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

Study Overview
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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.

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

Conditions
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Acute Coronary Syndrome

Intervention / Treatment
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* Device: Tiger catheter
* Device: Judkins catheter


Participation Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Diagnostic
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Tiger catheter<br>Tiger simple multipurpose catheter compared to Judkins catheters | Device: Tiger catheter<br> <br> * Other names: Tiger;|
| Active Comparator: Judkins catheter<br>Judkins right and judkins left catheter | Device: Judkins catheter<br> <br> * Other names: judkins left;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Produce time for the coronary angiography | 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 | Fluoroscopy time (min)was defined as fluoroscopy time during the procedure (between groups) | Day 0 (corresponding to time point of produce) | 
| Contrast Volume used | 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 | 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) | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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coronary angiography, diagnosctic transradial catheter, transradial catheter