A Prospective, Multicenter, Observational, Single-arm European Registry on the ACE Reperfusion Catheters and the Penumbra System in the Treatment of Acute Ischemic Stroke

Project

A Prospective, Multicenter, Observational, Single-arm European Registry on the ACE Reperfusion Catheters and the Penumbra System in the Treatment of Acute Ischemic Stroke

Completed · 2016 until 2017

Vehoff Jochen, Kägi Georg, Müller Anna

Type

Clinical Studies

Range

Multicentric, KSSG as participating partner

Units

Neurologie

Status

Completed

Start Date

2016

End Date

2017

Financing

Industry

Study Design

Prospective, single-arm, multicenter, observational registry of the ACE Reperfusion Catheters and the Penumbra System in Europe.

Keywords

prospective, single-arm, multicenter, observational, registry, ACE Reperfusion Catheter, Penumbra System, acute ischemic stroke, internal carotid artery, internal carotid terminus, middle cerebral artery, M1/M2 segments, anterior circulation large vessel occlusion (LVO), ADAPT technique, thrombo-aspiration, routine practice

Brief description/objective

Study Objective:
To observe the safety and effectiveness of the ACE Reperfusion Catheters and the Penumbra System in patients with acute ischemic stroke from large vessel occlusion, treated with the ADAPT technique in site routine practice.

Study Devices:
ACE™ Reperfusion Catheters and the Penumbra System. All devices received CE-mark and are used according to the Instructions For Use.

Study Design:
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.