Stable AnginaeCOBRANCT03103620
Safety and Effectiveness Evaluation of COBRA PzF Coronary Stent System: A Post Marketing Observational Registry
An observational study of Stable Angina and Unstable Angina, run by CeloNova BioSciences, Inc. at 18 sites in France.
Trial summary
A multi-center, prospective, consecutive enrolled, observational registry. The population being studied includes all patients undergoing treatment of "de novo" lesions in native coronary vessels, saphenous vein graft and/or arterial bypass conduits with the COBRA PzF coronary stent system. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Stable Angina, Unstable Angina, ACS - Acute Coronary Syndrome
- What is being tested?
- COBRA PzF Coronary Stent System
- Type of treatment
- Medical device
- How many people
- 1,027 participants
- Where
- 18 sitesFrance
- Study dates
- 10 Sep 2015to 31 Dec 2017
- Phase
- Observational
- 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
Study population: All patients undergoing treatment of "de novo" lesions in native coronary vessels, saphenous vein graft and/or arterial bypass conduits with the COBRA PzF coronary stent system
Who may be able to join
- Patient has given oral consent to participate in the registry Patient is implanted with a COBRA PzF stent Target lesion(s) is/are "de novo"
Who cannot join
- Pregnancy Age <18 years Refusal or inability to give oral consent
Trial locations and contacts
18 sites in 1 country.
18 sites in 1 country
France18 sites
Clinique Axium
Aix
GCS Cardio
Annecy
SCM Angioscan
Antony
Clinique La Casamance
Aubagne
Centre Hospitalier
Avignon
Clinique La Fourcade
Bayonne
Centre Hospitalier
Brivé
Clinique des Domes
Clermont
Clinique Cardiologie
Évecquemont
Clinique Mutualiste
Grenoble
Centre Hospitalier
Haguenau
Infirmerie Protestante
Lyon
Clinique du Pont de Chaume
Montauban
Clinique du Millenaire
Montpellier
Centre Hospitalier
Pau
Clinique St-Martin
Pessac
Polyclinique de Courlancy
Reims
Clinique St Hilaire
Rouen
About this study
Official title: Safety And Effectiveness Evaluation Of COBRA PzF™ Coronary Stent System: A French Observational Postmarketing Registry
A multi-center, prospective, consecutive enrolled, observational registry. The population being studied includes all patients undergoing treatment of "de novo" lesions in native coronary vessels, saphenous vein graft and/or arterial bypass conduits with the COBRA PzF coronary stent system. The registry will primarily assess the rate of MACE (cardiac death, myocardial infarction and clinically driven target lesion revascularization.
- Conditions
- Stable Angina, Unstable Angina, ACS - Acute Coronary Syndrome, STEMI, NSTEMI - Non-ST Segment Elevation MI, Myocardial Infarction
- Being tested
- COBRA PzF Coronary Stent System
- Medical subject headings
- Angina, Stable, Angina, Unstable, Acute Coronary Syndrome, ST Elevation Myocardial Infarction, Non-ST Elevated Myocardial Infarction, Myocardial Infarction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
COBRA PzF Coronary Stent SystemDevice
COBRA PzF Coronary Stent System
What is being measured
The primary outcome is the main question the study is designed to answer.
MACE
Composite clinical endpoint of cardiac death, myocardial infarction, and clinically driven target lesion revascularization
Measured: 12 months
Secondary outcomes (3)
Stent thrombosis
Stent thrombosis (according to ARC definition)
Measured: 12 months
TVR and TLR
Target vessel and lesion revascularization
Measured: 12 months
DAPT
Mean length of dual antiplatelet therapy
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Apr 2017
- Study start10 Sep 2015
- Primary completion31 Dec 2017
- Study completion31 Dec 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Stable AnginaStudies 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
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 1,027 participants (actual)
Sponsor and investigators
- Lead sponsor
- CeloNova BioSciences, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- AlpinARC
- Responsible party
- Sponsor
- Investigators
- Luc Maillard, MD, Principal investigator, Clinique Axium
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03103620
- Sponsor's protocol ID
- COBRA 2013-01
- Acronym
- eCOBRA
- Status last verified
- Aug 2018
- First submitted
- 31 Mar 2017
- Last updated
- 7 Aug 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Aug 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Safety And Effectiveness Evaluation Of COBRA PzF™ Coronary Stent System: A French Observational Postmarketing Registry
- ClinicalTrials.gov ID
- NCT03103620
- Acronym / sponsor ID
- eCOBRA / COBRA 2013-01
- Conditions
- Stable Angina, Unstable Angina, ACS - Acute Coronary Syndrome, STEMI, NSTEMI - Non-ST Segment Elevation MI, Myocardial Infarction
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 1,027 participants (actual)
- Lead sponsor
- CeloNova BioSciences, Inc.Industry (pharma, biotech, devices)
- Collaborators
- AlpinARC
- Study start
- 10 Sep 2015 (actual)
- Primary completion
- 31 Dec 2017 (actual)
- Study completion
- 31 Dec 2017 (actual)
- First posted
- 6 Apr 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.
A multi-center, prospective, consecutive enrolled, observational registry. The population being studied includes all patients undergoing treatment of "de novo" lesions in native coronary vessels, saphenous vein graft and/or arterial bypass conduits with the COBRA PzF coronary stent system. The registry will primarily assess the rate of MACE (cardiac death, myocardial infarction and clinically driven target lesion revascularization.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- All patients undergoing treatment of "de novo" lesions in native coronary vessels, saphenous vein graft and/or arterial bypass conduits with the COBRA PzF coronary stent system
Key inclusion criteria (1 listed)
- Patient has given oral consent to participate in the registry Patient is implanted with a COBRA PzF stent Target lesion(s) is/are "de novo"
Key exclusion criteria (1 listed)
- Pregnancy Age <18 years Refusal or inability to give oral 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 |
|---|---|---|
| COBRA PzF Coronary Stent SystemCOBRA PzF Coronary Stent System | Device | – |
Primary outcome
MACE
Time frame: 12 months
Composite clinical endpoint of cardiac death, myocardial infarction, and clinically driven target lesion revascularization
3 secondary outcomes
Stent thrombosis
Time frame: 12 months
TVR and TLR
Time frame: 12 months
DAPT
Time frame: 12 months
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 7 Aug 2018.
- Individual participant dataSharing planned: No
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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.
Luc Maillard, MD principal investigator
Clinique Axium
18 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Stable Angina and Unstable Angina, run by CeloNova BioSciences, Inc. at 18 sites in France.
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 1 inclusion and 1 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 7 Aug 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 18 sites in France. 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?
MACE (time frame: 12 months). 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 7 Aug 2018.