June 2026
• Est. primary completion date: June 2026
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Coronary Artery Disease
• Heart Diseases
• Ischemic Heart Disease
• Myocardial Ischemia

Intervention

Device:
• Philips SyncVision system with Philips pressure wires
Intent to use physiologically-guided PCI using the Philips SyncVision system 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

Locations

Country	Name	City	State
Australia	Lake Macquarie Private Hospital	Gateshead
Australia	Gosford Hospital	Gosford	New South Wales
Australia	Liverpool Hospital	Liverpool	New South Wales
Australia	Royal North Shore Hospital	Saint Leonards	New South Wales
Australia	Prince of Wales Hospital	Sydney	New South Wales
Austria	Akademisches Lehrkrankenhaus Feldkirch	Feldkirch
Belgium	Imeldaziekenhuis Bonheiden	Bonheiden
Canada	William Osler Health-Brampton Civic Hospital	Brampton
Canada	Hopital du Sacre-Coeur de Montreal	Montréal
Canada	Montreal Heart Institute	Montréal	Quebec
Canada	Royal Columbian Hospital	New Westminster	British Columbia
Canada	St. Michael's Hospital	Toronto
Denmark	Aarhus University Hospital	Aarhus
France	CHU Lille, Institut Coeur Poumon	Lille
France	CHU Nimes Caremeau	Nîmes
Germany	Vivantes Klinikum im Friedrichshain	Berlin
Germany	Erlangen University Hospital	Erlangen
Germany	University Hospital Essen	Essen
Germany	Universitsklinik Freiburg	Freiburg
Israel	Hillel Yaffe Medical Center	Hadera
Israel	Shamir Medical Center	Tel Aviv
Mexico	Hospital General Querétaro	Querétaro
Netherlands	Albert Schweitzer Ziekenhuis / Hartcentum Dordrecht- Gorinchem	Dordrecht
Netherlands	Medisch Spectrum Twente	Enschede
Netherlands	Medisch Centrum Leeuwarden	Leeuwarden
Netherlands	Radboud University Med Ctr	Nijmegen
Portugal	Hospital Prof. Doutour Fernando Foneseca	Amadora
Spain	Hospital Universitario Reina Sofía	Córdoba
Spain	Hospital Universitario de Leon	León
Spain	Hospital Clinico San Carlos	Madrid
Spain	Hospital Universitario Marqués de Valdecillas	Santander
Sweden	Skane University Hospital	Lund
Switzerland	Geneva University Hospital	Geneva
United Kingdom	Royal Bournemouth Hospital	Bournemouth
United Kingdom	University Hospital of Wales	Cardiff	Wales
United Kingdom	Imperial College Healthcare NHS Trust	London
United Kingdom	University Hospital Southampton	Southampton	Hampshire
United States	Summa Health System	Akron	Ohio
United States	Northwest Community Hospital	Arlington Heights	Illinois
United States	Emory University Hospital	Atlanta	Georgia
United States	University of Alabama Birmingham	Birmingham	Alabama
United States	Brigham and Women's Hospital	Boston	Massachusetts
United States	Mass General	Boston	Massachusetts
United States	Bryn Mawr Hospital	Bryn Mawr	Pennsylvania
United States	Gates Vascular Institute	Buffalo	New York
United States	Cleveland Clinic	Cleveland	Ohio
United States	Fairview Health Services	Edina	Minnesota
United States	Northeast Georgia Medical Center	Gainesville	Georgia
United States	Memorial Healthcare	Hollywood	Florida
United States	Straub Medical Center	Honolulu	Hawaii
United States	University of Kansas Medical Center	Kansas City	Kansas
United States	Gundersen Health	La Crosse	Wisconsin
United States	Northwell Health	Lake Success	New York
United States	Colorado Heart and Vascular	Lakewood	Colorado
United States	Dartmouth-Hitchcock Medical Center	Lebanon	New Hampshire
United States	Central Arkansas Veterans Healthcare System (CAVHS)	Little Rock	Arkansas
United States	Community Healthcare System	Munster	Indiana
United States	Centennial Medical Center	Nashville	Tennessee
United States	Yale University	New Haven	Connecticut
United States	Columbia University Medical Center	New York	New York
United States	University of Nebraska Medical Center	Omaha	Nebraska
United States	UPMC Presbyterian	Pittsburgh	Pennsylvania
United States	Baylor Scott & White, The Heart Hospital Plano	Plano	Texas
United States	NC Heart and Vascular Research, LLC	Raleigh	North Carolina
United States	St. Francis Hospital	Roslyn	New York
United States	Washington University School of Medicine	Saint Louis	Missouri
United States	North Central Heart	Sioux Falls	South Dakota
United States	Tampa Cardiovascular Innovations and Research	Tampa	Florida
United States	Pima Heart & Vascular	Tucson	Arizona
United States	Carle Foundation Hospital	Urbana	Illinois
United States	MedStar Washington Hospital Center	Washington	District of Columbia
United States	Lankenau Medical Center	Wynnewood	Pennsylvania

Sponsors (1)

Lead Sponsor	Collaborator
Philips Clinical & Medical Affairs Global

Countries where clinical trial is conducted

United States,  Australia,  Austria,  Belgium,  Canada,  Denmark,  France,  Germany,  Israel,  Mexico,  Netherlands,  Portugal,  Spain,  Sweden,  Switzerland,  United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	All-cause, cardiac and non-cardiac mortality		30 days, 1 year and 2 years
Secondary	All MI, target vessel MI, non-target vessel MI, procedural MI, non-procedural MI		30 days, 1 year and 2 years
Secondary	Ischemia-driven revascularization, including all revascularization, TVR, TLR, non-TLR TVR, and non-TVR		30 days, 1 year and 2 years
Secondary	Hospitalization for progressive or unstable ischemia		30 days, 1 year and 2 years
Secondary	Stent thrombosis (definite, probable and definite/probable)		30 days, 1 year and 2 years
Secondary	Angina-related Quality of Life	Change from baseline in the Seattle Angina Questionnaire (SAQ-7) summary score	30 days, 1 year and 2 years
Secondary	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
Secondary	Cost effectiveness	Cost per quality-adjusted life years gained	30 days, 1 year and 2 years