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

Not yet recruiting

Conditions: I70.25
I70.22

Registration Number: DRKS00032961

Lead Sponsor: niversitätsklinikum Augsburg, Abteilung für Gefäßchirurgie und endovaskuläre Chirurgie

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Pending

Sex: All

Target Recruitment: 80

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

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

Study & Design

Study Type: observational

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
Target vessel revascularization (TVR) after 90 days and 12 months<br><br>Target lesion revascularization (TLR) at 90 days 12 months<br><br>Rutherford classification at 90 days and 12 months compared to before use<br><br>Freedom from amputation after 90 days and 12 months<br><br>Therapeutic success of recanalization of the iliaco-femoro-popliteal vascular pathway depending on the approach (cross-over/antegrade/retrograde)<br><br>Assessment of the recanalization result using IVUS vs. angiography for the purpose of deciding on additional PTA/Stent/DEB therapy<br><br>Assessment of the recanalization result of in-stent restenoses/occlusions with and without prior wire passage<br><br>Assessment of the recanalization result of stenoses/occlusions in combination of hybrid interventions<br><br>Correlation between PACCS scoring and procedural complications