An Exploratory Study to Evaluate the Efficacy and Safety of the Cilostazol-Coated BioMimics 3D Stent System in Patients with Peripheral Occlusive Arterial Disease (Study Protocol Number: EVT-22-001)

Otsuka Medical Devices Co., Ltd.0 个研究点目标入组 24 人开始时间: 2023年3月10日最近更新: 2025年2月5日

适应症

试验速览

阶段: 不适用
状态: 进行中（未招募）
发起方: Otsuka Medical Devices Co., Ltd.
入组人数: 24
主要终点: Primary patency of the stent at 12 months after the investigational procedure

研究概览研究设计入排标准结局指标研究者记录与标识符相似试验

研究概览

简要总结

暂无简介。

研究设计

研究类型: Interventional
分配方式: Single Arm Study
干预模型: Single Assignment
主要目的: Treatment Purpose
盲法: Open(masking Not Used)

入排标准

年龄范围: 18age old over 至 No limit（—）
性别: All

入选标准

•Patients with an ankle-brachial index (ABI) of 0.90 or less in the target lower extremity at rest.
•Patients with stenotic lesions (target lesions) requiring treatment of SFA or PPA.
•Patients with Rutherford classification 2, 3, or
•The reference vessel diameter of the target lesion is between 4 mm or more and 5 mm by operator's visual estimate.
•The total length of target lesion measure =<50mm by operator's visual estimate.
•Target lesion lumen stenosis is >70% diameter stenosis by operator's visual estimate.

排除标准

•Patients with a history of surgical or endovascular treatment (including any percutaneous transluminal balloon angioplasty, stenting, atherectomy, or bypass) of the target lesion or vessel prior to enrollment in this study.
•However, a history of balloon dilatoplasty with POBA is acceptable if it was performed earlier than 12 months prior to enrollment.
•Patients with a history of major amputation of the target lower extremity.
•Patients with another stenotic lesion in the target or contralateral lower extremity other than the target lesion that is judged to require surgery or endovascular treatment at the time of consent or within 12 months after the procedure.
•However, if the patient has another stenotic lesion in the iliac artery other than the target lesion, treatment of the iliac artery lesion (POBA and stenting) is allowed at the time of the study procedure.
•Patients with acute coronary syndrome or stroke/cerebrovascular event within 3 months prior to obtaining consent.
•Patients with coagulopathy.
•Patients with renal insufficiencyor on dialysis.
•Patient who administered orally cilostazol within 7 days prior to the study procedure.

结局指标

主要结局

Primary patency of the stent at 12 months after the investigational procedure

时间窗: 12 months after the investigational procedure

Loss of primary patency of the stent is determined as any of the following cases. - The case as the peak systolic velocity ratio (PSVR) exceeds 2.4 - The case as the subject had a CDTLR. - The case as the angiography revealed > 50% lumen diameter stenosis.

Combined incidence of serious adverse events (MAEs) up to 12 months after the study procedure

时间窗: 12 months after the study procedure

MAE is defined as: - All death within 30 days after the study procedure. - Major amputation of target lower extrimity. - Clinically driven target lesion revascurarization.

次要结局

未报告次要终点

研究者

发起方

Otsuka Medical Devices Co., Ltd.

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