A Boston Scientific Trial of the EPIC™ Nitinol Stent System in the Treatment of Atherosclerotic Lesions in Iliac Arteries
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 125
- 试验地点
- 28
- 主要终点
- Device- and/or Procedure-related Major Adverse Events (MAE)
研究概览
简要总结
The ORION study is being conducted to determine whether the Epic™ Nitinol Stent for primary stenting of iliac atherosclerotic lesions shows acceptable performance at 9 months.
详细描述
ORION is a prospective, single arm, non-randomized, multicenter study. A subject could receive a maximum of 2 study stents for up to 2 target lesions. A maximum of 1 non-target lesion in 1 non-target vessel could be treated with a commercially approved treatment during the index procedure.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 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
- •Documented chronic, symptomatic iliac artery atherosclerotic disease (Rutherford/Becker category 1, 2, 3 or 4)
- •Lifestyle-limiting claudication or rest pain
- •De novo or restenotic lesions in the common and/or external iliac artery
- •Subjects with bilateral disease may have only one target lesion treated per side
- •Two target lesions may be treated with a maximum of two stents (if two target lesions are treated, each lesion must be covered with a maximum of one stent)
- •Length of diseased segment(s) <=13 cm and treatment is planned with no more than 2 overlapped Epic™ stents
- •Baseline diameter stenosis >= 50% (operator visual assessment)
- •Reference vessel diameter >= 5 mm and <=11 mm
- •At least one sufficient ipsilateral infrapopliteal run-off vessel
- •Origin of profunda femoris artery is patent
排除标准
- •Target vessel with in-stent restenosis
- •Acute critical limb ischemia
- •Tissue loss (Rutherford/Becker category 5 or 6)
- •Any major amputations to the target limb
- •Any minor amputation of the target limb in the last 12 months. If a minor amputation occurred greater than 12 months, stump needs to be completely healed.
- •Life expectancy less than 24 months due to other medical co-morbid condition(s) that could limit the subject's ability to participate in the trial, limit the subject's compliance with the follow-up requirements, or impact the scientific integrity of the trial
- •Known hypersensitivity or contraindication to contrast dye that, in the opinion of the investigator, cannot be adequately pre-medicated.
- •Intolerance to antiplatelet, anticoagulant, or thrombolytic medications
- •Platelet count < 150,000 mm3 or > 600,000 mm3
- •Serum creatinine > 2.0 mg/dL
- •Dialysis-dependent end stage renal disease
- •Pregnancy
- •Current participation in another drug or device trial that has not completed the primary endpoint or that may potentially confound the results of this trial
- •Known allergy to Nitinol
- •Presence of arterial lesions (with the exception of renal, carotid or short, focal SFA lesions) requiring intervention within 30 days of the index procedure - Superficial femoral artery occlusion in the limb supplied by target vessel
- •Heavily calcified and/or excessively tortuous lesions in the target vessel as determined by angiography
- •Target lesion is within or near an aneurysm
- •Persistent, intraluminal thrombus of the proposed target lesion post-thrombolytic therapy
- •Perforated vessel as evidenced by extravasation of contrast media
- •Vascular graft, aneurysm or postsurgical stenosis of the target vessel
- •Multiple lesions in the same target vessel unable to be treated with a maximum of two stents
研究组 & 干预措施
ORION
All subjects who meet the inclusion criteria and are enrolled in this trial will be treated with iliac artery stenting with the Epic™ Nitinol Stent System.
干预措施: Epic™ Nitinol Stent System (Device)
ORION
All subjects who meet the inclusion criteria and are enrolled in this trial will be treated with iliac artery stenting with the Epic™ Nitinol Stent System.
干预措施: Anti-platelet therapy (Drug)
ORION
All subjects who meet the inclusion criteria and are enrolled in this trial will be treated with iliac artery stenting with the Epic™ Nitinol Stent System.
干预措施: Anti-coagulation therapy (Drug)
结局指标
主要结局
Device- and/or Procedure-related Major Adverse Events (MAE)
时间窗: 9 Months
MAE is defined as any device-related or index procedure-related death within 30 days, myocardial infarction during index hospitalization, target vessel revascularization through 9 months, or amputation of the index limb through 9 months
次要结局
- Death(3 Years)
- Procedure Success(In hospital (1-2 days post procedure))
- Rutherford Classification Distribution(1 Year)
- Amputation of Index Limb(3 Years)
- Target Vessel Revascularization (TVR)(3 Years)
- Myocardial Infarction (MI)(Index hospitalization)
- Late Clinical Success(1 Year)
- Early Hemodynamic Success(30 Days)
- Acute Stent Thrombosis(24 Hours)
- Sub-acute Stent Thrombosis(>24 Hours to <=30 Days Post-index procedure)
- Technical Success(Index procedure)
- Walking Impairment Questionnaire Score - Stair Climbing(1 Year)
- Early Clinical Success(30 Days)
- Late Hemodynamic Success(1 Year)
- Stent Thrombosis(3 Years)
- Target Lesion Revascularization (TLR)(3 Years)
- Ankle-Brachial Index (ABI)(1 Year)
- Ankle-Brachial Index(Hospital Discharge (1-2 days post-procedure))
- Primary Patency(1 Year)
- Primary-assisted Patency (PAP)(1 Year)
- Secondary Patency(1 Year)
- Restenosis Assessed by Duplex Ultrasound(1 Year)
- Walking Impairment Questionnaire Score - Distance(1 Year)
- Walking Impairment Questionnaire Score - Speed(1 Year)
- Walking Impairment Questionnaire Score-Stair Climbing(Pre-procedure/baseline)