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

Not Applicable

Completed

• Conditions: Acute Coronary Syndrome
• Interventions: Device: Judkins catheter; Device: Tiger catheter

• Registration Number: NCT03273218
• Lead Sponsor: Marcelo Alberto OLIVA

Brief Summary

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

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 Timeline

• Study Start: 2015-12
• Primary Completion: 2016-07-20
• Study Completion: 2016-07-20
• Status Verified: 2017-08
• Study First Submitted: 2017-08-19
• Study First Submitted QC: 2017-09-05
• Study First Posted: 2017-09-06
• Last Update Submitted: 2019-03-05
• Last Update Posted: 2019-03-06

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 120

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Judkins catheter	Judkins catheter	Judkins right and judkins left catheter
Tiger catheter	Tiger catheter	Tiger simple multipurpose catheter compared to Judkins catheters

Primary Outcome Measures

Name	Time	Method
Produce time for the coronary angiography	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 Outcome Measures

Name	Time	Method
Radial artery Spasm	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
Fluoroscopy time	Day 0 (corresponding to time point of produce)	Fluoroscopy time (min)was defined as fluoroscopy time during the procedure (between groups)
Contrast Volume used	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

Trial Locations

Locations (1)

Hospital San Roque; 🇦🇷 Cordoba, Argentina