Unique ID issued by UMIN | UMIN000031526 |
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Receipt number | R000035999 |
Scientific Title | 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 |
Date of disclosure of the study information | 2018/03/01 |
Last modified on | 2020/05/26 14:53:58 |
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
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
Japan |
coronary artery disease
Cardiology |
Others
NO
To determine whether percutaneous coronary intervention (PCI) plus medical therapy is superior to medical therapy alone in reducing major cardiovascular events in patients presenting coronary stenosis with grey-zone fractional flow reserve (FFR).
Efficacy
Major adverse cardiac events defined as a composite of death, non-fatal myocardial infarction, and unplanned target vessel revascularisation
- 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
Interventional
Parallel
Randomized
Individual
Open -no one is blinded
Active
2
Treatment
Device,equipment |
percutaneous coronary intervention (PCI) + medical therapy
medical therapy alone
20 | years-old | <= |
Not applicable |
Male and Female
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
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.
410
1st name | Takashi |
Middle name | |
Last name | Akasaka |
Wakayama Medical University
Cardiovascular Medicine
641-8510
811-1 Kimiidera Wakayama Japan
073-441-0621
akasat@wakayama-med.ac.jp
1st name | Yasutsugu |
Middle name | |
Last name | Shiono |
Wakayama Medical University
Cardiovascular Medicine
641-8510
811-1 Kimiidera Wakayama Japan
073-441-0621
doors@herb.ocn.ne.jp
Wakayama Medical University
Seijin kekkanbyou kenkyu shinkou zaidan
Non profit foundation
Wakayama Medical University
811-1 Kimiidera Wakayama
073-447-2300
wa-rinri@wakayama-med.ac.jp
NO
2018 | Year | 03 | Month | 01 | Day |
Unpublished
Open public recruiting
2018 | Year | 03 | Month | 01 | Day |
2018 | Year | 04 | Month | 09 | Day |
2020 | Year | 05 | Month | 26 | Day |
2026 | Year | 10 | Month | 31 | Day |
2018 | Year | 03 | Month | 01 | Day |
2020 | Year | 05 | Month | 26 | Day |
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000035999
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