Post-Market Clinical Follow Up of Rotarex®S Catheter

A prospective, multi-center, non-randomized, multiple cohorts, observational, post market clinical follow-up study of the Rotarex®S Catheter to evaluate the safety, technical performance and medical efficacy of the Rotarex®S Catheter as a stand-alone and adjunctive therapy for the treatment of acute, subacute and chronic occlusions and sub-occlusions of arteries outside the cardiopulmonary, coronary and cerebral circulations, in accordance with Rotarex®S Catheter intended use.

Inclusion criteria

• Patient is ≥18 years old at the time of consent.
• Subject has provided written informed consent prior to participation in the study, understands the purpose of this study and agrees to comply with all protocol-specified examinations and follow-up appointments.
• Female patients of childbearing potential have negative pregnancy test ≤7 days before the procedure.
• Documented symptomatic peripheral arterial disease.
• Acute, subacute and chronic (sub-) occlusion, with ≥ 90% stenosis in native arteries and/or stents / stent grafts and/or Bypass grafts and/or AV Fistula (Dialysis access).
• De novo or re-occluded lesion.
• Vessel and/or stent diameter within treatable range as per Instruction For Use.
• Occlusion crossed intraluminally by a guidewire.

For patients requiring lower limb intervention:

• Patient presenting with a category from 2 to 5 according to the Rutherford classification for chronic limb ischemia or a category from I to IIb according to the Rutherford classification for acute limb ischemia.

Exclusion criteria

• Life expectancy < 2 years.
• Pregnant or nursing a child.
• Contraindication, intolerance, or allergy to contrast media that, in the opinion of the investigator, cannot be adequately pre-medicated.
• Myocardial infarction within 60 days prior to index procedure.
• History of severe trauma and/or sepsis within 60 days prior to index procedure.
• Cerebrovascular accident (CVA) or Transient Ischemic Attack (TIA) within 60 days prior to index procedure.
• Evidence of intracranial or gastrointestinal bleeding or intracranial aneurysm within 90 days prior to index procedure.
• Abnormal electrocardiogram or blood test results and/or any other factor that would increase risk by participating in the study in the opinion of the investigator.
• Target lesion not crossed with guidewire or extraluminal guidewire crossing (even if in short segments only).
• Additional lesion that is located >3cm away from the target lesion
• Treatment plan of the target lesion includes laser, brachytherapy, or atherectomy other than the Rotarex®S Catheter.
• Patient is currently participating in another investigational drug or device study that has not reached the primary endpoint.
• Patients contraindicated for antiplatelet therapy, anticoagulants or thrombolytics.
• Patients with uncorrected bleeding disorders.
• Thrombophlebitis or deep vein thrombosis within the past 30 days.