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Clinical Trial Details — Status: Active, not recruiting

Administrative data

NCT number NCT02594501
Other study ID # COBRA 2015-01
Secondary ID
Status Active, not recruiting
Phase N/A
First received
Last updated
Start date February 5, 2016
Est. completion date November 2021

Study information

Verified date October 2020
Source CeloNova BioSciences, Inc.
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

The purpose of this study is to determine whether patients undergoing coronary intervention that also require oral anticoagulation, treatment with the COBRA PzF stent plus 14-day dual anti-platelet therapy (DAPT) has higher safety and non-inferior outcomes for thrombo-embolic events than compared with standard FDA-approved drug eluting stent (DES) plus 3 or 6-month DAPT.


Recruitment information / eligibility

Status Active, not recruiting
Enrollment 996
Est. completion date November 2021
Est. primary completion date May 2021
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria: - Patients older than age 18 with ischemic symptoms (stable or unstable angina or NSTEMI without thrombosis of the target lesion on coronary angiography) or evidence of myocardial ischemia in the presence of = 50% de novo stenosis located in native coronary vessels (max. 2 lesions in one or 2 separate vessels). - Patient receiving or with an indication for new treatment with long-term oral anticoagulation with a coumadin derivatives or non-vitamin K oral anticoagulants. - Written, informed consent Exclusion Criteria: - Cardiogenic shock - Target lesion located in left main trunk - Bifurcation interventions with a planned 2-stent strategy - Vessel size too small for implantation of a 2.5 mm stent by visual estimation - Patient requiring staging PCI procedure within 6 months after the index procedure - Patients requiring DAPT for more than 2 weeks after the index procedure - Contraindications or allergy to cobalt, chromium, platinum, polyzene-F, everolimus, zotarolimus or the inability to take triple therapy for at least 6 months - Relevant hematologic deviations: platelet count <100x10^9 cells/L or >600x10^9 cells/L - Active bleeding; bleeding diathesis; recent trauma or major surgery in the last month; history of intracranial bleeding or structural abnormalities; suspected aortic dissection - Malignancies or other co-morbid conditions with life expectancy less than 12 months or that may result in protocol non-compliance - Pregnancy, present (positive pregnancy test), suspected or planned, breast feeding - Known allergy or intolerance to the study medications: ASA, clopidogrel, coumadin and its derivatives - Patient's inability to fully cooperate with the study protocol

Study Design


Intervention

Device:
COBRA PzF

Drug Eluting Stent


Locations

Country Name City State
Belgium ZNA Middelheim Antwerp
Denmark Aarhus University Hospital Aarhus
France Clinique Axium Aix
France Clinique Du Pont De Chaumes Montauban
France Clinique du Millénaire Montpellier
France Höpital George Pompidou Paris
France Hopital Pitie-Salpitierre Paris
France Clinique Pasteur Toulouse
France Institut Lorrain du Coeur et Vaisseaux, CHU Nancy-Barbois VandÅ“uvre-lès-Nancy
Germany Universitats Herzzentrum Freibourg Bad Krozingen
Germany Charite´ - Campus Benjamin Franklin Berlin
Germany Uni-Klinikum Erlangen Erlangen
Germany St. Josefskrankenhaus Freiburg
Germany Klinikum Fürth Fürth
Germany University of Jena Jena
Germany MediClin Herzzentrum Lahr
Germany Klinikum Landshut-Achdorf Landshut
Germany Deutsches Herzzentrum München Munich
Germany Klinikum Rechts der Isar München Munich
Germany Universitätsklinikum Regensburg Regensburg
Germany Hegau Bodensee Klinikum Singen Singen
Germany Univesitätsklinikum Tübingen Tübingen
Italy Ospedale Spaziani Frosinone
Latvia Paula Stradins Clinical University Hospital Riga
Switzerland Hopital Cantonal Fribourg Fribourg
Switzerland Kantonspital St Galen St Gallen
United States Augusta University Augusta Georgia
United States Beth Israel Deaconess Medical Center Boston Massachusetts
United States Deborah Heart and Lung Center Browns Mills New Jersey
United States Charleston Area Medical Center Charleston West Virginia
United States North Ohio Heart Center Elyria Ohio
United States Cleveland Clinic Fairview Park Ohio
United States Memorial Hospital Jacksonville Jacksonville Florida
United States University of Florida Jacksonville Florida
United States Texas Cardiac Center Lubbock Texas
United States Northwell Health Manhasset New York
United States Sebastian River Medical Center Melbourne Florida
United States Mt Sinai Medical Center Miami Beach Florida
United States NYU Winthrop Hospital Mineola New York
United States Minneapolis Heart Institute Minneapolis Minnesota
United States Rutgers Robert Wood Johnson Medical Schoo New Brunswick New Jersey
United States Christiana Care Health Services Newark Delaware
United States Sentara Heart Hospital (Sentara Cardiovascular Research Institute) Norfolk Virginia
United States Einstein Medical Center Philadelphia Pennsylvania
United States Carilion Medical Center Roanoke Virginia
United States Mercy St. Vincent Medical Center Toledo Ohio
United States University of Maryland St. Joseph Medical Center Towson Maryland
United States Tyler Cardiovascular Consultants Tyler Texas

Sponsors (1)

Lead Sponsor Collaborator
CeloNova BioSciences, Inc.

Countries where clinical trial is conducted

United States,  Belgium,  Denmark,  France,  Germany,  Italy,  Latvia,  Switzerland, 

Outcome

Type Measure Description Time frame Safety issue
Primary BARC class >=2 bleeding after hospital discharge (or beyond 14 days, whichever is "later"). 6 months
Primary Composite of all cause death, myocardial infarction, definite and probable stent thrombosis or ischemic stroke 6 months
Secondary Composite of all cause death, myocardial infarction, definite and probable stent thrombosis, ischemia-driven target lesion revascularization or ischemic stroke 12 months
Secondary Composite of cardiac death and myocardial infarction 12 months
Secondary Ischemia driven target lesion revascularization 12 months
Secondary Definite and probable stent thrombosis 12 months
Secondary Ischemic stroke 12 months
Secondary BARC class 3-5 bleeding 6 months
Secondary TIMI major bleeding; TIMI major and minor bleeding 6 months
Secondary Acute Success Rates Device success; Lesion success; Procedure success procedure
Secondary Health economic utility Total cardiovascular and bleeding related costs with cost effectiveness based on events avoided 12 months
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