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Safety and Effectiveness Evaluation of COBRA PzF Coronary Stent System: A Post Marketing Observational Registry

NCT ID: NCT03103620

Last Updated: 2018-08-07

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

1027 participants

Study Classification

OBSERVATIONAL

Study Start Date

2015-09-10

Study Completion Date

2017-12-31

Brief Summary

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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.

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Detailed Description

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Conditions

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Stable Angina Unstable Angina ACS - Acute Coronary Syndrome STEMI NSTEMI - Non-ST Segment Elevation MI Myocardial Infarction

Study Design

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Observational Model Type

CASE_ONLY

Study Time Perspective

PROSPECTIVE

Interventions

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COBRA PzF Coronary Stent System

COBRA PzF Coronary Stent System

Intervention Type DEVICE

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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AlpinARC

UNKNOWN

Sponsor Role collaborator

CeloNova BioSciences, Inc.

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Luc Maillard, MD

Role: PRINCIPAL_INVESTIGATOR

Clinique Axium

Locations

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Clinique Axium

Aix, , France

Site Status

GCS Cardio

Annecy, , France

Site Status

SCM Angioscan

Antony, , France

Site Status

Clinique La Casamance

Aubagne, , France

Site Status

Centre Hospitalier

Avignon, , France

Site Status

Clinique La Fourcade

Bayonne, , France

Site Status

Centre Hospitalier

Brivé, , France

Site Status

Clinique des Domes

Clermont, , France

Site Status

Clinique Cardiologie

Évecquemont, , France

Site Status

Clinique Mutualiste

Grenoble, , France

Site Status

Centre Hospitalier

Haguenau, , France

Site Status

Infirmerie Protestante

Lyon, , France

Site Status

Clinique du Pont de Chaume

Montauban, , France

Site Status

Clinique du Millenaire

Montpellier, , France

Site Status

Centre Hospitalier

Pau, , France

Site Status

Clinique St-Martin

Pessac, , France

Site Status

Polyclinique de Courlancy

Reims, , France

Site Status

Clinique St Hilaire

Rouen, , France

Site Status

Countries

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France

Other Identifiers

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COBRA 2013-01

Identifier Type: -

Identifier Source: org_study_id

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