Coronary Artery DiseasePhase 4NCT01078051
Drug-Eluting Stent Implantation Versus Optimal Medical Treatment in Patients With Chronic Total Occlusion (DECISION-CTO)
A Phase 4 study testing Cypher, xience, Endeavor, Taxus and optimal medical therapy in people with Coronary Artery Disease, run by Seung-Jung Park at 26 sites in 5 countries.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Coronary Artery Disease
- What is being tested?
- Cypher, xience, Endeavor, Taxus and optimal medical therapy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 840 participants
- Where
- 26 sitesin 5 countries
- Study dates
- 22 Mar 2010to 22 Jul 2019
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
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- 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)
Who cannot join
- 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
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- 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).
Trial locations and contacts
26 sites in 5 countries.
26 sites in 5 countries
South Korea21 sites
Sam Anyang Hospital
Anyang
Soonchunhyang University Hospital, Buchen
Bucheon-si
Soonchunhyang University Hospital, Cheonan
Cheonan
Chungbuk National University Hospital
Cheongju-si
Kangwon National University Hospital
Chuncheon
Keimyung University Dongsan Medical Center
Daegu
Chungnam National University Hospital
Daejeon
The Catholic University of Korea, Daejeon ST.Mary's Hospital
Daejeon
GangNeung Asan Hospital
Gangneung
Chonbuk National University Hospital
Jeonju
Chonnam National University Hospital
Kwangju
Dong-A University Medical Center
Pusan
Pusan National University Yangsan Hospital
Pusan
Asan Medical Center
Seoul
Hallym University Medical Center, Hangang Sacred Heart Hospital
Seoul
Kangbuk Samsung Hospital
Seoul
Korea University Guro Hospital
Seoul
The Catholic University of Korea, Kangnam ST.Mary's Hospital
Seoul
Bundang CHA Hospital
Sŏngnam
Ulsan University Hospital
Ulsan
Wonju Christian Hospital
Wŏnju
Taiwan2 sites
National Taiwan University hospital
Taipei
Shin Kong Hospital
Taipei
About this study
Official title: Drug-Eluting Stent Implantation Versus Optimal Medical Treatment in Patients
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.
Read the 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.
- Conditions
- Coronary Artery Disease
- Being tested
- Cypher, xience, Endeavor, Taxus, optimal medical therapy
- Keywords
- chronic total occlusion, stent, medical therapy
- Medical subject headings
- Coronary Artery Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cypher, xience, Endeavor, TaxusProcedure or surgery
Also called percutaneous coronary intervention
all species of drug-eluting stent implantation
optimal medical therapyDrug
Also called intensive medical therapy
optimal medical therapy
| Study group | Role | What they receive |
|---|---|---|
| Optimal medical therapy | Active comparator | optimal medical therapy Receives: Drug: optimal medical therapy |
| drug-eluting stent | Active comparator | Cypher, xience, Endeavor, Taxus Receives: Procedure: Cypher, xience, Endeavor, Taxus |
What is being measured
The primary outcome is the main question the study is designed to answer.
Composite outcomes of all cause death, myocardial infarction, stroke, and any revascularization for 3 years after randomization
at the median of 3 years
Measured: at 3 years
Secondary outcomes (3)
All Death (Cardiac death)
Measured: at 3 years & 5 years
Angina class; Quality of life, clinical outcomes at 5 years
Measured: at 3 years & 5 years
Myocardial infarction, stroke,any revascularization, CTO-vessel related revascularization, hospitalization due to acute coronary syndrome, left ventricular ejection fraction
Measured: at 3 years & 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Mar 2010 (estimated)
- Study start22 Mar 2010
- Primary completion22 Jul 2019
- Study completion22 Jul 2019
Why it stopped: at sponsor's discretion : Benefit is not guaranteed
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Coronary Artery DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 840 participants (actual)
Sponsor and investigators
- Lead sponsor
- Seung-Jung Park
- Sponsor type
- University, hospital or other
- Collaborators
- CardioVascular Research Foundation, Korea
- Responsible party
- Sponsor-investigator, Seung-Jung Park, CardioVascular Research Foundation, Korea
- Investigators
- Seung-Jung Park, MD,PhD, Principal investigator, Department of Medicine, Asan Medical Center, University of Ulsan College of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01078051
- Sponsor's protocol ID
- 2009-0647
- Status last verified
- Jul 2019
- First submitted
- 1 Mar 2010
- Last updated
- 2 Aug 2019
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- No: This is not a publicly funded trial.
Publications
Werner GS, Kim JH, Hildick-Smith D, Kang DY, Yuste VM, Ahn JM, Boudou N, Park DW, Louvard Y, Christiansen EH, Erglis A, Rumoroso JR, di Mario C, Escaned J, Teruel L, Bufe A, Park SJ; EUROCTO and DECISION-CTO Trial Investigators. Quality of Life After Percutaneous Coronary Intervention or Medical Therapy for Chronic Total Coronary Occlusions: EUROCTO and DECISION-CTO Meta-Analysis. J Am Coll Cardiol. 2026 Jul 7;88(1):24-37. doi: 10.1016/j.jacc.2026.02.5099. Epub 2026 Apr 8.
PubMed 41949523Lee 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.
PubMed 30813758Azzalini 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.
PubMed 26434510
Study at a glance
From the registry record, last updated by the sponsor on 2 Aug 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Drug-Eluting Stent Implantation Versus Optimal Medical Treatment in Patients
- ClinicalTrials.gov ID
- NCT01078051
- Acronym / sponsor ID
- 2009-0647
- Conditions
- Coronary Artery Disease
- Keywords
- chronic total occlusion, stent, medical therapy
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: at sponsor's discretion : Benefit is not guaranteed
- Enrolment
- 840 participants (actual)
- Lead sponsor
- Seung-Jung ParkUniversity, hospital or other
- Collaborators
- CardioVascular Research Foundation, Korea
- Study start
- 22 Mar 2010 (actual)
- Primary completion
- 22 Jul 2019 (actual)
- Study completion
- 22 Jul 2019 (actual)
- First posted
- 2 Mar 2010 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Optimal medical therapy | Active comparator | Drug: optimal medical therapyoptimal medical therapy |
| drug-eluting stent | Active comparator | Procedure: Cypher, xience, Endeavor, TaxusCypher, xience, Endeavor, Taxus |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- Clinical
- Patients with angina or silent ischemia and documented ischemia
- Patients who are eligible for intracoronary stenting
- Age > 18 years
- Angiographic
Key exclusion criteria (13 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Cypher, xience, Endeavor, TaxusAlso: percutaneous coronary interventionall species of drug-eluting stent implantation | Procedure or surgery | drug-eluting stent |
| optimal medical therapyAlso: intensive medical therapyoptimal medical therapy | Drug | Optimal medical therapy |
Primary outcome
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
3 secondary outcomes
All Death (Cardiac death)
Time frame: at 3 years & 5 years
Angina class; Quality of life, clinical outcomes at 5 years
Time frame: 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
Results and safety
The study was stopped early (reason given: at sponsor's discretion : Benefit is not guaranteed). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Aug 2019.
- Derived from this study: PubMed 41949523Werner GS, Kim JH, Hildick-Smith D, Kang DY, Yuste VM, Ahn JM, Boudou N, Park DW, Louvard Y, Christiansen EH, Erglis A, Rumoroso JR, di Mario C, Escaned J, Teruel L, Bufe A, Park SJ; EUROCTO and DECISION-CTO Trial Investigators. Quality of Life After Percutaneous Coronary Intervention or Medical Therapy for Chronic Total Coronary Occlusions: EUROCTO and DECISION-CTO Meta-Analysis. J Am Coll Cardiol. 2026 Jul 7;88(1):24-37. doi: 10.1016/j.jacc.2026.02.5099. Epub 2026 Apr 8.
- Derived from this study: PubMed 30813758Lee 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.
- Derived from this study: PubMed 26434510Azzalini 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.
- Individual participant dataSharing planned: No. This is not a publicly funded trial.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Seung-Jung Park, MD,PhD principal investigator
Department of Medicine, Asan Medical Center, University of Ulsan College of Medicine
26 sites in 5 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Cypher, xience, Endeavor, Taxus and optimal medical therapy in people with Coronary Artery Disease, run by Seung-Jung Park at 26 sites in 5 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 11 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 2 Aug 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 26 sites in South Korea, Taiwan, India, Indonesia, Thailand. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was stopped early (reason given: at sponsor's discretion : Benefit is not guaranteed). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Composite outcomes of all cause death, myocardial infarction, stroke, and any revascularization for 3 years after randomization (time frame: at 3 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01078051, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Aug 2019.