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O estudo clínico NCT06908499 (DecisionCTO10Y) para Doença arterial coronariana está ainda não recrutando. Consulte a visualização em cartões do Radar de Estudos Clínicos e as ferramentas de descoberta de IA para ver todos os detalhes. Ou pergunte qualquer coisa aqui.
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The DECISION-CTO Extended 10 Y Follow-up (DecisionCTO10Y) 840 Acomp. a longo prazo

Ainda não recrutando
Os detalhes do estudo clínico estão disponíveis principalmente em inglês. No entanto, a IA Trial Radar pode ajudar! Basta clicar em 'Explicar o estudo' para visualizar e discutir as informações do estudo no idioma selecionado.
O estudo clínico NCT06908499 (DecisionCTO10Y) é um estudo observacional para Doença arterial coronariana. Seu status atual é: ainda não recrutando. O recrutamento está programado para iniciar em 1 de abril de 2026, com o objetivo de incluir 840 participantes. Coordenado por Seung-Jung Park e deve ser concluído em 31 de maio de 2026. Essas informações foram atualizadas no ClinicalTrials.gov em 29 de dezembro de 2025.
Resumo
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.
Título oficial

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

Condições médicas
Doença arterial coronariana
Outros IDs do estudo
  • DecisionCTO10Y
  • AMCCV2025-01
Número NCT
NCT06908499
Data de início (real)
2026-04-01
Última atualização postada
2025-12-29
Data de conclusão (estimada)
2026-05-31
Inscrição (estimada)
840
Tipo de estudo
Observacional
Status
Ainda não recrutando
Palavras-chave
Chronic Total Occlusion
Drug-eluting Stent Implantation
Optimal Medical Treatment
Braços / Intervenções
Grupo de participantes/BraçoIntervenção/Tratamento
Patients with chronic total occlusion
Patients with chronic total occlusion who were enrolled in the original DECISION-CTO trial (NCT01078051)
N/A
Desfecho primário
Medida de desfechoDescrição da medidaPrazo
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
Desfecho secundário
Medida de desfechoDescrição da medidaPrazo
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
Assistente de participação
Critérios de elegibilidade

Idades elegíveis
Adulto, Idoso
Idade mínima
19 Years
Sexos elegíveis
Todos

  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)

  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).
Seung-Jung Park logoSeung-Jung Park
Responsável pelo estudo
Seung-Jung Park, Patrocinador-Investigador, Principal Investigator, Asan Medical Center
Contato central do estudo
Contato: Jung-min Ahn, MD, [email protected]
19 Locais do estudo em 5 países

Maharashtra

Ruby Hall Clinic, Pune, Maharashtra, 411001, India
Shirish Hiremath, MD, Contato
Shirish Hiremath, MD, Investigador principal

DKI Jakarta

Medistra Hospital, Jakarta, DKI Jakarta, 12950, Indonesia
Teguh Santoso, MD, Contato
Teguh Santoso, MD, Investigador principal
SAM hospital, Anyang, South Korea
Il-woo Seo, MD, Contato
Il-woo Seo, MD, Investigador principal
Soon Chun Hyang University Hospital Bucheon, Bucheon-si, South Korea
John Seo, MD, Contato
John Seo, MD, Investigador principal
Dong-A Medical Center, Busan, South Korea
Sang-yong Cho, MD, Contato
Sang-yong Cho, MD, Investigador principal
Kangwon National University Hospital, Chuncheon, South Korea
Bong-ki Lee, MD, Contato
Bong-ki Lee, MD, Investigador principal
Keimyung University Dongsan Medical Center, Daegu, South Korea
Hyuk-joon Yoon, MD, Contato
Hyuk-joon Yoon, MD, Investigador principal
Chungnam National University Hospital, Daejeon, South Korea
Jae-whan Lee, MD, Contato
Jae-whan Lee, MD, Investigador principal
The Catholic University of Korea, Daejeon St. Mary's Hosptial, Daejeon, South Korea
Kyu-seob Lee, MD, Contato
Kyu-seob Lee, MD, Investigador principal
Gangneung Asan Hospital, Gangneung, South Korea
Han-bit Park, MD, Contato
Han-bit Park, MD, Investigador principal
Chonnam National University Hospital, Gwangju, South Korea
Min-cheol Kim, MD, Contato
Min-cheol Kim, MD, Investigador principal
Bundang CHA Hospital, Seongnam, South Korea
Sang-wook Lim, MD, Contato
Sang-wook Lim, MD, Investigador principal
Asan Medical Center, Seoul, South Korea
Seung-jung Park, MD, Contato
Seung-jung Park, MD, Investigador principal
Hallym University Hangang Sacred Heart Hospital, Seoul, South Korea
Min-kyu Kim, MD, Contato
Min-kyu Kim, MD, Investigador principal
Kangbuk Samsung Hospital, Seoul, South Korea
Seung-jae Lee, MD, Contato
Seung-jae Lee, MD, Investigador principal
Korea University Guro Hospital, Seoul, South Korea
Seung-woon Rha, MD, Contato
Seung-woon Rha, MD, Investigador principal
Ulsan University Hospital, Ulsan, South Korea
Sang-gon Lee, MD, Contato
Sang-gon Lee, MD, Investigador principal

Taipei City

Shin Kong Wu Ho-Su Memorial Hospital, Taipei, Taipei City, 111013, Taiwan
Jun-Jack Cheng, MD, Contato
Jun-Jack Cheng, MD, Investigador principal
King Chulalongkorn Memorial Hospital, Bangkok, 10330, Thailand
Wasan Udayachalerm, MD, Contato
Wasan Udayachalerm, MD, Investigador principal