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CompletedNCT03273218TICKETUpdated Mar 6, 2019

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

An interventional study of Tiger catheter and Judkins catheter in Acute Coronary Syndrome, sponsored by Marcelo Alberto OLIVA. Completed at 1 site in Argentina. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2019-03-06.

Sponsored by Marcelo Alberto OLIVA · Not applicable, Interventional, and Diagnostic

Phase
Not applicable
Study type
Interventional
Enrollment
120
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Study 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.

Read the 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.

02

Conditions studied

  • Acute Coronary Syndrome

Keywords

  • coronary angiography
  • diagnosctic transradial catheter
  • transradial catheter
03

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  • written informed consent
  • indication for coronary angiography

Exclusion criteria

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
04

Study design

Phase
Not applicable
Primary purpose
Diagnostic
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Single (Participant)
Enrollment
120 participants (actual)

Study arms

  • Experimental
    Tiger catheter

    Tiger simple multipurpose catheter compared to Judkins catheters

    Device: Tiger catheter

  • Active comparator
    Judkins catheter

    Judkins right and judkins left catheter

    Device: Judkins catheter

Interventions

  • DeviceTiger catheter

    Also known as: Tiger

  • DeviceJudkins catheter

    Also known as: judkins right, judkins left

05

What researchers measure

Primary outcomes

  1. 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.

    Time frame: Day 0 (corresponding to time point of produce) assessed by intention - to - tresat analysis (IIT)

Secondary outcomes

  1. Fluoroscopy time

    Fluoroscopy time (min)was defined as fluoroscopy time during the procedure (between groups)

    Time frame: Day 0 (corresponding to time point of produce)

  2. Contrast Volume used

    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)

  3. Radial artery Spasm

    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)

06

Study locations

1 site
  • Hospital San Roque
    Cordoba, 5000, Argentina
07

References and documents

Study documents

  • Study protocol · Jul 20, 2017

Documents are hosted by the registry — open the source record to download them.

Individual participant data

Plan to share: No — The aim of this study was to assess effectiveness and safety of Tiger vs Judkins catheters, in coronary angiography.

08

Registry details

Key details

Study ID
NCT03273218
Lead sponsor
Marcelo Alberto OLIVA
Responsible party
Marcelo Alberto OLIVA (interventional cardiologist, Hospital San Roque) — Sponsor-investigator
First posted
Sep 6, 2017
Start date
Dec 2015
Primary completion
Jul 20, 2016
Completion
Jul 20, 2016
Last update
Mar 6, 2019

Study contacts

Marcelo OLIVA, MD
principal investigator · Hospital San Roque

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
Yes
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Aug 2017. You cannot join it, but the record below documents what was studied.

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