NCT01872208

Evaluation of the Safety and Efficacy of a Vascular Prosthesis as an Above-Knee Bypass Graft in Patients With PAD

A Pilot Study for Evaluation of the Safety and Efficacy of Humacyte's Human Acellular Vascular Graft as an Above-Knee Femoro-Popliteal Bypass Graft in Patients With Peripheral Arterial Disease

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 20 (actual)
• Sponsor: Humacyte, Inc. · Industry
• Sex: All
• Age: 18 Years – 80 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to assess the safety and efficacy of a novel, tissue-engineered vascular prosthesis, the Human Acellular Vessel (HAV). The HAV is intended as an alternative to synthetic materials and to autologous grafts in the creation of an above-knee femoro-popliteal bypass graft in patients with peripheral arterial disease.

Detailed description

The HAV is a sterile, non-pyrogenic, acellular tubular graft composed of human collagens and other natural extra-cellular matrix proteins. Upon implantation, it is anticipated (based on pre-clinical studies) that the collagen-based matrix comprising the graft will be infiltrated with host cells and re-modeled by the host. This will result in a vascular structure more similar to the histological composition of the native vascular tissue that may improve graft longevity and be less likely to become infected.

Conditions

• Peripheral Arterial Disease
• Peripheral Vascular Disease

Interventions

Type	Name	Description
BIOLOGICAL	HAV implantation	Patients will be implanted with a Human Acellular Vessel (HAV) as an above-knee femoro-popliteal bypass graft using standard vascular surgical techniques.

Timeline

• Start date: 2013-10-10
• Primary completion: 2016-05-30
• Completion: 2024-07-18
• First posted: 2013-06-07
• Last updated: 2024-11-13

Locations

3 sites across 1 country: Poland