Drug-Eluting Stent Implantation Versus Optimal Medical Treatment in Patients With Chronic Total Occlusion (DECISION-CTO)

This study is currently recruiting participants. (see Contacts and Locations)
Verified August 2012 by CardioVascular Research Foundation, Korea
Sponsor:
Collaborator:
CardioVascular Research Foundation, Korea
Information provided by (Responsible Party):
Seung-Jung Park, CardioVascular Research Foundation, Korea
ClinicalTrials.gov Identifier:
NCT01078051
First received: March 1, 2010
Last updated: August 7, 2012
Last verified: August 2012
  Purpose

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 Intervention Phase
Coronary Artery Disease
Procedure: Cypher, xience, Endeavor, Taxus
Drug: optimal medical therapy
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
Primary Purpose: Treatment
Official Title: Drug-Eluting Stent Implantation Versus Optimal Medical Treatment in Patients

Further study details as provided by CardioVascular Research Foundation, Korea:

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 ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • All Death (Cardiac death) [ Time Frame: at 3 years & 5 years ] [ Designated as safety issue: Yes ]
  • Angina class; Quality of life, clinical outcomes at 5 years [ Time Frame: at 3 years & 5 years ] [ Designated as safety issue: Yes ]
  • 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 ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 1284
Study Start Date: March 2010
Estimated Study Completion Date: March 2018
Estimated Primary Completion Date: March 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

Detailed Description:

Prospective, two arms, randomized multi-center trial of 1,100 patients enrolled at 26 centers in Korea and 11 centers 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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

Clinical

  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:

  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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01078051

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

Locations
China
Peking University First Hospital Recruiting
Beijing, China
Contact: Young Huo         
Sir Run Run Shaw Hospital Not yet recruiting
Hangzhou, China
Contact: Guo Sheng Fu         
Zhongshan Hospital Active, not recruiting
Shanghai, China
India
Heart Care Clinic Recruiting
Surat, India
Contact: Shirish Hiremath         
Indonesia
Medistra Hospital Not yet recruiting
Jakarta, Indonesia
Contact: Teguh Santoso         
Korea, Republic of
Sam Anyang Hospital Recruiting
Anyang, Korea, Republic of
Contact: Il-Woo Suh         
The Catholic University of Korea, Bucheon ST.Mary's Hospital Not yet recruiting
Bucheon, Korea, Republic of
Contact: Hee-Yeol Kim         
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: Jangwhan Bae         
Chungju ST.Mary's Hospital Not yet recruiting
Cheongju, Korea, Republic of
Contact: Yong-Mo Yang         
Kangwon National University Hospital Not yet recruiting
Chooncheon, Korea, Republic of
Contact: Bong-Ki Lee         
Kyungpook National University Hospital Not yet recruiting
Daegu, Korea, Republic of
Contact: Hun Sik Park         
Keimyung University Dongsan Medical Center Not yet 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 Not yet recruiting
GangNeung, Korea, Republic of
Contact: Sang-Sig Cheong         
Chonbuk National University Hospital Recruiting
Jeonju, Korea, Republic of
Contact: Jei Keon Chae         
Gyeongsang National University Hospital Recruiting
Jinju, Korea, Republic of
Contact: Choong-Hwan Kwak         
Chonnam National University Hospital Recruiting
Kwangju, Korea, Republic of
Contact: Young-Keun Ahn         
Inje University Pusan Paik Hospital Recruiting
Pusan, Korea, Republic of
Contact: Tae-Hyun Yang         
Dong-A University Medical Center Not yet recruiting
Pusan, Korea, Republic of
Contact: Moo Hyun Kim         
Pusan National University Yangsan Hospital Recruiting
Pusan, Korea, Republic of
Contact: Jun Hong Kim         
Korea University Guro Hospital Not yet recruiting
Seoul, Korea, Republic of
Contact: Seung Un Rha         
Seoul Veterans Hospital Not yet recruiting
Seoul, Korea, Republic of
Contact: Keun Lee         
Hallym University Medical Center, Hangang Sacred Heart Hospital Recruiting
Seoul, Korea, Republic of
Contact: Min-Kyu Kim         
The Catholic University of Korea, Kangnam ST.Mary's Hospital Not yet recruiting
Seoul, Korea, Republic of
Contact: Ki-Bae Seung, MD,PhD         
Asan Medical Center Not yet 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   
Ewha Women University Mokdong Hospital Recruiting
Seoul, Korea, Republic of
Contact: Si-Hoon Park         
Ulsan University Hospital Recruiting
Ulsan, Korea, Republic of
Contact: Sang Gon Lee         
Wonju Christian Hospital Recruiting
Wonju, Korea, Republic of
Contact: Junghan Yoon         
Taiwan
Shin Kong Hospital Recruiting
Taipei, Taiwan
Contact: Jun-Jack Cheng         
Taipei Veterans General Hospital Recruiting
Taipei, Taiwan
Contact: Chia-Yu Chou         
Chang-Gung Memorial Hospital Not yet recruiting
Taipei, Taiwan
Contact: Chiung-Jen Wu         
National Taiwan University hospital Not yet recruiting
Taipei, Taiwan
Contact: Paul-Hsien-Li Kao         
Thailand
Siriraj hospital Recruiting
Bangkok, Thailand
Contact: Damras Tresukosol         
King chulalongkorn Memorial Hospital Recruiting
Bangkok, Thailand
Contact: Wasan Udayachalerm         
Sponsors and Collaborators
Seung-Jung Park
CardioVascular Research Foundation, Korea
Investigators
Principal Investigator: Seung-Jung Park, MD,PhD Department of Medicine, Asan Medical Center, University of Ulsan College of Medicine
  More Information

No publications provided

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
Study First Received: March 1, 2010
Last Updated: August 7, 2012
Health Authority: South Korea: Korea Food and Drug Administration (KFDA)

Keywords provided by CardioVascular Research Foundation, Korea:
chronic total occlusion
stent
medical therapy

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

ClinicalTrials.gov processed this record on October 29, 2014