临床试验/NCT02418156

NCT02418156已完成不适用

A Post Market Observational Study on the Use of CorMatrix® ECM® for Femoral Arterial Reconstruction

Aziyo Biologics, Inc.0 个研究点目标入组 38 人开始时间: 2015年5月最近更新: 2023年7月21日

适应症

试验速览

阶段: 不适用
状态: 已完成
发起方: Aziyo Biologics, Inc.
入组人数: 38
主要终点: Device-Related Adverse Events

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

To gather information on the use of CorMatrix ECM for Vascular Repair in the reconstruction of the femoral artery.

详细描述

OBJECTIVE The objective of the study is to actively gather additional information on the use of CorMatrix ECM for vascular repair in the reconstruction of the femoral artery. The CorMatrix ECM for Vascular Repair may be used for patch closure of vessels, as a pledget, or for suture line buttressing when repairing peripheral vessels.

研究设计

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

入排标准

性别: All
接受健康志愿者: 否

入选标准

•Subjects must be undergoing femoral arterial reconstruction with patch angioplasty closure
•Surgeon intends to use CorMatrix ECM per FDA cleared Indications for Use
•Subject possesses ability to provide informed consent
•Subject expresses understanding and willingness to fulfill all expected requirements of protocol

排除标准

•Known sensitivity to porcine material

结局指标

主要结局

Device-Related Adverse Events

时间窗: Up to 12 months follow-up

Proportion of patients experiencing device related adverse events.

次要结局

未报告次要终点

研究者

发起方

Aziyo Biologics, Inc.

申办方类型

Industry

责任方

Sponsor

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