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

Last updated: October 20, 2022
Sponsor: Taryag Medical Ltd.
Overall Status: Active - Recruiting

Phase

N/A

Condition

Vascular Diseases

Claudication

Peripheral Arterial Occlusive Disease

Treatment

N/A

Clinical Study ID

NCT05110079
QA 366-02
  • Ages 18-100
  • All Genders

Study Summary

Post market clinical follow up of Bycross® device.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Subject has documented symptomatic chronic peripheral vascular disease at a vesselbelow 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-upvisits

Exclusion

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 prioratherectomy
  • 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 thewire 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 specificextremely sharp aortic bifurcation
  • In aneurysmatically altered iliac vessel segments
  • If the introducer sheath, the guide catheter, the guidewire or the BYCROSS® sustainsany 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 medicinalproduct to be administered in connection with the planned procedure
  • Persistent vasospasm
  • During use of a defibrillator on the patient

Study Design

Total Participants: 75
Study Start date:
June 02, 2021
Estimated Completion Date:
March 31, 2023

Study 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

Connect with a study center

  • Karolinen-Hospital, Klinik für Angiologie

    Arnsberg, 59755
    Germany

    Active - Recruiting

  • Universitätsklinikum Heidelberg

    Heidelberg, 69120
    Germany

    Active - Recruiting

  • Bonifatius Hospital Lingen

    Lingen, 49808
    Germany

    Active - Recruiting

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