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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.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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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

Other trials in Greece

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

  1. moderate opacification only in systole or diastole
  2. moderate opacification throughout cardiac cycle
  3. complete opacification but not throughout cardiac cycle
  4. 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.

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 groups in NCT03042845
Study groupRoleWhat they receive
Judkins L3.5/R4 cardiac cathetersActive comparatorNot described
Receives: Device: Judkins 3.5L/4R cardiac catheters
Tiger cardiac catheterExperimentalNot described
Receives: Device: Tiger cardiac catheter

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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)
  1. Contrast volume

    Contrast volume (in ml) between groups used for completion of coronary angiogram in per protocol analysis

    Measured: End of coronary angiography

  2. Dose Area Product (DAP)

    DAP (cGy*cm2) between groups in intention to treat and per protocol analysis

    Measured: End of coronary angiography

  3. Fluoroscopy time

    Fluoroscopy time (min) between groups in ITT and per protocol analysis

    Measured: End of coronary angiography

  4. Contrast induced nephropathy (CIN)

    CIN rate between groups in ITT and per protocol analysis

    Measured: End of coronary angiography

  5. Catheter failure

    Catheter failure rate between groups

    Measured: End of coronary angiography

  6. Severe spasm

    Severe spasm rate between groups

    Measured: End of coronary angiography

  7. Coronary angiogram time

    Duration of coronary angiogram between groups in ITT and per protocol analysis

    Measured: End of coronary angiography

  8. Opacification grade

    Opacification grade for LAD, LCX and RCA between study catheters

    Measured: End of coronary angiography

  9. Contact to coronary ostium

    Contact to left and right coronary ostium between study catheters

    Measured: End of coronary angiography

  10. 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.

  1. First posted3 Feb 2017 (estimated)
  2. Study start1 Oct 2016
  3. Primary completion25 May 2017
  4. Study completion25 May 2017

Resources

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)
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

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.

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