Clinical trial NCT05110079: Revascularization of Total or Sub-total Occluded Peripheral Arteries With ByCross® Device. Post Market Clinical Followup
Official title: Revascularization of Total or Sub-total Occluded Peripheral Arterial Vessels With ByCross
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Peripheral Arterial Disease
Lead sponsor: Taryag Medical Ltd.
Sponsor class: INDUSTRY
First posted: 2021-11-05
Enrollment: 75
Sex: ALL
Minimum age (years): 18
Maximum age (years): 100
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Adult subjects (male and female) with limb ischemia requiring treatment and target vessel stenosis ≥ 70%

Brief summary: Post market clinical follow up of Bycross® device.

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

Eligibility criteria: 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

Primary outcomes:
measure: Acute procedure success
timeFrame: Up to 8 hours post-procedure
measure: Freedom from device related serious adverse events
timeFrame: 90 days follow up
Secondary outcomes:
measure: Rate of Target vessel revascularization (TVR) at 12 months
timeFrame: 12 months
measure: Rate of Target lesion revascularization (TLR) at 12 months
timeFrame: 12 months
measure: Rutherford classification improvement at 12 months
timeFrame: 12 months
measure: Rate of amputations of at 12 months
timeFrame: 12 months
Other outcomes:
Locations:
city: Arnsberg
country: Germany
facility: Karolinen-Hospital, Klinik für Angiologie
city: Heidelberg
country: Germany
facility: Universitätsklinikum Heidelberg
city: Lingen
country: Germany
facility: Bonifatius Hospital Lingen
Study officials:
affiliation: Bonifatius Hospital Lingen
name: Joerg Tessarek, M.D.
role: PRINCIPAL_INVESTIGATOR
References: