Evaluation of HealinG of Polymer-Free Biomlimus A9-Coated Stent by Optical Coherence Tomography (EGO-BIOFREEDOM)
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.
|Study Design:||Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||Evaluation of Healing the Biofreedom Stent Study|
- OCT Findings on Coverage (Degree of Endothelialisation/Coverage) From 1 to 9 Months. [ Time Frame: 1 to 9 months ] [ Designated as safety issue: No ]
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.
- 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 ] [ Designated as safety issue: No ]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.
|Study Start Date:||December 2012|
|Study Completion Date:||August 2015|
|Primary Completion Date:||August 2015 (Final data collection date for primary outcome measure)|
Experimental: Biofreedom stent
Device: coronary intervention
The BioFreedom drug coated stent (DCS) Coronary Stent Delivery System is comprised of three key components
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Please refer to this study by its ClinicalTrials.gov identifier: NCT01760876
|Department of Medicine, the University of Hong Kong, Queen Mary Hospital, Hospital Authority|
|Hong Kong, Hong Kong|
|Principal Investigator:||Stephen WL Lee, MD FRCP FACC||Department of Medicine, The University of Hong Kong, Queen Mary Hospital, Hospital Authority|