Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03103620
Recruitment Status : Completed
First Posted : April 6, 2017
Last Update Posted : August 7, 2018
Sponsor:
Collaborator:
AlpinARC
Information provided by (Responsible Party):
CeloNova BioSciences, Inc.

Tracking Information
First Submitted Date March 31, 2017
First Posted Date April 6, 2017
Last Update Posted Date August 7, 2018
Actual Study Start Date September 10, 2015
Actual Primary Completion Date December 31, 2017   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: March 31, 2017)
MACE [ Time Frame: 12 months ]
Composite clinical endpoint of cardiac death, myocardial infarction, and clinically driven target lesion revascularization
Original Primary Outcome Measures Same as current
Change History
Current Secondary Outcome Measures
 (submitted: March 31, 2017)
  • Stent thrombosis [ Time Frame: 12 months ]
    Stent thrombosis (according to ARC definition)
  • TVR and TLR [ Time Frame: 12 months ]
    Target vessel and lesion revascularization
  • DAPT [ Time Frame: 12 months ]
    Mean length of dual antiplatelet therapy
Original Secondary Outcome Measures Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Safety and Effectiveness Evaluation of COBRA PzF Coronary Stent System: A Post Marketing Observational Registry
Official Title Safety And Effectiveness Evaluation Of COBRA PzF™ Coronary Stent System: A French Observational Postmarketing Registry
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.
Detailed Description Not Provided
Study Type Observational
Study Design Observational Model: Case-Only
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
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
Condition
  • Stable Angina
  • Unstable Angina
  • ACS - Acute Coronary Syndrome
  • STEMI
  • NSTEMI - Non-ST Segment Elevation MI
  • Myocardial Infarction
Intervention Device: COBRA PzF Coronary Stent System
COBRA PzF Coronary Stent System
Study Groups/Cohorts Not Provided
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Completed
Actual Enrollment
 (submitted: March 31, 2017)
1027
Original Actual Enrollment Same as current
Actual Study Completion Date December 31, 2017
Actual Primary Completion Date December 31, 2017   (Final data collection date for primary outcome measure)
Eligibility Criteria

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

Sex/Gender
Sexes Eligible for Study: All
Ages 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers No
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries France
Removed Location Countries  
 
Administrative Information
NCT Number NCT03103620
Other Study ID Numbers COBRA 2013-01
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement
Plan to Share IPD: No
Responsible Party CeloNova BioSciences, Inc.
Study Sponsor CeloNova BioSciences, Inc.
Collaborators AlpinARC
Investigators
Principal Investigator: Luc Maillard, MD Clinique Axium
PRS Account CeloNova BioSciences, Inc.
Verification Date August 2018