Trial Review

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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/ct2/show/NCT04789317




Registration number
NCT04789317
Ethics application status
Date submitted
26/02/2021
Date registered
9/03/2021
Date last updated
9/03/2021

Titles & IDs
Public title
Pullback Pressure Gradient (PPG) Global Registry
Scientific title
Pullback Pressure Gradient (PPG) Global Registry: Prospective Evaluation of the Impact of the PPG Index on Clinical Decision Making and Outcomes
Secondary ID [1] 0 0
CRI050
Universal Trial Number (UTN)
Trial acronym
PPG Global
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Chronic Coronary Insufficiency 0 0
Non ST Elevation Myocardial Infarction 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
Observational [Patient Registry]
Patient registry
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
Stable CAD or stabilized NSTEMI (ACS) with significant epicardial lesions defined as FFR=0.80. - The PPG Global Registry an investigator-initiated, observational, multicenter study of patients with an indication for PCI based on coronary angiography and FFR =0.80. After confirmation of intention to treat with PCI, a manual pullback with PPG analysis will be performed. A second level of decision making is then performed concerning PCI, coronary artery bypass grafting (CABG) or medical therapy (OMT). Patients will undergo PCI at operator discretion and post-PCI FFR will be measured. Clinical follow-up will be performed at 1, 2 and 3 years.
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Predictive capacity of the PPG index for post-PCI FFR.
Timepoint [1] 0 0
1 year
Secondary outcome [1] 0 0
To assess the relationship between baseline PPG index and major adverse cardiovascular events (cardiac death, peri-procedural and spontaneous myocardial infarction and target vessel revascularization) at one, two and three years.
Timepoint [1] 0 0
3 years after completion of inclusion
Secondary outcome [2] 0 0
Difference between baseline and 12 month follow-up in the Seattle Angina Questionnaire (SAQ) stratified by PPG index.
Timepoint [2] 0 0
1 years after completion of inclusion

Eligibility
Key inclusion criteria
- Consecutive patients with stable coronary artery disease or stabilized acute coronary
syndrome and invasive FFR measurement =0.80.
Minimum age
18 Years
Maximum age
100 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
- Angiographic exclusion criteria

1. Ostial lesions.

2. Severe vessel tortuosity.

3. Vessel rewiring deemed 'difficult' by the operator.

4. Bifurcation with planned two-stent strategy.

5. NSTEMI culprit vessel.

6. STEMI

7. Uncontrolled or recurrent ventricular tachycardia.

8. Hemodynamic instability

9. Severe renal dysfunction, defined as an eGFR <30 mL/min/1.73 m2

Study design
Purpose
Duration
Selection
Timing
Prospective
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
23/12/2020
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
31/12/2025
Actual
Sample size
Target
982
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
Clayton VI
Recruitment hospital [1] 0 0
Monash Medical Center - Melbourne
Recruitment postcode(s) [1] 0 0
3168 - Melbourne
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
Texas
Country [2] 0 0
Belgium
State/province [2] 0 0
Oost-Vlaanderen
Country [3] 0 0
Italy
State/province [3] 0 0
Milan
Country [4] 0 0
Japan
State/province [4] 0 0
Tokyo
Country [5] 0 0
United Kingdom
State/province [5] 0 0
Glasgow
Country [6] 0 0
United Kingdom
State/province [6] 0 0
London

Funding & Sponsors
Primary sponsor type
Other
Name
VZW Cardiovascular Research Center Aalst
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
The purpose of this study is to determine the predictive capacity of the Pullback Pressure
Gradient (PPG) index for post-PCI FFR and to determine the impact of the PPG index on
clinical decision making about revascularization and on clinical outcomes.
Trial website
https://clinicaltrials.gov/ct2/show/NCT04789317
Trial related presentations / publications
Collet C, Sonck J, Vandeloo B, Mizukami T, Roosens B, Lochy S, Argacha JF, Schoors D, Colaiori I, Di Gioia G, Kodeboina M, Suzuki H, Van 't Veer M, Bartunek J, Barbato E, Cosyns B, De Bruyne B. Measurement of Hyperemic Pullback Pressure Gradients to Characterize Patterns of Coronary Atherosclerosis. J Am Coll Cardiol. 2019 Oct 8;74(14):1772-1784. doi: 10.1016/j.jacc.2019.07.072.
Public notes

Contacts
Principal investigator
Name 0 0
Carlos Collet, MD PhD
Address 0 0
OLV Hospital
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Carlos Collet, MD PhD
Address 0 0
Country 0 0
Phone 0 0
003253721927
Fax 0 0
Email 0 0
[email protected]
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/ct2/show/NCT04789317