The purpose of this study is to compare the safety and effectiveness of drug-eluting stent implantation compared to optimal medical treatment in patients with chronic total occlusion.
Prospective, two arms, randomized multi-center trial in Asian-pacific region. Following angiography, patients with chronic total occlusion (more than 3 months) have documented myocardial ischemia or symptoms of angina, and eligible for stenting without any exclusion criteria will be randomized 1:1 to: a) drug-eluting stent vs. b) optimal medical treatment. All patients will be followed for at least 3 year. The subjects with chronic total occlusion but failed to random for any reason, they will be enrolled in registry group. The random design was closed at the date of 22 July 2019 however already randomized subjects and subjects from registry design continue 10 years follow-up on IRIS-CTO registry.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
840
all species of drug-eluting stent implantation
optimal medical therapy
Ruby Hall Clinic
Pune, India
Composite outcomes of all cause death, myocardial infarction, stroke, and any revascularization for 3 years after randomization
at the median of 3 years
Time frame: at 3 years
All Death (Cardiac death)
Time frame: at 3 years & 5 years
Angina class; Quality of life, clinical outcomes at 5 years
Time frame: at 3 years & 5 years
Myocardial infarction, stroke,any revascularization, CTO-vessel related revascularization, hospitalization due to acute coronary syndrome, left ventricular ejection fraction
Time frame: at 3 years & 5 years
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