BioFreedom US IDE Feasibility Trial

Status unconfirmed · Phase 2/Phase 3

Conditions studied: Ischemic Heart Disease, Stable Angina, Unstable Angina, Silent Ischemia

In brief

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.

Key facts

Study ID

NCT02131142

Run by

Biosensors Europe SA

People needed

72

Starts

2014-08-01

Expected to finish

2019-07-01

Last updated by the study team

2015-04-01

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

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;
• 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

Where it is running

• MedStar Washington Hospital Center — Washington D.C., District of Columbia, United States
• Baptist Cardiac & Vascular Institute — Miami, Florida, United States
• Emory University Hospital — Atlanta, Georgia, United States
• Jewish Hospital and Saint Mary's Healthcare — Louisville, Kentucky, United States
• MedStar Union Memorial Hospital — Baltimore, Maryland, United States
• MedStar Southern Maryland Hospital Center — Clinton, Maryland, United States
• Cardiac & Vascular Research Center of Northern Michigan — Petoskey, Michigan, United States
• Our Lady of Lourdes Medical Center — Voorhees Township, New Jersey, United States
• Columbia University Medical Center — New York, New York, United States
• NC Heart and Vascular Research-Rex Hospital — Raleigh, North Carolina, United States
• The Carl & Edyth Lindner Center for Research — Cincinnati, Ohio, United States
• Mercy St. Vincent Medical Center — Toledo, Ohio, United States
• Berks Cardiology — Wyomissing, Pennsylvania, United States

Full record on ClinicalTrials.gov

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