Safety and Effectiveness Evaluation of COBRA PzF Coronary Stent System: A Post Marketing Observational Registry
eCOBRA
Safety And Effectiveness Evaluation Of COBRA PzF™ Coronary Stent System: A French Observational Postmarketing Registry
1 other identifier
observational
1,027
1 country
18
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Sep 2015
Typical duration for all trials
18 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
September 10, 2015
CompletedFirst Submitted
Initial submission to the registry
March 31, 2017
CompletedFirst Posted
Study publicly available on registry
April 6, 2017
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 31, 2017
CompletedStudy Completion
Last participant's last visit for all outcomes
December 31, 2017
CompletedAugust 7, 2018
August 1, 2018
2.3 years
March 31, 2017
August 6, 2018
Conditions
Outcome Measures
Primary Outcomes (1)
MACE
Composite clinical endpoint of cardiac death, myocardial infarction, and clinically driven target lesion revascularization
12 months
Secondary Outcomes (3)
Stent thrombosis
12 months
TVR and TLR
12 months
DAPT
12 months
Interventions
COBRA PzF Coronary Stent System
Eligibility Criteria
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
You may qualify if:
- 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"
You may not qualify if:
- Pregnancy Age \<18 years Refusal or inability to give oral consent
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- CeloNova BioSciences, Inc.lead
- AlpinARCcollaborator
Study Sites (18)
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
Brivé, France
Clinique des Domes
Clermont, France
Clinique Cardiologie
Évecquemont, 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, France
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Luc Maillard, MD
Clinique Axium
Study Design
- Study Type
- observational
- Observational Model
- CASE ONLY
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
March 31, 2017
First Posted
April 6, 2017
Study Start
September 10, 2015
Primary Completion
December 31, 2017
Study Completion
December 31, 2017
Last Updated
August 7, 2018
Record last verified: 2018-08
Data Sharing
- IPD Sharing
- Will not share