I70.25 I70.22
Conditions
Interventions
Group 1: Total of 80 study participants, 20 each study center
[This study is designed to collect and document further clinical data on the safety and performance of the BYCROSS® Atherectomy System in
Sponsors
Universitätsklinikum Augsburg, Abteilung für Gefäßchirurgie und endovaskuläre Chirurgie
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: 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
Exclusion criteria
Exclusion criteria: 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/dL
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Primary Technical Success: Passage of in-stent restenosis/occlusion through the BYCROSS® Atherectomy System and post-atherectomy residual stenosis = 50% relative to the reference diameter to allow angioplasty and/or stenting if necessary, residual stenosis of = 30% in the Final angiography, also using adjunctive measures such as POBA, DCB or stent. | — |
Secondary
| Measure | Time frame |
|---|---|
| Target vessel revascularization (TVR) after 90 days and 12 months Target lesion revascularization (TLR) at 90 days 12 months Rutherford classification at 90 days and 12 months compared to before use Freedom from amputation after 90 days and 12 months Therapeutic success of recanalization of the iliaco-femoro-popliteal vascular pathway depending on the approach (cross-over/antegrade/retrograde) Assessment of the recanalization result using IVUS vs. angiography for the purpose of deciding on additional PTA/Stent/DEB therapy Assessment of the recanalization result of in-stent restenoses/occlusions with and without prior wire passage Assessment of the recanalization result of stenoses/occlusions in combination of hybrid interventions Correlation between PACCS scoring and procedural complications | — |
Countries
Germany
Contacts
Public ContactDominik Liebetrau
Universitätsklinikum Augsburg, Abteilung für Gefäßchirurgie und endovaskuläre Chirurgie
Outcome results
None listed