Myocardial Infarction Clinical Trial
— eCOBRAOfficial title:
Safety And Effectiveness Evaluation Of COBRA PzF™ Coronary Stent System: A French Observational Postmarketing Registry
Verified date | August 2018 |
Source | CeloNova BioSciences, Inc. |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Observational |
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.
Status | Completed |
Enrollment | 1027 |
Est. completion date | December 31, 2017 |
Est. primary completion date | December 31, 2017 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility |
Inclusion Criteria: 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" Exclusion Criteria: Pregnancy Age <18 years Refusal or inability to give oral consent |
Country | Name | City | State |
---|---|---|---|
France | Clinique Axium | Aix | |
France | GCS Cardio | Annecy | |
France | SCM Angioscan | Antony | |
France | Clinique La Casamance | Aubagne | |
France | Centre Hospitalier | Avignon | |
France | Clinique La Fourcade | Bayonne | |
France | Centre Hospitalier | Brive | |
France | Clinique des Domes | Clermont | |
France | Clinique Cardiologie | Evecquemont | |
France | Clinique Mutualiste | Grenoble | |
France | Centre Hospitalier | Haguenau | |
France | Infirmerie Protestante | Lyon | |
France | Clinique du Pont de Chaume | Montauban | |
France | Clinique du Millenaire | Montpellier | |
France | Centre Hospitalier | Pau | |
France | Clinique St-Martin | Pessac | |
France | Polyclinique de Courlancy | Reims | |
France | Clinique St Hilaire | Rouen |
Lead Sponsor | Collaborator |
---|---|
CeloNova BioSciences, Inc. | AlpinARC |
France,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | MACE | Composite clinical endpoint of cardiac death, myocardial infarction, and clinically driven target lesion revascularization | 12 months | |
Secondary | Stent thrombosis | Stent thrombosis (according to ARC definition) | 12 months | |
Secondary | TVR and TLR | Target vessel and lesion revascularization | 12 months | |
Secondary | DAPT | Mean length of dual antiplatelet therapy | 12 months |
Status | Clinical Trial | Phase | |
---|---|---|---|
Recruiting |
NCT06013813 -
Conventional vs. Distal Radial Access Outcomes in STEMI Patients Treated by PCI
|
N/A | |
Completed |
NCT04507529 -
Peer-mentor Support for Older Vulnerable Myocardial Infarction Patients
|
N/A | |
Recruiting |
NCT06066970 -
Cardiac Biomarkers for the Quantification of Myocardial Damage After Cardiac Surgery
|
||
Recruiting |
NCT03620266 -
Effects of Bilberry and Oat Intake After Type 2 Diabetes and/or MI
|
N/A | |
Completed |
NCT04097912 -
Study to Gather Information to What Extent Patients Follow the Treatment Regimen of Low-dose Aspirin for Primary and Secondary Prevention of Diseases of the Heart and Blood Vessels
|
||
Completed |
NCT04153006 -
Comparison of Fingerstick Versus Venous Sample for Troponin I.
|
||
Completed |
NCT03668587 -
Feasibility and Security of a Rapid Rule-out and rule-in Troponin Protocol in the Management of NSTEMI in an Emergency Departement
|
||
Recruiting |
NCT01218776 -
International Survey of Acute Coronary Syndromes in Transitional Countries
|
||
Completed |
NCT03076801 -
Does Choral Singing Help imprOve Stress in Patients With Ischemic HeaRt Disease?
|
N/A | |
Recruiting |
NCT05371470 -
Voice Analysis Technology to Detect and Manage Depression and Anxiety in Cardiac Rehabilitation
|
N/A | |
Recruiting |
NCT04562272 -
Attenuation of Post-infarct LV Remodeling by Mechanical Unloading Using Impella-CP
|
N/A | |
Completed |
NCT04584645 -
A Digital Flu Intervention for People With Cardiovascular Conditions
|
N/A | |
Active, not recruiting |
NCT04475380 -
Complex All-comers and Patients With Diabetes or Prediabetes, Treated With Xience Sierra Everolimus-eluting Stents
|
||
Not yet recruiting |
NCT06007950 -
Time-restricted Eating Study (TRES): Impacts on Anthropometric, Cardiometabolic and Cardiovascular Health
|
N/A | |
Withdrawn |
NCT05327855 -
Efficacy and Safety of OPL-0301 Compared to Placebo in Adults With Post-Myocardial Infarction (MI)
|
Phase 2 | |
Recruiting |
NCT02876952 -
High Intensity Aerobic Interval Training With Mediterranean Diet Recommendations in Post-Myocardial Infarct Patients
|
N/A | |
Completed |
NCT02917213 -
Imaging Silent Brain Infarct And Thrombosis in Acute Myocardial Infarction
|
||
Completed |
NCT02711631 -
Feasibility and Effectiveness of Remote Virtual Reality-Based Cardiac Rehabilitation
|
N/A | |
Completed |
NCT02305602 -
A Study of VentriGel in Post-MI Patients
|
Phase 1 | |
Completed |
NCT02382731 -
Interventions to Support Long-Term Adherence aNd Decrease Cardiovascular Events Post-Myocardial Infarction
|
N/A |