Post market clinical follow up of Bycross® device.
A prospective, multi-center, non-randomized, observational, post market clinical follow-up study of the ByCross® device to evaluate the safety, technical performance and effectiveness of the ByCross® device and effectiveness of the procedure using the device and adjunctive therapy. The ByCross® is a single use, disposable, minimal invasive aspiration rotational atherectomy device. The ByCross® is aimed to enable effective revascularization and restore blood flow in peripheral occluded vessels. In cases that the artery is completely blocked such that opening is not possible with currently available solutions and the procedure cannot be completed, the device is capable of crossing the blocked lesion without guiding wire and enables the completion of the procedure in a safe and effective manner, thus potentially eliminating the need for open bypass surgery. The ByCross® can be used in several pathologies: calcified atheroma, old and fresh thrombus and in stent restenosis at peripheral arteries including iliac
Study Type
OBSERVATIONAL
Enrollment
75
After assessment of the lesion by angiography the ByCross is advanced over a 0.035" guidewire through a sheath to the occlusion. Activation will rotate the shaft and start aspiration. Under fluoroscopy the ByCross is advanced continuously over the wire. in case passage with guidewire is not possible the ByCross tip is advanced into the occlusion for 10mm, then wire is advanced to check is passage is possible, this is repeated until passage by the wire is achieved. At harder lesion the speed is set to high. Once the occlusion is crossed the ByCross tip is enlarged, device is advanced once more to increase opening. Additional adjunctive treatment may be performed per physician's discretion and according to standard of care. Performance criteria of the complete procedure is to achieved more than 70% opening.
Karolinen-Hospital, Klinik für Angiologie
Arnsberg, Germany
RECRUITINGUniversitätsklinikum Heidelberg
Heidelberg, Germany
RECRUITINGBonifatius Hospital Lingen
Lingen, Germany
RECRUITINGAcute procedure success
Passage of the occlusion by the BYCROSS® device and post atherectomy residual stenosis ≤ 50% relative to reference diameter to allow for angioplasty and/or stenting if required, and complete procedural success of residual stenosis ≤ 30%
Time frame: Up to 8 hours post-procedure
Freedom from device related serious adverse events
Freedom, at any period between procedure and 90 days post procedure from device related Serious Adverse Events (SADEs) defined by the site as part of the normal reporting practice
Time frame: 90 days follow up
Rate of Target vessel revascularization (TVR) at 12 months
Rate of cases of vascular treatment in the same vessel treated during the study
Time frame: 12 months
Rate of Target lesion revascularization (TLR) at 12 months
Rate of cases of vascular re-intervention of the same lesion treated during the study
Time frame: 12 months
Rutherford classification improvement at 12 months
Improvement in Rutherford classification compared to pre-procedure
Time frame: 12 months
Rate of amputations of at 12 months
Rate of amputation of the limb treated during the study
Time frame: 12 months
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