Drug-Eluting Stent Implantation Versus Optimal Medical Treatment in Patients With Chronic Total Occlusion (DECISION-CTO)
NCT ID: NCT01078051
Last Updated: 2019-08-02
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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TERMINATED
PHASE4
840 participants
INTERVENTIONAL
2010-03-22
2019-07-22
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Optimal medical therapy
optimal medical therapy
optimal medical therapy
optimal medical therapy
drug-eluting stent
Cypher, xience, Endeavor, Taxus
Cypher, xience, Endeavor, Taxus
all species of drug-eluting stent implantation
Interventions
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Cypher, xience, Endeavor, Taxus
all species of drug-eluting stent implantation
optimal medical therapy
optimal medical therapy
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
1. Patients with angina or silent ischemia and documented ischemia
2. Patients who are eligible for intracoronary stenting
3. Age \> 18 years
Angiographic
1. De novo lesion CTO
2. Reference vessel size 2.5 mm by visual estimation
3. 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
1. Angiographically defined total occlusion over 3 months
2. 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
2. Pregnant state
3. Three vessel CTO
4. Known hypersensitivity or contra-indication to contrast agent and heparin
5. ST-elevation acute myocardial infarction requiring primary stenting
6. Characteristics of lesion 1) Left main disease 2) In-stent restenosis 3) Graft vessels 4) Distal epicardial coronary artery CTO lesions
7. Hematological disease
8. Hepatic dysfunction, liver enzyme (ALT and AST) elevation 3 times normal
9. Renal dysfunction, creatinine more than 2.0
10. Contraindication to aspirin, clopidogrel or other commercial antiplatelet agent
11. Left ventricular ejection fraction
12. Patients who are actively participating in another drug or device investigational study, which have not completed the primary endpoint follow-up period.
13. 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).
18 Years
ALL
No
Sponsors
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CardioVascular Research Foundation, Korea
OTHER
Seung-Jung Park
OTHER
Responsible Party
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Seung-Jung Park
MD,PhD, Chairman,Heart Institute, Asan Medical Center,University of Ulsan,College of Medicine
Principal Investigators
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Seung-Jung Park, MD,PhD
Role: PRINCIPAL_INVESTIGATOR
Department of Medicine, Asan Medical Center, University of Ulsan College of Medicine
Locations
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Ruby Hall Clinic
Pune, , India
Medistra Hospital
Jakarta, , Indonesia
Sam Anyang Hospital
Anyang, , South Korea
Soonchunhyang University Hospital, Buchen
Bucheon-si, , South Korea
Soonchunhyang University Hospital, Cheonan
Cheonan, , South Korea
Chungbuk National University Hospital
Cheongju-si, , South Korea
Kangwon National University Hospital
Chuncheon, , South Korea
Keimyung University Dongsan Medical Center
Daegu, , South Korea
Chungnam National University Hospital
Daejeon, , South Korea
The Catholic University of Korea, Daejeon ST.Mary's Hospital
Daejeon, , South Korea
GangNeung Asan Hospital
Gangneung, , South Korea
Chonbuk National University Hospital
Jeonju, , South Korea
Chonnam National University Hospital
Kwangju, , South Korea
Dong-A University Medical Center
Pusan, , South Korea
Pusan National University Yangsan Hospital
Pusan, , South Korea
Asan Medical Center
Seoul, , South Korea
Hallym University Medical Center, Hangang Sacred Heart Hospital
Seoul, , South Korea
Kangbuk Samsung Hospital
Seoul, , South Korea
Korea University Guro Hospital
Seoul, , South Korea
The Catholic University of Korea, Kangnam ST.Mary's Hospital
Seoul, , South Korea
Bundang CHA Hospital
Sŏngnam, , South Korea
Ulsan University Hospital
Ulsan, , South Korea
Wonju Christian Hospital
Wŏnju, , South Korea
National Taiwan University hospital
Taipei, , Taiwan
Shin Kong Hospital
Taipei, , Taiwan
King chulalongkorn Memorial Hospital
Bangkok, , Thailand
Countries
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References
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Lee SW, Lee PH, Ahn JM, Park DW, Yun SC, Han S, Kang H, Kang SJ, Kim YH, Lee CW, Park SW, Hur SH, Rha SW, Her SH, Choi SW, Lee BK, Lee NH, Lee JY, Cheong SS, Kim MH, Ahn YK, Lim SW, Lee SG, Hiremath S, Santoso T, Udayachalerm W, Cheng JJ, Cohen DJ, Muramatsu T, Tsuchikane E, Asakura Y, Park SJ. Randomized Trial Evaluating Percutaneous Coronary Intervention for the Treatment of Chronic Total Occlusion. Circulation. 2019 Apr 2;139(14):1674-1683. doi: 10.1161/CIRCULATIONAHA.118.031313.
Azzalini L, Vo M, Dens J, Agostoni P. Myths to Debunk to Improve Management, Referral, and Outcomes in Patients With Chronic Total Occlusion of an Epicardial Coronary Artery. Am J Cardiol. 2015 Dec 1;116(11):1774-80. doi: 10.1016/j.amjcard.2015.08.050. Epub 2015 Sep 11.
Other Identifiers
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2009-0647
Identifier Type: -
Identifier Source: org_study_id
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