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Comparison of treatment strategy for Multi-Vessel Disease (MVD) patients between conventional angiography and FFR based on SYNTAX score in a real-world scenario

The use of physiologic assessment and functional SYNTAX score in influencing the treatment strategy for Multi-Vessel Disease (MVD) patients involving intermediate decisions compared to conventional angiography and anatomical SYNTAX score in a real-world scenario

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2020/09/027770
Enrollment
650
Registered
2020-09-11
Start date
Unknown
Completion date
Unknown
Last updated
2025-08-18

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Health Condition 1: I248- Other forms of acute ischemic heart disease

Interventions

Intervention1: Angiogram & FFR/RFR: Patients will undergo a diagnostic coronary angiogram followed by FFR/RFR as per the routine clinical practice. Control Intervention1: Not applicable: Not applicabl

Sponsors

Dr Nattawut Wongpraparut from Faculty of Medicine Siriraj Hospital
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: 1. Age >18 years 2. Willing to participate and able to understand, read and sign the informed consent document before the planned procedure 3. Eligible for coronary angiography and/or percutaneous coronary intervention 4. Stable angina 5. Recent and stabilized NSTEMI Angiographic inclusion criteria - Coronary artery disease in two or more native major epicardial vessels or their branches by coronary angiogram with visually assessed de novo coronary stenosis in which one of the lesion has the physiological severity of the lesion is in question (typically 50-90% diameter stenosis) - All lesions are amenable to revascularization

Exclusion criteria

Exclusion criteria: - Terminal disease with life expectancy of less than 12 months - Any patient who at the time of planned angiography has ongoing ischemic symptoms - Angiography performed in the context of primary PCI of STEMI - Acute coronary syndrome with difficulty in assessing the culprit lesion - Pregnancy - Severe aortic stenosis - Significant valvular heart disease indicated for concomitant valve surgery - Cardiogenic shock or hemodynamic instability - Contraindication to adenosine - Previous CABG - Additional investigations planned for the assessment of myocardial viability. - Severe asthma Angiographic exclusion criteria - Heavily calcified or tortuous vessels that in the opinion of the investigator would result in uncrossable of pressure wire

Design outcomes

Primary

MeasureTime frame
Change in treatment strategy after physiologic assessment Healthcare costs Timepoint: In-hospital and at 1 year

Secondary

MeasureTime frame
The percentage rate of concordance between FFR and RFR  Procedural time Level of agreement in the decision-making strategy based on invasive angiography and physiologic assessment Functional SYNTAX score calculation based on FFR Composite of MACCE (all-cause death, documented myocardial infarction, stroke or unplanned revascularization) Rates of individual components of MACE Change in health status of patients from baselineTimepoint: IN-Hospital, 30 days and 1 year

Countries

Hong Kong, India, Thailand

Contacts

Public ContactDr Amol Gramle

BioQuest Solutions Pvt Ltd

gramle.amol@bioquestglobal.com

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 4, 2026