Ischemic Stroke
Conditions
Brief summary
Prospective, single-arm, multicenter, observational registry of the ACE Reperfusion Catheters and the Penumbra System in Europe. Consecutive patients presenting within 6 hours from symptom onset with an acute ischemic stroke (within the internal carotid artery and internal carotid terminus, middle cerebral - M1/M2 segments) due to anterior circulation large vessel occlusion (LVO) will be treated using the ADAPT technique with thrombo-aspiration as first intention and site routine practice.
Detailed description
Prospective, single-arm, multicenter, observational registry of the ACE Reperfusion Catheters and the Penumbra System in Europe. Consecutive patients presenting within 6 hours from symptom onset with an acute ischemic stroke (within the internal carotid artery and internal carotid terminus, middle cerebral - M1/M2 segments) due to anterior circulation large vessel occlusion (LVO) will be treated using the ADAPT technique with thrombo-aspiration as first intention and site routine practice. The follow-up visit will occur 24 hours, 7-10 days or discharge, 30 days and 90 days post-procedure and will review patient's functional outcome, quality of life, and adverse events.
Interventions
DEVICEPenumbra Aspiration System
Penumbra Aspiration System using the ADAPT technique for recanalization of an occlusion large vessel in the brain
Sponsors
Penumbra Inc.
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* General inclusion criteria: * From 18 years of age * Present with symptoms consistent with an acute ischemic stroke within 6 hours of stroke symptom onset * Arterial occlusion of the distal intracranial carotid artery (ICA and ICA terminus) or middle cerebral artery (M1/M2) * National Institute of Health Stroke Scale (NIHSS) ≥ 2 * Signed Informed Consent Form. Imaging inclusion criteria: • CT ASPECT score from 6 to 10 (\>6) or according to MR DWI ASPECT score from 5 to 10 (\>5).
Exclusion criteria
* General
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Angiographic revascularization of the occluded target vessel at immediate post-procedure as defined by a TICI 2b or 3 score. | Immediate post-procedure |
| Functional patient outcome at 90 days post-procedure as defined by a modified Rankin Score (mRS) 0-2. | 90 days post-procedure |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Incidence of device and procedure related Serious Adverse Events (SAEs) at 24 hours and 30 days from stroke treatment | 24 hours and 30 days from stroke treatment | — |
| All causes of mortality and morbidity at 90 days | 90 days | — |
| Occurrence of embolization in previously uninvolved (or new) territories (ENT) as seen on the final control angiogram at the end of procedure | At the end of interventional surgical procedure | — |
| Occurrence of vessel damages at the end of the ADAPT procedure. | At the end of the interventional surgical procedure | — |
| Times to revascularization | From symptom onset to various times during the interventional surgical procedure | * From symptom onset to CT-scan/MRI at the institution * From CT-scan/MRI at the institution to groin access * From groin puncture to final revascularization result. |
| Quality of Life: EQ-5D 3L score at 90 days compared to the one at 7-10 days post-procedure. | 90 days | — |
| Heath Economics: Total duration of hospitalization with related healthcare resources | Average time frame 3-7 days. | * Health care professionals encountered/consulted before/after intervention * Tests performed before/after intervention. |
| Occurrence of symptomatic intracranial hemorrhages (sICH) at 24 hours | 24 hours | — |
| NIHSS score at 7-10 days post-procedure. | 7-10 days post-procedure | — |
Countries
Germany
Outcome results
None listed