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

NCT05429658 | Completed FDA Device

• 1 other identifier: CIP 0605
• Study Type: interventional
• Target: 66
• Locations: 1 country
• Sites: 2

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.

Conditions

Acute Ischemic Stroke

Outcome Measures

Primary Outcomes (4)

• 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

• Device-related peri-procedural complications

  dissection or perforation

  Procedure

• 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

• Embolization to a previously uninvolved territory

  Embolization to a previously uninvolved territory

  Procedure

Secondary Outcomes (4)

• NIHSS score

  24 hours after treatment

• Modified Rankin Score

  90 days after treatment

• Procedure Time

  Procedure

• Procedure-Related SAEs

  Procedure

Study Arms (1)

Thrombectomy

EXPERIMENTAL

Aspiration of clot with large bore catheter in acute ischemic stroke patients

Device: Thrombectomy

Interventions

Thrombectomy DEVICE

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.

Thrombectomy

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Route 92 Medical, Inc.: lead

Study Sites (2)

Auckland City Hospital

Auckland, 1023, New Zealand

Location

Christchurch Hospital

Christchurch, 8011, New Zealand

Location

MeSH Terms

Conditions

Ischemic Stroke

Interventions

Thrombectomy

Condition Hierarchy (Ancestors)

Stroke; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases

Intervention Hierarchy (Ancestors)

Vascular Surgical Procedures; Cardiovascular Surgical Procedures; Surgical Procedures, Operative

Study Officials

• Stefan Brew, MBChB, MHB

  Auckland City Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DEVICE FEASIBILITY
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 16, 2022
• First Posted: June 23, 2022
• Study Start: September 27, 2019
• Primary Completion: November 22, 2021
• Study Completion: February 24, 2022
• Last Updated: March 28, 2024

Record last verified: 2022-06

Data Sharing

• IPD Sharing: Will not share

Locations

NZ (2)