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OpenTrials
Completed

NCT Number: NCT03273218

Effectiveness of the Tiger Catheter on Transradial Coronariography: Randomized Compared 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.

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Key information

Conditions

Acute Coronary Syndrome Cardiovascular Diseases Heart Diseases Myocardial Ischemia Vascular Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Hospital San Roque

Córdoba, 5000, Argentina

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Tiger catheter

Device

Other names: Tiger

Judkins catheter

Device

Other names: judkins right, judkins left

Primary outcomes

  1. 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.

Secondary outcomes

  1. 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)

  2. 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

  3. 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

Sponsors and collaborators

Lead sponsor

Marcelo Alberto OLIVA

Other

Registry information

Official study title

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

Acronym: TICKET

Important dates

Study start
2015
Primary completion
2016
Study completion
2016
First posted
Sep 6, 2017
Registry last updated
Mar 6, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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