Stroke Clinical Trial
Official title:
Akute Rekanalisation Eines ischämischen Schlaganfalls Mittels pREset
ARTESp is a prospective multicenter study in which the pREset thrombectomy system (phenox
GmbH* Germany) will be examined. The effectiveness, safety and the long-term success when
using the pREset to treat acute occlusions of cerebral vessels will be analyzed.
*German: "Gesellschaft mit beschränkter Haftung", limited liability company
ARTESp is a prospective multicenter study in which the pREset thrombectomy system (phenox
GmbH Germany) will be examined. The effectiveness, safety and the long-term success when
using the pREset to treat acute occlusions of cerebral vessels will be analyzed.
In this study the market-approved, self-expandable stent retriever (pREset, phenox GmbH,
Germany) will be used to achieve a direct flow recovery.
The thrombectomy system will be unfolded directly in the vessel occlusion. In a second step,
the system and the thrombus will be pulled back into the guide catheter.
It is planned to enroll 100 patients at the age of 18 until 85 years, with a NIHSS (National
Institutes of Health Stroke Scale) ≥ 8 and ≤ 30. The preconditions for study enrollment are
the written consent of the patient or of the legal representative and the fulfillment of all
mentioned inclusion and exclusion criteria. Pregnant women are excluded from study
participation.The clinical interventions are in accordance with the clinical standard of
care for the treatment of this patient population.
The mRS (Modified Rankin Scale) on day 30, the NIHSS on day 90 and an imaging procedure on
day 90 may be performed by the study site provided that it corresponds to the clinical
standards of the study site.
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Observational Model: Cohort, Time Perspective: Prospective
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