Overview

This trial is active, not recruiting.

Condition stroke
Treatment preset thrombectomy retriever
Sponsor Phenox GmbH
Start date February 2013
End date June 2015
Trial size 100 participants
Trial identifier NCT02437409, T01-072012

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

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Observational model cohort
Time perspective prospective

Primary Outcomes

Measure
Neurological condition of the patient
time frame: 90 days after treatment

Secondary Outcomes

Measure
Recanalization of the target vessel
time frame: immediately after treatment, an expected average of 1 hour
Neurological condition of the patient
time frame: 24 - 72 hr after treatment and at discharge (an expected average of 7 days)
Neurological condition of the patient
time frame: 24 hr after treatment
Patient safety
time frame: 24 hr after treatment
Time from groin puncture to recanalization
time frame: during treatment (an expected average of 1h)
Recanalization of the target vessel
time frame: after final recanalization (an expected average of 1h)
No. of passages needed to reach the final TICI score with pREset
time frame: while treatment (an expected average of 1h)

Eligibility Criteria

Male or female participants from 18 years up to 85 years old.

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, A. media , anterior cerebral artery, basilar artery, vertebral artery, posterior cerebral artery). - NIHSS ≥ 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 - NHISS > 30 - Anticoagulation with warfarin with INR (international normalized ratio) > 3.0, - Platelets <30,000, - Glucose <50mg/dl, - Life expectancy <90 days

Additional Information

Official title Akute Rekanalisation Eines ischämischen Schlaganfalls Mittels pREset
Principal investigator Wolfgang Reith, Prof.
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.
Trial information was received from ClinicalTrials.gov and was last updated in May 2015.
Information provided to ClinicalTrials.gov by Phenox GmbH.