Clinical Trials Logo

Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03103620
Other study ID # COBRA 2013-01
Secondary ID
Status Completed
Phase
First received
Last updated
Start date September 10, 2015
Est. completion date December 31, 2017

Study information

Verified date August 2018
Source CeloNova BioSciences, Inc.
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical 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. The registry will primarily assess the rate of MACE (cardiac death, myocardial infarction and clinically driven target lesion revascularization.


Recruitment information / eligibility

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

Study Design


Intervention

Device:
COBRA PzF Coronary Stent System
COBRA PzF Coronary Stent System

Locations

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

Sponsors (2)

Lead Sponsor Collaborator
CeloNova BioSciences, Inc. AlpinARC

Country where clinical trial is conducted

France, 

Outcome

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
See also
  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 NCT02711631 - Feasibility and Effectiveness of Remote Virtual Reality-Based Cardiac Rehabilitation N/A
Completed NCT02917213 - Imaging Silent Brain Infarct And Thrombosis in Acute Myocardial Infarction
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