Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12618001703291p
Ethics application status
Submitted, not yet approved
Date submitted
5/10/2018
Date registered
16/10/2018
Date last updated
19/09/2019
Date data sharing statement initially provided
19/09/2019
Type of registration
Prospectively registered

Titles & IDs
Public title
Repair of Ruptured Brain Aneurysms with a Novel Stent Device and Oral Aspirin
Scientific title
Repair of Ruptured Intracranial Aneurysms Using the Pipeline Shield with Aspirin Monotherapy: A Multicentre, Prospective, Single-Arm Clinical Trial
Secondary ID [1] 296269 0
Nil known
Universal Trial Number (UTN)
U1111-1221-7470
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Ruptured intracranial aneurysm 309946 0
Condition category
Condition code
Stroke 308720 308720 0 0
Haemorrhagic

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The intervention will consist of endovascular delivery one or more Pipeline-Shield devices to treat patients with this particular subset of difficult aneurysms using aspirin as the sole antiplatelet agent. This will be done by experienced (CCINR-certified) interventional neuroradiologists. The procedure will be a once-only intervention, with follow up on imaging studies using a combination of MRI and angiography. Clinical follow up will also be obtained. The follow up period for this trial will be 6 months.

Aspirin will be administered as a 500mg intravenous dose during the procedure and continued orally or via nasogastric administration post procedurally, depending on the patients' level of consciousness at a dose of 100-300mg daily in single or divided dose. Compliance will be monitored during the inpatient period by medication charts, and during the outpatient phase by regular follow up phone calls with patients/carers and at gazetted clinical face-to-face meetings.
Intervention code [1] 312606 0
Treatment: Devices
Comparator / control treatment
No control group
Control group
Uncontrolled

Outcomes
Primary outcome [1] 307700 0
Stent patency (short term)

This will be assessed between days 5-15 with digital subtraction angiography.
Timepoint [1] 307700 0
5-15 days post treatment.

This timepoint varies from patient to patient and will only be assessed at a single timepoint within these days unless further angiography is required on clinical grounds.
Secondary outcome [1] 352570 0
Aneurysm occlusion (short term)
Timepoint [1] 352570 0
Day 5-15. Patients with this condition will require at least one digital subtraction angiogram during their admission in the 5-15 day window. This varies from patient to patient depending on their clinical need. The trial merely stipulates that at least one DSA should be done in this window.
Secondary outcome [2] 352571 0
Aneurysm occlusion (long term)
Day 5-15 DSA (as per above)
MRI at day 60 post treatment
DSA at 6 months
Timepoint [2] 352571 0
180 days post treatment
Secondary outcome [3] 352572 0
Stent patency (long term)
MRI at day 60 post treatment
DSA at 6 months
Timepoint [3] 352572 0
60 and 180 days post treatment
Secondary outcome [4] 352574 0
New cerebral ischaemia
MRI within 72 hours of treatment
MRI at day 60 post treatment
Timepoint [4] 352574 0
Within 72 hours of treatment and at 60 days post treatment
Secondary outcome [5] 352575 0
Haemorrhagic complications

These will be assessed based on clinical evaluation since they are usually symptomatic. Occasionally, silent haemorrhagic changes can be seen on MRI (therefore possibly visible on MRI scans as above).

Examples would include:
Intracerebral haemorrhage
Aneurysm rebleeding
Gastrointestinal bleeding
Excessive bruising
Menorrhagia
Epistaxis
Timepoint [5] 352575 0
Any haemorrhagic complication up to 180 days post treatment.

Eligibility
Key inclusion criteria
• 18 years or older
• Ruptured intradural aneurysm with morphology not amenable to conventional open or
endovascular repair
• Ruptured intracranial aneurysm unsuitable for open repair, requiring stent support for
endovascular therapy (EVT), but with contraindication to dual antiplatelet therapy, for
example:
o Requirement for immediate ventricular drainage
o Requirement for urgent craniotomy and haematoma evacuation
o Requirement for tracheostomy or other major surgical procedure
o Allergy to clopidogrel, prasugrel
• Criteria above to be evaluated by consultation between the duty open and endovascular
consultants at the participating centre.
• Verbal and written consent from patient and/or next of kin
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
• All ruptured aneurysms where conventional open neurosurgical and endovascular repair
techniques are deemed feasible by the open and endovascular consultant on duty
• Inability to obtain consent from patient or guardian/next of kin
• Contraindication or allergy to aspirin
Age <18 years

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)
N/A
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
N/A
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
Safety
Statistical methods / analysis

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
1/12/2019
Actual
Date of last participant enrolment
Anticipated
1/12/2021
Actual
Date of last data collection
Anticipated
1/12/2023
Actual
Sample size
Target
150
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW,QLD
Recruitment hospital [1] 12108 0
Prince of Wales Hospital - Randwick
Recruitment hospital [2] 12109 0
Liverpool Hospital - Liverpool
Recruitment hospital [3] 12110 0
Gold Coast University Hospital - Southport
Recruitment postcode(s) [1] 24276 0
2031 - Randwick
Recruitment postcode(s) [2] 24277 0
2170 - Liverpool
Recruitment postcode(s) [3] 24278 0
4215 - Southport

Funding & Sponsors
Funding source category [1] 300862 0
Commercial sector/Industry
Name [1] 300862 0
Medtronic
Country [1] 300862 0
Australia
Primary sponsor type
Individual
Name
Dr Jason Wenderoth
Address
Institute of Neurosciences
Level 2
High Street Building
Prince of Wales Hospital
Randwick NSW 2031
Country
Australia
Secondary sponsor category [1] 300418 0
None
Name [1] 300418 0
N/A
Address [1] 300418 0
N/A
Country [1] 300418 0
Other collaborator category [1] 280383 0
Individual
Name [1] 280383 0
Dr Nathan Manning
Address [1] 280383 0
Department of Interventional Neuroradiology
Liverpool Hospital
Elizabeth Street
Liverpool NSW 2170
Country [1] 280383 0
Australia
Other collaborator category [2] 280384 0
Individual
Name [2] 280384 0
Dr Hal Rice
Address [2] 280384 0
Interventional Neuroradiology Department
Gold Coast University Hospital
1 Hospital Blvd
Southport QLD 4215
Country [2] 280384 0
Australia

Ethics approval
Ethics application status
Submitted, not yet approved
Ethics committee name [1] 301637 0
South East Sydney Local Health District HREC
Ethics committee address [1] 301637 0
Prince of Wales Hospital
High Street
Randwick NSW 2031
Ethics committee country [1] 301637 0
Australia
Date submitted for ethics approval [1] 301637 0
13/09/2018
Approval date [1] 301637 0
Ethics approval number [1] 301637 0

Summary
Brief summary
Some brain aneurysms, when they bleed, are difficult or impossible to treat safely with "conventional" techniques.

There is a device similar to a stent which has been used for 10 years to repair some aneurysms, called the Pipeline Embolisation Device, which has previously needed aspirin plus a stronger blood thinner before inserting it to prevent the device clotting and causing a stroke.

The latest version of this device Pipeline-Shield), in use in Australia for 3 years now, has a coating which mimics the lining of blood vessels. This means that the stronger blood thinner may not be required to keep the device from clotting.

We have been using the Pipeline-Shield with aspirin only to treat some patients with these "impossible" aneurysms under compassionate use for 2 years with very promising results.

We hypothesise that using the device in this manner with aspirin only is safe, and that the device will clot only very rarely if used in this manner.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 87618 0
Dr Jason Wenderoth
Address 87618 0
Institute of Neurosciences
Prince of Wales Hospital
Level 2
High Street
Randwick NSW 2031
Country 87618 0
Australia
Phone 87618 0
+61 2 9382 1111
Fax 87618 0
Email 87618 0
[email protected]
Contact person for public queries
Name 87619 0
Dr Jason Wenderoth
Address 87619 0
Institute of Neurosciences
Prince of Wales Hospital
Level 2
High Street
Randwick NSW 2031
Country 87619 0
Australia
Phone 87619 0
+61 2 9382 1111
Fax 87619 0
Email 87619 0
[email protected]
Contact person for scientific queries
Name 87620 0
Dr Jason Wenderoth
Address 87620 0
Institute of Neurosciences
Prince of Wales Hospital
Level 2
High Street
Randwick NSW 2031
Country 87620 0
Australia
Phone 87620 0
+61 2 9382 1111
Fax 87620 0
Email 87620 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
Protect patient privacy


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.