NCT00300131已完成不适用
Bioabsorbable Vascular Solutions First in Man Clinical Investigation: A Clinical Evaluation of the Bioabsorbable Vascular Solutions Everolimus Eluting Coronary Stent System (BVS EECSS) in the Treatment of Patients With Single de Novo Native Coronary Artery Lesions
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 30
- 试验地点
- 4
- 主要终点
- Ischemia Driven MACE
研究概览
简要总结
Prospective, open-labeled First in Man Clinical Investigation enrolling patients with visually estimated nominal vessel diameter of 3.0 mm receiving a single 3.0 x 12 mm or 3.0 x 18 mm BVS EECSS containing 98 microgramme per cm² of surface area.
详细描述
- Prospective, open-labeled Clinical Investigation enrolling patients with visually estimated nominal vessel diameter of 3.0 mm and lesion length ≥ 8 mm receiving a single 3.0 x 12 mm BVS Everolimus Eluting CSS containing 98 microgramme per cm² of surface area. Lesion length will be expanded to≥ 14 mm in length by visual estimation when 3.0 x 18 mm stent is available.
- Angiographic, Intravascular Ultrasound (IVUS), Intravascular Ultrasound- virtual histology (IVUS-VH) and Palpography follow-up will be carried out in all patients at 180 days and 2 years following the index procedure
- Optical Coherence Tomography (OCT) follow-up at 180 days and 2 years will be carried out in a subset of up to 10 patients in Cohorts A and B respectively who are enrolled in pre-determined clinical site(s)
- Multi-slice Spiral Computed Tomography (MSCT) is an optional procedure which may be carried out at 18 months post procedure and again between 4 and 5 year follow up.
- Additionally, coronary vasomotion test may be done at 2 years post procedure
Single patient Cohort of 30.
Pipeline products. Currently in development at Abbott Vascular. Not available for sale.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 时间视角
- Prospective
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
- •Target lesion must be located in a native epicardial vessel with visually estimated nominal vessel diameter of 3.0 mm
- •Target lesion must measure less/equal 8 mm in length by visual estimation for 3.0 x 12 mm, expanded to less/equal 14 mm in length by visual estimation when 3.0 x 18 mm stent is available
- •The target lesion(s) must be in a major artery or branch with a visually estimated stenosis of > 50% and < 100% with a TIMI flow of greater/equal 1
- •Non-Clinical Investigation, percutaneous intervention for lesions in a non-target vessel is allowed if done more/equal 90 days prior to or if planned to be done 6 months after the index procedure
- •Non-Clinical Investigation, percutaneous intervention for lesions in the target vessel is allowed if done > 6 months prior to or if planned to be done 6 months after the index procedure
排除标准
- •Located within an arterial or saphenous vein graft or distal to a diseased (defined as vessel irregularity per angiogram and > 20% stenosed lesion by visual estimation) arterial or saphenous vein graft
- •Lesion involving a bifurcation greater/equal 2 mm in diameter and ostial lesion > 40% stenosed by visual estimation or side branch requiring predilatation
- •Total occlusion (TIMI flow 0), prior to wire passing
- •The target vessel contains visible thrombus
- •Another clinically significant lesion is located in the same epicardial vessel (including side branch) as the target lesion
- •Patient has received brachytherapy in any epicardial vessel (including side branches)
结局指标
主要结局
Ischemia Driven MACE
时间窗: at 30, 180, 270 days, and 1, 2, 3, 4, 5 years;
Ischemia driven Target Vessel Failure (TVF)
时间窗: at 30, 180, 270 days, and 1, 2, 3, 4, 5 years;
Acute success (clinical device and clinical procedure)
时间窗: Acute
Ischemia Driven Target Lesion Revascularization (TLR)
时间窗: at 30, 180, 270 days and 1, 2, 3, 4, 5 years;
Ischemia Driven Target Vessel Revascularization (TVR)
时间窗: at 30, 180, 270 days and 1, 2, 3, 4, 5 years
次要结局
- In-stent Late Loss(LL)(at 180 days and 2 years)
- In-segment LL(at 180 days and 2 years)
- Proximal LL (proximal defined as within 5 mm of tissue proximal to stent placement)(at 180 days and 2 years)
- Distal LL (distal defined as within 5 mm of tissue distal to stent placement)(at 180 days and 2 years)
- In-stent and in-segment Angiographic Binary Restenosis (ABR) rate(at 180 days and 2 years)
- In-stent % Volume Obstruction (VO)(at 180 days and 2 years)
- Persisting incomplete apposition, late incomplete apposition, aneurysm, thrombus, persisting dissection(at 180 days and 2 years)
研究者
研究点 (4)
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