- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01078051
Drug-Eluting Stent Implantation Versus Optimal Medical Treatment in Patients With Chronic Total Occlusion (DECISION-CTO)
Drug-Eluting Stent Implantation Versus Optimal Medical Treatment in Patients
Study Overview
Status
Conditions
Intervention / Treatment
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 Type
Enrollment (Actual)
Phase
- Phase 4
Contacts and Locations
Study Locations
-
-
-
Pune, India, I
- Ruby Hall Clinic
-
-
-
-
-
Jakarta, Indonesia
- Medistra Hospital
-
-
-
-
-
Anyang, Korea, Republic of
- Sam Anyang Hospital
-
Bucheon, Korea, Republic of
- Soonchunhyang University Hospital, Buchen
-
Cheonan, Korea, Republic of
- Soonchunhyang University Hospital, Cheonan
-
Cheongju, Korea, Republic of
- Chungbuk National University Hospital
-
Chuncheon, Korea, Republic of
- Kangwon National University Hospital
-
Daegu, Korea, Republic of
- Keimyung University Dongsan Medical Center
-
Daejeon, Korea, Republic of
- Chungnam National University Hospital
-
Daejeon, Korea, Republic of
- The Catholic University of Korea, Daejeon ST.Mary's Hospital
-
GangNeung, Korea, Republic of
- Gangneung Asan Hospital
-
Jeonju, Korea, Republic of
- Chonbuk National University Hospital
-
Kwangju, Korea, Republic of
- Chonnam National University Hospital
-
Pusan, Korea, Republic of
- Pusan National University Yangsan Hospital
-
Pusan, Korea, Republic of
- Dong-A University Medical Center
-
Seoul, Korea, Republic of
- Asan Medical Center
-
Seoul, Korea, Republic of
- Korea University Guro Hospital
-
Seoul, Korea, Republic of
- Kangbuk Samsung Hospital
-
Seoul, Korea, Republic of
- Hallym University Medical Center, Hangang Sacred Heart Hospital
-
Seoul, Korea, Republic of
- The Catholic University of Korea, Kangnam ST.Mary's Hospital
-
Sŏngnam, Korea, Republic of
- Bundang CHA Hospital
-
Ulsan, Korea, Republic of
- Ulsan University Hospital
-
Wonju, Korea, Republic of
- Wonju Christian Hospital
-
-
-
-
-
Taipei, Taiwan
- National Taiwan University Hospital
-
Taipei, Taiwan
- Shin Kong Hospital
-
-
-
-
-
Bangkok, Thailand
- King Chulalongkorn Memorial Hospital
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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).
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Active Comparator: Optimal medical therapy
optimal medical therapy
|
optimal medical therapy
Other Names:
|
Active Comparator: drug-eluting stent
Cypher, xience, Endeavor, Taxus
|
all species of drug-eluting stent implantation
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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
|
at 3 years
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
All Death (Cardiac death)
Time Frame: at 3 years & 5 years
|
at 3 years & 5 years
|
Angina class; Quality of life, clinical outcomes at 5 years
Time Frame: at 3 years & 5 years
|
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
|
at 3 years & 5 years
|
Collaborators and Investigators
Sponsor
Collaborators
Publications and helpful links
General Publications
- 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.
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2009-0647
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Coronary Artery Disease
-
Elixir Medical CorporationIstituto Clinico HumanitasActive, not recruitingCoronary Artery Disease | Chronic Total Occlusion of Coronary Artery | Multi Vessel Coronary Artery Disease | Bifurcation of Coronary Artery | Long Lesions Coronary Artery DiseaseItaly
-
Fundación EPICActive, not recruitingCoronary Artery Disease | Left Main Coronary Artery Disease | Left Main Coronary Artery Stenosis | Restenosis, CoronarySpain
-
Peking Union Medical College HospitalRecruitingCoronary Artery Disease | Inflammation | Coronary Artery Disease Progression | Coronary Artery Stenosis | Coronary Artery Restenosis | Inflammatory Disease | Inflammation VascularChina
-
Peking Union Medical College HospitalNot yet recruitingCoronary Artery Disease | Inflammation | Coronary Artery Disease Progression | Coronary Artery Stenosis | Coronary Artery Restenosis | Inflammatory Disease | Inflammation VascularChina
-
IGLESIAS Juan FernandoUniversity of BernNot yet recruiting
-
National Institutes of Health Clinical Center (CC)National Heart, Lung, and Blood Institute (NHLBI)CompletedCoronary Arteriosclerosis | Coronary Artery Disease (CAD) | Obstructive Coronary Artery DiseaseUnited States
-
Barts & The London NHS TrustImperial College London; Brunel UniversityNot yet recruitingCORONARY ARTERY DISEASE
-
Abbott Medical DevicesCompletedCoronary Artery Disease | Coronary Disease | Coronary Occlusion | Chronic Total Occlusion of Coronary Artery | Coronary Restenosis | Coronary Artery Stenosis | Coronary Artery RestenosisBelgium
-
Fundación EPICRecruitingCoronary Artery Disease | Coronary Disease | Coronary Occlusion | Left Main Coronary Artery Disease | Coronary Artery StenosisSpain
-
San Luigi Gonzaga HospitalRecruitingCoronary Disease | STEMI | Coronary Artery Ectasia | Right Coronary Artery Occlusion | Right Coronary Artery StenosisSpain, Italy
Clinical Trials on optimal medical therapy
-
Toad Medical CorporationUniversity Hospitals Cleveland Medical CenterUnknownDiabetic Foot | Pedal UlcersUnited States
-
Uptake Medical Technology, Inc.MedPass InternationalNot yet recruiting
-
Aeris TherapeuticsTerminatedPulmonary EmphysemaUnited States, Spain, France, Israel, Netherlands, Greece, Italy
-
Ottawa Heart Institute Research CorporationCanadian Institutes of Health Research (CIHR)Active, not recruitingAtrial Fibrillation | Heart Disease | Congestive Heart FailureCanada
-
Ottawa Heart Institute Research CorporationCanadian Institutes of Health Research (CIHR); MedtronicCompletedHeart Failure, CongestiveCanada, Netherlands, Australia, Turkey, Denmark, Germany, Belgium
-
Centre Hospitalier St AnneHôpitaux Universitaires Paris Ile-de-Franc OuestNot yet recruiting
-
Uptake Medical CorpCompletedEmphysemaAustralia, Ireland, Germany, Austria, New Zealand, United Kingdom
-
Semmelweis University Heart and Vascular CenterUnknownMyocardial Infarction | Chronic Heart FailureHungary
-
Medical University of ViennaNot yet recruitingMitral Regurgitation | ATTR-Cardiomyopathy | Edge-to-Edge Mitral Valve Repair
-
Guangdong Provincial People's HospitalThe First Affiliated Hospital of Guangzhou Medical University; Shenzhen People... and other collaboratorsRecruitingIntramural HematomaChina