Effectiveness of the Tiger Catheter on Transradial Coronariography: Randomized Compared to JudKins cathETers

NCT ID: NCT03273218

Last Updated: 2019-03-06

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

120 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-12-31

Study Completion Date

2016-07-20

Brief Summary

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The aim of this study was to assess effectiveness and safety of Tiger (5Fr) vs Judkins (5Fr) catheters, in coronariography via the right transradial approach.

This was a prospective, randomized, study of paralled design. Consecutive patients with acute coronary syndrome (ACS), eligible for coronary angiography, was randomized after successuful cannulation of right artery and informed consent to either Tiger or Judkins catheters.

Detailed Description

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analyzed a total of 120 consective diagnostic coronary angioggraphy cases from the right radial approach. Of these 60 cases were performed with single catheter (Tiger) and 60 cases were performed with conventional catheters (Judkins). The patients of both group were overall well balanced for gender, age, risk factors, height, weight and body surface area. Diagnostic angiograms were successfully achieved in all cases via the radial approach.

Conditions

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Acute Coronary Syndrome

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

SINGLE

Participants

Study Groups

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Tiger catheter

Tiger simple multipurpose catheter compared to Judkins catheters

Group Type EXPERIMENTAL

Tiger catheter

Intervention Type DEVICE

Judkins catheter

Judkins right and judkins left catheter

Group Type ACTIVE_COMPARATOR

Judkins catheter

Intervention Type DEVICE

Interventions

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Tiger catheter

Intervention Type DEVICE

Judkins catheter

Intervention Type DEVICE

Other Intervention Names

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Tiger judkins right judkins left

Eligibility Criteria

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Inclusion Criteria

* written informed consent
* indication for coronary angiography

Exclusion Criteria

* negative Allen´s test
* Chronic renal failure (to preserve the right radial artery for potencial arteriovenous shunting)
* Hemodynamic instability
* coronary artery bypass grafting
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Marcelo Alberto OLIVA

OTHER

Sponsor Role lead

Responsible Party

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Marcelo Alberto OLIVA

interventional cardiologist

Responsibility Role SPONSOR_INVESTIGATOR

Principal Investigators

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Marcelo OLIVA, MD

Role: PRINCIPAL_INVESTIGATOR

Hospital San Roque

Locations

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Hospital San Roque

Córdoba, , Argentina

Site Status

Countries

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Argentina

Provided Documents

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Document Type: Study Protocol

View Document

Other Identifiers

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HospitalSR

Identifier Type: -

Identifier Source: org_study_id

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