REVASCULARIZATION OF TOTAL OR SUB-TOTAL OCCLUDED PERIPHERAL ARTERIAL VESSELS WITH BYCROSS® DEVICE- A prospective multicenter observational study

Recruiting

• Conditions: I70.22; I70.25

• Registration Number: DRKS00029947
• Lead Sponsor: niversitätsklinikum Augsburg, Abteilung für Gefäßchirurgie und endovaskuläre Chirurgie

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2022-09-19
• Last Update Posted: 19 August 2024

Recruitment & Eligibility

• Status: Recruiting
• Sex: All
• Target Recruitment: 20

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

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

Study & Design

• Study Type: observational
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
Target vessel revascularization (TVR) at 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 intervention<br><br>Freedom from amputation after 90 days and 12 months<br><br>Therapy success of the recanalization of the iliaco-femoro-popliteal vascular flow path depending on the access (crossover/antegrade/retrograde)<br><br>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<br><br>Evaluation of the recanalization result of occlusions with and without a guidewire<br><br>Evaluation of the recanalization result of stenoses/occlusions in combination with hybrid interventions<br><br>Correlation between PACCS scoring and procedural complications