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

phenox

Status: Completed

Conditions: Stroke

Treatments: Device: pREset thrombectomy retriever

Study type: Observational

Funder types: Industry

Identifiers

NCT02437409

T01-072012

Details and patient eligibility

About

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

Full 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.

Enrollment: 115 patients

Sex: All

Ages: 18 to 85 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Patient age ≥ 18 and ≤ 85 years.
• Patients with acute-onset stroke in the 0-6 hour time window for cerebral onset of symptoms and in angiography with a TICI reperfusion (Thrombolysis in Cerebral Infarction) value of 0 or 1 of at least one major cerebral artery (carotid artery, A. media , anterior cerebral artery, basilar artery, vertebral artery, posterior cerebral artery).
• NIHSS (National Institutes of Health Stroke Scale) ≥ 8
• Signed Informed Consent by patient / legal representative to participate in the study.

Exclusion criteria

• Pregnancy
• Demarcated infarcted area in the initial Cranial CT or intracranial haemorrhage,
• Rapid improvement of neurological symptoms
• NIHSS > 30
• Anticoagulation with warfarin with INR (international normalized ratio) > 3.0,
• Platelets <30,000,
• Glucose <50mg/dl,
• Life expectancy <90 days