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

This study is currently recruiting participants.
Verified November 2013 by The University of Hong Kong
Sponsor:
Information provided by (Responsible Party):
Prof. Stephen Lee, The University of Hong Kong
ClinicalTrials.gov Identifier:
NCT01760876
First received: December 20, 2012
Last updated: November 20, 2013
Last verified: November 2013
  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

Resource links provided by NLM:


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 ]
    OCT findings on coverage (degree of endothelialisation/coverage) from 1 to 9 months.


Secondary Outcome Measures:
  • OCT endpoints (neointimal area and neointimal thickness ), QCA endpoints (late lumen loss at 9 months), and clinical endpoints (MACE, components and stent thrombosis at 9 months and 12 months). A subgroup analysis will be performed for diabetics. [ Time Frame: 9 months and 12 months ] [ Designated as safety issue: No ]
    Secondary endpoints will consist of OCT endpoints (neointimal area and neointimal thickness ), QCA endpoints (late lumen loss at 9 months), and clinical endpoints (MACE, components and stent thrombosis at 9 months and 12 months). A subgroup analysis will be performed for diabetics.


Estimated Enrollment: 100
Study Start Date: December 2012
Estimated Study Completion Date: August 2014
Estimated Primary Completion Date: June 2014 (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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01760876

Contacts
Contact: Stephen WL Lee, MD FRCP FACC 852-22555409 drsl@i-cable.com
Contact: Shun Ling Kong, MN MSc(Stat) 852-97756950 kongsl@hku.hk

Locations
Hong Kong
Department of Medicine, the University of Hong Kong, Queen Mary Hospital, Hospital Authority Recruiting
Hong Kong, Hong Kong
Contact: Shun Ling Kong, MN MSc(Stat)    852-97756950    kongsl@hku.hk   
Sub-Investigator: Kelvin KW Chan, MD MRCP         
Sub-Investigator: Pak Hei Chan, MD MRCP         
Sub-Investigator: Frankie CC Tam, MD MRCP         
Sub-Investigator: Anthony YT Wong, MD         
Sub-Investigator: Arthur SY Yung, MD         
Sub-Investigator: Michael KL Wong, MD MRCP         
Sponsors and Collaborators
Prof. 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

No publications provided

Responsible Party: Prof. 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
Last Updated: November 20, 2013
Health Authority: Hong Kong: Ethics Committee

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

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

ClinicalTrials.gov processed this record on April 21, 2014