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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT05018650




Registration number
NCT05018650
Ethics application status
Date submitted
18/08/2021
Date registered
24/08/2021

Titles & IDs
Public title
A Randomized, Controlled Trial to Evaluate the Safety and Effectiveness of the Route 92 Medical Reperfusion System (SUMMIT MAX)
Scientific title
A Prospective, Randomized, Controlled, 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 (SUMMIT MAX)
Secondary ID [1] 0 0
CIP 0974
Universal Trial Number (UTN)
Trial acronym
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 - Route 92 Medical Reperfusion System

Experimental: Route 92 Medical Monopoint Reperfusion System - Aspiration thrombectomy with the Route 92 Medical HiPoint 88 and HiPoint 70 Reperfusion Catheters as part of the Monopoint Reperfusion System to treat acute ischemic stroke

Active comparator: Aspiration Predicate - Aspiration thrombectomy with a predicate aspiration device to treat acute ischemic stroke


Treatment: Devices: Route 92 Medical Reperfusion System
Mechanical thrombectomy for acute ischemic stroke patients with large vessel occlusions will be performed with direct aspiration consisting of navigating a large-bore catheter up to the face of the clot and initiating vacuum suction.
Intervention code [1] 0 0
Treatment: Devices
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Proportion of subjects with successful arterial revascularization defined as a modified Thrombolysis in Cerebrovascular Infarction (mTICI) score of 2b or greater
Timepoint [1] 0 0
During procedure
Primary outcome [2] 0 0
Incidence of all symptomatic intracerebral hemorrhage (sICH)
Timepoint [2] 0 0
within 24 hours post-procedure

Eligibility
Key inclusion criteria
1. The consent process has been completed and documented according to applicable country regulations and as approved by the IRB / Ethics Committee
2. Age >=18 years
3. Patient presenting with 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. Baseline ASPECTS >= 6
7. Endovascular treatment initiated (defined as time of groin puncture) within 8 hours from time last known well
8. If indicated, thrombolytic therapy shall be initiated per clinical guidelines. If eligible for thrombolytic therapy, subjects should be treated as soon as possible and lytic use should not be delayed regardless of potential eligibility for mechanical neurothrombectomy.
9. The patient is indicated for aspiration neurothrombectomy with the Route 92 Medical Reperfusion System as determined by the Investigator
10. Angiographic confirmation of a large vessel occlusion of the M1 segment of the middle cerebral artery or distal internal carotid artery
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. In the Investigator's opinion, any known comorbidity (including COVID-19 positivity) that may complicate treatment or prevent improvement or follow-up
3. Known serious, advanced, or terminal illness with anticipated life expectancy < 12 months
4. Known history of severe allergy to contrast medium
5. Known to have suffered a stroke in the past 90 days
6. Known connective tissue disorder affecting the arteries (e.g. Marfan syndrome, Ehlers-Danlos syndrome)
7. Any known previous cerebral hemorrhagic event
8. Any known pre-existing coagulation deficiency
9. Known hemorrhagic diathesis, coagulation factor deficiency, or oral anticoagulant therapy with INR >3.0
10. Known baseline platelet count <50,000/µL
11. Known baseline blood glucose of <50 mg/dL or >400 mg/dL
12. Known to be participating in another study involving an investigational device or drug
13. Clinical symptoms suggestive of bilateral stroke or stroke in multiple territories.
14. Computed Tomography (CT) or Magnetic Resonance Imaging (MRI) evidence of recent/ fresh cerebral hemorrhage (the presence of microbleeds is allowed)
15. Baseline CT or MRI showing intracranial tumor (except small meningioma <= 2cm) or significant mass effect with midline shift due to the tumor
16. Presumed septic thrombus, or suspicion of bacterial endocarditis
17. Inability to access the cerebral vasculature in the opinion of the neurointerventional team
18. Unlikely to be available for a 90-day follow-up (e.g. no fixed home address)
19. Evidence of arterial dissection in a vessel that must be traversed
20. Evidence of high-grade stenosis or occlusion (i.e., tandem occlusion) in a vessel that must be traversed
21. Known active or recent history of cocaine or methamphetamine abuse (within last 6 months)
22. Known history or presence of aneurysm or arteriovenous malformation (AVM) in the territory of the target lesion
23. For all patients, severe sustained hypertension with SBP >200 and/or DBP >120; for patients treated with a lytic, sustained hypertension despite treatment with SBP >185 and/or DBP >110
24. Treatment with heparin within 48 hours with a partial thromboplastic time more than two times the laboratory normal or treatment with any LMWH within 48 hours
25. Renal failure with serum creatinine >3.0 or Glomerular Filtration Rate (GFR) <30
26. Ongoing seizure due to stroke
27. Evidence of active systemic infection
28. Known cancer with metastases
29. Angiographic evidence of a dissection in the extracranial or intracranial cerebral arteries
30. Arterial stenosis requiring balloon angioplasty or stenting at the time of the procedure
31. Angiographic evidence of multiple cerebrovascular occlusions (e.g., bilateral anterior circulation, anterior/posterior circulation, tandem occlusions)
32. Angiographic evidence of known or suspected underlying intracranial vasculopathy or atherosclerotic lesions responsible for the target occlusion
33. Angiographic evidence or suspicion of aortic dissection
34. Angiographic evidence of an aneurysm or arteriovenous malformation (AVM) in the territory of the target lesion

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
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
Parallel
Other design features
Phase
Not applicable
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Active, not recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
21/12/2021
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
1/06/2024
Actual
Sample size
Target
Accrual to date
Final
250
Recruitment in Australia
Recruitment state(s)
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
Arizona
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United States of America
State/province [2] 0 0
California
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United States of America
State/province [3] 0 0
Delaware
Country [4] 0 0
United States of America
State/province [4] 0 0
Florida
Country [5] 0 0
United States of America
State/province [5] 0 0
Illinois
Country [6] 0 0
United States of America
State/province [6] 0 0
Kansas
Country [7] 0 0
United States of America
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Kentucky
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United States of America
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Massachusetts
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United States of America
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Missouri
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United States of America
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New Jersey
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United States of America
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New York
Country [12] 0 0
United States of America
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Ohio
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United States of America
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Oregon
Country [14] 0 0
United States of America
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Pennsylvania
Country [15] 0 0
United States of America
State/province [15] 0 0
Tennessee
Country [16] 0 0
United States of America
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Texas
Country [17] 0 0
United States of America
State/province [17] 0 0
Utah
Country [18] 0 0
United States of America
State/province [18] 0 0
West Virginia
Country [19] 0 0
New Zealand
State/province [19] 0 0
Auckland

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
Guilherme Dabus, MD
Address 0 0
Baptist Health - Miami
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/NCT05018650