Drug-Eluting Stent Implantation Versus Optimal Medical Treatment in Patients With Chronic Total Occlusion (DECISION-CTO)
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ClinicalTrials.gov Identifier: NCT01078051 |
Recruitment Status :
Terminated
(at sponsor's discretion : Benefit is not guaranteed)
First Posted : March 2, 2010
Last Update Posted : August 2, 2019
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Coronary Artery Disease | Procedure: Cypher, xience, Endeavor, Taxus Drug: optimal medical therapy | Phase 4 |
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 (Clinical Trial) |
Actual Enrollment : | 840 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Masking: | None (Open Label) |
Primary Purpose: | Treatment |
Official Title: | Drug-Eluting Stent Implantation Versus Optimal Medical Treatment in Patients |
Actual Study Start Date : | March 22, 2010 |
Actual Primary Completion Date : | July 22, 2019 |
Actual Study Completion Date : | July 22, 2019 |
Arm | Intervention/treatment |
---|---|
Active Comparator: Optimal medical therapy
optimal medical therapy
|
Drug: optimal medical therapy
optimal medical therapy
Other Name: intensive medical therapy |
Active Comparator: drug-eluting stent
Cypher, xience, Endeavor, Taxus
|
Procedure: Cypher, xience, Endeavor, Taxus
all species of drug-eluting stent implantation
Other Name: percutaneous coronary intervention |
- Composite outcomes of all cause death, myocardial infarction, stroke, and any revascularization for 3 years after randomization [ Time Frame: at 3 years ]at the median of 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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Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
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)
Exclusion Criteria:
- 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).

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01078051

Principal Investigator: | Seung-Jung Park, MD,PhD | Department of Medicine, Asan Medical Center, University of Ulsan College of Medicine |
Responsible Party: | Seung-Jung Park, MD,PhD, Chairman,Heart Institute, Asan Medical Center,University of Ulsan,College of Medicine, CardioVascular Research Foundation, Korea |
ClinicalTrials.gov Identifier: | NCT01078051 |
Other Study ID Numbers: |
2009-0647 |
First Posted: | March 2, 2010 Key Record Dates |
Last Update Posted: | August 2, 2019 |
Last Verified: | July 2019 |
Individual Participant Data (IPD) Sharing Statement: | |
Plan to Share IPD: | No |
Plan Description: | This is not a publicly funded trial. |
chronic total occlusion stent medical therapy |
Coronary Artery Disease Coronary Disease Myocardial Ischemia Heart Diseases |
Cardiovascular Diseases Arteriosclerosis Arterial Occlusive Diseases Vascular Diseases |