Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

BioFreedom US IDE Feasibility Trial

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: NCT02131142
Recruitment Status : Unknown
Verified March 2015 by Biosensors Europe SA.
Recruitment status was:  Active, not recruiting
First Posted : May 6, 2014
Last Update Posted : April 1, 2015
Sponsor:
Information provided by (Responsible Party):
Biosensors Europe SA

Brief Summary:
The purpose of this study is to collect additional safety and effectiveness data for on the Biosensors BioFreedom™ BA9 Drug Coated Coronary Stent in patients with native, de novo coronary artery disease.

Condition or disease Intervention/treatment Phase
Ischemic Heart Disease Stable Angina Unstable Angina Silent Ischemia Device: BioFreedom drug coated coronary stent Phase 2 Phase 3

Detailed Description:

This is a multi-center prospective trial of 100 patients at up to 15 centers. The study population will consist of patients preventing with symptomatic ischemic heart disease due to de novo stenotic lesion(s) in native coronary artery(ies) with reference vessel diameter between 2.25 mm and 4.0 mm.

The primary safety endpoint for this clinical trial is the occurrence of major adverse cardiac events (MACE) defined as the composite of cardiac death, myocardial infarction, target lesion revascularization and academic research consortium (ARC) definite stent thrombosis within 9 months following the implantation.

The primary effectiveness endpoint for this trial is in-stent late lumen loss at 9 months as compared to historical control

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 72 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: To Collect Additional Safety and Effectiveness Data for the Biosensors BioFreedom™ BA9 Drug Coated Coronary Stent in Patients With Native, de Novo Coronary Artery Disease
Study Start Date : August 2014
Estimated Primary Completion Date : August 2015
Estimated Study Completion Date : July 2019

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: BioFreedom Device: BioFreedom drug coated coronary stent
Placement of a BioFreedom drug coated stent in a narrow coronary artery




Primary Outcome Measures :
  1. Safety of the BioFreedom stent [ Time Frame: 9 month ]
    The occurrence of major adverse cardiac events (MACE) defined as the composite of cardiac death, myocardial infarction, target lesion revascularization and academic research consortium (ARC) definite stent thrombosis

  2. Efficacy of the BioFreedom stent [ Time Frame: 9 month ]
    Stent late lumen loss at 9 months as compared to historical control



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Individual is ≥ 18 years of age
  • Individual must have clinical evidence if ischemic heart disease, stable or unstable angina, silent ischemia, or a positive functional study;
  • Individual must be an acceptable candidate for percutaneous coronary intervention (PCI), stenting, and emergent coronary artery bypass graft (CABG) surgery
  • Individual is competent and willing to provide informed consent to participate in the trial

Exclusion Criteria:

  • A known hypersensitivity or contraindication to aspirin, heparin, clopidogrel, or a sensitivity to contrast media that cannot be adequately pre-medicated;
  • History or known allergic reaction or significant sensitivity to drugs similar to BA9;
  • A platelet count < 100,000 cells/mm3 or > 700,000 cells/mm3, or a WBC < 3,000 cells/mm3;
  • A creatinine level > 2.5 mg/dL;
  • Evidence of an acute myocardial infarction with 72 hours of the intended stenting (defined as: Q wave or non-Q wave myocardial infarction having a Troponin either I or T pre-procedure elevated above the Institution's upper limit of normal);
  • Previous or planned PCI of any vessel within 30 days pre or post procedure;
  • Patient unable to take clopidogrel for 3 months or patient who have comorbidities that would prohibit the cessation of clopidogrel at 3 months;
  • Planned adjunctive treatment during the intended stenting (eg balloon valvuloplasty, percutaneous endovascular intervention, etc)
  • During the intended or index procedure the target lesion(s) requires treatment with a device other than a plain old balloon prior to stent placement (such as, but not limited to, cutting balloon, directional atherectomy, excimer laser, rotational atherectomy, thrombectomy, etc);
  • History of documented prior stroke within 6 months of the intended procedure;
  • Active peptic ulcer or upper gastrointestinal bleeding documented within the prior 6 months;
  • History of active bleeding diathesis or coagulopathy or will refuse blood transfusion;
  • Individual is pregnant, nursing or planning to be pregnant;
  • Any previous or planned treatment of the target vessel(s) with anti-restenotic therapies including, but not limited to brachytherapy;
  • Concurrent medical condition with a life expectancy of less than 12 months or individual has any serious medical condition, which in the opinion of the investigator, may adversely affect the safety and/or effectiveness of the participant or the study;
  • Individual is currently enrolled in another investigational drug or device trial. If, however, if investigational trial device or drug becomes commercially available, these trials are not considered investigational;
  • Previous ACS within 9 months of pre or post procedure

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02131142


Locations
Layout table for location information
United States, District of Columbia
MedStar Washington Hospital Center
Washington, District of Columbia, United States, 20010
United States, Florida
Baptist Cardiac & Vascular Institute
Miami, Florida, United States, 33176
United States, Georgia
Emory University Hospital
Atlanta, Georgia, United States, 30322
United States, Kentucky
Jewish Hospital and Saint Mary's Healthcare
Louisville, Kentucky, United States, 40202
United States, Maryland
MedStar Union Memorial Hospital
Baltimore, Maryland, United States, 21218
MedStar Southern Maryland Hospital Center
Clinton, Maryland, United States, 20735
United States, Michigan
Cardiac & Vascular Research Center of Northern Michigan
Petoskey, Michigan, United States, 49770
United States, New Jersey
Our Lady of Lourdes Medical Center
Voorhees, New Jersey, United States, 08043
United States, New York
Columbia University Medical Center
New York, New York, United States, 10032,
United States, North Carolina
NC Heart and Vascular Research-Rex Hospital
Raleigh, North Carolina, United States, 27607
United States, Ohio
The Carl & Edyth Lindner Center for Research
Cincinnati, Ohio, United States, 45219
Mercy St. Vincent Medical Center
Toledo, Ohio, United States, 43608
United States, Pennsylvania
Berks Cardiology
Wyomissing, Pennsylvania, United States, 19610
Sponsors and Collaborators
Biosensors Europe SA
Layout table for additonal information
Responsible Party: Biosensors Europe SA
ClinicalTrials.gov Identifier: NCT02131142    
Other Study ID Numbers: 14US01
First Posted: May 6, 2014    Key Record Dates
Last Update Posted: April 1, 2015
Last Verified: March 2015
Keywords provided by Biosensors Europe SA:
ischemic heart disease
CAD
Additional relevant MeSH terms:
Layout table for MeSH terms
Heart Diseases
Angina Pectoris
Myocardial Ischemia
Coronary Artery Disease
Angina, Stable
Angina, Unstable
Ischemia
Pathologic Processes
Cardiovascular Diseases
Vascular Diseases
Chest Pain
Pain
Neurologic Manifestations
Coronary Disease
Arteriosclerosis
Arterial Occlusive Diseases