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

Primary Purpose

Coronary Artery Disease

Status
Terminated
Phase
Phase 4
Locations
International
Study Type
Interventional
Intervention
Cypher, xience, Endeavor, Taxus
optimal medical therapy
Sponsored by
Seung-Jung Park
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Coronary Artery Disease focused on measuring chronic total occlusion, stent, medical therapy

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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).

Sites / Locations

  • Ruby Hall Clinic
  • Medistra Hospital
  • Sam Anyang Hospital
  • Soonchunhyang University Hospital, Buchen
  • Soonchunhyang University Hospital, Cheonan
  • Chungbuk National University Hospital
  • Kangwon National University Hospital
  • Keimyung University Dongsan Medical Center
  • Chungnam National University Hospital
  • The Catholic University of Korea, Daejeon ST.Mary's Hospital
  • GangNeung Asan Hospital
  • Chonbuk National University Hospital
  • Chonnam National University Hospital
  • Dong-A University Medical Center
  • Pusan National University Yangsan Hospital
  • Asan Medical Center
  • Hallym University Medical Center, Hangang Sacred Heart Hospital
  • Kangbuk Samsung Hospital
  • Korea University Guro Hospital
  • The Catholic University of Korea, Kangnam ST.Mary's Hospital
  • Bundang CHA Hospital
  • Ulsan University Hospital
  • Wonju Christian Hospital
  • National Taiwan University hospital
  • Shin Kong Hospital
  • King chulalongkorn Memorial Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

Optimal medical therapy

drug-eluting stent

Arm Description

optimal medical therapy

Cypher, xience, Endeavor, Taxus

Outcomes

Primary Outcome Measures

Composite outcomes of all cause death, myocardial infarction, stroke, and any revascularization for 3 years after randomization
at the median of 3 years

Secondary Outcome Measures

All Death (Cardiac death)
Angina class; Quality of life, clinical outcomes at 5 years
Myocardial infarction, stroke,any revascularization, CTO-vessel related revascularization, hospitalization due to acute coronary syndrome, left ventricular ejection fraction

Full Information

First Posted
March 1, 2010
Last Updated
July 31, 2019
Sponsor
Seung-Jung Park
Collaborators
CardioVascular Research Foundation, Korea
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1. Study Identification

Unique Protocol Identification Number
NCT01078051
Brief Title
Drug-Eluting Stent Implantation Versus Optimal Medical Treatment in Patients With Chronic Total Occlusion (DECISION-CTO)
Official Title
Drug-Eluting Stent Implantation Versus Optimal Medical Treatment in Patients
Study Type
Interventional

2. Study Status

Record Verification Date
July 2019
Overall Recruitment Status
Terminated
Why Stopped
at sponsor's discretion : Benefit is not guaranteed
Study Start Date
March 22, 2010 (Actual)
Primary Completion Date
July 22, 2019 (Actual)
Study Completion Date
July 22, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Seung-Jung Park
Collaborators
CardioVascular Research Foundation, Korea

4. Oversight

Data Monitoring Committee
Yes

5. 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Coronary Artery Disease
Keywords
chronic total occlusion, stent, medical therapy

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
840 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Optimal medical therapy
Arm Type
Active Comparator
Arm Description
optimal medical therapy
Arm Title
drug-eluting stent
Arm Type
Active Comparator
Arm Description
Cypher, xience, Endeavor, Taxus
Intervention Type
Procedure
Intervention Name(s)
Cypher, xience, Endeavor, Taxus
Other Intervention Name(s)
percutaneous coronary intervention
Intervention Description
all species of drug-eluting stent implantation
Intervention Type
Drug
Intervention Name(s)
optimal medical therapy
Other Intervention Name(s)
intensive medical therapy
Intervention Description
optimal medical therapy
Primary Outcome Measure Information:
Title
Composite outcomes of all cause death, myocardial infarction, stroke, and any revascularization for 3 years after randomization
Description
at the median of 3 years
Time Frame
at 3 years
Secondary Outcome Measure Information:
Title
All Death (Cardiac death)
Time Frame
at 3 years & 5 years
Title
Angina class; Quality of life, clinical outcomes at 5 years
Time Frame
at 3 years & 5 years
Title
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

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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).
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Seung-Jung Park, MD,PhD
Organizational Affiliation
Department of Medicine, Asan Medical Center, University of Ulsan College of Medicine
Official's Role
Principal Investigator
Facility Information:
Facility Name
Ruby Hall Clinic
City
Pune
ZIP/Postal Code
I
Country
India
Facility Name
Medistra Hospital
City
Jakarta
Country
Indonesia
Facility Name
Sam Anyang Hospital
City
Anyang
Country
Korea, Republic of
Facility Name
Soonchunhyang University Hospital, Buchen
City
Bucheon
Country
Korea, Republic of
Facility Name
Soonchunhyang University Hospital, Cheonan
City
Cheonan
Country
Korea, Republic of
Facility Name
Chungbuk National University Hospital
City
Cheongju
Country
Korea, Republic of
Facility Name
Kangwon National University Hospital
City
Chuncheon
Country
Korea, Republic of
Facility Name
Keimyung University Dongsan Medical Center
City
Daegu
Country
Korea, Republic of
Facility Name
Chungnam National University Hospital
City
Daejeon
Country
Korea, Republic of
Facility Name
The Catholic University of Korea, Daejeon ST.Mary's Hospital
City
Daejeon
Country
Korea, Republic of
Facility Name
GangNeung Asan Hospital
City
GangNeung
Country
Korea, Republic of
Facility Name
Chonbuk National University Hospital
City
Jeonju
Country
Korea, Republic of
Facility Name
Chonnam National University Hospital
City
Kwangju
Country
Korea, Republic of
Facility Name
Dong-A University Medical Center
City
Pusan
Country
Korea, Republic of
Facility Name
Pusan National University Yangsan Hospital
City
Pusan
Country
Korea, Republic of
Facility Name
Asan Medical Center
City
Seoul
Country
Korea, Republic of
Facility Name
Hallym University Medical Center, Hangang Sacred Heart Hospital
City
Seoul
Country
Korea, Republic of
Facility Name
Kangbuk Samsung Hospital
City
Seoul
Country
Korea, Republic of
Facility Name
Korea University Guro Hospital
City
Seoul
Country
Korea, Republic of
Facility Name
The Catholic University of Korea, Kangnam ST.Mary's Hospital
City
Seoul
Country
Korea, Republic of
Facility Name
Bundang CHA Hospital
City
Sŏngnam
Country
Korea, Republic of
Facility Name
Ulsan University Hospital
City
Ulsan
Country
Korea, Republic of
Facility Name
Wonju Christian Hospital
City
Wonju
Country
Korea, Republic of
Facility Name
National Taiwan University hospital
City
Taipei
Country
Taiwan
Facility Name
Shin Kong Hospital
City
Taipei
Country
Taiwan
Facility Name
King chulalongkorn Memorial Hospital
City
Bangkok
Country
Thailand

12. IPD Sharing Statement

Plan to Share IPD
No
IPD Sharing Plan Description
This is not a publicly funded trial.
Citations:
PubMed Identifier
30813758
Citation
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.
Results Reference
derived
PubMed Identifier
26434510
Citation
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.
Results Reference
derived

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

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