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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 : Recruiting
First Posted : March 2, 2010
Last Update Posted : December 22, 2016
Information provided by (Responsible Party):

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.

Study Design

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 1284 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
Study Start Date : March 2010
Estimated Primary Completion Date : December 2023
Estimated Study Completion Date : December 2030
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 :
  1. 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 :
  1. All Death (Cardiac death) [ Time Frame: at 3 years & 5 years ]
  2. Angina class; Quality of life, clinical outcomes at 5 years [ Time Frame: at 3 years & 5 years ]
  3. 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

Information from the National Library of Medicine

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

Inclusion Criteria:


  1. Patients with angina or silent ischemia and documented ischemia
  2. Patients who are eligible for intracoronary stenting
  3. Age > 18 years


  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:

  1. History of bleeding diathesis or coagulopathy
  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).
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

Contact: Seung-Jung Park 82-2-3010-4812 sjpark@amc.seoul.kr
Contact: Seung-Whan Lee 82-2-3010-4812 seungwlee@amc.seoul.kr

Ruby Hall Clinic Recruiting
Pune, India, I
Contact: J.S. Hiremath, MD       shirish.hiremath2011@gmail.com   
Principal Investigator: J.S. Hiremath, MD         
Medistra Hospital Recruiting
Jakarta, Indonesia
Contact: Teguh Santoso         
Korea, Republic of
Sam Anyang Hospital Recruiting
Anyang, Korea, Republic of
Contact: Il-Woo Suh         
Soonchunhyang University Hospital, Buchen Recruiting
Bucheon, Korea, Republic of
Contact: Nae Hee Lee         
Soonchunhyang University Hospital, Cheonan Recruiting
Cheonan, Korea, Republic of
Contact: Won Yong Shin         
Chungbuk National University Hospital Recruiting
Cheongju, Korea, Republic of
Contact: Kyung-kuk Hwang, MD       kh3621@chollian.net   
Principal Investigator: Kyung-kuk Hwang, MD         
Kangwon National University Hospital Recruiting
Chooncheon, Korea, Republic of
Contact: Bong-Ki Lee         
Keimyung University Dongsan Medical Center Recruiting
Daegu, Korea, Republic of
Contact: Seung Ho Her         
Chungnam National University Hospital Recruiting
Daejeon, Korea, Republic of
Contact: Si Wan Choi         
The Catholic University of Korea, Daejeon ST.Mary's Hospital Recruiting
Daejeon, Korea, Republic of
Contact: Sung Ho Hur         
GangNeung Asan Hospital Recruiting
GangNeung, Korea, Republic of
Contact: Sang-Sig Cheong         
Chonbuk National University Hospital Recruiting
Jeonju, Korea, Republic of
Contact: Jei Keon Chae         
Chonnam National University Hospital Recruiting
Kwangju, Korea, Republic of
Contact: Young-Keun Ahn         
Dong-A University Medical Center Recruiting
Pusan, Korea, Republic of
Contact: Moo Hyun Kim         
Pusan National University Yangsan Hospital Recruiting
Pusan, Korea, Republic of
Contact: Kook-jin Chun, MD       ptca82@gmail.com   
Principal Investigator: Kook-jin Chun, MD         
Asan Medical Center Recruiting
Seoul, Korea, Republic of
Contact: Seung-Jung Park, MD,PhD    2-3010-4812 ext 82    sjpark@amc.seoul.kr   
Contact: Seung-Whan Lee, MD,PhD    2-3010-4812 ext 82    seungwlee@amc.seoul.kr   
Hallym University Medical Center, Hangang Sacred Heart Hospital Recruiting
Seoul, Korea, Republic of
Contact: Min-Kyu Kim         
Kangbuk Samsung Hospital Recruiting
Seoul, Korea, Republic of
Contact: Jong-young Lee, MD       jyleeheart@naver.com   
Principal Investigator: Jong-young Lee, MD         
Korea University Guro Hospital Recruiting
Seoul, Korea, Republic of
Contact: Seung Un Rha         
The Catholic University of Korea, Kangnam ST.Mary's Hospital Recruiting
Seoul, Korea, Republic of
Contact: Ki-Bae Seung, MD,PhD         
Bundang CHA Hospital Recruiting
Sungnam, Korea, Republic of
Contact: Sang-wook Lim, MD       swlim@cha.ac.kr   
Principal Investigator: Sang-wook Lim, MD         
Ulsan University Hospital Recruiting
Ulsan, Korea, Republic of
Contact: Sang Gon Lee         
Ulsan University Hospital Recruiting
Ulsan, Korea, Republic of
Contact: Eun-Seok Shin, MD       sesim98@yahoo.co.kr   
Principal Investigator: Eun-Seok Shin, MD         
Wonju Christian Hospital Recruiting
Wonju, Korea, Republic of
Contact: Junghan Yoon         
National Taiwan University hospital Recruiting
Taipei, Taiwan
Contact: Paul-Hsien-Li Kao         
Shin Kong Hospital Recruiting
Taipei, Taiwan
Contact: Jun-Jack Cheng         
King chulalongkorn Memorial Hospital Recruiting
Bangkok, Thailand
Contact: Wasan Udayachalerm         
Sponsors and Collaborators
Seung-Jung Park
CardioVascular Research Foundation, Korea
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):
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: December 22, 2016
Last Verified: December 2016
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
medical therapy

Additional relevant MeSH terms:
Coronary Artery Disease
Myocardial Ischemia
Coronary Disease
Heart Diseases
Cardiovascular Diseases
Arterial Occlusive Diseases
Vascular Diseases