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

NCT01078051 | Terminated Phase 4 DMC

• 1 other identifier: 2009-0647
• Study Type: interventional
• Target: 840
• Locations: 5 countries
• Sites: 26

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.

Conditions

Coronary Artery Disease

Keywords

chronic total occlusion; stent; medical therapy

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

• All Death (Cardiac death)

  at 3 years & 5 years

• Angina class; Quality of life, clinical outcomes at 5 years

  at 3 years & 5 years

• Myocardial infarction, stroke,any revascularization, CTO-vessel related revascularization, hospitalization due to acute coronary syndrome, left ventricular ejection fraction

  at 3 years & 5 years

Study Arms (2)

Optimal medical therapy

ACTIVE COMPARATOR

optimal medical therapy

Drug: optimal medical therapy

drug-eluting stent

ACTIVE COMPARATOR

Cypher, xience, Endeavor, Taxus

Procedure: Cypher, xience, Endeavor, Taxus

Interventions

Cypher, xience, Endeavor, Taxus PROCEDURE

all species of drug-eluting stent implantation

Also known as: percutaneous coronary intervention

drug-eluting stent

optimal medical therapy DRUG

optimal medical therapy

Also known as: intensive medical therapy

Optimal medical therapy

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• 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).

Sponsors & Collaborators

• Seung-Jung Park: lead
• CardioVascular Research Foundation, Korea: collaborator

Study Sites (26)

Ruby Hall Clinic

Pune, I, India

Location

Medistra Hospital

Jakarta, Indonesia

Location

Sam Anyang Hospital

Anyang, South Korea

Location

Soonchunhyang University Hospital, Buchen

Bucheon-si, South Korea

Location

Soonchunhyang University Hospital, Cheonan

Cheonan, South Korea

Location

Chungbuk National University Hospital

Cheongju-si, South Korea

Location

Kangwon National University Hospital

Chuncheon, South Korea

Location

Keimyung University Dongsan Medical Center

Daegu, South Korea

Location

Chungnam National University Hospital

Daejeon, South Korea

Location

The Catholic University of Korea, Daejeon ST.Mary's Hospital

Daejeon, South Korea

Location

GangNeung Asan Hospital

Gangneung, South Korea

Location

Chonbuk National University Hospital

Jeonju, South Korea

Location

Chonnam National University Hospital

Kwangju, South Korea

Location

Dong-A University Medical Center

Pusan, South Korea

Location

Pusan National University Yangsan Hospital

Pusan, South Korea

Location

Asan Medical Center

Seoul, South Korea

Location

Hallym University Medical Center, Hangang Sacred Heart Hospital

Seoul, South Korea

Location

Kangbuk Samsung Hospital

Seoul, South Korea

Location

Korea University Guro Hospital

Seoul, South Korea

Location

The Catholic University of Korea, Kangnam ST.Mary's Hospital

Seoul, South Korea

Location

Bundang CHA Hospital

Sŏngnam, South Korea

Location

Ulsan University Hospital

Ulsan, South Korea

Location

Wonju Christian Hospital

Wŏnju, South Korea

Location

National Taiwan University hospital

Taipei, Taiwan

Location

Shin Kong Hospital

Taipei, Taiwan

Location

King chulalongkorn Memorial Hospital

Bangkok, Thailand

Location

Related Publications (2)

• 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.

  PMID: 30813758 DERIVED

• 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.

  PMID: 26434510 DERIVED

MeSH Terms

Conditions

Coronary Artery Disease

Interventions

Percutaneous Coronary Intervention

Condition Hierarchy (Ancestors)

Coronary Disease; Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases

Intervention Hierarchy (Ancestors)

Endovascular Procedures; Vascular Surgical Procedures; Cardiovascular Surgical Procedures; Surgical Procedures, Operative; Minimally Invasive Surgical Procedures

Study Officials

• Seung-Jung Park, MD,PhD

  Department of Medicine, Asan Medical Center, University of Ulsan College of Medicine

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: MD,PhD, Chairman,Heart Institute, Asan Medical Center,University of Ulsan,College of Medicine

Study Record Dates

• First Submitted: March 1, 2010
• First Posted: March 2, 2010
• Study Start: March 22, 2010
• Primary Completion: July 22, 2019
• Study Completion: July 22, 2019
• Last Updated: August 2, 2019

Record last verified: 2019-07

Data Sharing

• IPD Sharing: Will not share

Locations

TW (2); TH (1); IN (1); KR (21); ID (1)