BioFreedom US IDE Feasibility Trial

Ischemic Heart Disease Clinical Trial

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT02131142
• Other study ID #: 14US01
• Status: Active, not recruiting
• Phase: Phase 2/Phase 3
• First received: May 5, 2014
• Last updated: March 31, 2015
• Start date: August 2014
• Est. completion date: July 2019

Study information

• Verified date: March 2015
• Source: Biosensors Europe SA
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

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

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 72
• Est. completion date: July 2019
• Est. primary completion date: August 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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 Design

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Angina, Stable
• Angina, Unstable
• Coronary Artery Disease
• Heart Diseases
• Ischemic Heart Disease
• Myocardial Ischemia
• Silent Ischemia
• Stable Angina
• Unstable Angina

Intervention

Device:
• BioFreedom drug coated coronary stent
Placement of a BioFreedom drug coated stent in a narrow coronary artery

Locations

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

Sponsors (1)

Lead Sponsor	Collaborator
Biosensors Europe SA

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Yes
Primary	Efficacy of the BioFreedom stent	Stent late lumen loss at 9 months as compared to historical control	9 month	No