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Effect of Introducer Length on the Rate of Radial Artery Occlusion During Endovascular Coronary Procedures

NCT ID: NCT03854253

Last Updated: 2020-01-13

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

100 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-02-26

Study Completion Date

2019-03-14

Brief Summary

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This study evaluates estimate impact of introducers length during endovascular coronary procedures on rate of a radial artery occlusion. For half of participants will use short introducers, while for other will use long introducers during transradial coronary intervention.

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Detailed Description

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The transradial approach for coronary angiography and interventions is increasingly utilized around the world. Radial artery occlusion is the most common significant complication after transradial catheterization, with incidence varying between 1% and 10%. Endothelial injury of the radial artery and decrease in blood flow after sheath and catheter insertion appear to contribute to thrombus formation and are predisposing factors for radial artery occlusion. Procedural factors can predict and influence radial artery occlusion incidence. Sheath size and its relation to radial artery diameter, as well as the utilization of specific pharmacological agents (such as anticoagulants and vasodilators) have been studied. But, impact of Introducer sheath length on the rate of a radial artery occlusion has not been studied. The investigators suggest that, longer introducer sheath sizes can prevented the vascular damage and a pro-thrombotic environment.

Conditions

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Coronary Artery Disease

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

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Long introducer 6Fr-25cm

The investigators will perform transradial coronary angiography and percutaneous coronary interventions using long introducer sheath 6Fr-25cm

Group Type EXPERIMENTAL

Long introducer sheath

Intervention Type PROCEDURE

The investigators will perform transradial coronary angiography and percutaneous coronary interventions using introducer sheath 6Fr-25cm

Short introducer 6Fr-10cm

The investigators will perform transradial coronary angiography and percutaneous coronary interventions using short introducer sheath 6Fr-10cm

Group Type ACTIVE_COMPARATOR

Short introducer sheath

Intervention Type PROCEDURE

The investigators will perform transradial coronary angiography and percutaneous coronary interventions using introducer sheath 6Fr-10cm

Interventions

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Long introducer sheath

The investigators will perform transradial coronary angiography and percutaneous coronary interventions using introducer sheath 6Fr-25cm

Intervention Type PROCEDURE

Short introducer sheath

The investigators will perform transradial coronary angiography and percutaneous coronary interventions using introducer sheath 6Fr-10cm

Intervention Type PROCEDURE

Eligibility Criteria

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Inclusion Criteria

* Age over 18 years old
* Applicability of transradial approach

Exclusion Criteria

* Failure of the transradial approach
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Tomsk National Research Medical Center of the Russian Academy of Sciences

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Sergey V Popov

Role: PRINCIPAL_INVESTIGATOR

Tomsk National Research Medical Center of the Russian Academy of Sciences

Locations

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Tyumen Cardiology Research Center, Tomsk National Research Medical Center, Russian Academy of Science

Tyumen, , Russia

Site Status

Countries

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Russia

Provided Documents

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Document Type: Study Protocol

View Document

Document Type: Statistical Analysis Plan

View Document

Other Identifiers

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IntroLength

Identifier Type: -

Identifier Source: org_study_id

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