Safety and effectiveness of bycross rotational atherectomy and aspiration device: a prospective, multi-center pre-market approval study.

ABSTRACT:

Purpose

To demonstrate safety and effectiveness of the novel ByCross® atherectomy system for treatment of complex femorodistal > 80% arterial stenosis.

Materials and methods

From September 2018 until April 2019 39 patients with 41 femorodistal lesions including the femoropopliteal and distal popliteal segments were treated in a prospective, nonrandomized pre-market approval study with 6 months follow up using the ByCross® atherectomy device (ClinicalTrials.gov identifier NCT03724279). Adjunctive treatment with balloon dilatation or stenting was allowed by the protocol. Mean patient age was 72 years with 62% male. The average lesions length was 125 ± 118 mm (30 and 450 mm) with an average reference vessel diameter of 5.2 ± 0.85 mm and a mean stenosis of 96.4 ± 6.2% based on C

SUBMITTER: Tessarek J 

PROVIDER: S-EPMC10060493 | biostudies-literature | 2023 Mar

REPOSITORIES: biostudies-literature