RED Penumbra System Registry

Conditions

None listed

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.

Related papers

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Interventions

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 As

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.

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Healthy volunteers

No

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).

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.

Outcome results