Try the modernized ClinicalTrials.gov beta website. Learn more about the modernization effort.
Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03667196
Recruitment Status : Recruiting
First Posted : September 12, 2018
Last Update Posted : September 12, 2018
Sponsor:
Collaborators:
Abbott Medical Devices
Biotronik SE & Co. KG
Information provided by (Responsible Party):
Seung-Whan Lee, M.D., Ph.D., Asan Medical Center

Study Description
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information
Brief Summary:
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.

Condition or disease Intervention/treatment
Chronic Total Occlusion of Coronary Artery Procedure: antegrade and retrograde approach

Study Design
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Layout table for study information
Study Type : Observational
Estimated Enrollment : 2000 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: 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
Actual Study Start Date : January 11, 2018
Estimated Primary Completion Date : December 31, 2022
Estimated Study Completion Date : December 31, 2027
Groups and Cohorts
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

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


Outcome Measures
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Primary Outcome Measures :
  1. Death [ Time Frame: 12-month after PCI ]
    Death

  2. 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

  3. the complex endpoints of target vessel revascularization/reocclusion occurrence [ Time Frame: 12-month after PCI ]
    including chronic total occlusion and angiostenosis


Secondary Outcome Measures :
  1. 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

  2. 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


Eligibility Criteria
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   20 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
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.
Criteria

Inclusion Criteria:

  • Patients aged>20
  • 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.)
Contacts and Locations
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03667196


Locations
Layout table for location information
Korea, Republic of
Hallym University Sacred Heart Hospital Recruiting
Anyang, Korea, Republic of
Contact: Hyun-Sook Kim, MD    8210-6678-1376    hearthsk@hotmail.com   
Principal Investigator: Hyun-Sool Kim, MD         
Soon Chun Hyang University Hospital Bucheon Recruiting
Bucheon, Korea, Republic of
Contact: JON Suh, MD    8210-3407-3843    immanuel@schmc.ac.kr   
Principal Investigator: JON Suh, MD         
Chungnam National University Hospital Recruiting
Daejeon, Korea, Republic of
Contact: Jae-Hwan Lee, MD    8210-9213-8237    myheart@cnu.ac.kr   
Principal Investigator: Jae-Hwan Lee, MD         
Gangwon National University Hospital Recruiting
Gangwon, Korea, Republic of
Contact: Bong-Ki Lee, MD    8210-6373-9290    mdbklee@kangwon.ac.kr   
Principal Investigator: Bong-Ki Lee, MD         
Seoul national university Bundang hospital Recruiting
Gyeonggi-do, Korea, Republic of
Contact: Chang-Hwan Yoon, MD    8210-2336-9000    changhwanyoon@gmail.com   
Principal Investigator: Chang-Hwan Yoon, MD         
Inje University Pusan Paik Hospital Recruiting
Pusan, Korea, Republic of
Contact: Tae Hyun Yang, MD    8210-4590-5067    yangthmd@naver.com   
Principal Investigator: Han-Young Jin, MD         
Veterans Hospital Recruiting
Pusan, Korea, Republic of
Contact: Su-Hong Kim, MD    8210-2571-2149    dhugie@naver.com   
Principal Investigator: Su-Hong Kim, MD         
Asan Medical Center Recruiting
Seoul, Korea, Republic of
Contact: Seung-Whan Lee, MD    8210-7398-9897    seungwlee@amc.seoul.kr   
Principal Investigator: Seung-Whan Lee, MD         
Kangbuk Samsung Medical Center Recruiting
Seoul, Korea, Republic of
Contact: Jong-Young Lee, MD    8210-2507-4780    jyleeheart@naver.com   
Principal Investigator: Jong-Young Lee, MD         
Veterans Hospital Service Medical Center Recruiting
Seoul, Korea, Republic of
Contact: Chang-Hoon Lee, MD    8210-5551-7867    changhoon.lee121@gmail.com   
Principal Investigator: Chang-Hoon Lee, MD         
Gyung-Min, Park Recruiting
Ulsan, Korea, Republic of
Contact: Gyung-Min Park, MD    8210-9995-8684    min8684@hanmail.net   
Principal Investigator: Gyung-Min Park, MD         
Sponsors and Collaborators
Seung-Whan Lee, M.D., Ph.D.
Abbott Medical Devices
Biotronik SE & Co. KG
More Information
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information
Layout table for additonal information
Responsible Party: Seung-Whan Lee, M.D., Ph.D., M.D., Asan Medical Center
ClinicalTrials.gov Identifier: NCT03667196    
Other Study ID Numbers: AMCCV 2017-07
First Posted: September 12, 2018    Key Record Dates
Last Update Posted: September 12, 2018
Last Verified: September 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No