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 sites80 target enrollmentOctober 30, 2023

Overview

Phase: Not Applicable
Intervention: Not specified
Conditions: I70.25
Sponsor: niversitätsklinikum Augsburg, Abteilung für Gefäßchirurgie und endovaskuläre Chirurgie
Enrollment: 80
Status: Not yet recruiting
Last Updated: last year

No summary available.

Registry

who.int

Start Date

October 30, 2023

End Date

TBD

Last Updated

last year

Study Type

Observational

Sex

All

Sponsor

niversitätsklinikum Augsburg, Abteilung für Gefäßchirurgie und endovaskuläre Chirurgie

•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