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A single-center, blind, randomized, noninferior-effect clinical trial of percutaneous coronary intervention by comparing coronary angiography blood flow reserve fraction (caFFR) with clinical observation.

A single-center, blind, randomized, noninferior-effect clinical trial of percutaneous coronary intervention by comparing coronary angiography blood flow reserve fraction (caFFR) with clinical observation.

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2100046714
Enrollment
Unknown
Registered
2021-05-27
Start date
2020-11-23
Completion date
Unknown
Last updated
2022-01-10

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

Conditions

Coronary artery disease

Interventions

caFFR group:The degree of myocardial ischemia was measured using coronary angiographic flow reserve fraction,thus the diagnosis and treatment plan was given
Control group:Diagnosis and treatment plan was determined based on the results of angiography

Sponsors

The University of Hong Kong- Shenzhen Hospital
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to No maximum

Inclusion criteria

Inclusion criteria: 1.For patients with stable or unstable angina pectoris, coronary angiography can be performed; 2.Coronary artery lesion diameter stenosis of 30%-90%. 3.Aged 18 or above, gender unlimited; 4.Intensive angiography is considered necessary and feasible, with PCI if necessary; 5.Non-convict vascular assessment of patients with suspected coronary heart disease and acute non-ST-elevation; myocardial infarction, and non-convict vascular assessment of patients with previous ST-elevation myocardial infarction; 6.Subjects volunteered to participate in the clinical trial and signed the informed consent.

Exclusion criteria

Exclusion criteria: 1. Patients with severe heart disease; 2. Congenital heart disease; 3 Patients with prior CABG or treatment with chronic obstructive vascular predisposition to CABG; 4. Patients lost to follow-up without follow-up; 5. Acute ST-segment elevation myocardial infarction within 6 days; 6. Cardiogenic shock or left ventricular ejection fraction <= 50%; 7. EGFR < 30ml/min(1.73m2); 8. Patients with severe coagulation dysfunction or hemorrhagic diseases; 9. People who are allergic to iodine contrast agent or adenosine and adenosine is not suitable for them; 10. Subsequent plans for heart valve or aortic surgery; 11. Expected survival of less than 1 year; 12. Women who are pregnant or who plan to become pregnant in the near future; 13. The subject has participated in or is participating in the clinical trial of any other device or drug within the last 1 month; 14. The investigator believes that there are other conditions in the subjects that are not suitable for the clinical trial.

Design outcomes

Primary

MeasureTime frame
MACE;

Secondary

MeasureTime frame
The composite end point was all-cause death, myocardial infarction (excluding perioperative MI), and unplanned revascularization;Cardiovascular, non-cardiovascular, and undetermined deaths;Target vascular-related and non-target vascular-related MI;Target vessel revascularization (TVR);Any coronary revascularization;Clear and possible stent thrombosis;Evaluation of health economics;Analysis of subjects' discomfort during the examination;

Countries

China

Contacts

Public ContactKai Hang Yiu

The University of Hong Kong - Shenzhen Hospital

khkyiu@hku.hk+852 22554694

Outcome results

None listed

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