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CompletedNCT03103620eCOBRAUpdated Aug 7, 2018

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

An observational study in Stable Angina, Unstable Angina and ACS - Acute Coronary Syndrome, sponsored by CeloNova BioSciences, Inc.. Completed at 18 sites in France. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2018-08-07.

Sponsored by CeloNova BioSciences, Inc. · Observational

Study type
Observational
Model
Case-only
Time perspective
Prospective
Enrollment
1,027
Ages
18 Years and older
Sex
All
01

Study 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.

02

Conditions studied

  • Stable Angina
  • Unstable Angina
  • ACS - Acute Coronary Syndrome
  • STEMI
  • NSTEMI - Non-ST Segment Elevation MI
  • Myocardial Infarction
03

In context

Myocardial Infarction

2,744 studies on the registry are indexed under Myocardial Infarction; 418 are open to participants now.

This study's enrollment of 1,027 is above the median of 500 across 983 observational studies indexed under Myocardial Infarction.

Browse Myocardial Infarction studies →

Lead sponsor

CeloNova BioSciences, Inc. is the lead sponsor of 6 studies on the registry; none are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No
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

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

Exclusion Criteria:

Pregnancy Age \<18 years Refusal or inability to give oral consent

05

Study design

Observational model
Case-only
Time perspective
Prospective
Enrollment
1,027 participants (actual)
Patient registry
No

Interventions

  • DeviceCOBRA PzF Coronary Stent System

    COBRA PzF Coronary Stent System

06

What researchers measure

Primary outcomes

  1. MACE

    Composite clinical endpoint of cardiac death, myocardial infarction, and clinically driven target lesion revascularization

    Time frame: 12 months

Secondary outcomes

  1. Stent thrombosis

    Stent thrombosis (according to ARC definition)

    Time frame: 12 months

  2. TVR and TLR

    Target vessel and lesion revascularization

    Time frame: 12 months

  3. DAPT

    Mean length of dual antiplatelet therapy

    Time frame: 12 months

07

Study locations

18 sites
  • 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, France
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Aug 7, 2018, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT03103620
Lead sponsor
CeloNova BioSciences, Inc.
Collaborators
AlpinARC
Responsible party
Sponsor
First posted
Apr 6, 2017
Start date
Sep 10, 2015
Primary completion
Dec 31, 2017
Completion
Dec 31, 2017
Last update
Aug 7, 2018

Study contacts

Luc Maillard, MD
principal investigator · Clinique Axium

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Aug 2018. You cannot join it, but the record below documents what was studied.

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