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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT05429658




Registration number
NCT05429658
Ethics application status
Date submitted
16/06/2022
Date registered
23/06/2022

Titles & IDs
Public title
Single Arm Trial to Evaluate the Safety and Effectiveness of the Route 92 Medical Reperfusion System
Scientific 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
Secondary ID [1] 0 0
CIP 0605
Universal Trial Number (UTN)
Trial acronym
SUMMITNZ
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Acute Ischemic Stroke 0 0
Condition category
Condition code
Stroke 0 0 0 0
Ischaemic

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Devices - Thrombectomy

Experimental: Thrombectomy - Aspiration of clot with large bore catheter in acute ischemic stroke patients


Treatment: Devices: 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.
Intervention code [1] 0 0
Treatment: Devices
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Effectiveness
Timepoint [1] 0 0
Procedure
Primary outcome [2] 0 0
Device-related peri-procedural complications
Timepoint [2] 0 0
Procedure
Primary outcome [3] 0 0
Symptomatic Intracranial Cerebral Hemorrhage (SICH)
Timepoint [3] 0 0
24 hour
Primary outcome [4] 0 0
Embolization to a previously uninvolved territory
Timepoint [4] 0 0
Procedure
Secondary outcome [1] 0 0
NIHSS score
Timepoint [1] 0 0
24 hours after treatment
Secondary outcome [2] 0 0
Modified Rankin Score
Timepoint [2] 0 0
90 days after treatment
Secondary outcome [3] 0 0
Procedure Time
Timepoint [3] 0 0
Procedure
Secondary outcome [4] 0 0
Procedure-Related SAEs
Timepoint [4] 0 0
Procedure

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 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
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
Other
Allocation to intervention
Not applicable
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Single group
Other design features
Phase
Not applicable
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
27/09/2019
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
24/02/2022
Sample size
Target
Accrual to date
Final
66
Recruitment in Australia
Recruitment state(s)
Recruitment outside Australia
Country [1] 0 0
New Zealand
State/province [1] 0 0
Auckland
Country [2] 0 0
New Zealand
State/province [2] 0 0
Christchurch

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
Route 92 Medical, Inc.
Address
Country

Ethics approval
Ethics application status

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

Contacts
Principal investigator
Name 0 0
Stefan Brew, MBChB, MHB
Address 0 0
Auckland City Hospital
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries

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

No documents have been uploaded by study researchers.


Results not provided in https://clinicaltrials.gov/study/NCT05429658