Drug-Eluting Stent Implantation Versus Optimal Medical Treatment in Patients With Chronic Total Occlusion (DECISION-CTO)
- Conditions
- Coronary Artery Disease
- Interventions
- Drug: optimal medical therapyProcedure: Cypher, xience, Endeavor, Taxus
- Registration Number
- NCT01078051
- Lead Sponsor
- Seung-Jung Park
- Brief Summary
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.
- Detailed Description
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.
Recruitment & Eligibility
- Status
- TERMINATED
- Sex
- All
- Target Recruitment
- 840
Clinical
- Patients with angina or silent ischemia and documented ischemia
- Patients who are eligible for intracoronary stenting
- Age > 18 years
Angiographic
- De novo lesion CTO
- Reference vessel size 2.5 mm by visual estimation
- At least one CTO lesions located in proximal or mid epicardial coronary artery. (If the patient has two CTO lesions, one CTO lesion should be located in proximal or mid epicardial coronary artery)
CTO definition: TIMI flow 0 and estimated duration over 3 months The duration of the occlusion was determined by the interval from the last episode of acute coronary syndrome, or In patients without a history of acute coronary syndrome, from the first episode of effort angina consistent with the location of the occlusion
- Angiographically defined total occlusion over 3 months
- If no definite symptom with total occlusion, two experienced operators decide CTO in consideration of angiographical morphology (degree of calcification, bridging collaterals, non-tapered stump, angiographic filling from collaterals)
- History of bleeding diathesis or coagulopathy
- Pregnant state
- Three vessel CTO
- Known hypersensitivity or contra-indication to contrast agent and heparin
- ST-elevation acute myocardial infarction requiring primary stenting
- Characteristics of lesion 1) Left main disease 2) In-stent restenosis 3) Graft vessels 4) Distal epicardial coronary artery CTO lesions
- Hematological disease
- Hepatic dysfunction, liver enzyme (ALT and AST) elevation 3 times normal
- Renal dysfunction, creatinine more than 2.0
- Contraindication to aspirin, clopidogrel or other commercial antiplatelet agent
- Left ventricular ejection fraction
- Patients who are actively participating in another drug or device investigational study, which have not completed the primary endpoint follow-up period.
- Non-cardiac co-morbid conditions are present with limited life expectancy or that may result in protocol non-compliance (per site investigator's medical judgment).
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Optimal medical therapy optimal medical therapy optimal medical therapy drug-eluting stent Cypher, xience, Endeavor, Taxus Cypher, xience, Endeavor, Taxus
- Primary Outcome Measures
Name Time Method Composite outcomes of all cause death, myocardial infarction, stroke, and any revascularization for 3 years after randomization at 3 years at the median of 3 years
- Secondary Outcome Measures
Name Time Method Angina class; Quality of life, clinical outcomes at 5 years at 3 years & 5 years Myocardial infarction, stroke,any revascularization, CTO-vessel related revascularization, hospitalization due to acute coronary syndrome, left ventricular ejection fraction at 3 years & 5 years All Death (Cardiac death) at 3 years & 5 years
Trial Locations
- Locations (26)
Korea University Guro Hospital
๐ฐ๐ทSeoul, Korea, Republic of
Bundang CHA Hospital
๐ฐ๐ทSลngnam, Korea, Republic of
Wonju Christian Hospital
๐ฐ๐ทWonju, Korea, Republic of
Medistra Hospital
๐ฎ๐ฉJakarta, Indonesia
Soonchunhyang University Hospital, Cheonan
๐ฐ๐ทCheonan, Korea, Republic of
Ulsan University Hospital
๐ฐ๐ทUlsan, Korea, Republic of
Soonchunhyang University Hospital, Buchen
๐ฐ๐ทBucheon, Korea, Republic of
The Catholic University of Korea, Kangnam ST.Mary's Hospital
๐ฐ๐ทSeoul, Korea, Republic of
King chulalongkorn Memorial Hospital
๐น๐ญBangkok, Thailand
Shin Kong Hospital
๐จ๐ณTaipei, Taiwan
Chungbuk National University Hospital
๐ฐ๐ทCheongju, Korea, Republic of
Chonnam National University Hospital
๐ฐ๐ทKwangju, Korea, Republic of
Hallym University Medical Center, Hangang Sacred Heart Hospital
๐ฐ๐ทSeoul, Korea, Republic of
Sam Anyang Hospital
๐ฐ๐ทAnyang, Korea, Republic of
Keimyung University Dongsan Medical Center
๐ฐ๐ทDaegu, Korea, Republic of
Chungnam National University Hospital
๐ฐ๐ทDaejeon, Korea, Republic of
Kangwon National University Hospital
๐ฐ๐ทChuncheon, Korea, Republic of
The Catholic University of Korea, Daejeon ST.Mary's Hospital
๐ฐ๐ทDaejeon, Korea, Republic of
Pusan National University Yangsan Hospital
๐ฐ๐ทPusan, Korea, Republic of
GangNeung Asan Hospital
๐ฐ๐ทGangNeung, Korea, Republic of
Dong-A University Medical Center
๐ฐ๐ทPusan, Korea, Republic of
National Taiwan University hospital
๐จ๐ณTaipei, Taiwan
Asan Medical Center
๐ฐ๐ทSeoul, Korea, Republic of
Kangbuk Samsung Hospital
๐ฐ๐ทSeoul, Korea, Republic of
Chonbuk National University Hospital
๐ฐ๐ทJeonju, Korea, Republic of
Ruby Hall Clinic
๐ฎ๐ณPune, India