Clinical trial NCT01078051: 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
Overall status: TERMINATED
Phase: PHASE4
Conditions: Coronary Artery Disease
Keywords: chronic total occlusion
stent
medical therapy
Lead sponsor: CardioVascular Research Foundation, Korea
Sponsor class: OTHER
Collaborators: name: CardioVascular Research Foundation, Korea
First posted: 2010-03-02
Enrollment: 840
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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 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).

Primary outcomes:
measure: Composite outcomes of all cause death, myocardial infarction, stroke, and any revascularization for 3 years after randomization
timeFrame: at 3 years
Secondary outcomes:
measure: All Death (Cardiac death)
timeFrame: at 3 years & 5 years
measure: Angina class; Quality of life, clinical outcomes at 5 years
timeFrame: at 3 years & 5 years
measure: Myocardial infarction, stroke,any revascularization, CTO-vessel related revascularization, hospitalization due to acute coronary syndrome, left ventricular ejection fraction
timeFrame: at 3 years & 5 years
Other outcomes:
Locations:
city: Pune
country: India
facility: Ruby Hall Clinic
city: Jakarta
country: Indonesia
facility: Medistra Hospital
city: Anyang
country: Korea, Republic of
facility: Sam Anyang Hospital
city: Bucheon
country: Korea, Republic of
facility: Soonchunhyang University Hospital, Buchen
city: Cheonan
country: Korea, Republic of
facility: Soonchunhyang University Hospital, Cheonan
city: Cheongju
country: Korea, Republic of
facility: Chungbuk National University Hospital
city: Chuncheon
country: Korea, Republic of
facility: Kangwon National University Hospital
city: Daegu
country: Korea, Republic of
facility: Keimyung University Dongsan Medical Center
city: Daejeon
country: Korea, Republic of
facility: Chungnam National University Hospital
city: Daejeon
country: Korea, Republic of
facility: The Catholic University of Korea, Daejeon ST.Mary's Hospital
city: GangNeung
country: Korea, Republic of
facility: GangNeung Asan Hospital
city: Jeonju
country: Korea, Republic of
facility: Chonbuk National University Hospital
city: Kwangju
country: Korea, Republic of
facility: Chonnam National University Hospital
city: Pusan
country: Korea, Republic of
facility: Dong-A University Medical Center
city: Pusan
country: Korea, Republic of
facility: Pusan National University Yangsan Hospital
city: Seoul
country: Korea, Republic of
facility: Asan Medical Center
city: Seoul
country: Korea, Republic of
facility: Hallym University Medical Center, Hangang Sacred Heart Hospital
city: Seoul
country: Korea, Republic of
facility: Kangbuk Samsung Hospital
city: Seoul
country: Korea, Republic of
facility: Korea University Guro Hospital
city: Seoul
country: Korea, Republic of
facility: The Catholic University of Korea, Kangnam ST.Mary's Hospital
city: Sŏngnam
country: Korea, Republic of
facility: Bundang CHA Hospital
city: Ulsan
country: Korea, Republic of
facility: Ulsan University Hospital
city: Wonju
country: Korea, Republic of
facility: Wonju Christian Hospital
city: Taipei
country: Taiwan
facility: National Taiwan University hospital
city: Taipei
country: Taiwan
facility: Shin Kong Hospital
city: Bangkok
country: Thailand
facility: King chulalongkorn Memorial Hospital
Study officials:
affiliation: Department of Medicine, Asan Medical Center, University of Ulsan College of Medicine
name: Seung-Jung Park, MD,PhD
role: PRINCIPAL_INVESTIGATOR
References:
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.
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.