None listed
Conditions
Brief summary
The objective of the SUMMIT NZ study is to evaluate the safety and effectiveness of the Route 92 Medical Reperfusion System when used to aspirate emboli in acute ischemic stroke patients.
Interventions
The Route 92 Medical Reperfusion System is intended for use in the revascularization of patients with acute ischemic stroke secondary to intracranial large vessel occlusive disease within the internal carotid and middle cerebral arteries.
An interventional neuroradiologist will administer the Reperfusion System during acute treatment for stroke.
The Route 92 Medical System is a system of products for accessing the neurovasculature and then aspirating clot in ischemic stroke patients. The syst
The Route 92 Medical Reperfusion System is intended for use in the revascularization of patients with acute ischemic stroke secondary to intracranial large vessel occlusive disease within the internal carotid and middle cerebral arteries. An interventional neuroradiologist will administer the Reperfusion System during acute treatment for stroke. The Route 92 Medical System is a system of products for accessing the neurovasculature and then aspirating clot in ischemic stroke patients. The system is comprised of the Base Camp Sheath System and the Reperfusion Systems. The Reperfusion System is provided in two sizes: 088 and 070. Each Reperfusion System is comprised of a Delivery Catheter and an Aspiration Catheter. The Base Camp Sheath is placed in the femoral artery and provides access to the carotid artery. The 088 Reperfusion System may be placed through the Base Camp Sheath. The 070 Reperfusion System may then be placed through the 088 Aspiration Catheter to form a “telescoping” family of products. Once an Aspiration Catheter has gained access to the neurovasculature, the stroke-causing embolus may be aspirated. The approximate duration of the revascularization procedure is expected to be less than 1 hour.
Sponsors
Route 92 Medical, Inc.
Study design
Allocation
Non-randomised trial
Intervention model
Single group
Primary purpose
Treatment
Masking
Open (masking not used)
Eligibility
Sex/Gender
All
Age
18 Years to 100 No limit
Healthy volunteers
No
Inclusion criteria
1. The consent process has been completed with the subject, Legally Authorized Representative, or two physician best interest and consent is documented 2. Age >=18 years 3. Clinical signs consistent with an acute ischemic stroke 4. Baseline National Institutes of Health Stroke Scale (NIHSS) score ? 6 5. Pre-stroke modified Rankin Score (mRS) ? 2 6. Acute occlusion of the middle cerebral artery (MCA), internal carotid artery (ICA), vertebral or basilar arteries confirmed via computed tomography angiography (CTA) and/or magnetic resonance angiography (MRA) 7. The Investigator estimates that at least one delivery of the Route 92 Medical Reperfusion System can be completed within 24 hours of time last known well 8. In the opinion of the Investigator, reperfusion of the ischemic territory will result in clinical benefit 9. Angiographic confirmation of an occlusion or near occlusion of the middle cerebral artery, internal carotid artery, vertebral or basilar arteries with a modified Thrombolysis In Cerebral Infarction (mTICI) scale score of 0-1
Exclusion criteria
1. Known pregnancy or breast feeding 2. Known comorbidity that may complicate treatment or prevent improvement or follow-up 3. Known life expectancy < 12 months 4. Known history of severe allergy to contrast medium 5. Subject known to have suffered a stroke in the past 90 days 6. Subject participating in another study involving an investigational device or drug. 7. Known connective tissue disorder affecting the arteries (e.g. Marfan syndrome, fibromuscular dysplasia, Ehlers-Danlos syndrome) 8. Any known pre-existing hemorrhagic or coagulation deficiency 9. Computed Tomography (CT) or Magnetic Resonance Imaging (MRI) evidence of recent/ fresh hemorrhage 10. Baseline CT or MRI showing intracranial tumor (except small meningioma) 11. Angiographic evidence of dissection in the extracranial or intracranial arteries 12. Angiographic evidence of carotid dissection 13. Angiographic evidence of multiple vascular occlusions (e.g., bilateral anterior circulation, anterior/posterior circulation). Note: tandem occlusions may be included at the discretion of the operating physician.
Outcome results
None listed