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

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

Post market clinical follow up of Bycross® device.

Study Overview

• Status: Recruiting
• Conditions: Peripheral Arterial Disease
• Intervention / Treatment: Device: ByCross Atherectomy and Thrombectomy

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 Type: Observational
• Enrollment (Anticipated): 75

Contacts and Locations

Study Locations

• Germany
  • Arnsberg, Germany, 59755
    • Recruiting
    • Karolinen-Hospital, Klinik für Angiologie
    • Contact: Simone Muller; Phone Number: +49 2932 952-244826; Email: s.mueller@klinikum-hochsauerland.de
    • Principal Investigator: Michael Lichtenberg, M.D.
  • Heidelberg, Germany, 69120
    • Recruiting
    • Universitätsklinikum Heidelberg
    • Contact: Ilka Buss; Phone Number: +49 6221 56-37920; Email: Ilka.Buss@med.uni-heidelberg.de
    • Principal Investigator: Christian Erbel, M.D.
  • Lingen, Germany, 49808
    • Recruiting
    • Bonifatius Hospital Lingen
    • Contact: Daniela Viehweider; Phone Number: 0591 910-6121; Email: Daniela.Viehweider@hospital-lingen.de
    • Principal Investigator: Joerg Tessarek, M.D.

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 100 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Adult subjects (male and female) with limb ischemia requiring treatment and target vessel stenosis ≥ 70%

Description

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 Plan

How is the study designed?

Design Details

• Observational Models: Case-Only
• Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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
Rutherford classification improvement at 12 months	Improvement in Rutherford classification compared to pre-procedure	12 months
Rate of amputations of at 12 months	Rate of amputation of the limb treated during the study	12 months

Collaborators and Investigators

• Sponsor: Taryag Medical Ltd.
• Investigators: Principal Investigator: Joerg Tessarek, M.D., Bonifatius Hospital Lingen

Study record dates

Study Major Dates

• Study Start (Actual): June 2, 2021
• Primary Completion (Anticipated): December 31, 2022
• Study Completion (Anticipated): March 31, 2023

Study Registration Dates

• First Submitted: October 26, 2021
• First Submitted That Met QC Criteria: October 27, 2021
• First Posted (Actual): November 5, 2021

Study Record Updates

• Last Update Posted (Actual): October 21, 2022
• Last Update Submitted That Met QC Criteria: October 20, 2022
• Last Verified: October 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Atherosclerosis; Peripheral Arterial Disease; Peripheral Vascular Diseases
• Other Study ID Numbers: QA 366-02

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No