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NCT Number: NCT03103620

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

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Key information

Conditions

Stable Angina ACS - Acute Coronary Syndrome Acute Coronary Syndrome Angina Pectoris Angina, Stable Angina, Unstable Cardiovascular Diseases Chest Pain Heart Diseases Infarction Ischemia Myocardial Infarction Myocardial Ischemia NSTEMI - Non-ST Segment Elevation MI Necrosis Neurologic Manifestations Non-ST Elevated Myocardial Infarction Pain Pathologic Processes Pathological Conditions, Signs and Symptoms ST Elevation Myocardial Infarction STEMI Signs and Symptoms Unstable Angina Vascular Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Clinique Axium, Aix, France

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

COBRA PzF Coronary Stent System

Device

COBRA PzF Coronary Stent System

Primary outcomes

  1. MACE

    Time frame: 12 months

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

Secondary outcomes

  1. Stent thrombosis

    Time frame: 12 months

    Stent thrombosis (according to ARC definition)

  2. TVR and TLR

    Time frame: 12 months

    Target vessel and lesion revascularization

  3. DAPT

    Time frame: 12 months

    Mean length of dual antiplatelet therapy

Sponsors and collaborators

Lead sponsor

CeloNova BioSciences, Inc.

Industry

Collaborators

  • AlpinARC

Registry information

Official study title

Safety And Effectiveness Evaluation Of COBRA PzF™ Coronary Stent System: A French Observational Postmarketing Registry

Acronym: eCOBRA

Important dates

Study start
2015
Primary completion
2017
Study completion
2017
First posted
Apr 6, 2017
Registry last updated
Aug 7, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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