Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12623001283662p
Ethics application status
Not yet submitted
Date submitted
28/06/2023
Date registered
8/12/2023
Date last updated
23/02/2024
Date data sharing statement initially provided
8/12/2023
Type of registration
Prospectively registered

Titles & IDs
Public title
RED Penumbra System Registry
Scientific title
A data registry of the efficacy and safety of Penumbra RED system in patients with acute ischemic stroke secondary to intracranial large vessel occlusion, requiring mechanical thrombectomy.
Secondary ID [1] 309996 0
Nil known
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
intracranial large vessel occlusion 330497 0
acute stroke 330498 0
Condition category
Condition code
Neurological 327344 327344 0 0
Other neurological disorders

Intervention/exposure
Study type
Observational
Patient registry
True
Target follow-up duration
90
Target follow-up type
Days
Description of intervention(s) / exposure
This will be a prospective, single-arm, multiple center observational registry which will include patients in whom the Penumbra RED System is used as part of a mechanical thrombectomy procedure to treat intracranial large vessel occlusion presenting with acute stroke (within 24 hours of stroke onset).

The “Penumbra RED system” includes a range of current generation large bore intracranial arterial thrombectomy catheters (RED-72, RED-68, RED-62, and RED-43) combined with pre-packaged Penumbra Aspiration Tubing, designed to be used with the Penumbra ENGINE suction machine.

The neurointerventionalist will determine which catheter (RED-72, RED-68, RED-62, and RED-43) to use on the day based on the size of the occlusion, the vessel and other factors.
This is a data registry. Only participants who are treated with the Penumbra RED system will have their safety data entered into the registry. There will be no direct patient contact. All data will be collected from medical records.

Procedural details including general anesthesic, arteriotomy site, time of arteriotomy, eTICI on first intracranial DSA, successful navigation of RED catheter to clot interface without stent-retriever, use of additional large bore aspiration catheter, use of stent-retriever device, number of passes, first pass effect (eTICI 2B-3 following first pass), date-time of first DSA demonstrating eTICI 2B-3, cervical carotid or vertebral artery stenting, are among the data we will be collecting.

Patient will be returning for follow-up at Day 1-30 and Day 90 post-procedure with final follow-up on Day 90 post procedure.
Intervention code [1] 326420 0
Not applicable
Comparator / control treatment
No control group
Control group
Uncontrolled

Outcomes
Primary outcome [1] 335215 0
Angiographic revascularization of the occluded target vessel at immediate post-procedure as defined by a modified treatment in cerebral infarction (eTICI) score.
Timepoint [1] 335215 0
Post Procedure
Primary outcome [2] 335216 0
Device-related Serious Adverse Events such as device malfunction will be assessed by the neurointerventionalist at the time of the procedure if the device malfunctions
Timepoint [2] 335216 0
Within 24 hours of procedure
Primary outcome [3] 335217 0
Time to Revascularization measured from arteriotomy to first digital subtraction angiography (DSA) demonstrating extended Thrombolysis in Cerebral Infarction (eTICI) grading of 2B to 3 reperfusion as seen on the DSA imaging.
Timepoint [3] 335217 0
During Procedure
Secondary outcome [1] 423524 0
Successful navigation of the Penumbra RED aspiration catheter to the clot interface without the use of a stent-retriever device seen via the DSA imaging
Timepoint [1] 423524 0
during Procedure
Secondary outcome [2] 423525 0
Emboli observed immediately after thrombectomy and in a previously unaffected territory, seen via the DSA imaging
Timepoint [2] 423525 0
during Procedure
Secondary outcome [3] 423526 0
Functional subject outcome at 90 days post-procedure as defined by a modified Rankin Scale.
Timepoint [3] 423526 0
90 days post procedure
Secondary outcome [4] 423527 0
All-cause mortality at 90 days.
Timepoint [4] 423527 0
90 days post procedure
Secondary outcome [5] 424560 0
Procedure-related serious adverse events (measured as primary outcome) such as intraprocedural arterial dissection
Timepoint [5] 424560 0
within 24 hours of procedure
Secondary outcome [6] 424562 0
The proportion of patients where the mTICI score is greater than or equal to 2b reperfusion was accomplished with the first pass (measured as primary outcome)
Timepoint [6] 424562 0
Intraprocedural

Eligibility
Key inclusion criteria
1. The patient would ordinarily be offered mechanical thrombectomy at the participating site, based on local protocols and standard of care.
2. The Penumbra RED system was used as the initial device to attempt to perform mechanical thrombectomy.
3. The neurointerventionist intended to perform aspiration thrombectomy by initially navigating the Penumbra RED catheter to the clot interface without the use of a stent-retriever device.
4. Stroke disease criteria
a. Patients presenting with acute ischaemic stroke within 24 hours of stroke onset.
b. Pre-stroke modified Rankin Score (mRS) score of 0-2.
c. Patients age equal and greater than 18 years.
d. NIHSS equal and greater than 5 or dysphasia if NIHSS <5.
e. CT imaging (non-contrast CT, CT angiography, +/- CT Perfusion) findings appropriate to offer mechanical thrombectomy according to the local investigator and local practices.
f. Arterial occlusion on CT Angiography (CTA) or MR Angiography (MRA) of the intracranial internal carotid artery (ICA), first the middle cerebral artery segment (MCA-M1), the second middle cerebral artery segment (MCA-M2), or the basilar artery (BA).
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
1. Any reason that mechanical thrombectomy would not ordinarily standard of care for this case at the local site (local investigators discretion).
2. Any intracranial haemorrhage at presentation identified by CT or MRI.
3. Rapidly improving symptoms at the discretion of the investigator.
4. Contraindication to imaging with iodinated contrast agents.
5. Any terminal illness such that the patient would not be expected to survive more than 1 year.
6. Currently undergoing treatment for cancer.
7. Any condition that, in the judgment of the investigator, could impose hazards to the patient if study therapy is initiated or affect the participation of the patient in the study.
8. Pregnant women.

Study design
Purpose
Duration
Selection
Timing
Statistical methods / analysis

Recruitment
Recruitment status
Withdrawn
Reason for early stopping/withdrawal
Other reasons/comments
Other reasons
Decided not to pursue this study
Date of first participant enrolment
Anticipated
1/01/2024
Actual
Date of last participant enrolment
Anticipated
1/01/2027
Actual
Date of last data collection
Anticipated
31/03/2027
Actual
Sample size
Target
100
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
SA,WA,VIC

Funding & Sponsors
Funding source category [1] 314173 0
Commercial sector/Industry
Name [1] 314173 0
Penumbra Inc
Country [1] 314173 0
United States of America
Primary sponsor type
Commercial sector/Industry
Name
Penumbra Inc
Address
1310 Harbor Bay ParkwayAlameda, CA 94502
Country
United States of America
Secondary sponsor category [1] 316091 0
None
Name [1] 316091 0
Address [1] 316091 0
Country [1] 316091 0

Ethics approval
Ethics application status
Not yet submitted
Ethics committee name [1] 313304 0
Sir Charles Gairdner and Osborne Park Health Care Group Human Research Ethics Committee
Ethics committee address [1] 313304 0
Level 2, A Block, QEII Medical Centre,Hospital Avenue, Nedlands 6009 WA
Ethics committee country [1] 313304 0
Australia
Date submitted for ethics approval [1] 313304 0
29/12/2023
Approval date [1] 313304 0
Ethics approval number [1] 313304 0

Summary
Brief summary
This will be a prospective, single-arm, multiple center observational registry which will include patients in whom the Penumbra RED System is used as part of a mechanical thrombectomy procedure to treat intracranial large vessel occlusion presenting with acute stroke.

Baseline patient information, relevant co-morbidities, stroke clinical data, procedural data, imaging (CT, DSA, MRI) data, periprocedural complication data, and clinical follow-up information at 90 days will be collected.

There is no alteration to the standard of care at the participating site.

The purpose of the registry is to collect and analyse data regarding the efficacy and safety of the TGA approved range of Penumbra RED thrombectomy catheters used with the Penumbra Aspiration Tubing and the Penumbra Machine suction pump (referred to together as the Penumbra RED System) that are already in clinical use at the participating sites.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 127666 0
Dr Timothy Phillips
Address 127666 0
The Neurological Intervention & Imaging Service of Western Australia [NIISwa] Level 1 G BlockHospital Avenue, Nedlands WA 6009
Country 127666 0
Australia
Phone 127666 0
+61 864573900
Fax 127666 0
Email 127666 0
timothy.phillips@health.wa.gov.au
Contact person for public queries
Name 127667 0
Dr Timothy Phillips
Address 127667 0
The Neurological Intervention & Imaging Service of Western Australia [NIISwa] Level 1 G BlockHospital Avenue, Nedlands WA 6009
Country 127667 0
Australia
Phone 127667 0
+61 864573900
Fax 127667 0
Email 127667 0
timothy.phillips@health.wa.gov.au
Contact person for scientific queries
Name 127668 0
Dr Timothy Phillips
Address 127668 0
The Neurological Intervention & Imaging Service of Western Australia [NIISwa] Level 1 G BlockHospital Avenue, Nedlands WA 6009
Country 127668 0
Australia
Phone 127668 0
+61 864573900
Fax 127668 0
Email 127668 0
timothy.phillips@health.wa.gov.au

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.