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

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 CT or MR angiography measurements. The primary performance endpoint was defined as acute procedural success with angiographically determined residual stenosis of ≤ 50% and of ≤ 30% after atherectomy or adjunctive treatment. The primary safety endpoint was the major adverse event (MAE) rate through 30 days. Secondary endpoints were stenosis of the target lesions measured by duplex ultrasound (DUS) and the ankle-brachial pressure index (ABPI) at discharge, 30 and 180 days as well as any major adverse event (MAE) through 6 months. RESULTS: The acute procedural success was achieved in 39/41 (95.12%) lesions, partially without wire guidance (11/41 (26.82%)). No embolic protection was used, and adjunctive angioplasty and stenting was performed in 40/41 (97.56%) and 12/41 (29.26%) lesions, respectively without device related MAE's at 30 days. Mean level of stenosis was 5.7% at discharge and 21.7% at 6 months FU measured by DUS. Mean ABPI was 0.8, 1.0 and 0.8 at baseline, discharge, and 6 months FU respectively. CONCLUSIONS: Based on the high technical success rate and the low rates of MAE`s through six months, the BYCROSS® Atherectomy System has shown to be safe and effective for the crossing and atherectomy of complex lower-extremity arterial occlusions. TRIAL REGISTRATION: October 17, 2018,retrospectively registered. CLINICALTRIALS: gov Identifier: NCT03724279; https://clinicaltrials.gov/ct2/show/record/NCT03724279.