--- title: Drug-Eluting Stent Implantation Versus Optimal Medical Treatment in Patients With Chronic Total Occlusion (DECISION-CTO) nct_id: NCT01078051 overall_status: TERMINATED phase: PHASE4 sponsor: Seung-Jung Park study_type: INTERVENTIONAL primary_condition: Coronary Artery Disease countries: India, Indonesia, South Korea, Taiwan, Thailand canonical_url: "https://parkinsonspathways.com/agent/trials/NCT01078051.md" clinicaltrials_gov: "https://clinicaltrials.gov/study/NCT01078051" ct_last_update_post_date: 2019-08-02 last_seen_at: "2026-05-12T06:24:16.385Z" source: ClinicalTrials.gov (mirrored, no enrichment) --- # 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 **NCT ID:** [NCT01078051](https://clinicaltrials.gov/study/NCT01078051) ## Key Facts - **Status:** TERMINATED - **Why Stopped:** at sponsor's discretion : Benefit is not guaranteed - **Phase:** PHASE4 - **Study Type:** INTERVENTIONAL - **Target Enrollment:** 840 - **Lead Sponsor:** Seung-Jung Park - **Collaborators:** CardioVascular Research Foundation, Korea - **Conditions:** Coronary Artery Disease - **Start Date:** 2010-03-22 - **Completion Date:** 2019-07-22 - **CT.gov Last Update:** 2019-08-02 ## 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. ## Eligibility - **Minimum age:** 18 Years - **Sex:** ALL - **Healthy Volunteers:** No ``` 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). ``` ## Arms - **Optimal medical therapy** (ACTIVE_COMPARATOR) — optimal medical therapy - **drug-eluting stent** (ACTIVE_COMPARATOR) — Cypher, xience, Endeavor, Taxus ## Interventions - **Cypher, xience, Endeavor, Taxus** (PROCEDURE) — all species of drug-eluting stent implantation - **optimal medical therapy** (DRUG) — optimal medical therapy ## Primary Outcomes - **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 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)_ ## Locations (26) - Ruby Hall Clinic, Pune, India - Medistra Hospital, Jakarta, Indonesia - Sam Anyang Hospital, Anyang, South Korea - Soonchunhyang University Hospital, Buchen, Bucheon-si, South Korea - Soonchunhyang University Hospital, Cheonan, Cheonan, South Korea - Chungbuk National University Hospital, Cheongju-si, South Korea - Kangwon National University Hospital, Chuncheon, South Korea - Keimyung University Dongsan Medical Center, Daegu, South Korea - Chungnam National University Hospital, Daejeon, South Korea - The Catholic University of Korea, Daejeon ST.Mary's Hospital, Daejeon, South Korea - GangNeung Asan Hospital, Gangneung, South Korea - Chonbuk National University Hospital, Jeonju, South Korea - Chonnam National University Hospital, Kwangju, South Korea - Dong-A University Medical Center, Pusan, South Korea - Pusan National University Yangsan Hospital, Pusan, South Korea - Asan Medical Center, Seoul, South Korea - Hallym University Medical Center, Hangang Sacred Heart Hospital, Seoul, South Korea - Kangbuk Samsung Hospital, Seoul, South Korea - Korea University Guro Hospital, Seoul, South Korea - The Catholic University of Korea, Kangnam ST.Mary's Hospital, Seoul, South Korea - Bundang CHA Hospital, Sŏngnam, South Korea - Ulsan University Hospital, Ulsan, South Korea - Wonju Christian Hospital, Wŏnju, South Korea - National Taiwan University hospital, Taipei, Taiwan - Shin Kong Hospital, Taipei, Taiwan - King chulalongkorn Memorial Hospital, Bangkok, Thailand ## Recent Field Changes (last 30 days) - `locations.kangwon national university hospital|chuncheon||south korea` — added _(2026-05-12)_ - `locations.gangneung asan hospital|gangneung||south korea` — added _(2026-05-12)_ - `status.overallStatus` — added _(2026-05-12)_ - `status.whyStopped` — added _(2026-05-12)_ - `status.primaryCompletionDate` — added _(2026-05-12)_ - `status.completionDate` — added _(2026-05-12)_ - `status.lastUpdatePostDate` — added _(2026-05-12)_ - `design.phases` — added _(2026-05-12)_ - `design.enrollmentCount` — added _(2026-05-12)_ - `locations.keimyung university dongsan medical center|daegu||south korea` — added _(2026-05-12)_ - `locations.chungnam national university hospital|daejeon||south korea` — added _(2026-05-12)_ - `locations.the catholic university of korea, daejeon st.mary's hospital|daejeon||south korea` — added _(2026-05-12)_ - `eligibility.criteria` — added _(2026-05-12)_ - `eligibility.minAge` — added _(2026-05-12)_ - `eligibility.sex` — added _(2026-05-12)_ - `outcomes.primary` — added _(2026-05-12)_ - `outcomes.secondary` — added _(2026-05-12)_ - `armsInterventions.arms` — added _(2026-05-12)_ - `armsInterventions.interventions` — added _(2026-05-12)_ - `sponsor.lead` — added _(2026-05-12)_ - `sponsor.collaborators` — added _(2026-05-12)_ - `results.hasResults` — added _(2026-05-12)_ - `locations.ruby hall clinic|pune||india` — added _(2026-05-12)_ - `locations.medistra hospital|jakarta||indonesia` — added _(2026-05-12)_ - `locations.sam anyang hospital|anyang||south korea` — added _(2026-05-12)_ - `locations.soonchunhyang university hospital, buchen|bucheon-si||south korea` — added _(2026-05-12)_ - `locations.soonchunhyang university hospital, cheonan|cheonan||south korea` — added _(2026-05-12)_ - `locations.chungbuk national university hospital|cheongju-si||south korea` — added _(2026-05-12)_ - `locations.chonbuk national university hospital|jeonju||south korea` — added _(2026-05-12)_ - `locations.chonnam national university hospital|kwangju||south korea` — added _(2026-05-12)_ - `locations.dong-a university medical center|pusan||south korea` — added _(2026-05-12)_ - `locations.pusan national university yangsan hospital|pusan||south korea` — added _(2026-05-12)_ - `locations.asan medical center|seoul||south korea` — added _(2026-05-12)_ - `locations.hallym university medical center, hangang sacred heart hospital|seoul||south korea` — added _(2026-05-12)_ - `locations.kangbuk samsung hospital|seoul||south korea` — added _(2026-05-12)_ - `locations.korea university guro hospital|seoul||south korea` — added _(2026-05-12)_ - `locations.the catholic university of korea, kangnam st.mary's hospital|seoul||south korea` — added _(2026-05-12)_ - `locations.bundang cha hospital|sŏngnam||south korea` — added _(2026-05-12)_ - `locations.ulsan university hospital|ulsan||south korea` — added _(2026-05-12)_ - `locations.wonju christian hospital|wŏnju||south korea` — added _(2026-05-12)_ - `locations.national taiwan university hospital|taipei||taiwan` — added _(2026-05-12)_ - `locations.shin kong hospital|taipei||taiwan` — added _(2026-05-12)_ - `locations.king chulalongkorn memorial hospital|bangkok||thailand` — added _(2026-05-12)_ --- *Canonical: https://parkinsonspathways.com/agent/trials/NCT01078051.md* *Source data (authoritative): https://clinicaltrials.gov/study/NCT01078051* *This page is a raw mirror with no AI summary, no editorial enrichment, and no Parkinson's-specific filtering.*