DRKS00032961尚未招募不适用

BYCROSS Atherectomy for the treatment of In-Stent Restenosis in the Femoropopliteal Segment –A prospective multicenter observational study - BYCROSS-ISR

niversitätsklinikum Augsburg, Abteilung für Gefäßchirurgie und endovaskuläre Chirurgie0 个研究点目标入组 80 人开始时间: 2023年10月30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 =50% symptomatic in-stent restenosis/occlusion of the femoropopliteal pathway
•3. The participant was informed about the study and gave written consent
•4. Participant is able to comply with study requirements, including maintaining attendance at follow-up visits
•5. Min. 1 patent infrapopliteal run-OFF vessel
•6. Stenosed (at least 50%)/occluded stent min. = 5mm - max = 8mm in diameter
•7. Stenosed (at least 50%/occluded stent distance at least 4cm

•1. Patient anatomy precludes use of the BYCROSS® Atherectomy System
•2. Vessels of the renal, coronary or cerebral circulation
•3. Vessel diameter<3mm
•4. Subintimal position of the guiding catheter or guide wire
•5. Use in stents or grafts when the guidewire breaks the wire mesh of the stent or the lining of the graft
•6. The target vessel has a radius of curvature < 40mm
•7. The access route is tortuous with a radius of curvature <=25mm
•8. In aneurysmally altered vessel segments
•9. If the sheath, guide catheter, guide wire or BYCROSS® suffers damage
•10. In the fracture areas of broken stents
•11. Known or suspected allergy to any component of the system or to any drug to be administered in connection with the planned procedure
•12. Persistent vasospasm
•13. Pregnancy
•14. Patients unable to consent or supervised
•15. Stents implanted less than 6 months ago
•16. Ocluded drug-eluting stents
•17. Serum creatinine =2.5 mg/d

发起方

niversitätsklinikum Augsburg, Abteilung für Gefäßchirurgie und endovaskuläre Chirurgie