Optical Coherence Tomography for EVERolimus Eluting STent (OCTEVEREST)
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 42
- 试验地点
- 2
- 主要终点
- Proportion of stent struts uncovered at 6 months as measured by OCT
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patient is ≥ 18 years of age
- •Patient is eligible for percutaneous coronary intervention (PCI)
- •Patient has documented stable angina pectoris (Canadian Cardiovascular Society [CCS] Classification 1, 2, 3, or 4) or documented silent ischemia; or unstable angina pectoris (Braunwald Class IB-C, IIB-C, or IIIB-C)
- •Patient demonstrates a left ventricular ejection fraction (LVEF) of ≥ 40% as measured prior to enrollment
- •Patient understands and agrees to comply with all specified study requirements and provides written Informed Consent to this effect.
- •Angiographic Inclusion Criteria
- •Target lesion must be located in a native coronary artery with a visually estimated reference vessel diameter (RVD) ≥ 2.50 mm and ≤ 3,75 mm.
- •Target lesion length must measure (by visual estimate) ≤ 24 mm.
- •Target lesion must be in a major coronary artery or branch with visually estimated stenosis ≥ 50% and <100% with TIMI flow >1.
排除标准
- •General Exclusion Criteria
- •The patient has a life expectancy of less than 24 months due to another medical condition
- •Patient has a history of hypersensitivity to everolimus or paclitaxel or structurally related compounds
- •Patient exhibits cardiogenic shock (systolic pressure < 80mm Hg and PCWP > 20mm Hg or cardiac index <1.8 liters/minute/m2 or intra-aortic balloon pump or intravenous inotropes are needed to maintain a systolic pressure>80 mm Hg) for any time within 24 hours prior to index procedure
- •Patient demonstrates evidence of acute or chronic renal dysfunction (serum creatinine > 2.0 mg/dl or 177 μmol/l)
- •Planned cardiac surgery procedure ≤ 6 months post-index procedure
- •Patient demonstrates evidence of a acute myocardial infarction (eg. STEMI or enzyme elevation CK > 2X local laboratory's ULN unless CK-MB is < 2X ULN) 7)
- •Cerebrovascular accident (CVA) including stroke or TIA within previous 3 months
- •Patient demonstrates evidence of leukopenia (leukocyte count < 3.5 X 109/liter)
- •Patient demonstrates evidence of thrombocytopenia (platelet count < 100,000/mm3) or thrombocytosis (>750,000/mm3)
- •Patient is contraindicated to Aspirin (successful prior desensitization to Aspirin is not an exclusion), clopidogrel, or ticlopidine
- •Patient is currently on warfarin, or possibility of treatment with warfarin during the following 6 months post index procedure
- •Patient has been treated with paclitaxel, everolimus or other chemotherapeutic agents within 12-months prior to planned index procedure
- •Anticipated treatment with paclitaxel, everolimus or oral rapamycin during any period in the 6-months after the index procedure
- •Known allergy to stainless steel
- •Female or male with known intention to procreate within 3 months after the index procedure (due to the exposure to paclitaxel and unknown affect it may have on the fetus)
- •Female of childbearing potential with a positive pregnancy test within 7 days before the index procedure, or lactating, or intends to become pregnant during the 9 months post index procedure
- •Patient that in the opinion of the investigator is not clinically appropriate for OCT evaluation.
- •Angiographic Exclusion Criteria
- •Evidence of thrombus of the study vessel, based on angiography or IVUS
- •Study lesion is totally occluded (TIMI flow ≤ 1) either at baseline or before predilatation
- •Study lesion, or the study vessel proximal to the study lesion is moderately or severely calcified, by visual estimate
- •Study lesion is ostial in location (within 5.0 mm of vessel origin)
- •Study lesion involving arterial segments with highly tortuous anatomy or where lesion is located within or distal to a >60 degree bend in the vessel
- •Study lesion involves a bifurcation with a diseased (>50% stenotic) branch - Left main coronary artery disease (stenosis >50%) whether protected or unprotected
- •Target lesion length > 24 mm, based on visual estimate by operator
- •Target vessel diameter > 3.75 mm, based on visual estimate by operator
- •Target vessel diameter < 2.5 mm based on visual estimate by operator
- •Pre-treatment of the target lesion (excluding predilation) with another interventional device.
- •Target lesion is restenotic from previous intervention
结局指标
主要结局
Proportion of stent struts uncovered at 6 months as measured by OCT
时间窗: 6 months
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.
次要结局
- Stent Thrombosis rate through 24 months(24 months)
- Target Lesion Revascularization(24 months)
- Additional OCT parameters(6 months)
- IVUS parameters(6 months)
- Major Adverse Cardiac Events (MACE)(1,6,12,24 months)
- QCA parameters:(6 months)
研究者
GGuagliumi
MD
A.O. Ospedale Papa Giovanni XXIII