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

August 6, 2018 updated by: CeloNova BioSciences, Inc.

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Device: COBRA PzF Coronary Stent System

Study Type

Observational

Enrollment (Actual)

1027

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

France
- - Aix, France
    - Clinique Axium
  - Annecy, France
    - GCS Cardio
  - Antony, France
    - SCM Angioscan
  - Aubagne, France
    - Clinique La Casamance
  - Avignon, France
    - Centre Hospitalier
  - Bayonne, France
    - Clinique La Fourcade
  - Brive, France
    - Centre Hospitalier
  - Clermont, France
    - Clinique Des Dômes
  - Evecquemont, France
    - Clinique Cardiologie
  - Grenoble, France
    - Clinique Mutualiste
  - Haguenau, France
    - Centre Hospitalier
  - Lyon, France
    - Infirmerie Protestante
  - Montauban, France
    - Clinique Du Pont De Chaume
  - Montpellier, France
    - Clinique du Millénaire
  - Pau, France
    - Centre Hospitalier
  - Pessac, France
    - Clinique St-Martin
  - Reims, France
    - Polyclinique de Courlancy
  - Rouen, France
    - Clinique St Hilaire

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

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

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Observational Models: Case-Only
Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
MACE Time Frame: 12 months	Composite clinical endpoint of cardiac death, myocardial infarction, and clinically driven target lesion revascularization	12 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Stent thrombosis Time Frame: 12 months	Stent thrombosis (according to ARC definition)	12 months
TVR and TLR Time Frame: 12 months	Target vessel and lesion revascularization	12 months
DAPT Time Frame: 12 months	Mean length of dual antiplatelet therapy	12 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

CeloNova BioSciences, Inc.

Collaborators

AlpinARC

Investigators

Principal Investigator: Luc Maillard, MD, Clinique Axium

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 10, 2015

Primary Completion (Actual)

December 31, 2017

Study Completion (Actual)

December 31, 2017

Study Registration Dates

First Submitted

March 31, 2017

First Submitted That Met QC Criteria