Comparison of Left and Right Transradial Approach for CAG and PCI

NCT ID: NCT03389503

Last Updated: 2018-01-03

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

322 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-03-08

Study Completion Date

2017-09-07

Brief Summary

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This trial will compare the procedural success rate between right and left radial approach in patients undergoing coronary angiography and coronary intervention.

Detailed Description

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The three operators who are proficient in the left radial approach for coronary angiography and coronary intervention will be assigned to the right radial approach for 3 months (phase 1). After then, these three operators will switch approach site to the left radial for another 3 months (phase 2).

Procedural success, time of the procedure, use of contrast agent, and fluoroscopic data will be compared between right radial approach (phase 1) group and left radial approach (phase 2).

Conditions

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Coronary Artery Disease Stable Angina Unstable Angina Non-ST Elevation Myocardial Infarction ST-segment Elevation Myocardial Infarction Ischemic Heart Disease Without Angina

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SEQUENTIAL

1\~3 months: Right radial approach 4\~6 months: Left radial approach
Primary Study Purpose

OTHER

Blinding Strategy

NONE

Study Groups

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Right radial approach

Right radial approach for coronary angiography and coronary intervention

Group Type ACTIVE_COMPARATOR

Radial approach

Intervention Type PROCEDURE

Approach site for coronary angiography and coronary intervention

Left radial approach

Left radial approach for coronary angiography and coronary intervention

Group Type ACTIVE_COMPARATOR

Radial approach

Intervention Type PROCEDURE

Approach site for coronary angiography and coronary intervention

Interventions

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Radial approach

Approach site for coronary angiography and coronary intervention

Intervention Type PROCEDURE

Eligibility Criteria

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Inclusion Criteria

* Subjects undergoing coronary angiography via radial approach
* Subjects undergoing coronary intervention via radial approach
* Subjects give written informed consent

Exclusion Criteria

* Subjects undergoing procedure(s) other than coronary angiography or intervention
* Subjects with contraindication of radial approach (i.e, non-palpable radial pulsation, abnormal Allen's test, known radial artery tortuosity or occlusion, arteriovenous fistula for dialysis)
Minimum Eligible Age

18 Years

Maximum Eligible Age

100 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Wonju Severance Christian Hospital

OTHER

Sponsor Role lead

Responsible Party

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Young Jin Youn

Assistant professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Wonju Severance Christian Hospital

Wŏnju, Gangwon-do, South Korea

Site Status

Countries

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South Korea

Other Identifiers

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CR316096

Identifier Type: -

Identifier Source: org_study_id

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