At a glance
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Evaluation of Healing the Biofreedom Stent Study
In Brief
A clinical study evaluating coronary intervention for Coronary Disease. Completed, enrolled 106 participants across 1 site.
Detailed 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.
Study Details
Timeline
Interventions
The BioFreedom drug coated stent (DCS) Coronary Stent Delivery System is comprised of three key components