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

Coronary Artery Disease Clinical Trial

Official title:

Drug-Eluting Stent Implantation Versus Optimal Medical Treatment in Patients

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT01078051
• Other study ID #: 2009-0647
• Status: Terminated
• Phase: Phase 4
• Start date: March 22, 2010
• Est. completion date: July 22, 2019

Study information

• Verified date: July 2019
• Source: CardioVascular Research Foundation, Korea
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 840
• Est. completion date: July 22, 2019
• Est. primary completion date: July 22, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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).

Related Conditions & MeSH terms

• Coronary Artery Disease
• Coronary Disease
• Myocardial Ischemia

Intervention

Procedure:
• Cypher, xience, Endeavor, Taxus
all species of drug-eluting stent implantation

Drug:
• optimal medical therapy
optimal medical therapy

Locations

Country	Name	City	State
India	Ruby Hall Clinic	Pune
Indonesia	Medistra Hospital	Jakarta
Korea, Republic of	Sam Anyang Hospital	Anyang
Korea, Republic of	Soonchunhyang University Hospital, Buchen	Bucheon
Korea, Republic of	Soonchunhyang University Hospital, Cheonan	Cheonan
Korea, Republic of	Chungbuk National University Hospital	Cheongju
Korea, Republic of	Kangwon National University Hospital	Chuncheon
Korea, Republic of	Keimyung University Dongsan Medical Center	Daegu
Korea, Republic of	Chungnam National University Hospital	Daejeon
Korea, Republic of	The Catholic University of Korea, Daejeon ST.Mary's Hospital	Daejeon
Korea, Republic of	GangNeung Asan Hospital	GangNeung
Korea, Republic of	Chonbuk National University Hospital	Jeonju
Korea, Republic of	Chonnam National University Hospital	Kwangju
Korea, Republic of	Dong-A University Medical Center	Pusan
Korea, Republic of	Pusan National University Yangsan Hospital	Pusan
Korea, Republic of	Asan Medical Center	Seoul
Korea, Republic of	Hallym University Medical Center, Hangang Sacred Heart Hospital	Seoul
Korea, Republic of	Kangbuk Samsung Hospital	Seoul
Korea, Republic of	Korea University Guro Hospital	Seoul
Korea, Republic of	The Catholic University of Korea, Kangnam ST.Mary's Hospital	Seoul
Korea, Republic of	Bundang CHA Hospital	Songnam
Korea, Republic of	Ulsan University Hospital	Ulsan
Korea, Republic of	Wonju Christian Hospital	Wonju
Taiwan	National Taiwan University hospital	Taipei
Taiwan	Shin Kong Hospital	Taipei
Thailand	King chulalongkorn Memorial Hospital	Bangkok

Sponsors (2)

Lead Sponsor	Collaborator
Seung-Jung Park	CardioVascular Research Foundation, Korea

Countries where clinical trial is conducted

India,  Indonesia,  Korea, Republic of,  Taiwan,  Thailand, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Composite outcomes of all cause death, myocardial infarction, stroke, and any revascularization for 3 years after randomization	at the median of 3 years	at 3 years
Secondary	All Death (Cardiac death)		at 3 years & 5 years
Secondary	Angina class; Quality of life, clinical outcomes at 5 years		at 3 years & 5 years
Secondary	Myocardial infarction, stroke,any revascularization, CTO-vessel related revascularization, hospitalization due to acute coronary syndrome, left ventricular ejection fraction		at 3 years & 5 years