Back to resultsEffectiveness of the Tiger Catheter on Transradial Coronariography: Randomized Compared to JudKins cathETers (TICKET)
Primary Purpose
Acute Coronary Syndrome
Status
Completed
Phase
Not Applicable
Locations
Argentina
Study Type
Interventional
Intervention
Tiger catheter
Judkins catheter
Sponsored by
About this trial
This is an interventional diagnostic trial for Acute Coronary Syndrome focused on measuring coronary angiography, diagnosctic transradial catheter, transradial catheter
Eligibility Criteria
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
Sites / Locations
- Hospital San Roque
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Tiger catheter
Judkins catheter
Arm Description
Tiger simple multipurpose catheter compared to Judkins catheters
Judkins right and judkins left catheter
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
Fluoroscopy time
Fluoroscopy time (min)was defined as fluoroscopy time during the procedure (between groups)
Contrast Volume used
contrast volume used (ml) was defined as the contrast volume between groups used for completion of coronary angiogram
Radial artery Spasm
Radial artery Spasm was defined as the discomfort or pain in the arm, between groups
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT03273218
Brief Title
Effectiveness of the Tiger Catheter on Transradial Coronariography: Randomized Compared to JudKins cathETers
Acronym
TICKET
Official Title
Effectiveness of the Tiger Catheter as a Simple Multipurpuse Catheter in Transradial Coronariography: Randomized Comparerd to Judkins Catheters
Study Type
Interventional
2. Study Status
Record Verification Date
August 2017
Overall Recruitment Status
Completed
Study Start Date
December 2015 (undefined)
Primary Completion Date
July 20, 2016 (Actual)
Study Completion Date
July 20, 2016 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Marcelo Alberto OLIVA
4. Oversight
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
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Acute Coronary Syndrome
Keywords
coronary angiography, diagnosctic transradial catheter, transradial catheter
7. Study Design
Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
120 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Tiger catheter
Arm Type
Experimental
Arm Description
Tiger simple multipurpose catheter compared to Judkins catheters
Arm Title
Judkins catheter
Arm Type
Active Comparator
Arm Description
Judkins right and judkins left catheter
Intervention Type
Device
Intervention Name(s)
Tiger catheter
Other Intervention Name(s)
Tiger
Intervention Type
Device
Intervention Name(s)
Judkins catheter
Other Intervention Name(s)
judkins right, judkins left
Primary Outcome Measure Information:
Title
Produce time for the coronary angiography
Description
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.
Time Frame
Day 0 (corresponding to time point of produce) assessed by intention - to - tresat analysis (IIT)
Secondary Outcome Measure Information:
Title
Fluoroscopy time
Description
Fluoroscopy time (min)was defined as fluoroscopy time during the procedure (between groups)
Time Frame
Day 0 (corresponding to time point of produce)
Title
Contrast Volume used
Description
contrast volume used (ml) was defined as the contrast volume between groups used for completion of coronary angiogram
Time Frame
Day 0 (corresponding to time point of produce)
Title
Radial artery Spasm
Description
Radial artery Spasm was defined as the discomfort or pain in the arm, between groups
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)
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Marcelo OLIVA, MD
Organizational Affiliation
Hospital San Roque
Official's Role
Principal Investigator
Facility Information:
Facility Name
Hospital San Roque
City
Cordoba
ZIP/Postal Code
5000
Country
Argentina
12. IPD Sharing Statement
Plan to Share IPD
No
IPD Sharing Plan Description
The aim of this study was to assess effectiveness and safety of Tiger vs Judkins catheters, in coronary angiography.
Learn more about this trial
Effectiveness of the Tiger Catheter on Transradial Coronariography: Randomized Compared to JudKins cathETers
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