The DECISION-CTO Extended 10 Y Follow-up

NCT ID: NCT06908499

Last Updated: 2025-12-29

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Total Enrollment: 840 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2026-04-01
• Study Completion Date: 2026-05-31

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

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: RETROSPECTIVE

Study Groups

Patients with chronic total occlusion

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

No interventions assigned to this group

Eligibility Criteria

Inclusion Criteria

1. Clinical 1) Patients with angina or silent ischemia and documented ischemia 2) Patients who are eligible for intracoronary stenting 3) Age >18 years

2. 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)

3. 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

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 CTOs

4. Known hypersensitivity or contra-indication to contrast agent and heparin

5. ST-elevation acute myocardial infarction requiring primary stenting

6. Culprit total occlusion presented with acute coronary syndrome suggesting acute or recent occlusion

7. 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

8. Hematological disease (Neutropenia <3000/mm3, Thrombocytopenia <100,000/mm3)

9. Hepatic dysfunction, liver enzyme (ALT and AST) elevation ≥ 3 times normal

10. Renal dysfunction, creatinine ≥ 2.0mg/dL

11. Contraindication to aspirin, clopidogrel or other commercial antiplatelet agent

12. Left ventricular ejection fraction <30%

13. Patients who are actively participating in another drug or device investigational study, which have not completed the primary endpoint follow-up period.

14. 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).

• Minimum Eligible Age: 19 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Seung-Jung Park

OTHER

Sponsor Role: lead

Responsible Party

Seung-Jung Park

Principal Investigator

Responsibility Role: SPONSOR_INVESTIGATOR

Locations

Ruby Hall Clinic

Pune, Maharashtra, India

Medistra Hospital

Jakarta, DKI Jakarta, Indonesia

SAM hospital

Anyang, , South Korea

Soon Chun Hyang University Hospital Bucheon

Bucheon-si, , South Korea

Dong-A Medical Center

Busan, , South Korea

Kangwon National University Hospital

Chuncheon, , South Korea

Keimyung University Dongsan Medical Center

Daegu, , South Korea

Chungnam National University Hospital

Daejeon, , South Korea

The Catholic University of Korea, Daejeon St. Mary's Hosptial

Daejeon, , South Korea

Gangneung Asan Hospital

Gangneung, , South Korea

Chonnam National University Hospital

Gwangju, , South Korea

Bundang CHA Hospital

Seongnam, , South Korea

Asan Medical Center

Seoul, , South Korea

Hallym University Hangang Sacred Heart Hospital

Seoul, , South Korea

Kangbuk Samsung Hospital

Seoul, , South Korea

Korea University Guro Hospital

Seoul, , South Korea

Ulsan University Hospital

Ulsan, , South Korea

Shin Kong Wu Ho-Su Memorial Hospital

Taipei, Taipei City, Taiwan

King Chulalongkorn Memorial Hospital

Bangkok, , Thailand

Countries

India; Indonesia; South Korea; Taiwan; Thailand

Central Contacts

Jung-min Ahn, MD

Role: CONTACT

Email: drjmahn@gmail.com

Facility Contacts

Shirish Hiremath, MD

Role: primary

Teguh Santoso, MD

Role: primary

Il-woo Seo, MD

Role: primary

John Seo, MD

Role: primary

Sang-yong Cho, MD

Role: primary

Bong-ki Lee, MD

Role: primary

Hyuk-joon Yoon, MD

Role: primary

Jae-whan Lee, MD

Role: primary

Kyu-seob Lee, MD

Role: primary

Han-bit Park, MD

Role: primary

Min-cheol Kim, MD

Role: primary

Sang-wook Lim, MD

Role: primary

Seung-jung Park, MD

Role: primary

Min-kyu Kim, MD

Role: primary

Seung-jae Lee, MD

Role: primary

Seung-woon Rha, MD

Role: primary

Sang-gon Lee, MD

Role: primary

Jun-Jack Cheng, MD

Role: primary

Wasan Udayachalerm, MD

Role: primary

Other Identifiers

AMCCV2025-01

Identifier Type: -

Identifier Source: org_study_id