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임상시험 NCT06908499 (DecisionCTO10Y)은(는) 관상동맥 질환에 대해 대상자모집전 상태입니다. 모든 세부 정보를 보려면 임상시험 레이더 카드 뷰와 AI 발견 도구를 확인하거나 여기에서 무엇이든 물어보세요.
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The DECISION-CTO Extended 10 Y Follow-up (DecisionCTO10Y) 840 장기 추적

대상자모집전
임상시험 세부 정보는 주로 영어로 제공됩니다. 하지만 임상 레이더 AI가 도와드릴 수 있습니다! '임상시험 설명'를 클릭하여 선택한 언어로 임상시험 정보를 확인하고, 이에 대해 AI와 논의해 보세요.
임상시험 NCT06908499 (DecisionCTO10Y)은(는) 관상동맥 질환에 대해 알아보는 관찰연구입니다. 현재 상태는 대상자모집전이며, 2026년 4월 1일부터 참여 신청이 가능합니다. 840명의 참여자를 모집할 예정입니다. Seung-Jung Park이(가) 진행하는 이 연구는 2026년 5월 31일까지 진행될 예정입니다. ClinicalTrials.gov의 가장 최근 정보는 2025년 12월 29일에 갱신되었습니다.
간단한 개요
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.
공식 제목

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

질환명
관상동맥 질환
기타 연구 식별자
  • DecisionCTO10Y
  • AMCCV2025-01
NCT 번호
NCT06908499
실제 연구 시작일
2026-04-01
최신 업데이트 게시
2025-12-29
예상 연구 완료일
2026-05-31
계획된 등록 인원
840
연구종류
관찰연구
상태
대상자모집전
키워드
Chronic Total Occlusion
Drug-eluting Stent Implantation
Optimal Medical Treatment
시험군 / 개입
참가자 그룹/시험군개입/치료
Patients with chronic total occlusion
Patients with chronic total occlusion who were enrolled in the original DECISION-CTO trial (NCT01078051)
해당 없음
주요결과변수
결과변수측정값 설명시간 범위
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
이차결과변수
결과변수측정값 설명시간 범위
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
참여 도우미
적격성 기준

연령대
성인, 노인
최소 연령
19 Years
참여 가능한 성별
전체

  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
연구 책임자
Seung-Jung Park, 의뢰자-연구자, Principal Investigator, Asan Medical Center
연구 대표 연락처
연락처: Jung-min Ahn, MD, [email protected]
19 5개국에 임상시험 장소
SAM hospital, Anyang, South Korea
Il-woo Seo, MD, 연락처
Il-woo Seo, MD, 책임연구자
Soon Chun Hyang University Hospital Bucheon, Bucheon-si, South Korea
John Seo, MD, 연락처
John Seo, MD, 책임연구자
Dong-A Medical Center, Busan, South Korea
Sang-yong Cho, MD, 연락처
Sang-yong Cho, MD, 책임연구자
Kangwon National University Hospital, Chuncheon, South Korea
Bong-ki Lee, MD, 연락처
Bong-ki Lee, MD, 책임연구자
Keimyung University Dongsan Medical Center, Daegu, South Korea
Hyuk-joon Yoon, MD, 연락처
Hyuk-joon Yoon, MD, 책임연구자
Chungnam National University Hospital, Daejeon, South Korea
Jae-whan Lee, MD, 연락처
Jae-whan Lee, MD, 책임연구자
The Catholic University of Korea, Daejeon St. Mary's Hosptial, Daejeon, South Korea
Kyu-seob Lee, MD, 연락처
Kyu-seob Lee, MD, 책임연구자
Gangneung Asan Hospital, Gangneung, South Korea
Han-bit Park, MD, 연락처
Han-bit Park, MD, 책임연구자
Chonnam National University Hospital, Gwangju, South Korea
Min-cheol Kim, MD, 연락처
Min-cheol Kim, MD, 책임연구자
Bundang CHA Hospital, Seongnam, South Korea
Sang-wook Lim, MD, 연락처
Sang-wook Lim, MD, 책임연구자
Asan Medical Center, Seoul, South Korea
Seung-jung Park, MD, 연락처
Seung-jung Park, MD, 책임연구자
Hallym University Hangang Sacred Heart Hospital, Seoul, South Korea
Min-kyu Kim, MD, 연락처
Min-kyu Kim, MD, 책임연구자
Kangbuk Samsung Hospital, Seoul, South Korea
Seung-jae Lee, MD, 연락처
Seung-jae Lee, MD, 책임연구자
Korea University Guro Hospital, Seoul, South Korea
Seung-woon Rha, MD, 연락처
Seung-woon Rha, MD, 책임연구자
Ulsan University Hospital, Ulsan, South Korea
Sang-gon Lee, MD, 연락처
Sang-gon Lee, MD, 책임연구자

Maharashtra

Ruby Hall Clinic, Pune, Maharashtra, 411001, India
Shirish Hiremath, MD, 연락처
Shirish Hiremath, MD, 책임연구자

DKI Jakarta

Medistra Hospital, Jakarta, DKI Jakarta, 12950, Indonesia
Teguh Santoso, MD, 연락처
Teguh Santoso, MD, 책임연구자

Taipei City

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