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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
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
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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
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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
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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
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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

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

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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    
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