Optical Coherence Tomography Assessment of Intimal Tissue and Malapposition (OPTIMA)
Recruitment status was: Active, not recruiting
|Coronary Heart Disease||Device: Biolimus-eluting stent Device: Everolimus-eluting coronary stent||Phase 3|
|Study Design:||Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (Participant, Outcomes Assessor)
Primary Purpose: Treatment
|Official Title:||Optical Coherence Tomography Assessment of Intimal Tissue and Malapposition: A Randomized Comparison of the Biolimus A9-eluting and Everolimus-eluting Coronary Stents|
- Rate of stent strut malapposition [ Time Frame: 0 Days ]Apposition will be examined immediately following stent implantation following angiographic optimization of stent deployment
- Rate of stent strut tissue coverage [ Time Frame: At follow-up (one of either 3, 6, 12 or 15 months) ]Subjects will be randomized to follow-up at either one of the time points post stenting (3, 6, 12 or 15 months).
- Major Adverse Cardiac Events [ Time Frame: 15 months ]
|Study Start Date:||October 2010|
|Estimated Study Completion Date:||December 2014|
|Estimated Primary Completion Date:||December 2014 (Final data collection date for primary outcome measure)|
|Active Comparator: Biolimus-eluting stent||
Device: Biolimus-eluting stent
The biolimus-eluting coronary stent contains a stainless steel platform on which an abluminally coated polylactic acid (PLA) biodegradable polymer is placed that eludes biolimus-A9.
Other Name: Biomatrix Flex (Biosensors International)
|Active Comparator: Everolimus-eluting stent||
Device: Everolimus-eluting coronary stent
The everolimus-eluting coronary stent is a cobalt chromium platform stent with a permanent fluorinated copolymer matrix that eludes everolimus
Other Name: Promus (BSC)
The development of coronary stents has significantly improved the safety and efficacy of percutaneous coronary intervention (PCI) compared to balloon angioplasty alone. Nevertheless, restenosis is still encountered in 20 to 40% of coronary lesions after implantation of bare metal stents, inferring frequent repeat revascularization procedures with a negative impact on quality of life and health care expenditures. Drug-eluting stents (DES), with their controlled release of therapeutic agents, have significantly reduced the rate of major adverse cardiac events (MACE) following coronary stent implantation, primarily by a reduction in restenosis and target lesion revascularization.
Optical coherence tomography (OCT) is an optical analogue of intravascular ultrasound (IVUS): it uses an infrared light source (wavelength 1310nm) and measures the backscatter of light in a technique similar to conventional ultrasound. With this technique a resolution up to 10μm in-vivo has been reported, a far better level of resolution compared with IVUS. Optical coherence tomography has been used in vivo and has detected early atherosclerotic plaques previously not visualised by IVUS. Segments with strut malapposition and the presence or thickness of neointimal hyperplasia can also be more accurately assessed with OCT compared with IVUS.
The present study will utilize the imaging capabilities of OCT to assess stent strut malapposition and tissue coverage in two different types of DES. The biolimus-eluting stent eludes biolimus from a biodegradable polylactic acid polymer on the abluminal surface of a stainless steel stent. This stent will be compared in a randomized fashion to the permanent polymer based everolimus-eluting coronary stent made of cobalt chromium alloy.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01137019
|The Northern Hospital|
|Epping, Victoria, Australia, 3076|
|Principal Investigator:||Peter Barlis, MBBS PhD FRACP||Northern Hospital, Department of Cardiology, Victoria, Australia|