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Crossing Atheroma or Thrombus With ByCross Device for Revascularization of Peripheral Arteries of Diameter ≥ 3mm

NCT03724279 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 42

Last updated 2020-04-14

No results posted yet for this study

Summary

The aim of the study is to demonstrate safety and effectiveness of ByCross Rotational and Aspiration device used for revascularization of total or sub-total occluded peripheral arterial vessels equal to or larger than 3mm in diameter.

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.

Eligible adult patients with symptoms due to chronic sub-total and total occlusion will be enrolled and undergo percutaneous procedure including use of ByCross which will normally be followed by balloon inflation (Percutaneous Transluminal Angioplasty) in the artery at location where blockage has been opened by ByCross to further open the artery and restore full opening, and in some case followed by placement of a stent for long term stabilization.

For demonstrating safety and effectiveness up to 42 patients will be enrolled. the procedure will take up to 2 hours followed by up to 48 hour hospitalization. Patients will then come for follow-up monitoring and examination 30 days and 6 months after procedure. Although this is unlikely, in some cases the physician can decide during procedure that following ByCross opening of the artery, ballooning or stent is not required. In this case the patient will come for another follow-up visit after 12 month.

Conditions

  • Arterial Occlusive Diseases

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 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 intervention is to achieved more than 70% opening.

Sponsors & Collaborators

  • Taryag Medical Ltd.

    lead INDUSTRY

Principal Investigators

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

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-09-24
Primary Completion
2019-07-01
Completion
2019-10-09

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 NCT03724279 on ClinicalTrials.gov