Evaluation of HealinG of Polymer-Free Biomlimus A9-Coated Stent by Optical Coherence Tomography (EGO-BIOFREEDOM)
This study is currently recruiting participants.
Verified February 2013 by The University of Hong Kong
Sponsor:
Prof. Stephen Lee
Information provided by (Responsible Party):
Prof. Stephen Lee, The University of Hong Kong
ClinicalTrials.gov Identifier:
NCT01760876
First received: December 20, 2012
Last updated: February 27, 2013
Last verified: February 2013
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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: | February 27, 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 May 19, 2013