Skip to main content
OpenTrials
Recruiting

NCT Number: NCT06908499

The DECISION-CTO Extended 10 Y Follow-up

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.

Recruiting

Interested in participating?

Request Info

Key information

Age range

19 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Ruby Hall Clinic, Pune, Maharashtra, India

Loading trial locations.

Who can participate

Only the study team can determine whether someone qualifies for participation.

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 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)

Exclusion criteria

  • 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).

Treatment and study plan

Primary outcomes

  1. Event rate of the composite event

    Time frame: 10 years

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

Secondary outcomes

  1. Event rate of all cause death

    Time frame: 10 years

  2. Event rate of myocardial infarction

    Time frame: 10 years

  3. Event rate of stroke

    Time frame: 10 years

  4. Event rate of any revascularization

    Time frame: 10 years

Study contacts

Contact information is provided by the study sponsor or research team.

Jung-min Ahn, MD

CONTACT

[email protected]

Sponsors and collaborators

Lead sponsor

Seung-Jung Park

Other

Registry information

Official study title

Ten-Year Outcomes of Randomized Comparison of Drug-eluting Stent Implantation Versus Optimal Medical Treatment in Patient With Chronic Total Occlusion: DECISION-CTO Trial

Acronym: DecisionCTO10Y

Important dates

Study start
2026
Primary completion
2026
Study completion
2026
First posted
Apr 3, 2025
Registry last updated
Jun 24, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.