Coronary Artery DiseaseJUDGENCT03042845
Randomized Comparison of JUDkins vs tiGEr Catheter in Coronary Angiography Via the Right Radial Artery: the JUDGE Study
A study testing Tiger cardiac catheter and Judkins 3.5L/4R cardiac catheters in people with Coronary Artery Disease, run by University Hospital of Patras at 2 sites in Greece.
Trial summary
The investigators aim to assess safety and efficiency of Tiger II (5Fr; Terumo Interventional Systems, Somerset, New Jersey) vs Judkins (5Fr; 3.5L/4R, Medtronic Co) catheters, in coronary angiography via the right transradial route. This is a prospective, randomized, two-centre, study of parallel design. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Coronary Artery Disease
- What is being tested?
- Tiger cardiac catheter and Judkins 3.5L/4R cardiac catheters
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 640 participants
- Where
- 2 sitesGreece
- Study dates
- 1 Oct 2016to 25 May 2017
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Written informed consent
- Indication for non-urgent coronary angiography
- Successful cannulation of right radial artery
- Availability of both Tiger and JL3.5/JR4 catheters
Who cannot join
- Indication for urgent coronary angiography (ST-elevation myocardial infarction or non ST-elevation myocardial infarction with indication for coronary angiogram within 2 hours)
- Hemodynamic instability
- Non palpable right coronary artery
- Abnormal Allen test
- Prior coronary artery bypass grafting
- Chronic kidney disease or dialysis
Trial locations and contacts
2 sites in 1 country.
Greece2 sites
Second Department of Cardiology, Red Cross General Hospital
Athens
Patras University Hospital
Pátrai, Achaia, 26500
About this study
The investigators aim to assess safety and efficiency of Tiger II (5Fr; Terumo Interventional Systems, Somerset, New Jersey) vs Judkins (5Fr; 3.5L/4R, Medtronic Co) catheters, in coronary angiography via the right transradial route. This is a prospective, randomized, two-centre, study of parallel design. Consecutive patients with acute coronary syndrome (ACS), eligible for non-urgent coronary angiography, are randomized after successful cannulation of right radial artery and informed consent to either Tigger II or Judkins 3.5L/4R catheters.
Read the detailed description
From the entrance of the first diagnostic catheter into the sheath and until the completion of the diagnostic coronary angiography will be the measurement of the endpoints of the study.
In case of failure to complete the coronary angiogram with the catheter study a crossover to the other catheter of the study will take place except in cases of severe spasm, where catheter choice will be at the discretion of the operator. In case of failure of the other study's catheter, next catheter's selection will be at operator's discretion. Patients included in the study, who do not process to adhoc PCI, will be monitored with baseline creatinine and creatinine value at day 2 or 3 after coronary angiography.
In all angiography films will be conducted offline analysis by two experienced operators for scoring opacification grade and coronary ostium contact with the catheters used.
DEFINITIONS Mild spasm Spasm causing well tolerated local pain Moderate spasm Spasm which causes severe pain but the handling of catheters remains satisfactory Severe spasm Spasm that leads to change diagnostic catheter or access site Duration of coronary angiogram Is defined as the time from the insertion of the first diagnostic coronary catheter in the sheath to the exit of the last diagnostic catheter from the sheath Radiation time Radiation time from the insertion of the first diagnostic coronary catheter in the right radial sheath to the exit of the last diagnostic catheter from the sheath Dose area product (DAP) DAP from the insertion of the first diagnostic coronary catheter in the sheath to the exit of the last diagnostic catheter from the sheath Contrast volume Contrast volume (ml) used from the insertion of the first diagnostic coronary catheter in the sheath to the exit of the last diagnostic catheter from the sheath Contrast induced nephropathy (CIN) Relative increase ≥25% from baseline or absolute increase ≥ 0.5mg/dl of serum creatinine within 48-72 hours of intravenous contrast administration Opacification grade 0=poor/non-diagnostic
- moderate opacification only in systole or diastole
- moderate opacification throughout cardiac cycle
- complete opacification but not throughout cardiac cycle
- complete opacification throughout cardiac cycle Catheter contact with coronary ostium
0=none and non-diagnostic study
1=none but diagnostic study 2=non-coaxial contact 3=coaxial contact Catheter stability within the coronary ostium 0=no catheter's steady engagement of the ostium throughout the angiographic view
1=catheter's steady engagement of the ostium throughout the angiographic view Catheter failure Completion of coronary angiogram after study catheter crossover with or without right radial access site crossover Based on pilot data and previously published data we hypothesized that Tiger catheter use will lead to an absolute decrease of at least 5 ml in contrast volume compared with Judkins catheters (48 and 53 ml for Tiger και Judkins catheters respectively, with estimated standard deviation of 17 for both). With a 2-sided alpha of 0.05, group sample sizes of 316 and 316 will achieve 95% power to detect this difference.
- Conditions
- Coronary Artery Disease
- Being tested
- Tiger cardiac catheter, Judkins 3.5L/4R cardiac catheters
- Medical subject headings
- Coronary Artery Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Tiger cardiac catheterDevice
Tiger cardiac catheter
Judkins 3.5L/4R cardiac cathetersDevice
Judkins 3.5L/4R cardiac catheters
| Study group | Role | What they receive |
|---|---|---|
| Judkins L3.5/R4 cardiac catheters | Active comparator | Not described Receives: Device: Judkins 3.5L/4R cardiac catheters |
| Tiger cardiac catheter | Experimental | Not described Receives: Device: Tiger cardiac catheter |
What is being measured
The primary outcome is the main question the study is designed to answer.
Contrast volume
Contrast volume (in ml) between groups used for completion of coronary angiogram in intention to treat analysis analysis
Measured: End of coronary angiography
Secondary outcomes (10)
Contrast volume
Contrast volume (in ml) between groups used for completion of coronary angiogram in per protocol analysis
Measured: End of coronary angiography
Dose Area Product (DAP)
DAP (cGy*cm2) between groups in intention to treat and per protocol analysis
Measured: End of coronary angiography
Fluoroscopy time
Fluoroscopy time (min) between groups in ITT and per protocol analysis
Measured: End of coronary angiography
Contrast induced nephropathy (CIN)
CIN rate between groups in ITT and per protocol analysis
Measured: End of coronary angiography
Catheter failure
Catheter failure rate between groups
Measured: End of coronary angiography
Severe spasm
Severe spasm rate between groups
Measured: End of coronary angiography
Coronary angiogram time
Duration of coronary angiogram between groups in ITT and per protocol analysis
Measured: End of coronary angiography
Opacification grade
Opacification grade for LAD, LCX and RCA between study catheters
Measured: End of coronary angiography
Contact to coronary ostium
Contact to left and right coronary ostium between study catheters
Measured: End of coronary angiography
Stability within the coronary ostium
Catheter's steady engagement of the ostium throughout the angiographic view
Measured: 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 posted3 Feb 2017 (estimated)
- Study start1 Oct 2016
- Primary completion25 May 2017
- Study completion25 May 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Coronary Artery DiseaseStudies 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
- None (open label)
- Enrolment
- 640 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital of Patras
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Xanthopoulou Ioanna, University Hospital of Patras
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03042845
- Sponsor's protocol ID
- PUH1
- Acronym
- JUDGE
- Status last verified
- May 2017
- First submitted
- 1 Feb 2017
- Last updated
- 30 May 2017
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 30 May 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized Comparison of JUDkins vs tiGEr Catheter in Coronary Angiography Via the Right Radial Artery: the JUDGE Study
- ClinicalTrials.gov ID
- NCT03042845
- Acronym / sponsor ID
- JUDGE / PUH1
- Conditions
- Coronary Artery Disease
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 640 participants (actual)
- Lead sponsor
- University Hospital of PatrasUniversity, hospital or other
- Study start
- 1 Oct 2016 (actual)
- Primary completion
- 25 May 2017 (actual)
- Study completion
- 25 May 2017 (actual)
- First posted
- 3 Feb 2017 (estimated)
- 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 investigators aim to assess safety and efficiency of Tiger II (5Fr; Terumo Interventional Systems, Somerset, New Jersey) vs Judkins (5Fr; 3.5L/4R, Medtronic Co) catheters, in coronary angiography via the right transradial route. This is a prospective, randomized, two-centre, study of parallel design. Consecutive patients with acute coronary syndrome (ACS), eligible for non-urgent coronary angiography, are randomized after successful cannulation of right radial artery and informed consent to either Tigger II or Judkins 3.5L/4R catheters.
Detailed description
From the entrance of the first diagnostic catheter into the sheath and until the completion of the diagnostic coronary angiography will be the measurement of the endpoints of the study.
In case of failure to complete the coronary angiogram with the catheter study a crossover to the other catheter of the study will take place except in cases of severe spasm, where catheter choice will be at the discretion of the operator. In case of failure of the other study's catheter, next catheter's selection will be at operator's discretion. Patients included in the study, who do not process to adhoc PCI, will be monitored with baseline creatinine and creatinine value at day 2 or 3 after coronary angiography.
In all angiography films will be conducted offline analysis by two experienced operators for scoring opacification grade and coronary ostium contact with the catheters used.
DEFINITIONS Mild spasm Spasm causing well tolerated local pain Moderate spasm Spasm which causes severe pain but the handling of catheters remains satisfactory Severe spasm Spasm that leads to change diagnostic catheter or access site Duration of coronary angiogram Is defined as the time from the insertion of the first diagnostic coronary catheter in the sheath to the exit of the last diagnostic catheter from the sheath Radiation time Radiation time from the insertion of the first diagnostic coronary catheter in the right radial sheath to the exit of the last diagnostic catheter from the sheath Dose area product (DAP) DAP from the insertion of the first diagnostic coronary catheter in the sheath to the exit of the last diagnostic catheter from the sheath Contrast volume Contrast volume (ml) used from the insertion of the first diagnostic coronary catheter in the sheath to the exit of the last diagnostic catheter from the sheath Contrast induced nephropathy (CIN) Relative increase ≥25% from baseline or absolute increase ≥ 0.5mg/dl of serum creatinine within 48-72 hours of intravenous contrast administration Opacification grade 0=poor/non-diagnostic
- moderate opacification only in systole or diastole
- moderate opacification throughout cardiac cycle
- complete opacification but not throughout cardiac cycle
- complete opacification throughout cardiac cycle Catheter contact with coronary ostium
0=none and non-diagnostic study
1=none but diagnostic study 2=non-coaxial contact 3=coaxial contact Catheter stability within the coronary ostium 0=no catheter's steady engagement of the ostium throughout the angiographic view
1=catheter's steady engagement of the ostium throughout the angiographic view Catheter failure Completion of coronary angiogram after study catheter crossover with or without right radial access site crossover Based on pilot data and previously published data we hypothesized that Tiger catheter use will lead to an absolute decrease of at least 5 ml in contrast volume compared with Judkins catheters (48 and 53 ml for Tiger και Judkins catheters respectively, with estimated standard deviation of 17 for both). With a 2-sided alpha of 0.05, group sample sizes of 316 and 316 will achieve 95% power to detect this difference.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Judkins L3.5/R4 cardiac catheters | Active comparator | Device: Judkins 3.5L/4R cardiac catheters |
| Tiger cardiac catheter | Experimental | Device: Tiger cardiac catheter |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (4 listed)
- Written informed consent
- Indication for non-urgent coronary angiography
- Successful cannulation of right radial artery
- Availability of both Tiger and JL3.5/JR4 catheters
Key exclusion criteria (6 listed)
- Indication for urgent coronary angiography (ST-elevation myocardial infarction or non ST-elevation myocardial infarction with indication for coronary angiogram within 2 hours)
- Hemodynamic instability
- Non palpable right coronary artery
- Abnormal Allen test
- Prior 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 cardiac catheterTiger cardiac catheter | Device | Tiger cardiac catheter |
| Judkins 3.5L/4R cardiac cathetersJudkins 3.5L/4R cardiac catheters | Device | Judkins L3.5/R4 cardiac catheters |
Primary outcome
Contrast volume
Time frame: End of coronary angiography
Contrast volume (in ml) between groups used for completion of coronary angiogram in intention to treat analysis analysis
10 secondary outcomes
Contrast volume
Time frame: End of coronary angiography
Dose Area Product (DAP)
Time frame: End of coronary angiography
Fluoroscopy time
Time frame: End of coronary angiography
Contrast induced nephropathy (CIN)
Time frame: End of coronary angiography
Catheter failure
Time frame: End of coronary angiography
Severe spasm
Time frame: End of coronary angiography
Coronary angiogram time
Time frame: End of coronary angiography
Opacification grade
Time frame: End of coronary angiography
Contact to coronary ostium
Time frame: End of coronary angiography
Stability within the coronary ostium
Time frame: 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 30 May 2017.
- Individual participant dataSharing planned: Undecided
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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.
The record lists no contact. Use the official record to reach the sponsor.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Tiger cardiac catheter and Judkins 3.5L/4R cardiac catheters in people with Coronary Artery Disease, run by University Hospital of Patras at 2 sites in Greece.
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 4 inclusion and 6 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 30 May 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Greece. 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?
Contrast volume (time frame: End of coronary angiography). 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 30 May 2017.