None listed
Conditions
Interventions
Procedure/Surgery : This study is a non-randomized, prospective, open-label registry study for measuring the FFR of the donor feeding vessels in patients with coronary artery CTO lesions, and waiting
Sponsors
The Catholic University of Korea, St. Vincent's Hospital
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Nineteen years old or older, with coronary artery CTO lesions, and waiting for revascularization treatment 2. Must agree (personally or through his/her legal guardian) with the study protocol and the clinical follow-up schedules, and must sign the informed-consent form voluntarily (This study can proceed after its approval from the IRB of each center.) 3. With a coronary artery CTO lesion on the left anterior descending artery or the right coronary artery
Exclusion criteria
Exclusion criteria: 1. Currently pregnant or breastfeeding or with a possibility of such 2. Contraindicated or hypersensitive to the contrast agent or heparin 3. Contraindicated to aspirin, clopidogrel, cilostazol, ticagrelor, or prasugrel 4. Scheduled to undergo operation, etc. requiring antiplatelet drugs to be stopped within 12 months from participation in the study 5. Has had MI with an acute ST fragment rise 6. Has a terminal disease, with a remaining life expectancy of less than 1 year 7. Has a serious disease that can limit the remaining life expectancy or compliance with the study protocol (e.g. oxygen-dependent COPD, active hepatitis, severe liver failure, severe renal disease, or others believed by the investigator to applicable)
Design outcomes
Secondary
| Measure | Time frame |
|---|---|
| The occurrence of each of the following events 12 months after the coronary intervention: - any death- cardiac death- MI- a combination of death and MI- a combination of cardiac death and MI- death, MI, or revascularization of the target vessel- a combination of death, MI, and revascularization of the target vessel- a combination of death, MI, and revascularization of the target lesion- a combination of cardiac death, MI, and revascularization of the target lesion- TVR- TLR- stent thrombosis- a successful treatment outcome (based on visual evaluation via angiography, the stenosis rate of the inner diameter is less than 30%, and there was no death or Q-wave MI or urgent revascularization during the hospitalization period)- changes in the IMR of the CTO lesions- changes in the IMR values of the main retrograde donor feeding artery | — |
Primary
| Measure | Time frame |
|---|---|
| 1.The changes in the FFR of the CTO lesions at the baseline and immediately upon and 12 (+/- 2) months after the coronary intervention for the CTO lesion;2.The changes in the FFR in the main retrograde donor feeding vessel immediately upon and 12 (+/-2) months after the coronary intervention for the CTO lesion | — |
Countries
Korea, Republic of
Contacts
Public ContactSUNG- HO HER
The Catholic University of Korea, St. Vincent's Hospital
Outcome results
None listed