Single Arm Trial to Evaluate the Safety and Effectiveness of the Route 92 Medical Reperfusion System (SUMMITNZ)
Primary Purpose
Acute Ischemic Stroke
Status
Completed
Phase
Not Applicable
Locations
New Zealand
Study Type
Interventional
Intervention
Thrombectomy
Sponsored by

About this trial
This is an interventional treatment trial for Acute Ischemic Stroke
Eligibility Criteria
Inclusion Criteria:
- 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 Criteria:
- 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.
Sites / Locations
- Auckland City Hospital
- Christchurch Hospital
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Thrombectomy
Arm Description
Aspiration of clot with large bore catheter in acute ischemic stroke patients
Outcomes
Primary Outcome Measures
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.
Device-related peri-procedural complications
dissection or perforation
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
Embolization to a previously uninvolved territory
Embolization to a previously uninvolved territory
Secondary Outcome Measures
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
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
Procedure Time
Total procedure time from insertion of Route 92 Reperfusion System to final angiogram
Procedure-Related SAEs
Serious Adverse Events related to the interventional procedure
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT05429658
Brief Title
Single Arm Trial to Evaluate the Safety and Effectiveness of the Route 92 Medical Reperfusion System
Acronym
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
Study Type
Interventional
2. Study Status
Record Verification Date
June 2022
Overall Recruitment Status
Completed
Study Start Date
September 27, 2019 (Actual)
Primary Completion Date
November 22, 2021 (Actual)
Study Completion Date
February 24, 2022 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Route 92 Medical, Inc.
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
Yes
Product Manufactured in and Exported from the U.S.
Yes
Data Monitoring Committee
No
5. Study Description
Brief Summary
The objective of the study is to evaluate the safety and effectiveness of the Route 92 Medical Reperfusion System 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 Reperfusion System when used to aspirate emboli in acute ischemic stroke patients.
The study design is an interventional, prospective, single-arm, open label clinical trial.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Acute Ischemic Stroke
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
66 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Thrombectomy
Arm Type
Experimental
Arm Description
Aspiration of clot with large bore catheter in acute ischemic stroke patients
Intervention Type
Device
Intervention Name(s)
Thrombectomy
Intervention Description
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.
Primary Outcome Measure Information:
Title
Effectiveness
Description
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.
Time Frame
Procedure
Title
Device-related peri-procedural complications
Description
dissection or perforation
Time Frame
Procedure
Title
Symptomatic Intracranial Cerebral Hemorrhage (SICH)
Description
defined as type 2 parenchymal hemorrhage with a deterioration in National Institutes of Health Stroke Scale [NIHSS] score of >=4 points
Time Frame
24 hour
Title
Embolization to a previously uninvolved territory
Description
Embolization to a previously uninvolved territory
Time Frame
Procedure
Secondary Outcome Measure Information:
Title
NIHSS score
Description
The National Institutes of Health Stroke Scale (NIHSS) is a tool used by healthcare providers to objectively quantify the impairment caused by a stroke
Time Frame
24 hours after treatment
Title
Modified Rankin Score
Description
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
Time Frame
90 days after treatment
Title
Procedure Time
Description
Total procedure time from insertion of Route 92 Reperfusion System to final angiogram
Time Frame
Procedure
Title
Procedure-Related SAEs
Description
Serious Adverse Events related to the interventional procedure
Time Frame
Procedure
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
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 Criteria:
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Stefan Brew, MBChB, MHB
Organizational Affiliation
Auckland City Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Auckland City Hospital
City
Auckland
ZIP/Postal Code
1023
Country
New Zealand
Facility Name
Christchurch Hospital
City
Christchurch
ZIP/Postal Code
8011
Country
New Zealand
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Single Arm Trial to Evaluate the Safety and Effectiveness of the Route 92 Medical Reperfusion System
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