European Registry on the ACE Reperfusion Catheters and the Penumbra System in the Treatment of Acute Ischemic Stroke

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

204 participants

Study Classification

OBSERVATIONAL

Study Start Date

2016-02-29

Study Completion Date

2017-11-30

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Ischemic Stroke

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Penumbra Aspiration System

Penumbra Aspiration System with the ADAPT technique

Penumbra Aspiration System

Intervention Type DEVICE

Penumbra Aspiration System using the ADAPT technique for recanalization of an occlusion large vessel in the brain

Interventions

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Penumbra Aspiration System

Penumbra Aspiration System using the ADAPT technique for recanalization of an occlusion large vessel in the brain

Intervention Type DEVICE

Eligibility Criteria

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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.

• CT ASPECT score from 6 to 10 (\>6) or according to MR DWI ASPECT score from 5 to 10 (\>5).

Exclusion Criteria

* Associated myocardial infarction or severe infection (endocarditis or sepsis)
* Laboratory evidence of coagulation abnormalities, with an International Normalized Ratio (INR) of \> 3.0 or platelets count \< 40 x109/L or APTT \> 50 sec
* Uncontrolled hypertension (defined as systolic blood pressure \> 185 mmHg or diastolic blood pressure \> 110 mmHg)
* Baseline glucose \< 2.7 or \> 22.2 mmol/L
* Pre-stroke mRS score \> 2
* Seizure at the onset of stroke
* Arterial tortuosity that would prevent the device from reaching the target vessel
* Time of stroke symptoms onset unknown
* Life expectancy less than 90 days prior to stroke onset
* Females who are pregnant or lactating
* Known serious sensitivity to radiographic contrast media.

* CT/MRI evidence of the following conditions at screening:

* Significant mass effect with midline shift
* Evidence of intracranial hemorrhage (ICH), aneurysm, or arteriovenous malformation (AVM)
* Angiographic evidence of tandem extracranial occlusion or an arterial stenosis proximal to the occlusion that requires treatment prior to thrombus removal. Moderate stenosis not requiring treatment is not an exclusion criterion.
* Angiographic evidence of preexisting arterial injury, such as carotid dissection, complete cervical carotid occlusion, or vasculitis.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No