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

Acute Ischemic Stroke Clinical Trial

— SUMMITNZ  

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05429658
• Other study ID #: CIP 0605
• Status: Completed
• Phase: N/A
• Start date: September 27, 2019
• Est. completion date: February 24, 2022

Study information

• Verified date: June 2022
• Source: Route 92 Medical, Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 66
• Est. completion date: February 24, 2022
• Est. primary completion date: November 22, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Acute Ischemic Stroke
• Ischemic Stroke

Intervention

Device:
• Thrombectomy
The Route 92 Medical Reperfusion System is indicated for use in the revascularization of patients with acute ischemic stroke secondary to intracranial large vessel occlusive disease within the internal carotid, middle cerebral, basilar and vertebral arteries.

Locations

Country	Name	City	State
New Zealand	Auckland City Hospital	Auckland
New Zealand	Christchurch Hospital	Christchurch

Sponsors (1)

Lead Sponsor	Collaborator
Route 92 Medical, Inc.

Country where clinical trial is conducted

New Zealand, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Effectiveness	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.	Procedure
Primary	Device-related peri-procedural complications	dissection or perforation	Procedure
Primary	Symptomatic Intracranial Cerebral Hemorrhage (SICH)	defined as type 2 parenchymal hemorrhage with a deterioration in National Institutes of Health Stroke Scale [NIHSS] score of >=4 points	24 hour
Primary	Embolization to a previously uninvolved territory	Embolization to a previously uninvolved territory	Procedure
Secondary	NIHSS score	The National Institutes of Health Stroke Scale (NIHSS) is a tool used by healthcare providers to objectively quantify the impairment caused by a stroke	24 hours after treatment
Secondary	Modified Rankin Score	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	90 days after treatment
Secondary	Procedure Time	Total procedure time from insertion of Route 92 Reperfusion System to final angiogram	Procedure
Secondary	Procedure-Related SAEs	Serious Adverse Events related to the interventional procedure	Procedure