Single Arm Trial to Evaluate the Safety and Effectiveness of the Route 92 Medical Reperfusion System

Not Applicable

Completed

• Conditions: Acute Ischemic Stroke
• Interventions: Device: Thrombectomy

• Registration Number: NCT05429658
• Lead Sponsor: Route 92 Medical, Inc.

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.

Study Timeline

• Study Start: 2019-09-27
• Primary Completion: 2021-11-22
• Study Completion: 2022-02-24
• Status Verified: 2022-06
• Study First Submitted: 2022-06-16
• Study First Submitted QC: 2022-06-17
• Study First Posted: 2022-06-23
• Last Update Submitted: 2024-03-26
• Last Update Posted: 2024-03-28

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 66

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Thrombectomy	Thrombectomy	Aspiration of clot with large bore catheter in acute ischemic stroke patients

Primary Outcome Measures

Name	Time	Method
Effectiveness	Procedure	The primary effectiveness endpoint is arterial revascularization as measured by a modified Thrombolysis in Cerebrovascular Infarction (mTICI) score of 2b or greater at the end of angiography after all endovascular treatments.
Device-related peri-procedural complications	Procedure	dissection or perforation
Symptomatic Intracranial Cerebral Hemorrhage (SICH)	24 hour	defined as type 2 parenchymal hemorrhage with a deterioration in National Institutes of Health Stroke Scale \[NIHSS\] score of \>=4 points
Embolization to a previously uninvolved territory	Procedure	Embolization to a previously uninvolved territory

Secondary Outcome Measures

Name	Time	Method
NIHSS score	24 hours after treatment	The National Institutes of Health Stroke Scale (NIHSS) is a tool used by healthcare providers to objectively quantify the impairment caused by a stroke
Modified Rankin Score	90 days after treatment	The modified Rankin Scale (mRS) is a commonly used scale for measuring the degree of disability or dependence in the daily activities of people who have suffered a stroke or who have other causes of neurological disability
Procedure Time	Procedure	Total procedure time from insertion of Route 92 Reperfusion System to final angiogram
Procedure-Related SAEs	Procedure	Serious Adverse Events related to the interventional procedure

Trial Locations

Locations (2)

Auckland City Hospital; 🇳🇿 Auckland, New Zealand

Christchurch Hospital; 🇳🇿 Christchurch, New Zealand