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Korea Transradial Coronary Intervention Prospective Registry (KOTRI) (KOTRI)

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ClinicalTrials.gov Identifier: NCT01803841
Recruitment Status : Completed
First Posted : March 4, 2013
Last Update Posted : November 15, 2016
Sponsor:
Collaborator:
The Korean Society of Cardiology
Information provided by (Responsible Party):
Yoon Junghan, Yonsei University

Brief Summary:
The aim of this registry is to analyze several factors affecting the procedural success and clinical outcomes at 1 year of follow-up according to the approach site.

Condition or disease Intervention/treatment Phase
Coronary Artery Disease Procedure: Transradial coronary angiography and intervention Procedure: Transfemoral coronary angiography and intervention Phase 4

Detailed Description:
This registry is a multi-center prospective registry for patients undergoing coronary angiography or percutaneous coronary intervention either transradial or transfemoral approach from 22 centers in South Korea. The aim of this registry is to analyze several factors affecting the procedural success and clinical outcomes at 1 year of follow-up according to the approach site.

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 7300 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Korea Transradial Coronary Intervention Prospective Registry (KOTRI)
Study Start Date : February 2013
Actual Primary Completion Date : April 2015
Actual Study Completion Date : June 2015

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arm Intervention/treatment
Active Comparator: Transradial access
Coronary angiography and intervention via radial artery approach
Procedure: Transradial coronary angiography and intervention
Active Comparator: Transfemoral access
Coronary angiography and intervention via femoral artery approach
Procedure: Transfemoral coronary angiography and intervention



Primary Outcome Measures :
  1. Patient-oriented composite outcome [ Time Frame: 1 year ]
    The composite of any death, non-fatal myocardial infarction, and any revascularization


Secondary Outcome Measures :
  1. Access failure [ Time Frame: Day 0 (end of procedure) ]
    Conversion rate of access site

  2. Success of percutaneous coronary intervention [ Time Frame: Day 3 (day of discharge) ]

    Combination of angiographic success and procedural success

    1. Angiographic success; thrombolysis in myocardial infarction (TIMI) flow grad 3 and <30% residual diameter stenosis
    2. Procedural success; Angiographic success without major procedural or in-hospital complications such as death, Q-wave myocardial infarction, or emergency bypass surgery

  3. Procedure time [ Time Frame: Day 0 (end of procedure) ]
    Procedure time according to the access site

  4. Fluoroscopic time [ Time Frame: Day 0 (end of procedure) ]
    Fluoroscopic time according to the access site



Information from the National Library of Medicine

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Ages Eligible for Study:   19 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • All consecutive hospitalized patients undergoing coronary angiography or percutaneous coronary intervention

Exclusion Criteria:

  • No exclusion criteria

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): NCT01803841


Locations
Korea, Republic of
Wonju Severance Christian Hospital
Wonju, Gangwon, Korea, Republic of, 220-701
Sponsors and Collaborators
Yonsei University
The Korean Society of Cardiology

Additional Information:
Publications of Results:
Other Publications:
Responsible Party: Yoon Junghan, Professor of Cardiology, Department of Internal Medicine, Yonsei University
ClinicalTrials.gov Identifier: NCT01803841     History of Changes
Other Study ID Numbers: KOTRI
First Posted: March 4, 2013    Key Record Dates
Last Update Posted: November 15, 2016
Last Verified: November 2016

Keywords provided by Yoon Junghan, Yonsei University:
Coronary artery disease

Additional relevant MeSH terms:
Coronary Artery Disease
Myocardial Ischemia
Coronary Disease
Heart Diseases
Cardiovascular Diseases
Arteriosclerosis
Arterial Occlusive Diseases
Vascular Diseases