Clinical trial NCT05429658: Single Arm Trial to Evaluate the Safety and Effectiveness of the Route 92 Medical Reperfusion System
Official title: A Prospective, Single-arm, Interventional Clinical Trial to Evaluate the Safety and Effectiveness of the Route 92 Medical MonoPoint Reperfusion System for Aspiration Embolectomy in Acute Ischemic Stroke Patients
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Acute Ischemic Stroke
Lead sponsor: Route 92 Medical, Inc.
Sponsor class: INDUSTRY
First posted: 2022-06-23
Enrollment: 66
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DEVICE_FEASIBILITY

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 aspirate emboli in acute ischemic stroke patients.

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 aspirate emboli in acute ischemic stroke patients.

The study design is an interventional, prospective, single-arm, open label clinical trial.

Eligibility criteria: 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 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)
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 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 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.

Primary outcomes:
measure: Effectiveness
timeFrame: Procedure
measure: Device-related peri-procedural complications
timeFrame: Procedure
measure: Symptomatic Intracranial Cerebral Hemorrhage (SICH)
timeFrame: 24 hour
measure: Embolization to a previously uninvolved territory
timeFrame: Procedure
Secondary outcomes:
measure: NIHSS score
timeFrame: 24 hours after treatment
measure: Modified Rankin Score
timeFrame: 90 days after treatment
measure: Procedure Time
timeFrame: Procedure
measure: Procedure-Related SAEs
timeFrame: Procedure
Other outcomes:
Locations:
city: Auckland
country: New Zealand
facility: Auckland City Hospital
city: Christchurch
country: New Zealand
facility: Christchurch Hospital
Study officials:
affiliation: Auckland City Hospital
name: Stefan Brew, MBChB, MHB
role: PRINCIPAL_INVESTIGATOR
References: