NCT01803841

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
7,300

participants targeted

Target at P75+ for phase_4 coronary-artery-disease

Timeline
Completed

Started Feb 2013

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 2013

Completed
24 days until next milestone

First Submitted

Initial submission to the registry

February 25, 2013

Completed
7 days until next milestone

First Posted

Study publicly available on registry

March 4, 2013

Completed
2.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2015

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2015

Completed
Last Updated

November 15, 2016

Status Verified

November 1, 2016

Enrollment Period

2.2 years

First QC Date

February 25, 2013

Last Update Submit

November 14, 2016

Conditions

Coronary Artery Disease

Keywords

Coronary artery disease

Outcome Measures

Primary Outcomes (1)

  • Patient-oriented composite outcome

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

    1 year

Secondary Outcomes (4)

  • Access failure

    Day 0 (end of procedure)

  • Success of percutaneous coronary intervention

    Day 3 (day of discharge)

  • Procedure time

    Day 0 (end of procedure)

  • Fluoroscopic time

    Day 0 (end of procedure)

Study Arms (2)

Transradial access

ACTIVE COMPARATOR

Coronary angiography and intervention via radial artery approach

Procedure: Transradial coronary angiography and intervention

Transfemoral access

ACTIVE COMPARATOR

Coronary angiography and intervention via femoral artery approach

Procedure: Transfemoral coronary angiography and intervention

Interventions

Transradial coronary angiography and interventionPROCEDURE
Transradial access
Transfemoral coronary angiography and interventionPROCEDURE
Transfemoral access

Eligibility Criteria

Age19 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Wonju Severance Christian Hospital

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

Location

Related Publications (3)

  • Choe JC, Cha KS, Choi JH, Kim BW, Park JS, Lee HW, Oh JH, Choi JH, Lee HC, Hong TJ, Youn YJ, Lee SH, Cho BR, Kim DI, Han KR, Jeong MH, Yoon J; Korea Transradial Coronary Intervention (KOTRI) Prospective Registry Investigators. Comparison of Frequency of Bleeding and Major Adverse Cardiac Events After Transradial Versus Transfemoral Intervention in the Recent Antiplatelet Era. Am J Cardiol. 2016 May 15;117(10):1588-1595. doi: 10.1016/j.amjcard.2016.02.033. Epub 2016 Mar 2.

    PMID: 27026640BACKGROUND

  • Lee SH, Jeong MH, Han KR, Sim DS, Yoon J, Youn YJ, Cho BR, Cha KS, Hyon MS, Rha SW, Kim BO, Shin WY, Park KS, Cheong SS; Korean Transradial Coronary Intervention Registry Investigators. Comparison of Transradial and Transfemoral Approaches for Percutaneous Coronary Intervention in Patients With Acute Coronary Syndrome and Anemia. Am J Cardiol. 2016 May 15;117(10):1582-1587. doi: 10.1016/j.amjcard.2016.02.030. Epub 2016 Mar 2.

    PMID: 27018932BACKGROUND

  • Youn YJ, Lee JW, Ahn SG, Lee SH, Yoon J, Cho BR, Cheong SS, Kim HY, Lee JH, Bae JH, Lee JB, Suh J, Park KS, Han KR, Jeong MH, Rha SW, Her SH, Cho YH, Kim SW. Current Practice of Transradial Coronary Angiography and Intervention: Results from the Korean Transradial Intervention Prospective Registry. Korean Circ J. 2015 Nov;45(6):457-68. doi: 10.4070/kcj.2015.45.6.457. Epub 2015 Nov 25.

    PMID: 26617647RESULT

Related Links

MeSH Terms

Conditions

Coronary Artery Disease

Interventions

Methods

Condition Hierarchy (Ancestors)

Coronary DiseaseMyocardial IschemiaHeart DiseasesCardiovascular DiseasesArteriosclerosisArterial Occlusive DiseasesVascular Diseases

Intervention Hierarchy (Ancestors)

Investigative Techniques

Study Design

Study Type
interventional
Phase
phase 4
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor of Cardiology, Department of Internal Medicine

Study Record Dates

First Submitted

February 25, 2013

First Posted

March 4, 2013

Study Start

February 1, 2013

Primary Completion

April 1, 2015

Study Completion

June 1, 2015

Last Updated

November 15, 2016

Record last verified: 2016-11

Locations

KR(1)