N/A Completed N=106 Treatment

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

Coronary Disease

Source: ClinicalTrials.gov NCT01760876 ↗

Enrolled (actual)

106

Serious AEs

28.8%

Results posted

Jan 2016

Primary outcomePrimary: OCT Findings on Coverage (Degree of Endothelialisation/Coverage) From 1 to 9 Months. — 85.77; 86.95; 88.56; 96.79 percentage of strut coverage (D+E+F)

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.

Outcome Measures

Outcome	Result	p-value
PRIMARY OCT Findings on Coverage (Degree of Endothelialisation/Coverage) From 1 to 9 Months.	85.77; 86.95; 88.56; 96.79; 97.14; 99.55	—
SECONDARY 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.	—	—

Eligibility Criteria

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

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT01760876). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.