Optical Coherence Tomography for EVERolimus Eluting STent (OCTEVEREST)
Recruitment status was Recruiting
|First Received Date ICMJE||June 16, 2010|
|Last Updated Date||June 16, 2010|
|Start Date ICMJE||February 2010|
|Estimated Primary Completion Date||November 2010 (final data collection date for primary outcome measure)|
|Current Primary Outcome Measures ICMJE
||Proportion of stent struts uncovered at 6 months as measured by OCT [ Time Frame: 6 months ] [ Designated as safety issue: Yes ]
The proportion of stent struts uncovered by endothelial tissue will be determined by measuring the number of exposed struts, defined as a measured neointimal hyperplasia (NIH) thickness less than 10 μm, at 0.5 mm cross section analysis, divided by the total number of stent struts. This analysis shall be performed using a dedicated software, as assessed by OCT core lab at 6 month follow up.
|Original Primary Outcome Measures ICMJE||Same as current|
|Change History||No Changes Posted|
|Current Secondary Outcome Measures ICMJE
|Original Secondary Outcome Measures ICMJE||Same as current|
|Current Other Outcome Measures ICMJE||Not Provided|
|Original Other Outcome Measures ICMJE||Not Provided|
|Brief Title ICMJE||Optical Coherence Tomography for EVERolimus Eluting STent|
|Official Title ICMJE||Optical Coherence Tomography for EVERolimus Eluting STent (OCTEVEREST)|
Compared with bare metal stents (BMS), both paclitaxel-eluting stents (PES) and sirolimus-eluting stents (SES) significantly reduce angiographic restenosis and the need for repeat revascularization in coronary arteries across a broad range of patient and lesion types. However the increased risk of very late stent thrombosis represents a major concern for patients treated with both PES and SES. Optical coherence tomography (OCT), a new imaging technique based on the back reflection of near infrared light, enables real-time, full tomographic, in-vivo visualization of coronary vessel microstructure. Struts coverage and vessel response of drug eluting stent (DES) compared to BMS are the most immediate clinical applications of OCT. Thickness of coverage and strut apposition can be quantified at micron-scale level with a resolution 10-30 times higher than conventional intravascular ultrasound (IVUS). The objective of this study OCTEVEREST (Optical Coherence Tomography for EVERolimus Eluting STent) is to evaluate the long term struts coverage and vessel wall response (abnormal intraluminal defects, strut malapposition, vessel expansions) to the PROMUS™ Everolimus Eluting Stent compared to PROMUS ELEMENT™ Everolimus Eluting Stent implanted for the treatment of stenosis in native coronaries. To investigate the completeness of struts coverage as well as the proportion of malapposed struts and the neointima characteristics, high resolution (~ 10 µ axial) intracoronary Optical Coherence Tomography (OCT) and intravascular coronary ultrasound (IVUS) will be used.
This is a prospective single center clinical study designed to evaluate the long term struts coverage and vessel wall response (abnormal intraluminal defects, strut malapposition, vessel espansions) to the PROMUS™ Everolimus Eluting Stent compared to PROMUS ELEMENT ™ Everolimus Eluting Stent implanted for the treatment of stenosis in native coronaries. The difference between the two stents is in the stent platform made of a novel alloy of chromium-platinum with low strut thickness and stent crossing profile (0.042" [1.062 mm]) for PROMUS ELEMENT ™ Everolimus Eluting Stent. To investigate the completeness of struts coverage as well as the proportion of malapposed struts and the neointima characteristics, high resolution (~ 10 µ axial) intracoronary Optical Coherence Tomography (OCT) and intravascular coronary ultrasound (IVUS) will be used. The study will be carried out at Ospedali Riuniti di Bergamo, Italy with a target enrollment of consecutive 21 patients for each group receiving one or two Everolimus Eluting stents. All patients enrolled in the study will be followed to 12 months post stent placement.
PLATFORM TO BE USED PROMUS™ everolimus eluting stent. Stent sizes: 2.5 to 3.5 mm, 12 - 15 - 20 - 23 - 28 mm in lengths (according to product specifications).
PROMUS ELEMENT ™ Everolimus Eluting Stent. Stent sizes: 2.5 to 3.5 mm, 12 - 15 -20 - 23 - 28 mm in lengths (according to product specifications).
Patients presenting with a coronary artery lesion who are considered candidates for percutaneous coronary intervention and stent placement are eligible for the OCTEVEREST (Optical Coherence Tomography for EVERolimus Eluting STent)trial. Patients may have a second study lesion that can be treated with a second PROMUS™ Stent or PROMUS ELEMENT ™ Everolimus Eluting Stent.
Patients who do not meet all inclusion/exclusion criteria will not be enrolled or followed in the study. All patients who are candidates for the OCTEVEREST trial and undergo placement of the device must be consented prior to any data collection by a member of the institution's research team. All patients enrolled will be evaluated according to this protocol, regardless of sequence of treatment that ensues. More than one study lesion in different epicardial vessels may be treated in the same stage procedure. Actual study enrollment occurs following successful pre-dilatation of the study vessel, when the study device is introduced into the body. The target lesion must be able to be covered with a single stent. For diffuse lesions the total lesion length will be measured from the proximal shoulder of the most proximal lesion to the distal shoulder of the most distal lesion and should not exceed 24 mm. At 6 month follow-up, the entire stented region will be used to determine the mean lumen diameter and the percent diameter stenosis.
Optical coherence tomography (OCT) will be performed baseline and at 6 month follow up. Study site is requested to use the same OCT equipment for both procedures. The OCT procedure will be conducted according to Optical Coherence Tomography as specified by the Protocol. Optical Coherence Tomography images will be acquired at 15-30 frames per second (500 angular pixels x 250 radial pixels), from a 0.006" micro-optic core, 0.014" image wire, displayed with an inverse gray-scale lookup table, and digitally archived. The optical source used in this study has a center wavelength of 1310 nm and a bandwidth of 70 nm, providing an axial resolution of (10-12 μm in tissue with a tissue penetration of 2 mm). The transverse resolution, determined by the spot size of the sample arm beam, is 25 μm. OCT images will be analyzed by an independent Corelab (Cardialysis, Cleveland) expert in high resolution OCT analysis. An automatic analysis with novel dedicated software will be used for quantitative assessment. Interactive revision of contour appropriateness will be performed by experienced readers. In a blind fashion 10% of all sections will be re-evaluated to estimate the measurement variability (k value). The existence of malapposition will be assessed.
Angiography Angiography will be performed at baseline prior to stent placement, after stent placement, and at 6 month follow up. The Angiography procedure will be conducted according to Angiographic Core Laboratory procedure .A baseline angiography of the involved vessel will be performed in at least two near orthogonal views. Visual angiographic assessment will be used to determine if the lesion meets angiographic entry criteria. The study lesion must be free of foreshortening or vessel overlap. If angiography demonstrates that the target lesion meets study eligibility criteria, then the patient may be enrolled in the study.
Intravascular Ultrasound IVUS will be performed at the time of index procedure and at 6 month follow up. IVUS will initially be performed after successful, uncomplicated stent implantation (diameter stenosis <10%, TIMI-3 flow). Study site IS requested to use the same IVUS equipment for both procedures. IVUS will be performed on all patients according to IVUS Core. Laboratory Acquisition Protocol. Imaging will be performed with a 40 MHz Atlantis catheter (Boston Scientific), after 50- 200 mcg of intracoronary nitroglycerin. Automated motorized pullback at 0.5 mm/sec will utilized during all IVUS runs (Hi-Lab Boston Scientific). Imaging will include the edges at least 5 mm proximal and distal to the stent. The transducer will be advanced at least 10 mm distal to the distal edge of the stent(s), and a continuous, uninterrupted imaging run performed to a point at least 10mm proximal to the proximal edge of the stent(s). All IVUS studies will be archived for subsequent CoreLab analysis in DICOM format. IVUS analysis will include measurements of external elastic membrane (EEM), stent, and lumen cross-sectional areas and volumes according to the Standards for the Acquisition, Measurement, and Reporting of Intravascular Ultrasound Studies. In addition, qualitative analysis (incomplete apposition, dissections) will also be performed according to the same standards document.
|Study Type ICMJE||Interventional|
|Study Phase||Phase 3|
|Study Design ICMJE||Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
|Condition ICMJE||Coronary Artery Disease|
|Study Arm (s)||
|Publications *||Guagliumi G, Capodanno D, Ikejima H, Bezerra HG, Sirbu V, Musumeci G, Fiocca L, Lortkipanidze N, Vassileva A, Tahara S, Valsecchi O, Costa MA. Impact of different stent alloys on human vascular response to everolimus-eluting stent: an optical coherence tomography study: the OCTEVEREST. Catheter Cardiovasc Interv. 2013 Feb;81(3):510-8. doi: 10.1002/ccd.24374. Epub 2012 May 2.|
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
|Recruitment Status ICMJE||Recruiting|
|Estimated Enrollment ICMJE||42|
|Estimated Completion Date||December 2011|
|Estimated Primary Completion Date||November 2010 (final data collection date for primary outcome measure)|
|Eligibility Criteria ICMJE||
Angiographic Inclusion Criteria
|Ages||18 Years and older|
|Accepts Healthy Volunteers||No|
|Location Countries ICMJE||Italy|
|NCT Number ICMJE||NCT01146080|
|Other Study ID Numbers ICMJE||BG-001-09|
|Has Data Monitoring Committee||Yes|
|Responsible Party||Giulio Guagliumi, Cardiovascular Department Ospedali Riuniti di Bergamo, Italy|
|Study Sponsor ICMJE||Ospedali Riuniti di Bergamo|
|Information Provided By||Ospedali Riuniti di Bergamo|
|Verification Date||June 2010|
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