Drug-Eluting Stent Implantation Versus Optimal Medical Treatment in Patients With Chronic Total Occlusion

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

CRIS

Registry ID

KCT0002918

Enrollment

840

Registered

2018-06-07

Start date

2010-03-22

Completion date

Unknown

Last updated

2020-04-21

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Interventions

Drug, Medical Device, Procedure/Surgery : Percutaneous coronary intervention with Drug eluting stent vs optimal medical therapy(long acting metoprolol, amlodipine, nitrate, statin, blood pressure lowe

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 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 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)

Exclusion criteria

Exclusion criteria: 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 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).

Design outcomes

Primary

Measure	Time frame
Composite outcomes of all cause death, myocardial infarction, stroke, and any revascularization	—

Secondary

Measure	Time frame
all death;Acute myocardial infarction;stroke;Revascularization;Revascularization due to chronic total occlusion;Hospitalization due to acute coronary syndome;left ventricular ejection fraction;Angina class;Quality of Life;Composite outcomes of all cause death, myocardial infarction, stroke, and any revascularization	—

Countries

Korea, Republic of

Contacts

Public ContactSeung-jung Park

University of Ulsan

Outcome results