Acute Coronary SyndromeTICKETNCT03273218
Effectiveness of the Tiger Catheter on Transradial Coronariography: Randomized Compared to JudKins cathETers
A study testing Tiger catheter and Judkins catheter in people with Acute Coronary Syndrome, run by Marcelo Alberto OLIVA at 1 site in Argentina.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Acute Coronary Syndrome
- What is being tested?
- Tiger catheter and Judkins catheter
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 120 participants
- Where
- 1 siteArgentina
- Study dates
- Dec 2015to 20 Jul 2016
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- written informed consent
- indication for coronary angiography
Who cannot join
- negative Allen´s test
- Chronic renal failure (to preserve the right radial artery for potencial arteriovenous shunting)
- Hemodynamic instability
- coronary artery bypass grafting
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effectiveness of the Tiger Catheter as a Simple Multipurpuse Catheter in Transradial Coronariography: Randomized Comparerd to Judkins Catheters
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.
- Conditions
- Acute Coronary Syndrome
- Being tested
- Tiger catheter, Judkins catheter
- Keywords
- coronary angiography, diagnosctic transradial catheter, transradial catheter
- Medical subject headings
- Acute Coronary Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Tiger catheterDevice
Also called Tiger
Judkins catheterDevice
Also called judkins right, judkins left
| Study group | Role | What they receive |
|---|---|---|
| Tiger catheter | Experimental | Tiger simple multipurpose catheter compared to Judkins catheters Receives: Device: Tiger catheter |
| Judkins catheter | Active comparator | Judkins right and judkins left catheter Receives: Device: Judkins catheter |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Day 0 (corresponding to time point of produce) assessed by intention - to - tresat analysis (IIT)
Secondary outcomes (3)
Fluoroscopy time
Fluoroscopy time (min)was defined as fluoroscopy time during the procedure (between groups)
Measured: 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
Measured: 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
Measured: 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)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Sep 2017
- Study startDec 2015
- Primary completion20 Jul 2016
- Study completion20 Jul 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acute Coronary SyndromeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 120 participants (actual)
Sponsor and investigators
- Lead sponsor
- Marcelo Alberto OLIVA
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Marcelo Alberto OLIVA, Hospital San Roque
- Investigators
- Marcelo OLIVA, MD, Principal investigator, Hospital San Roque
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03273218
- Sponsor's protocol ID
- HospitalSR
- Acronym
- TICKET
- Status last verified
- Aug 2017
- First submitted
- 19 Aug 2017
- Last updated
- 6 Mar 2019
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No: The aim of this study was to assess effectiveness and safety of Tiger vs Judkins catheters, in coronary angiography.
Study at a glance
From the registry record, last updated by the sponsor on 6 Mar 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effectiveness of the Tiger Catheter as a Simple Multipurpuse Catheter in Transradial Coronariography: Randomized Comparerd to Judkins Catheters
- ClinicalTrials.gov ID
- NCT03273218
- Acronym / sponsor ID
- TICKET / HospitalSR
- Conditions
- Acute Coronary Syndrome
- Keywords
- coronary angiography, diagnosctic transradial catheter, transradial catheter
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 120 participants (actual)
- Lead sponsor
- Marcelo Alberto OLIVAUniversity, hospital or other
- Study start
- Dec 2015
- Primary completion
- 20 Jul 2016 (actual)
- Study completion
- 20 Jul 2016 (actual)
- First posted
- 6 Sep 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Tiger catheter | Experimental | Device: Tiger catheterTiger simple multipurpose catheter compared to Judkins catheters |
| Judkins catheter | Active comparator | Device: Judkins catheterJudkins right and judkins left catheter |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- written informed consent
- indication for coronary angiography
Key exclusion criteria (4 listed)
- negative Allen´s test
- Chronic renal failure (to preserve the right radial artery for potencial arteriovenous shunting)
- Hemodynamic instability
- coronary artery bypass grafting
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Tiger catheterAlso: Tiger | Device | Tiger catheter |
| Judkins catheterAlso: judkins right, judkins left | Device | Judkins catheter |
Primary outcome
Produce time for the coronary angiography
Time frame: 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.
3 secondary outcomes
Fluoroscopy time
Time frame: Day 0 (corresponding to time point of produce)
Contrast Volume used
Time frame: Day 0 (corresponding to time point of produce)
Radial artery Spasm
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)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Mar 2019.
- Individual participant dataSharing planned: No. The aim of this study was to assess effectiveness and safety of Tiger vs Judkins catheters, in coronary angiography.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Marcelo OLIVA, MD principal investigator
Hospital San Roque
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Tiger catheter and Judkins catheter in people with Acute Coronary Syndrome, run by Marcelo Alberto OLIVA at 1 site in Argentina.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 6 Mar 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Argentina. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Produce time for the coronary angiography (time frame: Day 0 (corresponding to time point of produce) assessed by intention - to - tresat analysis (IIT)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Mar 2019.