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. 2023 Dec 5;6(1):61.
doi: 10.1186/s42155-023-00404-8.

Revascularization with BYCROSS atherectomy device- protocol of a prospective multicenter observational study

Dominik Liebetrau  1 , Joerg Teßarek  2 , Florian Elger  3 , Sebastian Zerwes  4 , Viktoria Peters  4 , Christian Scheurig-Münkler  5 , Alexander Hyhlik-Dürr  4
Affiliations

Revascularization with BYCROSS atherectomy device- protocol of a prospective multicenter observational study

Dominik Liebetrau et al. CVIR Endovasc. .

Abstract

Background: The BYCROSS™ device is a novel device intended for use in atherectomy of the peripheral arterial disease (PAD). With the BYCROSS™ atherectomy system, also prolonged calcifying lesions can be treated in a minimally invasive manner, which was previously reserved for bypass surgery. The aim of this study is to collect additional clinical data on safety and performance of the BYCROSS™ from patients undergoing revascularization of severely stenotic or occluded peripheral arterial vessels with the BYCROSS™.

Methods and design: This is an investigator-initiated national prospective multicenter observational study in patients with PAD. Sixty patients (20 per center) with PAD with stenosis higher than 80% or complete occlusion (de novo or recurrent stenosis) of vessels below the aortic bifurcation (min 3 mm vessel diameter) will be recruited. Three vascular surgery centers are participating in the study. The primary efficacy endpoint is procedural success, defined as passage of the occlusion through the BYCROSS device, and safety outcomes, explicated as freedom from device-related serious adverse events (SADEs). Secondary endpoints include primary and secondary patency rates, change in Rutherford classification, and freedom from amputation at 3 and 12 months.

Discussion: The BYCROSS atherectomy system may be a novel device for the minimally invasive treatment of prolonged calcified lesions previously reserved for bypass surgery. This national prospective multicenter observational study could represent another step in demonstrating the efficancy and safety of this device for treatment of PAD.

Trial registration: #DRKS00029947 (who.int). PROTOCOL APPROVAL ID: #22-0047(Ethics Committee at Ludwig-Maximilians-University Munich).

Keywords: BYCROSS™ atherectomy device; Bi-directional rotational atherectomy; Critical limb ischemia; Crossing the occlusion device; Endovascular revascularization; Limb salvage; Mechanical thrombectomy; Thromboaspiration.

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Conflict of interest statement

The author declares a potential conflict of interest. Dominik Liebetrau is a consultant for Medtronic GmbH, Earl-Bakken-Platz 1 40670 Meerbusch, Germany. Dominik Liebetrau declares to have received honorary fees from plus medica GmbH & Co, Willstätterstraße 13, 40549 Düsseldorf for professional presentations. Jörg Teßarek declares to have received honorary fees from plus medica GmbH & Co, Willstätterstraße 13, 40549 Düsseldorf for professional presentations. All other authors have declared no potential conflicts of interest with respect to this research, authorship, and/or publication of this article.

The authors have no competing interests to declare.

Figures

Fig. 1
Fig. 1
Special features of the ByCross® system: The system is advanced into the target vessel in a 6-French sheath (a) attached to the handle, through which the suction pump housed in the handle simultaneously with the porous shaft below the tip (b), which follows the principle of the Archimedean screw, aspirates and transports debris. The catheter tip has a variable diameter. This measures between 1.9 mm (b) and 4.7 mm (c) with the nitinol cutting wire extended. d Overview of Bycross atherectomy device, (Courtesy of Taryag Medical Inc., Israel
Fig. 2
Fig. 2
Study Activity Flow Chart. 1SAE Serious adverse event, 2ABI Ankle-Brachial-Index, 3Rutherford scale [12]; 4FU Follow-up
Fig. 3
Fig. 3
Participant flow through study
See this image and copyright information in PMC

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