Prospective, multicenter, open-label, investigator-initiated, post marketing interventional study

Not Applicable

• Conditions: Stable angina Recent and stabilized NSTEMI; coronary angiography; NSTEMI; STEMI; PCI; FFR; RFR; Anatamical Syntax score; Functional syntax score

• Registration Number: TCTR20190915003
• Lead Sponsor: Siriraj Hospital

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2019-09-15
• Study Completion: 2021-07-14
• Last Update Posted: 19 August 2024

Recruitment & Eligibility

• Status: Pending (Not yet recruiting)
• Sex: All
• Target Recruitment: 650

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 braches 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 (≥50-90% diameter stenosis).

- All lesions are amenable to revascularization

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

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Change in treatment strategy after physiologic assessment At Day 1 FFR and Coronary Angiography,Healthcare costs At 12 months after treatment From cost of procedures

Secondary Outcome Measures

Name	Time	Method
The percentage rate of concordance between FFR and RFR At day 1 & at 12 month after treatment FFR and RFR,The percentage rate of concordance in functional SS between RFR and FFR At 12 months after treatment FFR and RFR,Clinical outcomes in concordance | discordant group At day 1 , At day 30 and at 12 month after treatment FFR and RFR,Composite of MACCE (all-cause death, documented MI, stroke or unplanned revascularization) 12 month after treatment Patient reporting,Rates of individual components of MACE 12 month after treatment Patient reporting,Level of agreement in the decision making strategy At Day 1 FFR and RFR,Functional SYNTAX score calculation based on FFR At Day 1 FFR,Change in health status of patients from baseline to one year At 12 month after treatment EQ-5D-5