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

Sponsor:

Collaborator:

CardioVascular Research Foundation, Korea

Information provided by (Responsible Party):

Seung-Jung Park, CardioVascular Research Foundation, Korea

Study Description

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.

Condition or disease	Intervention/treatment	Phase
Coronary Artery Disease	Procedure: Cypher, xience, Endeavor, Taxus Drug: optimal medical therapy	Phase 4

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.

Study Design

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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

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures :

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

Secondary Outcome Measures :

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 ]

Eligibility Criteria

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Ages Eligible for Study:	18 Years and older (Adult, Older Adult)
Sexes Eligible for Study:	All
Accepts Healthy Volunteers:	No

Criteria

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).

Contacts and Locations

Information from the National Library of Medicine

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

Locations

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India
Ruby Hall Clinic
Pune, India, I
Indonesia
Medistra Hospital
Jakarta, Indonesia
Korea, Republic of
Sam Anyang Hospital
Anyang, Korea, Republic of
Soonchunhyang University Hospital, Buchen
Bucheon, Korea, Republic of
Soonchunhyang University Hospital, Cheonan
Cheonan, Korea, Republic of
Chungbuk National University Hospital
Cheongju, Korea, Republic of
Kangwon National University Hospital
Chuncheon, Korea, Republic of
Keimyung University Dongsan Medical Center
Daegu, Korea, Republic of
Chungnam National University Hospital
Daejeon, Korea, Republic of
The Catholic University of Korea, Daejeon ST.Mary's Hospital
Daejeon, Korea, Republic of
GangNeung Asan Hospital
GangNeung, Korea, Republic of
Chonbuk National University Hospital
Jeonju, Korea, Republic of
Chonnam National University Hospital
Kwangju, Korea, Republic of
Dong-A University Medical Center
Pusan, Korea, Republic of
Pusan National University Yangsan Hospital
Pusan, Korea, Republic of
Asan Medical Center
Seoul, Korea, Republic of
Hallym University Medical Center, Hangang Sacred Heart Hospital
Seoul, Korea, Republic of
Kangbuk Samsung Hospital
Seoul, Korea, Republic of
Korea University Guro Hospital
Seoul, Korea, Republic of
The Catholic University of Korea, Kangnam ST.Mary's Hospital
Seoul, Korea, Republic of
Bundang CHA Hospital
Sŏngnam, Korea, Republic of
Ulsan University Hospital
Ulsan, Korea, Republic of
Wonju Christian Hospital
Wonju, Korea, Republic of
Taiwan
National Taiwan University hospital
Taipei, Taiwan
Shin Kong Hospital
Taipei, Taiwan
Thailand
King chulalongkorn Memorial Hospital
Bangkok, Thailand

Sponsors and Collaborators

Seung-Jung Park

CardioVascular Research Foundation, Korea

Investigators

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Principal Investigator:	Seung-Jung Park, MD,PhD	Department of Medicine, Asan Medical Center, University of Ulsan College of Medicine

More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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. Review.

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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 History of Changes
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.

Keywords provided by Seung-Jung Park, CardioVascular Research Foundation, Korea:


chronic total occlusion stent medical therapy

Additional relevant MeSH terms:

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Coronary Artery Disease Coronary Disease Myocardial Ischemia Heart Diseases	Cardiovascular Diseases Arteriosclerosis Arterial Occlusive Diseases Vascular Diseases

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