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

March 5, 2019 updated by: Marcelo Alberto OLIVA

Effectiveness of the Tiger Catheter as a Simple Multipurpuse Catheter in Transradial Coronariography: Randomized Comparerd to Judkins Catheters

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

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.

Study Type

Interventional

Enrollment (Actual)

120

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Argentina
      • Cordoba, Argentina, 5000
        • Hospital San Roque

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: DIAGNOSTIC
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: SINGLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: Tiger catheter
Tiger simple multipurpose catheter compared to Judkins catheters
Device: Tiger catheter
Other Names:
  • Tiger
ACTIVE_COMPARATOR: Judkins catheter
Judkins right and judkins left catheter
Device: Judkins catheter
Other Names:
  • judkins right
  • judkins left

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Produce time for the coronary angiography
Time Frame: Day 0 (corresponding to time point of produce) assessed by intention - to - tresat analysis (IIT)
Produce time (min) was defined as the time from the insertion of the first diagnostic coronary catheter in the sheath to the exist of the las diagnostic catheter the sheath.
Day 0 (corresponding to time point of produce) assessed by intention - to - tresat analysis (IIT)

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Fluoroscopy time
Time Frame: Day 0 (corresponding to time point of produce)
Fluoroscopy time (min)was defined as fluoroscopy time during the procedure (between groups)
Day 0 (corresponding to time point of produce)
Contrast Volume used
Time Frame: Day 0 (corresponding to time point of produce)
contrast volume used (ml) was defined as the contrast volume between groups used for completion of coronary angiogram
Day 0 (corresponding to time point of produce)
Radial artery Spasm
Time Frame: Day 0 (corresponding to time point of produce). The radial artery spasm was recorded like YES or NOT.(registry did by nurse from beginning to end of coronary angiography)
Radial artery Spasm was defined as the discomfort or pain in the arm, between groups
Day 0 (corresponding to time point of produce). The radial artery spasm was recorded like YES or NOT.(registry did by nurse from beginning to end of coronary angiography)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Marcelo Alberto OLIVA

Investigators

  • Principal Investigator: Marcelo OLIVA, MD, Hospital San Roque

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

December 1, 2015

Primary Completion (ACTUAL)

July 20, 2016

Study Completion (ACTUAL)

July 20, 2016

Study Registration Dates

First Submitted

August 19, 2017

First Submitted That Met QC Criteria

September 5, 2017

First Posted (ACTUAL)

September 6, 2017

Study Record Updates

Last Update Posted (ACTUAL)

March 6, 2019

Last Update Submitted That Met QC Criteria

March 5, 2019

Last Verified

August 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • HospitalSR

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

The aim of this study was to assess effectiveness and safety of Tiger vs Judkins catheters, in coronary angiography.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

Yes

product manufactured in and exported from the U.S.

Yes

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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