Status:
COMPLETED
Single Arm Trial to Evaluate the Safety and Effectiveness of the Route 92 Medical Reperfusion System
Lead Sponsor:
Route 92 Medical, Inc.
Conditions:
Acute Ischemic Stroke
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
The objective of the study is to evaluate the safety and effectiveness of the Route 92 Medical Monopoint Reperfusion System with the Hi Point 88 and HiPoint 70 Reperfusion Catheters when used to aspir...
Detailed Description
The objective of the study is to evaluate the safety and effectiveness of the Route 92 Medical Monopoint Reperfusion System with the Hi Point 88 and HiPoint 70 Reperfusion Catheters when used to aspir...
Eligibility Criteria
Inclusion
- The consent process has been completed with the subject, Legally Authorized Representative, or two physician best interest and consent is documented
- Age \>18 years
- Clinical signs consistent with an acute ischemic stroke
- Baseline National Institutes of Health Stroke Scale (NIHSS) score \>= 6
- Pre-stroke modified Rankin Score (mRS) \<= 2
- Acute occlusion of the M1 segment 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)
- 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
- In the opinion of the Investigator, reperfusion of the ischemic territory will result in clinical benefit
- Angiographic confirmation of an occlusion of the M1 segment\* 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
- Known pregnancy or breast feeding
- Known comorbidity that may complicate treatment or prevent improvement or follow-up
- Known life expectancy \< 12 months
- Known history of severe allergy to contrast medium
- Subject known to have suffered a stroke in the past 90 days
- Subject participating in another study involving an investigational device or drug.
- Known connective tissue disorder affecting the arteries (e.g. Marfan syndrome, fibromuscular dysplasia, Ehlers-Danlos syndrome)
- Any known pre-existing hemorrhagic or coagulation deficiency
- Computed Tomography (CT) or Magnetic Resonance Imaging (MRI) evidence of recent/ fresh hemorrhage
- Baseline CT or MRI showing intracranial tumor (except small meningioma)
- Angiographic evidence of dissection in the extracranial or intracranial arteries
- Angiographic evidence of carotid dissection
- 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.
Key Trial Info
Start Date :
September 27 2019
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 24 2022
Estimated Enrollment :
66 Patients enrolled
Trial Details
Trial ID
NCT05429658
Start Date
September 27 2019
End Date
February 24 2022
Last Update
March 28 2024
Active Locations (2)
Enter a location and click search to find clinical trials sorted by distance.
1
Auckland City Hospital
Auckland, New Zealand, 1023
2
Christchurch Hospital
Christchurch, New Zealand, 8011