NCT02793492已完成不适用
OSPREY ILIAC: Occlusive/Stenotic Peripheral Artery REvascularization StudY for Common and/or External ILIAC Artery Using the Misago® RX Self-expanding Peripheral Stent
适应症
干预措施
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 75
- 试验地点
- 18
- 主要终点
- Freedom from the composite Major Adverse Event rate, defined as periprocedural related death, amputation of the target limb, and clinically driven TLR assessed at 9 months post-procedure.
研究概览
简要总结
This is a multi-center, single arm, non-randomized, prospective clinical study using the Misago® RX Self-expanding Peripheral Stent for treatment of de novo, restenotic, and/or occlusive lesion(s) of the common and/or external iliac artery.
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
- •Is ≥ 18 years old and of legal consent.
- •Is willing to comply with all follow-up evaluations at the specified times.
- •Subject or subject's legal representative has been informed of and understands the nature of the study and provides signed informed consent to participate in the study.
- •Has a Rutherford Clinical Category Score of 2, 3 or
- •Radiographic evidence of ≥ 50% stenosis or restenosis (from PTA or adjunct therapy, not including stents or stent grafts), or occlusion of target lesion(s) in the common iliac artery and/or external iliac artery.
排除标准
- •Has had previous stent or stent-graft implantation in the target lesion(s).
- •Has a contraindication or known untreatable allergy to antiplatelet therapy, anticoagulants, thrombolytic drugs or any other drug used during the study according to the protocol.
- •Has known hypersensitivity to contrast material that cannot be adequately pretreated.
- •Has known hypersensitivity to nickel-titanium (nitinol).
研究组 & 干预措施
Misago® RX Self-expanding Stent
Experimental
Eligible participants will undergo stent implantation with the Misago® RX Self-expanding Stent
干预措施: Misago® RX Self-expanding Peripheral Stent (Device)
结局指标
主要结局
Freedom from the composite Major Adverse Event rate, defined as periprocedural related death, amputation of the target limb, and clinically driven TLR assessed at 9 months post-procedure.
时间窗: 9 months post-procedure
次要结局
- Major Adverse Event rate at 30 days, and 12- and 24- months post-procedure defined as a composite of peri-procedural related death, amputation of the target limb, and clinically driven TLR.(30 days, 12- and 24- months post-procedure)
- Primary stent patency at 9 months defined by a binary duplex ultrasound peak systolic velocity ratio ≤ 2.4 at the stented target lesion and absence of TLR.(9 months post-procedure)
- Technical Success defined by the following conditions: 1) Successful delivery of the stent at the lesion site 2) Stent(s) successfully deployed in lesion with adequate lesion coverage(The outcome is assessed up to 24 hours from time of enrollment through index procedure.)
- Procedural Success: Attainment of < 30% residual stenosis of the target lesion and no peri-procedural complications.(The outcome is assessed up to 24 hours from time of enrollment through index procedure)
- Clinical Success: Relief or improvement (without increase of one or more in the score) from baseline symptoms as measured by the Rutherford score for chronic limb ischemia at 30 days as compared to baseline.(30 days post-procedure)
- Ankle Brachial Index (ABI) change from baseline(through 9 months post-procedure)
- Clinically driven Target Vessel Revascularization (TVR) at 30 days and 9, 12- and 24- months post-procedure(30 days and 9, 12 and 24 months post-procedure)
- Clinically driven TLR through 30 days and 9-, 12- and 24-months post-procedure.(30 days and 9-, 12- and 24-months post-procedure)
- Walking Impairment Questionnaire(change from baseline (pre-procedure) at 30 days and 9 months post procedure)
- Evaluation of all AEs(pre-discharge through 24 months post-procedure)
- Evaluation of access site complications including severe bleeding, hematoma, and pseudoaneurysm, occurring prior to hospital discharge.(The event is assessed from time of enrollment through hospital discharge or up to 7 days post procedure, whichever occurs first)
- Occurrence of device deficiency(through 24 months post-procedure)
- Device Related Complications(9 months post-procedure)
研究者
研究点 (18)
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