BioFreedom US IDE Feasibility Trial
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
1 other identifier
interventional
72
1 country
13
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_2
Started Aug 2014
Longer than P75 for phase_2
13 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
May 5, 2014
CompletedFirst Posted
Study publicly available on registry
May 6, 2014
CompletedStudy Start
First participant enrolled
August 1, 2014
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 1, 2015
CompletedStudy Completion
Last participant's last visit for all outcomes
July 1, 2019
CompletedApril 1, 2015
March 1, 2015
1 year
May 5, 2014
March 31, 2015
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
Safety of the BioFreedom stent
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
9 month
Efficacy of the BioFreedom stent
Stent late lumen loss at 9 months as compared to historical control
9 month
Study Arms (1)
BioFreedom
EXPERIMENTALInterventions
Placement of a BioFreedom drug coated stent in a narrow coronary artery
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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;
- +2 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (13)
MedStar Washington Hospital Center
Washington D.C., District of Columbia, 20010, United States
Baptist Cardiac & Vascular Institute
Miami, Florida, 33176, United States
Emory University Hospital
Atlanta, Georgia, 30322, United States
Jewish Hospital and Saint Mary's Healthcare
Louisville, Kentucky, 40202, United States
MedStar Union Memorial Hospital
Baltimore, Maryland, 21218, United States
MedStar Southern Maryland Hospital Center
Clinton, Maryland, 20735, United States
Cardiac & Vascular Research Center of Northern Michigan
Petoskey, Michigan, 49770, United States
Our Lady of Lourdes Medical Center
Voorhees Township, New Jersey, 08043, United States
Columbia University Medical Center
New York, New York, 10032,, United States
NC Heart and Vascular Research-Rex Hospital
Raleigh, North Carolina, 27607, United States
The Carl & Edyth Lindner Center for Research
Cincinnati, Ohio, 45219, United States
Mercy St. Vincent Medical Center
Toledo, Ohio, 43608, United States
Berks Cardiology
Wyomissing, Pennsylvania, 19610, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
May 5, 2014
First Posted
May 6, 2014
Study Start
August 1, 2014
Primary Completion
August 1, 2015
Study Completion
July 1, 2019
Last Updated
April 1, 2015
Record last verified: 2015-03