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

• Conditions: Peripheral Arterial Disease

• Registration Number: NCT05110079
• Lead Sponsor: Taryag Medical Ltd.

Brief 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

Study Timeline

• Study Start: 2021-06-02
• Status Verified: 2021-10
• Study First Submitted: 2021-10-26
• Study First Submitted QC: 2021-10-27
• Study First Posted: 2021-11-05
• Last Update Submitted: 2022-10-20
• Last Update Posted: 2022-10-21
• Primary Completion: 2022-12-31
• Study Completion: 2023-03-31

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 75

Inclusion Criteria

• Subject has documented symptomatic chronic peripheral vascular disease at a vessel below the aorta bifurcation
• Candidate for percutaneous intervention
• Severely stenotic occlusion target vessel (stenosis ≥70%)
• Subject has been informed on the nature of the study and has provided informed consent
• Subject is capable of meeting study requirements including presences at follow-up visits

Exclusion Criteria

• Patient anatomy excludes use of BYCROSS® device
• Vessels of the cardiopulmonary, coronary or cerebral circulations
• Undersized vessel diameters (<3mm)
• Perforation of the vessel distally or proximally to the occlusion segment prior atherectomy
• Subintimal position of the guiding catheter or the guidewire
• Use in stents or stent grafts if the guidewire has become threaded at any point in the wire mesh of stent or stent graft or the lining of the stent graft
• Target is at vessel segment which includes tortuous course with radius of curvature <= 40mm
• Access pathway includes tortuous course with radius of curvature <= 25mm, in specific extremely sharp aortic bifurcation
• In aneurysmatically altered iliac vessel segments
• If the introducer sheath, the guide catheter, the guidewire or the BYCROSS® sustains any visible damage, especially kinking
• In the fracture areas of broken stents
• Known or suspected allergy to any of the components of the system or to a medicinal product to be administered in connection with the planned procedure
• Persistent vasospasm
• During use of a defibrillator on the patient

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Freedom from device related serious adverse events	90 days follow up	Freedom, at any period between procedure and 90 days post procedure from device related Serious Adverse Events (SADEs) defined by the site as part of the normal reporting practice
Acute procedure success	Up to 8 hours post-procedure	Passage of the occlusion by the BYCROSS® device and post atherectomy residual stenosis ≤ 50% relative to reference diameter to allow for angioplasty and/or stenting if required, and complete procedural success of residual stenosis ≤ 30%

Secondary Outcome Measures

Name	Time	Method
Rate of Target vessel revascularization (TVR) at 12 months	12 months	Rate of cases of vascular treatment in the same vessel treated during the study
Rate of Target lesion revascularization (TLR) at 12 months	12 months	Rate of cases of vascular re-intervention of the same lesion treated during the study
Rutherford classification improvement at 12 months	12 months	Improvement in Rutherford classification compared to pre-procedure
Rate of amputations of at 12 months	12 months	Rate of amputation of the limb treated during the study

Trial Locations

Locations (3)

Karolinen-Hospital, Klinik für Angiologie; 🇩🇪 Arnsberg, Germany

Bonifatius Hospital Lingen; 🇩🇪 Lingen, Germany

Universitätsklinikum Heidelberg; 🇩🇪 Heidelberg, Germany