Prospective, Non-randomized Multi-center, Controlled Physician-initiated Trial: Rotarex Belgium In-stent Occlusion (ROBINSON)

This is an interventional treatment trial for Peripheral Vascular Disease Read More

Inclusion Criteria:

• Patient is willing to comply with specified follow-up evaluations at the specified times
• Patient is >18 years old
• Patient understands the nature of the procedure and provides written informed consent, prior to enrolment in the study
• Patient has a projected life-expectancy of at least 6 months
• Symptomatic acute or subacute stent occlusion in the femoropopliteal artery
• Target vessel diameter ≥ 3 mm and ≤ 8 mm
• Patient is candidate for thrombolytic or anticoagulation medication
• Patient is able and willing to comply with study follow-up requirements

Exclusion Criteria:

• No patent artery until the foot
• Inability of crossing lesion with guidewire
• Known active infection at the time of intervention
• Untreated flow-limiting inflow lesions
• Perioperative unsuccessful ipsilateral percutaneous vascular procedure to treat inflow disease just prior to enrolment
• Aneurysm in the target vessel
• Severe medical comorbidities (untreated CAD/CHF, severe COPD, metastatic malignancy, dementia, etc) or other medical condition that would preclude compliance with the study protocol
• Major distal amputation (above the transmetatarsal) in the study limb or non-study limb
• Septicemia or bacteremia
• Any previously known coagulation disorder, including hypercoagulability
• Contraindication to anticoagulation or antiplatelet therapy
• Patient with known hypersensitivity to heparin, including those patients who have had a previous incidence of heparin-induced thrombocytopenia (HIT) type II
• Currently participating in another clinical research trial
• The patient must be excluded in case any of the following contraindications as listed in the IFU is present:

Rotarex®S catheters must not be used in case of:

• Patient not suitable for thrombectomy
• Target vessel belonging to the vessels of the cardiopulmonary, coronary or cerebral circulations
• Use inside or via undersized or oversized vessel diameters
• Impossibility to pass the lesion completely with the guidewire
• Subintimal position of the guidewire - even if only in short segments
• 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
• The introducer sheath, the guide catheter, the guidewire or the Rotarex®S catheter sustaining any damage, especially kinking
• Target lesions situated in the fracture areas of broken stents
• 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
• Persistent vasospasm
• Imaging by Magnetic Resonance Imaging (MRI)
• Use of a defibrillator on the patient
• Use of electrosurgery on the patient
• Veterinary purposes
• Patients with hemodynamic instability or shock
• Patients with severe coagulatory disorders
• Situations where an embolism potentially triggered by the use of the catheter may have a very harmful effect on the patient
• Use inside or via narrow vessel radii or in tortuous vessel courses (radius of curvature < 2cm)
• Target lesion in severely calcified vessel segments
• Target lesion in aneurysmatically altered vessel segments
• Known or suspected infection, especially of the puncture site or the vessel segment being treated
• Known, unhealed pre-existing mechanical damage to the vessel wall, especially caused by surgical procedures or interventional complications

• Impossibility to achieve sufficient anticoagulation and platelet aggregation inhibition

  • Patient is pregnant or nursing a child