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

Area of Science:

• Vascular Surgery
• Interventional Cardiology
• Medical Device Technology

Background:

• Peripheral arterial disease (PAD) often involves complex, calcified lesions that are challenging to treat.
• Traditional treatments for such lesions may include invasive bypass surgery.
• The BYCROSS™ atherectomy system presents a novel, minimally invasive approach.

Purpose of the Study:

• To collect clinical data on the safety and performance of the BYCROSS™ atherectomy system.
• To evaluate the device's efficacy in treating severely stenotic or occluded peripheral arteries.
• To assess the device's potential as an alternative to bypass surgery for complex PAD cases.

Main Methods:

• An investigator-initiated, national, prospective, multicenter observational study.
• Sixty patients with PAD (stenosis >80% or occlusion) in vessels below the aortic bifurcation were recruited across three vascular surgery centers.
• Primary endpoints included procedural success and freedom from device-related serious adverse events (SADEs).

Main Results:

• Procedural success was defined as successful passage of the occlusion with the BYCROSS device.
• Safety outcomes focused on freedom from device-related serious adverse events (SADEs).
• Secondary endpoints assessed patency rates, Rutherford classification changes, and amputation rates at 3 and 12 months.

Conclusions:

• The BYCROSS™ atherectomy system shows potential as a novel device for minimally invasive treatment of complex, calcified PAD lesions.
• This study contributes to demonstrating the efficacy and safety of the BYCROSS™ device for PAD treatment.
• The findings may support the use of BYCROSS™ as an alternative to bypass surgery for specific patient populations.