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Clinical Trial Details — Status: Terminated

Administrative data

NCT number NCT01078051
Other study ID # 2009-0647
Secondary ID
Status Terminated
Phase Phase 4
First received
Last updated
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
Health authority
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).

Study Design


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
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