Optical Coherence Tomography Assessment of Intimal Tissue and Malapposition

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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Optical Coherence Tomography Assessment of Intimal Tissue and Malapposition: A Randomized Comparison of the Biolimus A9-eluting and Everolimus-eluting Coronary Stents

Conditions
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Coronary Heart Disease

Intervention / Treatment
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* Device: Biolimus-eluting stent
* Device: Everolimus-eluting coronary stent


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Biolimus-eluting stent<br> | Device: Biolimus-eluting stent<br>* 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.<br>* Other names: Biomatrix Flex (Biosensors International);|
| Active Comparator: Everolimus-eluting stent<br> | Device: Everolimus-eluting coronary stent<br>* The everolimus-eluting coronary stent is a cobalt chromium platform stent with a permanent fluorinated copolymer matrix that eludes everolimus<br>* Other names: Promus (BSC);|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Rate of stent strut malapposition | Apposition will be examined immediately following stent implantation following angiographic optimization of stent deployment | 0 Days | 
| 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) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Major Adverse Cardiac Events |  | 15 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Drug-eluting stents, Tomography, Optical Coherence