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

NCT05110079 · Status: UNKNOWN · Type: OBSERVATIONAL · Enrollment: 75

Last updated 2022-10-21

No results posted yet for this study

Summary

Post market clinical follow up of Bycross® device.

Conditions

  • Peripheral Arterial Disease

Interventions

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.

Sponsors & Collaborators

  • Taryag Medical Ltd.

    lead INDUSTRY

Principal Investigators

  • Joerg Tessarek, M.D. · Bonifatius Hospital Lingen

Eligibility

Min Age
18 Years
Max Age
100 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-06-02
Primary Completion
2022-12-31
Completion
2023-03-31

Countries

  • Germany

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05110079 on ClinicalTrials.gov