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Validation study of 3-Dimension quantitative coronary angiography determining the ratio between the maximum achievable blood flow in a diseased coronary artery (fractional flow reserve )against pressure wire measured fractional flow reserve.

Validation study of 3-D quantitative coronary angiography derived fractional flow reserve against pressure wire measured fractional flow reserve

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
CTRI
Registry ID
CTRI/2021/10/037341
Enrollment
300
Registered
2021-10-18
Start date
Unknown
Completion date
Unknown
Last updated
2021-11-24

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

Conditions

Health Condition 1: I214- Non-ST elevation (NSTEMI) myocardial infarction

Interventions

None listed

Sponsors

siemens healthcare private limited
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: Adult patients aged above 18 years with chronic coronary syndrome or acute coronary syndrome (unstable angina/non-ST elevation myocardial infarction) after 24 hours free of angina and those who would be showing intermediate coronary artery stenosis (40%-70% diameter stenosis by visual estimation) will be included in the study.

Exclusion criteria

Exclusion criteria: Exclusion criteria a. ST elevation myocardial infarction (STEMI) b. Previous STEMI in the same vessel will be being interrogated c. Previous PCI in the same vessel will be being interrogated d. LMCA lesions e. Bifurcation lesions f. Instent restenosis g. Patient with ongoing arrhythmias (supraventricular arrhythmias, atrial fibrillation or ventricular arrhythmias) h. Previous coronary artery bypass surgery (CABG) i. Previous heart valve surgery (Transcatheter or open surgery) j. Co-existing more than mild valvular stenosis or regurgitation k. Previous heart transplantation l. Left ventricular ejection fraction m. Less than thrombolysis in myocardial infarction (TIMI) 3 flow n. Chronic total occlusions o. Severe diffuse disease p. Target vessel supplied by collaterals q. Not willing to provide informed consent

Design outcomes

Primary

MeasureTime frame
Primary endpoint of the study is the sensitivity of vFFR for predicting FFR per vessel with an abnormal FFR defined as â?¤ 0.80 and a normal FFR as 0.80.Timepoint: At baseline

Secondary

MeasureTime frame
Secondary endpoint of the study is the specificity of vFFR for predicting FFR per vessel with an abnormal FFR defined as â?¤ 0.80 and a normal FFR as 0.80.Timepoint: At baseline

Countries

India

Contacts

Public ContactDrAjit Mullasari S

The Madras Medical Mission

clireco@mmm.org.in914426565974

Outcome results

None listed

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