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Completed

NCT Number: NCT01803841

Korea Transradial Coronary Intervention Prospective Registry (KOTRI)

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.

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Key information

Conditions

Coronary Artery Disease Arterial Occlusive Diseases Arteriosclerosis Cardiovascular Diseases Coronary Disease Heart Diseases Myocardial Ischemia Vascular Diseases

Age range

19 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Wonju Severance Christian Hospital

Wŏnju, Gangwon-do, 220-701, South Korea

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

  • No exclusion criteria

Treatment and study plan

Transradial coronary angiography and intervention

Procedure

Transfemoral coronary angiography and intervention

Procedure

Primary outcomes

  1. Patient-oriented composite outcome

    Time frame: 1 year

    The composite of any death, non-fatal myocardial infarction, and any revascularization

Secondary outcomes

  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

    • Angiographic success; thrombolysis in myocardial infarction (TIMI) flow grad 3 and <30% residual diameter stenosis
    • 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

Sponsors and collaborators

Lead sponsor

Yonsei University

Other

Collaborators

  • The Korean Society of Cardiology

Registry information

Acronym: KOTRI

Important dates

Study start
2013
Primary completion
2015
Study completion
2015
First posted
Mar 4, 2013
Registry last updated
Nov 15, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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