Korea Transradial Coronary Intervention Prospective Registry (KOTRI)

This study is currently recruiting participants. (see Contacts and Locations)
Verified September 2013 by Yonsei University
Sponsor:
Collaborator:
The Korean Society of Cardiology
Information provided by (Responsible Party):
Yoon Junghan, Yonsei University
ClinicalTrials.gov Identifier:
NCT01803841
First received: February 25, 2013
Last updated: September 22, 2013
Last verified: September 2013
  Purpose

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 Intervention Phase
Coronary Artery Disease
Procedure: Transradial coronary angiography and intervention
Procedure: Transfemoral coronary angiography and intervention
Phase 4

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Korea Transradial Coronary Intervention Prospective Registry (KOTRI)

Resource links provided by NLM:


Further study details as provided by Yonsei University:

Primary Outcome Measures:
  • Patient-oriented composite outcome [ Time Frame: 1 year ] [ Designated as safety issue: Yes ]
    The composite of any death, non-fatal myocardial infarction, and any revascularization


Secondary Outcome Measures:
  • Access failure [ Time Frame: Day 0 (end of procedure) ] [ Designated as safety issue: No ]
    Conversion rate of access site

  • Success of percutaneous coronary intervention [ Time Frame: Day 3 (day of discharge) ] [ Designated as safety issue: Yes ]

    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

  • Procedure time [ Time Frame: Day 0 (end of procedure) ] [ Designated as safety issue: No ]
    Procedure time according to the access site

  • Fluoroscopic time [ Time Frame: Day 0 (end of procedure) ] [ Designated as safety issue: No ]
    Fluoroscopic time according to the access site


Estimated Enrollment: 5000
Study Start Date: February 2013
Estimated Study Completion Date: August 2014
Estimated Primary Completion Date: August 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Transradial access
Coronary angiography and intervention via radial artery approach
Procedure: Transradial coronary angiography and intervention
Other Name: Transradial coronary angiography and intervention
Active Comparator: Transfemoral access
Coronary angiography and intervention via femoral artery approach
Procedure: Transfemoral coronary angiography and intervention

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.

  Eligibility

Ages Eligible for Study:   19 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

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

Exclusion Criteria:

  • No exclusion criteria
  Contacts and Locations
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01803841

Contacts
Contact: J Yoon, MD, PhD +82-33-741-0906 jyoon@yonsei.ac.kr
Contact: Young Jin Youn, MD +82-33-741-0920 younyj@yonsei.ac.kr

Locations
Korea, Republic of
Wonju Severance Christian Hospital Recruiting
Wonju, Gangwon, Korea, Republic of, 220-701
Contact: J Yoon, MD, PhD       jyoon@yonsei.ac.kr   
Sub-Investigator: Seung-Hwan Lee, MD, PhD         
Sub-Investigator: Sung-Gyun Ahn, MD         
Sub-Investigator: Young Jin Youn, MD         
Sponsors and Collaborators
Yonsei University
The Korean Society of Cardiology
  More Information

Additional Information:
No publications provided

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
Study First Received: February 25, 2013
Last Updated: September 22, 2013
Health Authority: Korea: Institutional Review Board

Keywords provided by 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

ClinicalTrials.gov processed this record on August 21, 2014