NCT02437409

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

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 115 (actual)
• Sponsor: Phenox GmbH · Industry
• Sex: All
• Age: 18 Years – 85 Years
• Healthy volunteers: Not accepted

Summary

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

• Stroke

Interventions

Type	Name	Description
DEVICE	pREset thrombectomy retriever	Interventional recanalization of acute cerebral vessel occlusions with the pREset thrombectomy system alone or in combination with intravenous or intraarterial thrombolytics (rt-PA).

Timeline

• Start date: 2013-02-01
• Primary completion: 2015-03-01
• Completion: 2015-08-01
• First posted: 2015-05-07
• Last updated: 2017-08-23
• Results posted: 2015-11-06

Locations

4 sites across 1 country: Germany