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Japanese CTO PCI Expert Registry

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ClinicalTrials.gov Identifier: NCT01889459
Recruitment Status : Recruiting
First Posted : June 28, 2013
Last Update Posted : July 2, 2013
Sponsor:
Collaborator:
Japanese CTO PCI Expert Registry investigators
Information provided by (Responsible Party):
Kurashiki Central Hospital

Brief Summary:
The purpose of this study is to establish a consensus of treatment strategy of percutaneous coronary intervention (PCI) for chronic total occlusion (CTO) through patient registry of PCI for CTO performed by Japanese certified operators.

Condition or disease
Chronic Total Occlusion of Coronary Artery

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Study Type : Observational
Estimated Enrollment : 19000 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Patient Registry of Percutaneous Coronary Intervention (PCI) for Chronic Total Occlusion (CTO) by Japanese Experts
Study Start Date : July 2013
Estimated Primary Completion Date : December 2022
Estimated Study Completion Date : December 2027

Group/Cohort
PCI for CTO



Primary Outcome Measures :
  1. successful revascularization without any major adverse cardiocerebral events (MACCE) at early follow-up and MACCE during the 5-year follow-up [ Time Frame: within the first 1 month (plus 1 month) after PCI and during the 5-year follow-up ]
    early and late results on major adverse cardiocerebral events (MACCE): all-cause death, coronary artery bypass grafting, re-PCI (target lesion revascularization/target vessel revascularization), admission for heart failure, myocardial infarction, admission for unstable angina, cerebrovascular disease, stent thrombosis in 19000 patients in and outside Japan



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Ages Eligible for Study:   20 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
Patients who underwent PCI for CTO lesions by Japanese certified operators
Criteria

Inclusion Criteria:

Patients eligible for PCI

Patients who underwent PCI for CTO lesions that contain the following:

  1. Thrombolysis in myocardial infarction trial (TIMI) 0
  2. The occlusive period more than 3 months or unknown
  3. The main coronary arteries (segment 1-3, 5-8, 11, 13), branches that have large perfusion area (segment 4PL, 9/10, 12) and graft

Exclusion Criteria:

Patients ineligible for PCI judged in clinical practice


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): NCT01889459


Contacts
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Contact: Keiko Oka 81-86-422-0210 ext 2742 cto.e.registry@gmail.com
Contact: Harumi Katoh, MD, PhD 81-86-422-0210 hk10731@kchnet.or.jp

Locations
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Japan
Kurashiki Central Hospital Recruiting
Kurashiki, Japan, 710-8602
Contact: Keiko Oka    81-86-422-0210      
Sponsors and Collaborators
Kurashiki Central Hospital
Japanese CTO PCI Expert Registry investigators
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Responsible Party: Kurashiki Central Hospital
ClinicalTrials.gov Identifier: NCT01889459    
Other Study ID Numbers: J-CTOPCI-ER2013
First Posted: June 28, 2013    Key Record Dates
Last Update Posted: July 2, 2013
Last Verified: July 2013