Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12621000178842
Ethics application status
Approved
Date submitted
17/11/2020
Date registered
22/02/2021
Date last updated
8/10/2021
Date data sharing statement initially provided
22/02/2021
Type of registration
Prospectively registered

Titles & IDs
Public title
Safety and Feasibility of the Millipede System
Scientific title
Safety and Feasibility of the Millipede System in Patients with Acute Ischemic Stroke
Secondary ID [1] 302778 0
Nil known
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Acute ischemic stroke 319721 0
Condition category
Condition code
Stroke 317653 317653 0 0
Ischaemic

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The Millipede System is intended for use in intracranial vessels for the aspiration of occlusive thrombus in subjects experiencing an ischemic stroke and as a conduit for delivery and retrieval of other devices to and from the neurovasculature.

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

Millipede is a system of sterile, single use aspiration catheters. The catheters are tracked through a sheath placed in the femoral artery that provides access to the carotid artery. The system may be used as a conduit to deliver mechanical thrombectomy devices to the neurovasculature. Alternatively, it may be used to access the neurovasculature and to aspirate thrombus.

The approximate duration of the revascularization procedure is expected to be less than 1 hour.
Intervention code [1] 319054 0
Treatment: Devices
Comparator / control treatment
No control group
Control group
Uncontrolled

Outcomes
Primary outcome [1] 325703 0
Incidence of symptomatic Millipede device-related arterial vascular perforation or dissection as reported by the investigator and verified by an independent reviewer. The data will be reported by the investigator on a case report form.
Timepoint [1] 325703 0
Within 24 hours post-procedure.
Secondary outcome [1] 388804 0
Incidence of serious adverse device effects (SADEs) as reported by the investigator and verified by an independent reviewer. The data will be reported by the investigator on a case report form.

Potential complications associated with the Millipede device include, but may not be limited to, the following:
• Arterial perforation or dissection
• Haematoma or haemorrhage at access site
• Intracranial haemorrhage
• Vasospasm
• Inability to completely remove thrombus
• Distal embolization of clot
• Poor clinical outcome (mRS >2)
• Acute occlusion or thrombosis
• Ischemia
• Air embolism
• Device embolism
• Device malfunction
• New, recurrent or progressive ischemic stroke
• Infection
• Allergic reaction or anaphylaxis
• Blood loss
• Death
Timepoint [1] 388804 0
Within 24 hours post-procedure
Secondary outcome [2] 388805 0
Rate of successful placement of the Millipede device proximal to the target occlusion in the intracranial ICA (achieving contact aspiration) or M1 segment of the MCA (achieving local or contact aspiration) as reported by the investigator. The data will be reported by the investigator on a case report form.
Timepoint [2] 388805 0
At the time of the procedure
Secondary outcome [3] 388806 0
Rate of first pass near complete reperfusion or better, as measured by a mTICI score greater than or equal to 2C (composite).
Timepoint [3] 388806 0
At the time of the procedure
Secondary outcome [4] 388807 0
Rate of final near-complete reperfusion or better at the end of the procedure, as measured by a mTICI score greater than or equal to 2C (composite).
Timepoint [4] 388807 0
At the time of the procedure
Secondary outcome [5] 388808 0
Rate of successful reperfusion, as measured by a mTICI score greater than or equal to 2B.
Timepoint [5] 388808 0
At the time of the procedure
Secondary outcome [6] 388809 0
Number of passes to achieve final reperfusion as reported by the investigator. The data will be reported by the investigator on a case report form.
Timepoint [6] 388809 0
At the time of the procedure
Secondary outcome [7] 388810 0
Rate of distal embolization of clot to new territories as determined by angiography
Timepoint [7] 388810 0
At the time of the procedure
Secondary outcome [8] 388811 0
Rate of non-device related symptomatic intracranial haemorrhage, as reported by the investigator and verified by an independent reviewer. The data will be reported by the investigator on a case report form.
Timepoint [8] 388811 0
Within 36 hours of the procedure
Secondary outcome [9] 388812 0
All-cause mortality
Timepoint [9] 388812 0
Within 30 days and 90 days of the procedure

Eligibility
Key inclusion criteria
1. Patients age greater than or equal to 18 years.
2. Pre-stroke mRS of less than or equal to 2.
3. NIHSS score of greater than or equal to 6.
4. Single LVO of the intracranial ICA or M1 segment of the MCA as confirmed through non-invasive neuroimaging (CTA or MRA).
5. ASPECTS 6-10 on baseline CT OR volume of irreversibly injured brain tissue visually assessed as less than or equal to 50 ml using CT perfusion or MRI.
6. The neurointerventionalist estimates that at least one deployment of the Millipede device can be completed within 24 hours of time last known well.
7. IV-tPA, if used, was initiated using standard institutional and national guideline criteria.
8. The patient, the patient’s legally authorised representative or person responsible has signed and dated an Informed Consent Form per local Ethics Committee (EC) and institutional requirements.
9. Digital subtraction angiographic confirmation of an intracranial ICA or M1 occlusion with mTICI 0 or 1.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
1. Female subject who is known to be pregnant or breastfeeding.
2. Intracranial haemorrhage (ICH) identified by CT or MRI.
3. Subject has known diagnosis of bilateral acute stroke.
4. Patient presents with an NIHSS score of less than or equal to 5.
5. Presence of pre-existing large (>50 ml) vessel infarction.
6. Subject is known to have more than one target intracranial occlusion or a tandem occlusion.
7. Subject has a known history of severe intracranial atherosclerotic disease (ICAD).
8. Evidence of dissection in the cervical or cerebral arteries.
9. Evidence of internal carotid artery stenosis or fibromuscular dysplasia in the target circulation which could preclude placement of the device.
10. Subject is known to be participating in another investigational drug or device study.

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)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Who is / are masked / blinded?



Intervention assignment
Other design features
Phase
Not Applicable
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Withdrawn
Reason for early stopping/withdrawal
Other reasons/comments
Other reasons
Change in company strategy
Date of first participant enrolment
Anticipated
29/03/2021
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
10
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
VIC

Funding & Sponsors
Funding source category [1] 307194 0
Commercial sector/Industry
Name [1] 307194 0
Perfuze
Country [1] 307194 0
Ireland
Primary sponsor type
Commercial sector/Industry
Name
Perfuze
Address
Unit 6, Galway Business Park, Dangan, Galway, H91 W7CP
Country
Ireland
Secondary sponsor category [1] 307800 0
None
Name [1] 307800 0
Address [1] 307800 0
Country [1] 307800 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 307303 0
Monash Health Human Research Ethics Committee
Ethics committee address [1] 307303 0
Ethics committee country [1] 307303 0
Australia
Date submitted for ethics approval [1] 307303 0
12/05/2020
Approval date [1] 307303 0
21/01/2021
Ethics approval number [1] 307303 0

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

Contacts
Principal investigator
Name 106754 0
A/Prof Ronil V. Chandra
Address 106754 0
Head of NeuroInterventional Radiology
Monash Health,
246 Clayton Road,
Clayton VIC 3168
Country 106754 0
Australia
Phone 106754 0
+61 3 9594 7649
Fax 106754 0
Email 106754 0
[email protected]
Contact person for public queries
Name 106755 0
Ronil V. Chandra
Address 106755 0
Head of NeuroInterventional Radiology
Monash Health,
246 Clayton Road,
Clayton VIC 3168
Country 106755 0
Australia
Phone 106755 0
+61 3 9594 7649
Fax 106755 0
Email 106755 0
[email protected]
Contact person for scientific queries
Name 106756 0
Ronil V. Chandra
Address 106756 0
Head of NeuroInterventional Radiology
Monash Health,
246 Clayton Road,
Clayton VIC 3168
Country 106756 0
Australia
Phone 106756 0
+61 3 9594 7649
Fax 106756 0
Email 106756 0
[email protected]

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.