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

Acute Coronary Syndrome Clinical Trial

— TICKET  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03273218
• Other study ID #: HospitalSR
• Status: Completed
• Phase: N/A
• Start date: December 2015
• Est. completion date: July 20, 2016

Study information

• Verified date: August 2017
• Source: Hospital San Roque
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 120
• Est. completion date: July 20, 2016
• Est. primary completion date: July 20, 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Acute Coronary Syndrome

Intervention

Device:
• Tiger catheter

• Judkins catheter

Locations

Country	Name	City	State
Argentina	Hospital San Roque	Cordoba

Sponsors (1)

Lead Sponsor	Collaborator
Marcelo Alberto OLIVA

Country where clinical trial is conducted

Argentina, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Fluoroscopy time	Fluoroscopy time (min)was defined as fluoroscopy time during the procedure (between groups)	Day 0 (corresponding to time point of produce)
Secondary	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)
Secondary	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)