Six-year outcomes of a phase II study of human-tissue engineered blood vessels for peripheral arterial bypass.

ABSTRACT:

Objective

The human acellular vessel (HAV) was evaluated for surgical bypass in a phase II study. The primary results at 24 months after implantation have been reported, and the patients will be evaluated for ≤10 years.

Methods

In the present report, we have described the 6-year results of a prospective, open-label, single-treatment arm, multicenter study. Patients with advanced peripheral artery disease (PAD) requiring above-the-knee femoropopliteal bypass surgery without available autologous graft options had undergone implantation with the HAV, a bioengineered human tissue replacement blood vessel. The patients who completed the 24-month primary portion of the study will be evaluated for ≤10 years after implantation. The present mid-term analysis was performed at the 6-ye

SUBMITTER: Gutowski P 

PROVIDER: S-EPMC9976461 | biostudies-literature | 2023

REPOSITORIES: biostudies-literature