Acute Recanalization of Thrombo-Embolic Ischemic Stroke With pREset (ARTESp) "ARTESp"

Completed

Phase N/A Results

Trial Description

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

Detailed Description

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.

Conditions

Interventions

  • PREset thrombectomy retriever Device
    Intervention Desc: Interventional recanalization of acute cerebral vessel occlusions with the pREset thrombectomy system alone or in combination with intravenous or intraarterial thrombolytics (rt-PA).

Trial Design

  • Observation: Cohort
  • Perspective: Prospective
  • Sampling: Non-Probability Sample

Trial Population

100 patient harboring an acute ischemic stroke in at least one of the major intracranial arteries

Outcomes

Type Measure Time Frame Safety Issue
Primary Neurological condition of the patient 90 days after treatment Yes
Secondary Recanalization of the target vessel immediately after treatment, an expected average of 1 hour No
Secondary Patient safety 24 hr after treatment Yes
Secondary Time from groin puncture to recanalization during treatment (an expected average of 1h) No
Secondary No. of passages needed to reach the final TICI score with pREset while treatment (an expected average of 1h) No

Sponsors