Stable Coronary Heart DiseaseUDDCNCT02947542
Use of Different Diagnostic Coronary Catheters Over the Radial Access - the UDDC - Radial Trial
A study testing One-catheter concept and Standard catheter in people with Stable Coronary Heart Disease, run by Charite University, Berlin, Germany at 1 site in Germany.
Trial summary
There is no evidence from prospective randomized clinical trials regarding the performance of conventional (two-catheter-concept; TCC) versus one-catheter-concepts (OCC) for invasive coronary angiography over the radial access. Read more about this study
- Who is it for?
- Ages 18 to 95 years
- Conditions the study is for
- Stable Coronary Heart Disease
- What is being tested?
- One-catheter concept and Standard catheter
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 300 participants
- Where
- 1 siteGermany
- Study dates
- Apr 2016to Dec 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 to 95 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age ≥ 18 years and ≤ 95 years
- Body weight > 60kg
Who cannot join
- Acute coronary syndrome or cardiogenic shock
- Contraindications for transracial access such as absence of radial pulse or abnormal Allen test
- Prior unsuccessful transradial coronary angiography
- Estimated glomerular filtration rate <40 ml/kg/min
- Patients not able to give informed consent
- Participation in another trial
Trial locations and contacts
1 site in 1 country.
Germany1 site
Department of Cardiology, Campus Benjamin Franklin, Charité - Universitätsmedizin Berlin
Berlin, 12203
About this study
There is no evidence from prospective randomized clinical trials regarding the performance of conventional (two-catheter-concept; TCC) versus one-catheter-concepts (OCC) for invasive coronary angiography over the radial access.
The aim of the present trial is to evaluate the efficacy and safety of different one-catheter concepts by use of the BLK and Tiger catheter compared to a TCC using standard Judkins catheters in diagnostic coronary angiography via transradial access. Patients with stable angina pectoris will be randomly assigned to coronary angiography performed with the BLK or Tiger (OCC) or Judkins catheters (TCC). The primary endpoint is coronary angiography duration.
Read the detailed description
The aim of the present trial is to evaluate the efficacy and safety of a one-catheter concept using the BLK (Terumo, Somerset, USA) or the Tiger catheter (Terumo, Somerset, USA) compared to the standard Judkins catheters in diagnostic coronary angiography by the transradial access. Patients with stable angina pectoris will be randomly assigned to coronary angiography performed with the BLK (Group I), Tiger (Group II) or Judkins catheters (Group III). Primary endpoint is the time duration (sec) that is necessary to perform complete coronary angiography including 6 different projections for the left-coronary system and 3 different projections of the right-coronary-system. Secondary endpoints will cover safety and imaging quality of the different catheter systems.
- Conditions
- Stable Coronary Heart Disease
- Being tested
- One-catheter concept, Standard catheter
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
One-catheter conceptDevice
Coronary angiography will be performed using the one-catheter concept.
Standard catheterDevice
Coronary angiography will be performed using a standard catheter.
| Study group | Role | What they receive |
|---|---|---|
| BLK catheter | Experimental | Coronary angiography will be performed with the BLK catheter (one-catheter concept). Receives: Device: One-catheter concept |
| Tiger catheter | Experimental | Coronary angiography will be performed with the Tiger catheter (one-catheter concept). Receives: Device: One-catheter concept |
| Judkins catheter | Active comparator | Coronary angiography will be performed with the Judkins catheter (standard catheter). Receives: Device: Standard catheter |
What is being measured
The primary outcome is the main question the study is designed to answer.
Coronary angiography Duration (sec)
assessed by Intention-to-treat analysis (IIT)
Measured: Day 0 (corresponding to time point of procedure)
Secondary outcomes (5)
Cross over rate to another catheter or transfemoral access.
Measured: Day 0 (corresponding to time point of procedure)
Flouroscopy time (sec)
Measured: Day 0 (corresponding to time point of procedure)
Contrast volume (ml)
Measured: Day 0 (corresponding to time point of procedure)
Safety endpoints (kinking, radial spasm, vascular access complications, bleeding complications).
Measured: Day 0 (corresponding to time point of procedure)
Imaging Quality (ostial stability, diagnostic value)
Measured: Day 0 (corresponding to time point of procedure)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Oct 2016 (estimated)
- Study startApr 2016
- Primary completionNov 2016
- Study completionDec 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Stable Coronary Heart DiseaseStudies of the same condition, open and under way.
- More trials run by Charite University, Berlin, GermanyThe sponsor's other registered studies.
- 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
- 300 participants (actual)
Sponsor and investigators
- Lead sponsor
- Charite University, Berlin, Germany
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, David Manuel Leistner, Charite University, Berlin, Germany
- Investigators
- David M Leistner, PD, Principal investigator, Department of Cardiology, Campus Benjamin Franklin, Charité - Universitätsmedizin Berlin
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02947542
- Sponsor's protocol ID
- 1.1
- Acronym
- UDDC
- Status last verified
- May 2017
- First submitted
- 18 Oct 2016
- Last updated
- 16 May 2017
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 16 May 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Use of Different Diagnostic Coronary Catheters Over the Radial Access - the UDDC - Radial Trial
- ClinicalTrials.gov ID
- NCT02947542
- Acronym / sponsor ID
- UDDC / 1.1
- Conditions
- Stable Coronary Heart Disease
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 300 participants (actual)
- Lead sponsor
- Charite University, Berlin, GermanyUniversity, hospital or other
- Study start
- Apr 2016
- Primary completion
- Nov 2016 (actual)
- Study completion
- Dec 2016 (actual)
- First posted
- 28 Oct 2016 (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.
There is no evidence from prospective randomized clinical trials regarding the performance of conventional (two-catheter-concept; TCC) versus one-catheter-concepts (OCC) for invasive coronary angiography over the radial access.
The aim of the present trial is to evaluate the efficacy and safety of different one-catheter concepts by use of the BLK and Tiger catheter compared to a TCC using standard Judkins catheters in diagnostic coronary angiography via transradial access. Patients with stable angina pectoris will be randomly assigned to coronary angiography performed with the BLK or Tiger (OCC) or Judkins catheters (TCC). The primary endpoint is coronary angiography duration.
Detailed description
The aim of the present trial is to evaluate the efficacy and safety of a one-catheter concept using the BLK (Terumo, Somerset, USA) or the Tiger catheter (Terumo, Somerset, USA) compared to the standard Judkins catheters in diagnostic coronary angiography by the transradial access. Patients with stable angina pectoris will be randomly assigned to coronary angiography performed with the BLK (Group I), Tiger (Group II) or Judkins catheters (Group III). Primary endpoint is the time duration (sec) that is necessary to perform complete coronary angiography including 6 different projections for the left-coronary system and 3 different projections of the right-coronary-system. Secondary endpoints will cover safety and imaging quality of the different catheter systems.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| BLK catheter | Experimental | Device: One-catheter conceptCoronary angiography will be performed with the BLK catheter (one-catheter concept). |
| Tiger catheter | Experimental | Device: One-catheter conceptCoronary angiography will be performed with the Tiger catheter (one-catheter concept). |
| Judkins catheter | Active comparator | Device: Standard catheterCoronary angiography will be performed with the Judkins catheter (standard catheter). |
Who may qualify
- Ages
- 18 to 95 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Age ≥ 18 years and ≤ 95 years
- Body weight > 60kg
Key exclusion criteria (6 listed)
- Acute coronary syndrome or cardiogenic shock
- Contraindications for transracial access such as absence of radial pulse or abnormal Allen test
- Prior unsuccessful transradial coronary angiography
- Estimated glomerular filtration rate <40 ml/kg/min
- Patients not able to give informed consent
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 |
|---|---|---|
| One-catheter conceptCoronary angiography will be performed using the one-catheter concept. | Device | BLK catheter, Tiger catheter |
| Standard catheterCoronary angiography will be performed using a standard catheter. | Device | Judkins catheter |
Primary outcome
Coronary angiography Duration (sec)
Time frame: Day 0 (corresponding to time point of procedure)
assessed by Intention-to-treat analysis (IIT)
5 secondary outcomes
Cross over rate to another catheter or transfemoral access.
Time frame: Day 0 (corresponding to time point of procedure)
Flouroscopy time (sec)
Time frame: Day 0 (corresponding to time point of procedure)
Contrast volume (ml)
Time frame: Day 0 (corresponding to time point of procedure)
Safety endpoints (kinking, radial spasm, vascular access complications, bleeding complications).
Time frame: Day 0 (corresponding to time point of procedure)
Imaging Quality (ostial stability, diagnostic value)
Time frame: Day 0 (corresponding to time point of procedure)
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 16 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.
David M Leistner, PD principal investigator
Department of Cardiology, Campus Benjamin Franklin, Charité - Universitätsmedizin Berlin
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing One-catheter concept and Standard catheter in people with Stable Coronary Heart Disease, run by Charite University, Berlin, Germany at 1 site in Germany.
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 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 16 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 1 site in Germany. 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?
Coronary angiography Duration (sec) (time frame: Day 0 (corresponding to time point of procedure)). 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 16 May 2017.