Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12619000890134
Ethics application status
Approved
Date submitted
13/06/2019
Date registered
26/06/2019
Date last updated
27/02/2020
Date data sharing statement initially provided
26/06/2019
Type of registration
Prospectively registered

Titles & IDs
Public title
A Clinical Trial to Evaluate the Safety and Effectiveness of the Route 92 Medical MonoPointTM Reperfusion SystemTM for Aspiration Embolectomy in Acute Ischemic Stroke Patients
Scientific title
A Prospective, Single-arm, Interventional Clinical Trial to Evaluate the Safety and Effectiveness of the Route 92 Medical MonoPointTM Reperfusion SystemTM for Aspiration Embolectomy in Acute Ischemic Stroke Patients
Secondary ID [1] 298487 0
Nil
Universal Trial Number (UTN)
U1111-1235-2464
Trial acronym
SUMMIT NZ
Linked study record
Nil

Health condition
Health condition(s) or problem(s) studied:
Acute Ischemic Stroke 313267 0
Condition category
Condition code
Stroke 311711 311711 0 0
Ischaemic
Neurological 311768 311768 0 0
Other neurological disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The Route 92 Medical Reperfusion System is intended for use in the revascularization of patients with acute ischemic stroke secondary to intracranial large vessel occlusive disease within the internal carotid and middle cerebral arteries.

An interventional neuroradiologist will administer the Reperfusion System during acute treatment for stroke.

The Route 92 Medical System is a system of products for accessing the neurovasculature and then aspirating clot in ischemic stroke patients. The system is comprised of the Base Camp Sheath System and the Reperfusion Systems. The Reperfusion System is provided in two sizes: 088 and 070. Each Reperfusion System is comprised of a Delivery Catheter and an Aspiration Catheter.

The Base Camp Sheath is placed in the femoral artery and provides access to the carotid artery. The 088 Reperfusion System may be placed through the Base Camp Sheath. The 070 Reperfusion System may then be placed through the 088 Aspiration Catheter to form a “telescoping” family of products. Once an Aspiration Catheter has gained access to the neurovasculature, the stroke-causing embolus may be aspirated.

The approximate duration of the revascularization procedure is expected to be less than 1 hour.
Intervention code [1] 314737 0
Treatment: Devices
Comparator / control treatment
No control group
Control group
Uncontrolled

Outcomes
Primary outcome [1] 320401 0
Arterial revascularization as measured by a modified Thrombosis in Cerebrovascular Infarction (mTICI) score of 2b or greater
Timepoint [1] 320401 0
immediately after reperfusion with the Route 92 Reperfusion System
Secondary outcome [1] 371480 0
National Institutes of Health Stroke Scale Score (NIHSSS)
Timepoint [1] 371480 0
24 hours after treatment
Secondary outcome [2] 371481 0
Modified Rankin Score
Timepoint [2] 371481 0
90 days after treatment
Secondary outcome [3] 371641 0
Device-related peri-procedural complications such as dissection or perforation as reported by the the surgeon and reviewed by an independent medical monitor.
Timepoint [3] 371641 0
at the time of the procedure
Secondary outcome [4] 371642 0
Symptomatic Intracranial Cerebral Hemorrhage (SICH) at 24 hours (Type 2 parenchymal hemorrhage with a deteriorization in National Institutes of Health Stroke Scale [NIHSS] score of >= 4 points)
Timepoint [4] 371642 0
24 hours post procedure
Secondary outcome [5] 371643 0
Embolization to a previously uninvolved territory as reported by the the surgeon and reviewed by an independent medical monitor.
Timepoint [5] 371643 0
at the time of the procedure
Secondary outcome [6] 371644 0
Procedure-related Serious Adverse Events (SAEs) as reported by the the surgeon and reviewed by an independent medical monitor.

A summary of the known risks is detailed below however, there may be risks that are not known or are unforeseen at this time:
• allergic reaction and anaphylaxis from contrast media
• acute occlusion
• air embolism
• arteriovenous fistula
• death
• device malfunction
• distal embolization
• emboli
• false aneurysm formation
• hematoma or hemorrhage at access site
• infection
• intracranial hemorrhage
• ischemia
• neurological deficits including stroke
• residual thrombus
• vasospasm
• vessel perforation or dissection
Timepoint [6] 371644 0
At the time of the procedure and throughout follow-up

Eligibility
Key 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 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 or near occlusion 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
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key 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
Purpose of the study
Treatment
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
NA
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
NA
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Single group
Other design features
None
Phase
Not Applicable
Type of endpoint/s
Safety/efficacy
Statistical methods / analysis
This is an initial feasibility study with no planned hypothesis testing. Data collected from this study will primarily be categorical in nature and summarized using frequency tables, presenting the patient counts, percentages, mean, standard deviation, median, minimum and maximum, as applicable.

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
19/08/2019
Actual
27/09/2019
Date of last participant enrolment
Anticipated
31/03/2020
Actual
Date of last data collection
Anticipated
30/06/2020
Actual
Sample size
Target
15
Accrual to date
12
Final
Recruitment outside Australia
Country [1] 21600 0
New Zealand
State/province [1] 21600 0
Auckland and Christchurch

Funding & Sponsors
Funding source category [1] 303032 0
Commercial sector/Industry
Name [1] 303032 0
Route 92 Medical, Inc.
Country [1] 303032 0
United States of America
Primary sponsor type
Commercial sector/Industry
Name
Route 92 Medical, Inc.
Address
155 Bovet Road, Suite 100, San Mateo, California 94402 USA
Country
United States of America
Secondary sponsor category [1] 303011 0
None
Name [1] 303011 0
Address [1] 303011 0
Country [1] 303011 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 303585 0
Health and Disability Ethics Committee - Northern B
Ethics committee address [1] 303585 0
Ethics committee country [1] 303585 0
New Zealand
Date submitted for ethics approval [1] 303585 0
18/07/2019
Approval date [1] 303585 0
06/09/2019
Ethics approval number [1] 303585 0

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 94162 0
Dr Stefan Brew
Address 94162 0
Auckland City Hospital
2 Park Road
Grafton, Auckland 1023
New Zealand
Country 94162 0
New Zealand
Phone 94162 0
+64 9 307 4949
Fax 94162 0
Email 94162 0
StefanB@adhb.govt.nz
Contact person for public queries
Name 94163 0
Elleni Takele
Address 94163 0
Auckland City Hospital
2 Park Rd, Grafton
Auckland 1023
New Zealand
Country 94163 0
New Zealand
Phone 94163 0
+64 9 307 4949
Fax 94163 0
Email 94163 0
ElleniT@adhb.govt.nz
Contact person for scientific queries
Name 94164 0
Stefan Brew
Address 94164 0
Auckland City Hospital
2 Park Road
Grafton, Auckland 1023
New Zealand
Country 94164 0
New Zealand
Phone 94164 0
+64 9 307 4949
Fax 94164 0
Email 94164 0
StefanB@adhb.govt.nz

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.