NCT05110079

Revascularization of Total or Sub-total Occluded Peripheral Arteries With ByCross® Device. Post Market Clinical Followup

Revascularization of Total or Sub-total Occluded Peripheral Arterial Vessels With ByCross

• Status: Unknown
• Phase: —
• Study type: Observational
• Enrollment: 75 (estimated)
• Sponsor: Taryag Medical Ltd. · Industry
• Sex: All
• Age: 18 Years – 100 Years
• Healthy volunteers: Not accepted

Summary

Post market clinical follow up of Bycross® device.

Detailed description

A prospective, multi-center, non-randomized, observational, post market clinical follow-up study of the ByCross® device to evaluate the safety, technical performance and effectiveness of the ByCross® device and effectiveness of the procedure using the device and adjunctive therapy. The ByCross® is a single use, disposable, minimal invasive aspiration rotational atherectomy device. The ByCross® is aimed to enable effective revascularization and restore blood flow in peripheral occluded vessels. In cases that the artery is completely blocked such that opening is not possible with currently available solutions and the procedure cannot be completed, the device is capable of crossing the blocked lesion without guiding wire and enables the completion of the procedure in a safe and effective manner, thus potentially eliminating the need for open bypass surgery. The ByCross® can be used in several pathologies: calcified atheroma, old and fresh thrombus and in stent restenosis at peripheral arteries including iliac

Conditions

• Peripheral Arterial Disease

Interventions

Type	Name	Description
DEVICE	ByCross Atherectomy and Thrombectomy	After assessment of the lesion by angiography the ByCross is advanced over a 0.035" guidewire through a sheath to the occlusion. Activation will rotate the shaft and start aspiration. Under fluoroscopy the ByCross is advanced continuously over the wire. in case passage with guidewire is not possible the ByCross tip is advanced into the occlusion for 10mm, then wire is advanced to check is passage is possible, this is repeated until passage by the wire is achieved. At harder lesion the speed is set to high. Once the occlusion is crossed the ByCross tip is enlarged, device is advanced once more to increase opening. Additional adjunctive treatment may be performed per physician's discretion and according to standard of care. Performance criteria of the complete procedure is to achieved more than 70% opening.

Timeline

• Start date: 2021-06-02
• Primary completion: 2022-12-31
• Completion: 2023-03-31
• First posted: 2021-11-05
• Last updated: 2022-10-21

Locations

3 sites across 1 country: Germany