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Trial details imported from ClinicalTrials.gov

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




Registration number
NCT04789317
Ethics application status
Date submitted
26/02/2021
Date registered
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
Trial website
Trial related presentations / publications
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
carloscollet@gmail.com
Contact person for scientific queries

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

No documents have been uploaded by study researchers.


Results not provided in https://clinicaltrials.gov/study/NCT04789317