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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Professor Stephen Lee, The University of Hong Kong
ClinicalTrials.gov Identifier:
NCT01760876
First received: December 20, 2012
Last updated: December 10, 2015
Last verified: December 2015
  Purpose

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 Intervention
Coronary Disease
Device: coronary intervention

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Evaluation of Healing the Biofreedom Stent Study

Further study details as provided by The University of Hong Kong:

Primary Outcome Measures:
  • 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.


Secondary Outcome Measures:
  • 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.


Enrollment: 106
Study Start Date: December 2012
Study Completion Date: August 2015
Primary Completion Date: August 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Biofreedom stent
Coronary intervention
Device: coronary intervention
The BioFreedom drug coated stent (DCS) Coronary Stent Delivery System is comprised of three key components

  Show Detailed Description

  Eligibility

Ages Eligible for Study:   18 Years to 85 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
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Please refer to this study by its ClinicalTrials.gov identifier: NCT01760876

Locations
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
Investigators
Principal Investigator: Stephen WL Lee, MD FRCP FACC Department of Medicine, The University of Hong Kong, Queen Mary Hospital, Hospital Authority
  More Information

Publications:

Responsible Party: Professor Stephen Lee, Professor and Chief, The University of Hong Kong
ClinicalTrials.gov Identifier: NCT01760876     History of Changes
Other Study ID Numbers: UW 12-454 
Study First Received: December 20, 2012
Results First Received: May 27, 2015
Last Updated: December 10, 2015
Health Authority: Hong Kong: Ethics Committee

Keywords provided by The University of Hong Kong:
Optical Coherence Tomography
Biofreedom Stent

Additional relevant MeSH terms:
Coronary Artery Disease
Coronary Disease
Arterial Occlusive Diseases
Arteriosclerosis
Cardiovascular Diseases
Heart Diseases
Myocardial Ischemia
Vascular Diseases

ClinicalTrials.gov processed this record on May 22, 2016