Evaluation of Effectiveness and Safety of Antegrade and Retrograde Approach of Percutaneous Coronary Intervention for Chronic Total Occlusions (STRIKE-CTO)

November 14, 2023 updated by: Seung-Whan Lee, M.D., Ph.D.

Evaluation of Effectiveness and Safety of Antegrade and Retrograde Approach of Percutaneous Coronary Intervention for Chronic Total Occlusions; Systemic Chronic Total Occlusion Revascularization Korea Research-Chronic Total Occlusion (STRIKE-CTO) Study

Objective of this study is to 1) analyze the clinical, anatomical and periprocedural differences of patients who underwent a procedure related to coronary CTO through the antergrade approach and retrograde approach; 2) analyze the success rate of the procedures and the incidence and patterns of complications; 3) compare and analyze long-term performances after the successful procedure; and 4) identify the independent factors that require a retrograde approach and the prognostic factor regarding long-term performances after use of each approach.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Estimated)

4000

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Korea, Republic of
      • Anyang, Korea, Republic of
        • Recruiting
        • Hallym University Sacred Heart Hospital
        • Contact:
        • Principal Investigator:
          • Hyun-Sook Kim, MD
      • Bucheon, Korea, Republic of
        • Recruiting
        • SoonChunHyang University Hospital Bucheon
        • Contact:
        • Principal Investigator:
          • Nae Hee Lee, MD
      • Changwon, Korea, Republic of
        • Recruiting
        • Gyeongsang National University Changwon Hospital
        • Contact:
        • Principal Investigator:
          • Jae Seok Bae, MD
      • Cheongju-si, Korea, Republic of
        • Recruiting
        • Chungbuk National University Hospital
        • Contact:
        • Principal Investigator:
          • Sang-Min Kim, DM
      • Chuncheon, Korea, Republic of
        • Recruiting
        • Gangwon National University Hospital
        • Contact:
        • Principal Investigator:
          • Bong-Ki Lee, MD
      • Daegu, Korea, Republic of
        • Recruiting
        • Keimyung University Dongsan Medical Center
        • Contact:
        • Principal Investigator:
          • Hyuck Jun Yoon, MD
      • Daegu, Korea, Republic of
        • Recruiting
        • Yeungnam University Medical Center
        • Contact:
        • Principal Investigator:
          • Ung Kim, MD
      • Daejeon, Korea, Republic of
        • Recruiting
        • Chungnam National University Hospital
        • Principal Investigator:
          • Jae-Hyeong Park, MD
        • Contact:
      • Daejeon, Korea, Republic of
        • Recruiting
        • The Catholic University of Korea, Daejeon St. Mary's Hospital
        • Contact:
        • Principal Investigator:
          • Kyu-sup Lee
      • Daejeon, Korea, Republic of
        • Recruiting
        • The Catholic University of Korea, St. Vincent's Hospital
        • Principal Investigator:
          • Sung-ho Her, MD
        • Contact:
      • Gangneung, Korea, Republic of
        • Recruiting
        • Gangneung Asan Hospital
        • Contact:
        • Principal Investigator:
          • Han-bit LeePark, MD
      • Goyang-si, Korea, Republic of
        • Recruiting
        • Myongji Hospital
        • Contact:
        • Principal Investigator:
          • Ji-Hyun Lee, MD
      • Guri-si, Korea, Republic of
        • Recruiting
        • Hanyang University Medical Center
        • Contact:
        • Principal Investigator:
          • Yong-gu Lee, MD
      • Gyeonggi-do, Korea, Republic of
        • Recruiting
        • Seoul National University Bundang Hospital
        • Contact:
        • Principal Investigator:
          • Chang-Hwan Yoon, MD
      • Incheon, Korea, Republic of
        • Recruiting
        • Inha University Hospital
        • Contact:
        • Contact:
          • Seong-Ill Woo, MD
        • Principal Investigator:
          • Seong-Ill Woo, MD
      • Incheon, Korea, Republic of
        • Recruiting
        • The Catholic University of Korea, Incheon St. Mary's Hospital
        • Contact:
        • Principal Investigator:
          • Doo Soo Jeon, MD
      • Pusan, Korea, Republic of
        • Recruiting
        • Inje University Haeundae Paik Hospital
        • Contact:
        • Principal Investigator:
          • Dong-Kie Kim, MD
      • Pusan, Korea, Republic of
        • Recruiting
        • Inje University Pusan Paik Hospital
        • Contact:
        • Principal Investigator:
          • Tae Hyun Yang, MD
      • Pusan, Korea, Republic of
        • Recruiting
        • Dong-A University Hospital
        • Principal Investigator:
          • Yong-rak Cho, MD
        • Contact:
      • Pusan, Korea, Republic of
        • Recruiting
        • Busan Veterans Hospital, Korea Veterans Health Service
        • Principal Investigator:
          • Su-Hong Kim, MD
        • Contact:
      • Pusan, Korea, Republic of
        • Recruiting
        • Gosin University Gospel Hospital
        • Contact:
        • Principal Investigator:
          • Jeong Ho Heo, MD
      • Sejong, Korea, Republic of
        • Recruiting
        • Chungnam National University Sejong Hospital
        • Contact:
        • Principal Investigator:
          • Jae-Hwan Jae-Hwan, MD
      • Seoul, Korea, Republic of
        • Recruiting
        • Asan Medical Center
        • Principal Investigator:
          • Seung-Whan Lee, MD
        • Contact:
      • Seoul, Korea, Republic of
        • Recruiting
        • Samsung Medical Center
        • Contact:
        • Principal Investigator:
          • Joo-Yong Hahn, MD
      • Seoul, Korea, Republic of
        • Recruiting
        • Kangbuk Samsung Hospital
        • Principal Investigator:
          • Jong-young Lee, MD
        • Contact:
      • Seoul, Korea, Republic of
        • Recruiting
        • Veterans Hospital Service Medical Center
        • Principal Investigator:
          • Chang-Hoon Lee, MD
        • Contact:
      • Seoul, Korea, Republic of
        • Recruiting
        • The Catholic University of Korea, Eunpyeong
        • Principal Investigator:
          • Suk-min Seo, MD
        • Contact:
      • Seoul, Korea, Republic of
        • Recruiting
        • The Catholic University of Seoul St. Mary's Hospital
        • Principal Investigator:
          • Byung-hee Hwang, MD
        • Contact:
      • Ulsan, Korea, Republic of
        • Recruiting
        • Ulsan University Hospital
        • Contact:
        • Principal Investigator:
          • Gyung-Min Park, MD
      • Yangsan, Korea, Republic of
        • Recruiting
        • Pusan National University Yangsan Hospital
        • Contact:
        • Principal Investigator:
          • Kook Jin Chun, MD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

19 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

Subject selection will be determined after screening patients who undergo PCI for CTO lesions and completing the evaluation of all inclusion/exclusion criteria.

Description

Inclusion Criteria:

  • Patients aged>=19
  • Patients who have a CTO lesion in at least one or more epicardial coronary artery 2.5 mm in blood vessel diameter
  • Patients who have symptoms of angina or objectively proven myocardial ischemia (asymptomatic myocardial ischemia, stable or unstable angina, non - -ST-segment elevation myocardial infarction)
  • Patients who voluntarily agreed to the protocol and the clinical follow-up plan (or let their representative do this), and signed the informed consent form approved by the IRB of each study institute

Exclusion Criteria:

  • Patients who are pregnant or lactating or have childbearing potential Patients in whom contrast medium and heparin are contraindicated or who are hypersensitive to them
  • Patients in whom aspirin, clopidogrel, ticagrelor and prasugrel, cilostazol are contraindicated
  • Patients scheduled to undergo a surgery, etc. that requires discontinuance of an antiplatelet drug within 12 months after participation in the study
  • Acute ST elevation myocardial infarction at the time of hospitalization
  • Terminally ill patients with their life expectancy < one year
  • Patients who have serious diseases other than cardiac diseases that may affect limitation of residual life time or observation of the protocol (e.g. oxygen-independent chronic obstructive pulmonary disease, persisting hepatitis or serious hepatic insufficiency, severe renal disease, etc. Be left up to the discretion of the investigator.)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Observational
Procedure: antegrade and retrograde approach
This study intends to identify and compare the clinical, anatomical and periprocedural factors of the patients who used only the antergrade approach and the patients who needed the retrograde approach among the patients with coronary CTO

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Death
Time Frame: 12-month after PCI
Death
12-month after PCI
myocardial infarction
Time Frame: 12-month after PCI
the periprocedural myocardial infarction under the SCAI definition or the non-lethal myocardial infarction during the follow-up observations
12-month after PCI
the complex endpoints of target vessel revascularization/reocclusion occurrence
Time Frame: 12-month after PCI
including chronic total occlusion and angiostenosis
12-month after PCI

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Procedure success rate
Time Frame: every 1-year up-to 5-year
A procedure success defined as the case where a final vessel diameter stenosis < 30% is achieved after the stent insertion
every 1-year up-to 5-year
Myocardial infarction
Time Frame: every 1-year up-to 5-year
Q-wave VS non-Q-wave, periprocedural myocardial infarction VS follow-up myocardial infarction (spontaneous myocardial infarction
every 1-year up-to 5-year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Seung-Whan Lee, M.D., Ph.D.

Collaborators

Medtronic
Abbott Medical Devices
Biotronik SE & Co. KG
Dio Medical

Investigators

  • Principal Investigator: Seung-Whan Lee, MD, Asan Medical Center

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 11, 2018

Primary Completion (Estimated)

December 31, 2027

Study Completion (Estimated)

December 31, 2027

Study Registration Dates

First Submitted

September 10, 2018

First Submitted That Met QC Criteria

September 10, 2018

First Posted (Actual)

September 12, 2018

Study Record Updates

Last Update Posted (Estimated)

November 16, 2023

Last Update Submitted That Met QC Criteria

November 14, 2023

Last Verified

November 1, 2023

More Information

Terms related to this study

Other Study ID Numbers

  • AMCCV 2017-07

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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