DRKS00029947招募中不适用

REVASCULARIZATION OF TOTAL OR SUB-TOTAL OCCLUDED PERIPHERAL ARTERIAL VESSELS WITH BYCROSS® DEVICE- A prospective multicenter observational study

niversitätsklinikum Augsburg, Abteilung für Gefäßchirurgie und endovaskuläre Chirurgie0 个研究点目标入组 20 人开始时间: 2022年9月19日最近更新: 2024年8月19日

适应症

试验速览

暂无简介。

•1. Age =18
•2. Patient has documented symptomatic chronic peripheral vascular disease affecting a vessel below the aortic bifurcation with a total or sub-total occlusion (stenosis =80%)
•3. The participant has been informed of the nature of the study and has given informed consent.
•4. The participant is able to meet study requirements, including attendance at follow-up visits

•1. Patient anatomy excludes use of BYCROSS® device
•2. Vessels of the cardiopulmonary, coronary or cerebral circulations
•3. Undersized vessel diameters (<3mm)
•4. Subintimal position of the guiding catheter or the guidewire
•5. 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
•6. Target is at vessel segment which includes tortuous course with radius of curvature <= 40mm
•7. Access pathway includes tortuous course with radius of curvature <= 25mm, in specific extremely sharp aortic bifurcation
•8. In aneurysmatically altered iliac vessel segments
•9. If the introducer sheath, the guide catheter, the guidewire or the BYCROSS® sustains any visible damage, especially kinking
•10. In the fracture areas of broken stents
•11. 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
•12. Persistent vasospasm
•13. Pregnancy
•14. Patients who are not able to consent or who are legally supervised

发起方

niversitätsklinikum Augsburg, Abteilung für Gefäßchirurgie und endovaskuläre Chirurgie