临床试验/NCT05873959

NCT05873959已完成不适用

An Observational Multicenter Study to Evaluate the Safety and Efficacy of Humacyte's Human Acellular Vessel in a Real World Setting for Arterial Replacement or Reconstruction in Ukrainian Patients With Life or Limb-threatening Vascular Trauma

Humacyte, Inc.3 个研究点分布在 1 个国家目标入组 17 人开始时间: 2023年5月1日最近更新: 2024年11月25日

适应症

试验速览

阶段: 不适用
状态: 已完成
发起方: Humacyte, Inc.
入组人数: 17
试验地点: 3
主要终点: Safety and tolerability of the HAV

研究概览研究设计入排标准结局指标研究者研究点记录与标识符相似试验

研究概览

简要总结

Humacyte provided HAVs as humanitarian aid to Ukraine. This retrospective observational study is designed to collect data from patients in whom the HAVs have already been implanted on a humanitarian basis between June 2022 and May 2023.

研究设计

研究类型: Observational
观察模型: Case Only
时间视角: Retrospective

入排标准

年龄范围: 18 Years 至 85 Years（Adult, Older Adult）
性别: All
接受健康志愿者: 否

入选标准

•Patients with an HAV implanted to repair or reconstruct an arterial vessel following life- or limb-threatening traumatic vascular injury of an extremity.
•Aged 18 to 85 years old, inclusive.
•Patient or legal representative is able, willing, and competent to give informed consent.

排除标准

•Employees of the sponsor or patients who are employees or relatives of the investigator.

结局指标

主要结局

Safety and tolerability of the HAV

时间窗: up to 12 months

To determine the rate of adverse events after impanation

Primary patency of the HAV after implantation

时间窗: 30 days

To determine the rate of HAV primary patency at 30 days after implantation

次要结局

HAV durability(up to 12 months)
Rate of affected limb salvage/amputation after implantation(up to 12 months)
Patency of the HAV after implantation(up to 12 months)
Frequency of Adverse Events of Special Interest (AESIs)(up to 12 months)

研究者

发起方

Humacyte, Inc.

申办方类型

Industry

责任方

Sponsor

研究点 (3)

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