None listed
Conditions
Brief summary
The objective of the study is to assess the safety and feasibility of using the Millipede System to remove occlusive thrombus and improve blood flow in subjects experiencing an ischemic stroke due to large vessel occlusion.
Interventions
The Millipede System is intended for use in intracranial vessels for the aspiration of occlusive thrombus in subjects experiencing an ischemic stroke and as a conduit for delivery and retrieval of other devices to and from the neurovasculature.
An interventional neuroradiologist will administer the Millipede System during acute treatment for stroke.
Millipede is a system of sterile, single use aspiration catheters. The catheters are tracked through a sheath placed in the femoral artery that pr
The Millipede System is intended for use in intracranial vessels for the aspiration of occlusive thrombus in subjects experiencing an ischemic stroke and as a conduit for delivery and retrieval of other devices to and from the neurovasculature. An interventional neuroradiologist will administer the Millipede System during acute treatment for stroke. Millipede is a system of sterile, single use aspiration catheters. The catheters are tracked through a sheath placed in the femoral artery that provides access to the carotid artery. The system may be used as a conduit to deliver mechanical thrombectomy devices to the neurovasculature. Alternatively, it may be used to access the neurovasculature and to aspirate thrombus. The approximate duration of the revascularization procedure is expected to be less than 1 hour.
Sponsors
Perfuze
Study design
Allocation
Non-randomised trial
Primary purpose
Treatment
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Patients age greater than or equal to 18 years. 2. Pre-stroke mRS of less than or equal to 2. 3. NIHSS score of greater than or equal to 6. 4. Single LVO of the intracranial ICA or M1 segment of the MCA as confirmed through non-invasive neuroimaging (CTA or MRA). 5. ASPECTS 6-10 on baseline CT OR volume of irreversibly injured brain tissue visually assessed as less than or equal to 50 ml using CT perfusion or MRI. 6. The neurointerventionalist estimates that at least one deployment of the Millipede device can be completed within 24 hours of time last known well. 7. IV-tPA, if used, was initiated using standard institutional and national guideline criteria. 8. The patient, the patient’s legally authorised representative or person responsible has signed and dated an Informed Consent Form per local Ethics Committee (EC) and institutional requirements. 9. Digital subtraction angiographic confirmation of an intracranial ICA or M1 occlusion with mTICI 0 or 1.
Exclusion criteria
1. Female subject who is known to be pregnant or breastfeeding. 2. Intracranial haemorrhage (ICH) identified by CT or MRI. 3. Subject has known diagnosis of bilateral acute stroke. 4. Patient presents with an NIHSS score of less than or equal to 5. 5. Presence of pre-existing large (>50 ml) vessel infarction. 6. Subject is known to have more than one target intracranial occlusion or a tandem occlusion. 7. Subject has a known history of severe intracranial atherosclerotic disease (ICAD). 8. Evidence of dissection in the cervical or cerebral arteries. 9. Evidence of internal carotid artery stenosis or fibromuscular dysplasia in the target circulation which could preclude placement of the device. 10. Subject is known to be participating in another investigational drug or device study.
Outcome results
None listed