I70.22 I70.25
Conditions
Interventions
Group 1: 20 patients per study center
[This study serves to collect and document further clinical data on the safety and performance of the BYCROSS® atherectomy system.]
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 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
Exclusion criteria
Exclusion criteria: 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Technical succes: Stenosis/occlusion passage through the BYCROSS® Atherectomy System and post-atherectomy residual stenosis = 50% relative to reference diameter to allow for angioplasty and/or stenting if needed, residual stenosis = 30% on terminal angiography, including under Use of adjunctive therapy such as POBA, DCB or stent | — |
Secondary
| Measure | Time frame |
|---|---|
| Target vessel revascularization (TVR) at 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 intervention Freedom from amputation after 90 days and 12 months Therapy success of the recanalization of the iliaco-femoro-popliteal vascular flow path depending on the access (crossover/antegrade/retrograde) Evaluation of the recanalization result of long-range AFS stenoses/occlusions using IVUS vs. angiography for the purpose of deciding on therapy for additional PTA/stent/DEB Evaluation of the recanalization result of occlusions with and without a guidewire Evaluation of the recanalization result of stenoses/occlusions in combination with 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