The DECISION-CTO Extended 10 Y Follow-up

NCT06908499 | Not Yet Recruiting

• 1 other identifier: AMCCV2025-01
• Study Type: observational
• Target: 840
• Locations: 5 countries
• Sites: 19

Brief Summary

The goal of this clinical trial is to compare long term efficacy of drug-eluting stent implantation compare to optimal medical treatment in patient with chronic total occlusion in a very long-term follow-up (minimum 10 years) period.

Conditions

Coronary Artery Disease

Keywords

Chronic Total Occlusion; Drug-eluting Stent Implantation; Optimal Medical Treatment

Outcome Measures

Primary Outcomes (1)

• Event rate of the composite event

  The composite of all cause death, myocardial infarction, stroke and any revascularization at minimum of 10 years follow-up.

  10 years

Secondary Outcomes (4)

• Event rate of all cause death

  10 years

• Event rate of myocardial infarction

  10 years

• Event rate of stroke

  10 years

• Event rate of any revascularization

  10 years

Study Arms (1)

Patients with chronic total occlusion

Patients with chronic total occlusion who were enrolled in the original DECISION-CTO trial (NCT01078051)

Eligibility Criteria

• Age: 19 Years+
• Sex: all
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients with chronic total occlusion who were enrolled in the original DECISION-CTO trial (NCT01078051)

You may qualify if:

• 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 Chronic Total Occlusion (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 (Thrombolysis in Myocardial Infarction) flow 0 or 1 with 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 CTOs
• Known hypersensitivity or contra-indication to contrast agent and heparin
• ST-elevation acute myocardial infarction requiring primary stenting
• Culprit total occlusion presented with acute coronary syndrome suggesting acute or recent occlusion
• Characteristics of lesion 1) Left main disease 2) In-stent restenosis 3) Graft vessels 4) Distal epicardial coronary artery CTO lesions 5) Two vessel proximal segment CTOs
• Hematological disease (Neutropenia \<3000/mm3, Thrombocytopenia \<100,000/mm3)
• Hepatic dysfunction, liver enzyme (ALT and AST) elevation ≥ 3 times normal
• Renal dysfunction, creatinine ≥ 2.0mg/dL
• Contraindication to aspirin, clopidogrel or other commercial antiplatelet agent
• Left ventricular ejection fraction \<30%
• 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

Study Sites (19)

Ruby Hall Clinic

Pune, Maharashtra, 411001, India

Location

Medistra Hospital

Jakarta, DKI Jakarta, 12950, Indonesia

Location

SAM hospital

Anyang, South Korea

Location

Soon Chun Hyang University Hospital Bucheon

Bucheon-si, South Korea

Location

Dong-A Medical Center

Busan, 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 Hosptial

Daejeon, South Korea

Location

Gangneung Asan Hospital

Gangneung, South Korea

Location

Chonnam National University Hospital

Gwangju, South Korea

Location

Bundang CHA Hospital

Seongnam, South Korea

Location

Asan Medical Center

Seoul, South Korea

Location

Hallym University Hangang Sacred Heart Hospital

Seoul, South Korea

Location

Kangbuk Samsung Hospital

Seoul, South Korea

Location

Korea University Guro Hospital

Seoul, South Korea

Location

Ulsan University Hospital

Ulsan, South Korea

Location

Shin Kong Wu Ho-Su Memorial Hospital

Taipei, Taipei City, 111013, Taiwan

Location

King Chulalongkorn Memorial Hospital

Bangkok, 10330, Thailand

Location

MeSH Terms

Conditions

Coronary Artery Disease

Condition Hierarchy (Ancestors)

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

Central Study Contacts

Jung-min Ahn, MD

CONTACT

drjmahn@gmail.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: April 1, 2025
• First Posted: April 3, 2025
• Study Start: April 1, 2026
• Primary Completion: April 30, 2026
• Study Completion (Estimated): May 31, 2026
• Last Updated: December 29, 2025

Record last verified: 2025-12

Locations

KR (15); TW (1); IN (1); TH (1); ID (1)