COMparison of clinical outcomes Following percutaneous coronary intervention versus Optimal medical therapy based on gray zone fractional flow Reserve in sTABLE angina patients with intermediate coronary artery stenosis

COMparison of clinical outcomes Following percutaneous coronary intervention versus Optimal medical therapy based on gray zone fractional flow Reserve in sTABLE angina patients with intermediate coronary artery stenosis - COMFORTABLE prospective

Status

Recruiting

Phases

Unknown

Study type

Interventional

Source

JPRN

Registry ID

JPRN-UMIN000031526

Enrollment

410

Registered

2018-03-01

Start date

2020-05-26

Completion date

Unknown

Last updated

2026-06-29

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

Conditions

coronary artery disease

Interventions

percutaneous coronary intervention (PCI) + medical therapy medical therapy alone

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1. Patients with an intermediate coronary lesion presenting with FFR between 0.75 and 0.80 2. Patients must be more than 20 years old. 3. Provision of informed consent prior to any study specific procedures

Exclusion criteria

Exclusion criteria: 1. culprit vessel in acute coronary syndrome 2. patients with untreated significant lesions (%DS>70 and/or FFR <0.75) in coronary arteries other than the target vessel. 3. unstable hemodynamics 4. hemodyalysis 5. previous bypass graft surgery 6. allergy to antiplatelet therapy, anticoagulants, and contrast medium 7. intracranial and/or gastrointestinal bleeding 8. planned surgical procedure within 12 months 9. Known terminal disease with a life expectancy of less than 12 months 10. pregnant women 11. significant valvular disease 12. 13.1. left main disease (%DS > 50%) or planned PCI to left main disease 13.2 chronic total occlusion 13.3 Heavily calcified or tortuous vessels where inability to cross the lesion with a pressure wire is expected. 13.4 diffuse diseases, heavily calcified lesions, small vessels, and/or aneurysmal lesions where PCI is thought to be unsuitable by operators.

Design outcomes

Primary

Measure	Time frame
Major adverse cardiac events defined as a composite of death, non-fatal myocardial infarction, and unplanned target vessel revascularisation	—

Secondary

Measure	Time frame
- MACE at 2 and 5 years - death from any cause at 1, 2, and 5 years - cardiovascular death at 1, 2, and 5 years - target vessel myocardial infarction at 1, 2, and 5 years - non-target vessel myocardial infarction at 1, 2, and 5 years - all myocardial infarction at 1, 2, and 5 years - target vessel revascularisation at 1, 2, and 5 years - non-target vessel revascularisation at 1, 2, and 5 years - all revascularisation at 1, 2, and 5 years - stent thrombosis at 1, 2, and 5 years - angina symptom assessed by Canadian Cardiovascular Society (CCS) functional classification at 1, 2, and 5 years	—

Measure

Time frame

- MACE at 2 and 5 years - death from any cause at 1, 2, and 5 years - cardiovascular death at 1, 2, and 5 years - target vessel myocardial infarction at 1, 2, and 5 years - non-target vessel myocardial infarction at 1, 2, and 5 years - all myocardial infarction at 1, 2, and 5 years - target vessel revascularisation at 1, 2, and 5 years - non-target vessel revascularisation at 1, 2, and 5 years - all revascularisation at 1, 2, and 5 years - stent thrombosis at 1, 2, and 5 years - angina symptom assessed by Canadian Cardiovascular Society (CCS) functional classification at 1, 2, and 5 years

—

Countries

Japan

Contacts

Public ContactYasutsugu Shiono

Wakayama Medical University Cardiovascular Medicine

doors@herb.ocn.ne.jp073-441-0621

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026