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/AClinical Study ID
NCT05110079
QA 366-02
Ages 18-100 All Genders
Study Summary
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
Connect with a study center
Karolinen-Hospital, Klinik für Angiologie
Arnsberg, 59755
GermanyActive - Recruiting
Universitätsklinikum Heidelberg
Heidelberg, 69120
GermanyActive - Recruiting
Bonifatius Hospital Lingen
Lingen, 49808
GermanyActive - Recruiting
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