Coronary Heart Disease Clinical Trial
— OPTIMAOfficial title:
Optical Coherence Tomography Assessment of Intimal Tissue and Malapposition: A Randomized Comparison of the Biolimus A9-eluting and Everolimus-eluting Coronary Stents
Verified date | August 2014 |
Source | Northern Hospital, Australia |
Contact | n/a |
Is FDA regulated | No |
Health authority | Australia: Human Research Ethics Committee |
Study type | Interventional |
The purpose of this study is to use a high-resolution intracoronary imaging modality, called optical coherence tomography (OCT) to examine two different types of coronary artery stents used to treat patients with coronary artery disease.
Status | Active, not recruiting |
Enrollment | 80 |
Est. completion date | December 2014 |
Est. primary completion date | December 2014 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 18 Years and older |
Eligibility |
Inclusion Criteria: - Age = 18 years - Symptomatic coronary artery disease including patients with chronic stable angina, silent ischemia, and acute coronary syndromes including non-ST elevation myocardial infarction - Presence of one or more coronary artery stenosis > 50% in a native coronary artery with a reference diameter ranging from 2.25 to 4.0 mm which can be covered with one or multiple stents - No limitation to the number of treated lesions, number of vessels or lesion length according to the randomization group Exclusion Criteria: - Known intolerance to aspirin, clopidogrel, heparin, stainless steel, cobalt chromium, Biolimus, everolimus, contrast material - Acute ST-segment elevation myocardial infarction - Bypass graft - Inability to provide informed consent - Pregnancy - Planned surgery within 12 months of PCI unless dual antiplatelet therapy is maintained throughout the peri-surgical period - Left ventricular ejection fraction < 25% - Serum creatinine > 180mmol/L |
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Outcomes Assessor), Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
Australia | The Northern Hospital | Epping | Victoria |
Lead Sponsor | Collaborator |
---|---|
Dr Peter Barlis | Biosensors International |
Australia,
Barlis P, Dimopoulos K, Tanigawa J, Dzielicka E, Ferrante G, Del Furia F, Di Mario C. Quantitative analysis of intracoronary optical coherence tomography measurements of stent strut apposition and tissue coverage. Int J Cardiol. 2010 May 28;141(2):151-6. doi: 10.1016/j.ijcard.2008.11.204. Epub 2009 Jan 19. — View Citation
Barlis P, Regar E, Serruys PW, Dimopoulos K, van der Giessen WJ, van Geuns RJ, Ferrante G, Wandel S, Windecker S, van Es GA, Eerdmans P, Jüni P, di Mario C. An optical coherence tomography study of a biodegradable vs. durable polymer-coated limus-eluting stent: a LEADERS trial sub-study. Eur Heart J. 2010 Jan;31(2):165-76. doi: 10.1093/eurheartj/ehp480. Epub 2009 Nov 4. — View Citation
Barlis P, van Soest G, Serruys PW, Regar E. Intracoronary optical coherence tomography and the evaluation of stents. Expert Rev Med Devices. 2009 Mar;6(2):157-67. doi: 10.1586/17434440.6.2.157. Review. — View Citation
Tanigawa J, Barlis P, Dimopoulos K, Dalby M, Moore P, Di Mario C. The influence of strut thickness and cell design on immediate apposition of drug-eluting stents assessed by optical coherence tomography. Int J Cardiol. 2009 May 15;134(2):180-8. doi: 10.1016/j.ijcard.2008.05.069. Epub 2008 Sep 4. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Rate of stent strut malapposition | Apposition will be examined immediately following stent implantation following angiographic optimization of stent deployment | 0 Days | No |
Primary | Rate of stent strut tissue coverage | Subjects will be randomized to follow-up at either one of the time points post stenting (3, 6, 12 or 15 months). | At follow-up (one of either 3, 6, 12 or 15 months) | No |
Secondary | Major Adverse Cardiac Events | 15 months | Yes |
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