Clinical trial NCT02437409: Acute Recanalization of Thrombo-Embolic Ischemic Stroke With pREset (ARTESp)
Official title: Acute Recanalization of Thrombo-Embolic Ischemic Stroke With pREset (ARTESp)
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Stroke
Keywords: Ischemic, Acute
Lead sponsor: Phenox GmbH
Sponsor class: INDUSTRY
First posted: 2015-05-07
Enrollment: 115
Sex: ALL
Minimum age (years): 18
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: 100 patients harboring an acute ischemic stroke in at least one of the major intracranial arteries

Brief 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.

Eligibility criteria: 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

Primary outcomes:
measure: Neurological Condition of the Patient
timeFrame: 90 days after treatment
Secondary outcomes:
measure: Neurological Condition of the Patient
timeFrame: 24 to 72 hr after treatment
measure: Intracranial Hemorrhage (ICH)
timeFrame: 24 hr after treatment
measure: Time From Groin Puncture to Recanalization
timeFrame: during intervention, up to 3 hr
measure: Recanalization of the Target Vessel
timeFrame: at the end of intervention, up to 3 hr
measure: No. of Passages Needed to Reach the Final TICI Score With pREset
timeFrame: during intervention, up to 3 hr
Other outcomes:
Locations:
city: Stuttgart
country: Germany
facility: Katharinenhospital
state: Baden-Württemberg
city: München
country: Germany
facility: Klinikum rechts der Isar
state: Bayern
city: Münster
country: Germany
facility: Universitätsklinikum Münster
state: Nordrhein-Westfalen
city: Homburg
country: Germany
facility: Universitätsklinikum des Saarlandes
state: Saarland
Study officials:
affiliation: Universitätsklinikum des Saarlands
name: Wolfgang Reith, Prof.
role: PRINCIPAL_INVESTIGATOR
References:
citation: Prothmann S, Schwaiger BJ, Gersing AS, Reith W, Niederstadt T, Felber A, Kurre W. Acute Recanalization of Thrombo-Embolic Ischemic Stroke with pREset (ARTESp): the impact of occlusion time on clinical outcome of directly admitted and transferred patients. J Neurointerv Surg. 2017 Sep;9(9):817-822. doi: 10.1136/neurintsurg-2016-012556. Epub 2016 Aug 16.