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

Peripheral Arterial Disease Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05110079
• Other study ID #: QA 366-02
• Status: Recruiting
• Start date: June 2, 2021
• Est. completion date: March 31, 2023

Study information

• Verified date: October 2021
• Source: Taryag Medical Ltd.
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

Post market clinical follow up of Bycross® device.

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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 75
• Est. completion date: March 31, 2023
• Est. primary completion date: December 31, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 100 Years

Eligibility

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

Related Conditions & MeSH terms

• Peripheral Arterial Disease
• Peripheral Vascular Diseases

Intervention

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.

Locations

Country	Name	City	State
Germany	Karolinen-Hospital, Klinik für Angiologie	Arnsberg
Germany	Universitätsklinikum Heidelberg	Heidelberg
Germany	Bonifatius Hospital Lingen	Lingen

Sponsors (1)

Lead Sponsor	Collaborator
Taryag Medical Ltd.

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Acute procedure success	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%	Up to 8 hours post-procedure
Primary	Freedom from device related serious adverse events	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	90 days follow up
Secondary	Rate of Target vessel revascularization (TVR) at 12 months	Rate of cases of vascular treatment in the same vessel treated during the study	12 months
Secondary	Rate of Target lesion revascularization (TLR) at 12 months	Rate of cases of vascular re-intervention of the same lesion treated during the study	12 months
Secondary	Rutherford classification improvement at 12 months	Improvement in Rutherford classification compared to pre-procedure	12 months
Secondary	Rate of amputations of at 12 months	Rate of amputation of the limb treated during the study	12 months