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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT04451044




Registration number
NCT04451044
Ethics application status
Date submitted
23/06/2020
Date registered
30/06/2020
Date last updated
12/08/2024

Titles & IDs
Public title
Distal Evaluation of Functional Performance With Intravascular Sensors to Assess the Narrowing Effect: Guided Physiologic Stenting
Scientific title
Distal Evaluation of Functional Performance With Intravascular Sensors to Assess the Narrowing Effect: Guided Physiologic Stenting
Secondary ID [1] 0 0
190103
Universal Trial Number (UTN)
Trial acronym
DEFINE GPS
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Coronary Artery Disease 0 0
Ischemic Heart Disease 0 0
Condition category
Condition code
Cardiovascular 0 0 0 0
Coronary heart disease
Cardiovascular 0 0 0 0
Other cardiovascular diseases

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Devices - Philips SyncVision system with Philips pressure wires
Treatment: Surgery - standard of care angiographically-guided PCI

Experimental: physiologically-guided arm - 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


Treatment: Devices: Philips SyncVision system with Philips pressure wires
Intent to use physiologically-guided PCI using the Philips SyncVision system for determining the PCI strategy

Treatment: Surgery: standard of care angiographically-guided PCI
Intent to use PCI standard of care angiographically-guided PCI for determining the PCI strategy
Intervention code [1] 0 0
Treatment: Devices
Intervention code [2] 0 0
Treatment: Surgery
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Major Adverse Cardiac Events (MACE; composite of cardiac death, target vessel MI (TVMI), or ischemia-driven revascularization) or hospitalization for progressive or unstable angina at 2 years
Timepoint [1] 0 0
2 years
Secondary outcome [1] 0 0
Major Adverse Cardiac Events (MACE; composite of cardiac death, target vessel MI (TVMI), or ischemia-driven revascularization) or hospitalization for progressive or unstable angina
Timepoint [1] 0 0
30 days, 1 year
Secondary outcome [2] 0 0
All-cause, cardiac and non-cardiac mortality
Timepoint [2] 0 0
30 days, 1 year and 2 years
Secondary outcome [3] 0 0
All MI, target vessel MI, non-target vessel MI, procedural MI, non-procedural MI
Timepoint [3] 0 0
30 days, 1 year and 2 years
Secondary outcome [4] 0 0
Ischemia-driven revascularization, including all revascularization, TVR, TLR, non-TLR TVR, and non-TVR
Timepoint [4] 0 0
30 days, 1 year and 2 years
Secondary outcome [5] 0 0
Hospitalization for progressive or unstable ischemia
Timepoint [5] 0 0
30 days, 1 year and 2 years
Secondary outcome [6] 0 0
Stent thrombosis (definite, probable and definite/probable)
Timepoint [6] 0 0
30 days, 1 year and 2 years
Secondary outcome [7] 0 0
Angina-related Quality of Life
Timepoint [7] 0 0
30 days, 1 year and 2 years
Secondary outcome [8] 0 0
Resource utilization
Timepoint [8] 0 0
30 days, 1 year and 2 years
Secondary outcome [9] 0 0
Cost effectiveness
Timepoint [9] 0 0
30 days, 1 year and 2 years

Eligibility
Key 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
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key 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.

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s

The people assessing the outcomes
Intervention assignment
Parallel
Other design features
Phase
Not applicable
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
17/06/2021
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
1/06/2028
Actual
Sample size
Target
3212
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW
Recruitment hospital [1] 0 0
Gosford Hospital - Gosford
Recruitment hospital [2] 0 0
Liverpool Hospital - Liverpool
Recruitment hospital [3] 0 0
Royal North Shore Hospital - Saint Leonards
Recruitment hospital [4] 0 0
Prince of Wales Hospital - Sydney
Recruitment hospital [5] 0 0
Lake Macquarie Private Hospital - Gateshead
Recruitment postcode(s) [1] 0 0
- Gosford
Recruitment postcode(s) [2] 0 0
- Liverpool
Recruitment postcode(s) [3] 0 0
- Saint Leonards
Recruitment postcode(s) [4] 0 0
- Sydney
Recruitment postcode(s) [5] 0 0
- Gateshead
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
Alabama
Country [2] 0 0
United States of America
State/province [2] 0 0
Arizona
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United States of America
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Arkansas
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United States of America
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California
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United States of America
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Colorado
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United States of America
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Connecticut
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United States of America
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District of Columbia
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United States of America
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Florida
Country [9] 0 0
United States of America
State/province [9] 0 0
Georgia
Country [10] 0 0
United States of America
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Hawaii
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United States of America
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Illinois
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Indiana
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Kansas
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United States of America
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Massachusetts
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Minnesota
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Missouri
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Nebraska
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New Hampshire
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New York
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North Carolina
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Ohio
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Pennsylvania
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South Dakota
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Tennessee
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Texas
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Virginia
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Wisconsin
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Austria
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Feldkirch
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Canada
State/province [29] 0 0
British Columbia
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Canada
State/province [30] 0 0
Quebec
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Canada
State/province [31] 0 0
Brampton
Country [32] 0 0
Canada
State/province [32] 0 0
Montréal
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Canada
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Toronto
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Denmark
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Aarhus
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France
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Lille
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France
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Nîmes
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Germany
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Berlin
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Germany
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Erlangen
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Germany
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Essen
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Germany
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Freiburg
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Israel
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Hadera
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Israel
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Tel Aviv
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Italy
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Florence
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Korea, Republic of
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Bucheon
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Korea, Republic of
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Daegu
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Korea, Republic of
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Seoul
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Mexico
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Querétaro
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Netherlands
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Dordrecht
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Netherlands
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Enschede
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Netherlands
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Leeuwarden
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Netherlands
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Nieuwegein
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Netherlands
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Nijmegen
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Poland
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Warsaw
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Portugal
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Amadora
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Spain
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Córdoba
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León
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Spain
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Madrid
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Spain
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Santander
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Sweden
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Lund
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Sweden
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Örebro
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Switzerland
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Geneva
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United Kingdom
State/province [62] 0 0
Hampshire
Country [63] 0 0
United Kingdom
State/province [63] 0 0
Wales
Country [64] 0 0
United Kingdom
State/province [64] 0 0
Bournemouth
Country [65] 0 0
United Kingdom
State/province [65] 0 0
London

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
Philips Clinical & Medical Affairs Global
Address
Country

Ethics approval
Ethics application status

Summary
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.
Trial website
https://clinicaltrials.gov/study/NCT04451044
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Allen Jeremias, MD MSC FACC FSCAI
Address 0 0
Saint Francis Hospital
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/study/NCT04451044