The Success of Opening Single CTO Lesions to Improve Myocardial Viability Study (SOS-comedy)
Hibernation, Myocardial, Complete Occlusion of Coronary Artery
About this trial
This is an interventional treatment trial for Hibernation, Myocardial focused on measuring PET-CT, Cardiac magnetic resonance (CMR) imaging, Major adverse cardiac events (MACEs), coronary artery disease
Eligibility Criteria
Inclusion Criteria:
- History of stable or unstable angina
- LVEF > 35% on transthoracic echocardiography measurement
- Single lesion occluding the coronary artery detected by angiography or MSCTA, with or without stenosis of other coronary arteries (≤ 50% stenotic lesion)
- Availability for follow-up for up to 12 months
- No major barriers to provide written consent
Exclusion Criteria:
- Acute Q-wave myocardial infarction during the latest 3 months
- Revascularization in the non-culprit artery during the latest one month
- Unsuitable for PCI
- Unable to tolerate dual antiplatelet treatment (DAPT)
- Severe abnormal hematopoietic system, such as platelet count of < 100×109/L or > 700×109/L and white blood cell count of < 3×109/L
- Active bleeding or bleeding tendency
- Severe coexisting conditions, such as severe renal insufficiency (GFR < 60 ml/min•1.73m2), severe hepatic dysfunction [elevated ALT (glutamic-pyruvic transaminase) or AST (glutamic-oxal acetic transaminase) level by more than three-fold of the normal limitation], acute or chronic heart failure (NYHA III-IV), acute infectious diseases, immune disorders, malignancy, etc.
- Life expectancy < 12 months
- Pregnancy or planning pregnancy
- Drug allergies or contraindications to aspirin, clopidogrel, ticagrelor, statins, contract, anticoagulant, stent, etc.
- Participation or planning to participate in another clinical trial during the same period
- Refusal to comply with the study protocol
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Active Comparator
No Intervention
PCI using stenting or balloon expansion
Optimal medical therapy
Opening single CTO lesions using drug-eluting stents (such as Xience V and Prime, Endeavor Resolute, Taxus express and Libete, Excel, Partner, BUMA, YINYI, TIVOLI,Firebird2,FireHawk, and Coroflex) or balloon expansion plus optimal medical therapy. Intravascular ultrasound (IVUS),optimal coherence tomgraphy (OCT) or fractional flow reserve (FFR) is used if they are needed. Optimal medical therapy includes dual antiplatelet therapy and statins. And optimal medical therapy should include adequate ventricular rate-limiting medication (i.e. Beta-blocker or rate-limiting calcium antagonist) where appropriate. Anti-angina therapy should be used if the patients have symptoms.
Optimal medical therapy. It includes dual antiplatelet therapy and statins. And optimal medical therapy should include adequate ventricular rate-limiting medication (i.e. Beta-blocker or rate-limiting calcium antagonist) where appropriate. Anti-anginal therapy should be used if the patients have symptom.