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Evaluation of HealinG of Polymer-Free Biomlimus A9-Coated Stent by Optical Coherence Tomography (EGO-BIOFREEDOM)

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. Identifier: NCT01760876
Recruitment Status : Completed
First Posted : January 4, 2013
Results First Posted : January 18, 2016
Last Update Posted : August 14, 2017
Information provided by (Responsible Party):
Professor Stephen Lee, The University of Hong Kong

Brief Summary:

Since polymers have been identified as a possible cause of late complications of drug eluting stents, new stents are being designed to improve polymers' biocompatibility or to bond drugs on stents without polymers.

Biolimus A9 is the therapeutic agent used in the BioFreedom drug coated stent. Biolimus A9 is a proprietary semi-synthetic sirolimus derivative. It is highly lipophilic, rapidly absorbed in tissues, and able to reversibly inhibit growth factor-stimulated cell proliferation.

In this study, we use intracoronary optical coherence tomography (OCT) to evaluate the BioFreedom Stents after implantation regarding endovascular healing over time as primary objective; and also to evaluate secondary OCT, angiographic and clinical outcomes at various specific time points.

Condition or disease Intervention/treatment Phase
Coronary Disease Device: coronary intervention Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 106 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Evaluation of Healing the Biofreedom Stent Study
Study Start Date : December 2012
Actual Primary Completion Date : August 2015
Actual Study Completion Date : August 2015

Arm Intervention/treatment
Experimental: Biofreedom stent
Coronary intervention
Device: coronary intervention
The BioFreedom drug coated stent (DCS) Coronary Stent Delivery System is comprised of three key components

Primary Outcome Measures :
  1. OCT Findings on Coverage (Degree of Endothelialisation/Coverage) From 1 to 9 Months. [ Time Frame: 1 to 9 months ]

    The percentage of strut coverage and category of coverage (A to F) from 1 month to 9 months by longitudinal sequential OCT assessments.

    A. Definitely uncovered - strut not covered by tissue, and both sides appear square; B. Uncovered with abnormal in-stent tissue - strut covered by irregular tissue or fibrin, and both sides appear square; C. Partially uncovered - strut partially covered by tissue but only one side has a smooth continuous shoulder; D. Covered (protruding) - strut covered by thin continuous tissue on both sides but still extending into the lumen; E. Covered (embedded) - strut covered by continuous tissue or neointima and not interrupting the smooth lumen contour; F. Covered (proliferative) - strut covered with excessive growth of neointima with thickness >0.3 mm.

Secondary Outcome Measures :
  1. OCT Endpoints (Neointimal Metrics), QCA Endpoints (Late Lumen Loss at 9 Months), and Clinical Endpoints (MACE at 9 Months and 12 Months). A Subgroup Analysis Would be Performed for Diabetic Patients. [ Time Frame: 9 months and 12 months ]
    Secondary endpoints would consist of OCT endpoints (neointimal area, neointimal thickness, neointimal volume, and percentage neointimal volume ), QCA endpoints (late lumen loss at 9 months), and clinical endpoints (MACE, including stent thrombosis up to 12 months). A subgroup analysis will be performed for DM patients.

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 85 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • Patient aged 18-85 years old
  • Patient indicated for percutaneous coronary intervention with coronary artery disease and without contraindications to implantation of drug eluting stents
  • Patient who agrees to have follow-up coronary angiograms

Exclusion Criteria:

  • Patient who refuses to consent to multiple coronary angiograms or coronary angioplasty

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 identifier (NCT number): NCT01760876

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Hong Kong
Department of Medicine, the University of Hong Kong, Queen Mary Hospital, Hospital Authority
Hong Kong, Hong Kong
Sponsors and Collaborators
Professor Stephen Lee
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Principal Investigator: Stephen WL Lee, MD FRCP FACC Department of Medicine, The University of Hong Kong, Queen Mary Hospital, Hospital Authority
Publications of Results:

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Responsible Party: Professor Stephen Lee, Professor and Chief, The University of Hong Kong Identifier: NCT01760876    
Other Study ID Numbers: UW 12-454
First Posted: January 4, 2013    Key Record Dates
Results First Posted: January 18, 2016
Last Update Posted: August 14, 2017
Last Verified: June 2017
Keywords provided by Professor Stephen Lee, The University of Hong Kong:
Optical Coherence Tomography
Biofreedom Stent
Additional relevant MeSH terms:
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Coronary Disease
Myocardial Ischemia
Heart Diseases
Cardiovascular Diseases
Vascular Diseases