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

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.

Study Overview

• Status: Unknown
• Conditions: Ischemic Heart Disease; Stable Angina; Unstable Angina; Silent Ischemia
• Intervention / Treatment: Device: BioFreedom drug coated coronary stent

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

• Study Type: Interventional
• Enrollment (Actual): 72
• Phase: Phase 2; Phase 3

Contacts and Locations

Study Locations

• United States
  • District of Columbia
    • Washington, District of Columbia, United States, 20010
      • MedStar Washington Hospital Center
  • Florida
    • Miami, Florida, United States, 33176
      • Baptist Cardiac & Vascular Institute
  • Georgia
    • Atlanta, Georgia, United States, 30322
      • Emory University Hospital
  • Kentucky
    • Louisville, Kentucky, United States, 40202
      • Jewish Hospital and Saint Mary's Healthcare
  • Maryland
    • Baltimore, Maryland, United States, 21218
      • MedStar Union Memorial Hospital
    • Clinton, Maryland, United States, 20735
      • MedStar Southern Maryland Hospital Center
  • Michigan
    • Petoskey, Michigan, United States, 49770
      • Cardiac & Vascular Research Center of Northern Michigan
  • New Jersey
    • Voorhees, New Jersey, United States, 08043
      • Our Lady of Lourdes Medical Center
  • New York
    • New York, New York, United States, 10032,
      • Columbia University Medical Center
  • North Carolina
    • Raleigh, North Carolina, United States, 27607
      • NC Heart and Vascular Research-Rex Hospital
  • Ohio
    • Cincinnati, Ohio, United States, 45219
      • The Carl & Edyth Lindner Center for Research
    • Toledo, Ohio, United States, 43608
      • Mercy St. Vincent Medical Center
  • Pennsylvania
    • Wyomissing, Pennsylvania, United States, 19610
      • Berks Cardiology

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: BioFreedom	Device: BioFreedom drug coated coronary stent; Placement of a BioFreedom drug coated stent in a narrow coronary artery

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: Biosensors Europe SA

Study record dates

Study Major Dates

• Study Start: August 1, 2014
• Primary Completion (Anticipated): August 1, 2015
• Study Completion (Anticipated): July 1, 2019

Study Registration Dates

• First Submitted: May 5, 2014
• First Submitted That Met QC Criteria: May 5, 2014
• First Posted (Estimate): May 6, 2014

Study Record Updates

• Last Update Posted (Estimate): April 1, 2015
• Last Update Submitted That Met QC Criteria: March 31, 2015
• Last Verified: March 1, 2015

More Information

Terms related to this study

• Keywords: ischemic heart disease; CAD
• Additional Relevant MeSH Terms: Pathologic Processes; Cardiovascular Diseases; Vascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Pain; Neurologic Manifestations; Coronary Disease; Chest Pain; Heart Diseases; Coronary Artery Disease; Myocardial Ischemia; Ischemia; Angina Pectoris; Angina, Stable; Angina, Unstable
• Other Study ID Numbers: 14US01