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

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

Study Overview

• Status: Completed
• Conditions: Stroke
• Intervention / Treatment: Device: pREset thrombectomy retriever

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.

• Study Type: Observational
• Enrollment (Actual): 115

Contacts and Locations

Study Locations

• Germany
  • Baden-Württemberg
    • Stuttgart, Baden-Württemberg, Germany, 70174
      • Katharinenhospital
  • Bayern
    • München, Bayern, Germany, 81675
      • Klinikum rechts der Isar
  • Nordrhein-Westfalen
    • Münster, Nordrhein-Westfalen, Germany, 48149
      • Universitatsklinikum Münster
  • Saarland
    • Homburg, Saarland, Germany, 66424
      • Universitätsklinikum des Saarlandes

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 85 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

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

Description

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

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Neurological Condition of the Patient	modified Rankin Scale (mRS) Neurological Condition is measured by the "Modified Rankin Scale (mRS)". This scale ranges from 0 - 6: 0 = No symptoms at all; = able to carry out all usual duties and activities;; = unable to carry out all previous activities, but able to look after own affairs without assistance;; = requiring some help, but able to walk without assistance;; = unable to walk without assistance and unable to attend to own bodily needs without assistance;; = bedridden, incontinent and requiring constant nursing care and attention;; = dead	90 days after treatment

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Neurological Condition of the Patient	The National Institutes of Health Stroke Scale (NIHSS) is a commonly used measure to assess the severity of a stroke. All items are rated and scores are added at the end. A higher score corresponds to a more severe stroke. Assessed are: Level of Conciousness (LOC) (0-3) 1a. LOC Questions (0-2) 1b. LOC Commands (0-2); Best Gaze (0-2); Visual (0-3); Facial palsy (0-3); Motor arm (0-4); Motor leg (0-4); Limb ataxia (0-2); Sensory (0-2); Best Language (0-3); Dysarthria (0-2); Extinction and Inattention (0-2) CLASSIFICATION: 0 No stroke symptoms 1-4 Minor stroke 5-15 Moderate stroke 16-20 Moderate to severe stroke 21-42 Severe stroke As published by ninds.nih.gov: http://www.ninds.nih.gov/doctors/NIH_Stroke_Scale.pdf	24 to 72 hr after treatment
Intracranial Hemorrhage (ICH)	Intracranial hemorrhage was assessed via imaging material (e.g. Digital Subtraction Angiography - DSA or CT) as forwarded by the clinical sites.	24 hr after treatment
Time From Groin Puncture to Recanalization		during intervention, up to 3 hr
Recanalization of the Target Vessel	original Thrombolysis in Cerebral Infarction score (o-TICI) The TICI scale indicates perfusion of an occluded blood vessel, it is used in angiographic imaging. Grade 0 = no perfusion Grade 1 = Penetration with minimal perfusion. The contrast material passes beyond the area of obstruction but fails to opacify the entire cerebral bed distal to the obstruction for the duration of the angiographic run, Grade 2a = Only partial filling (<2/3) of the entire vascular territory is visualized, Grade 2b = Complete filling of all of the expected vascular territory is visualized, but the filling is slower than normal, Grade 3 = complete perfusion.	at the end of intervention, up to 3 hr
No. of Passages Needed to Reach the Final TICI Score With pREset		during intervention, up to 3 hr

Collaborators and Investigators

• Sponsor: Phenox GmbH
• Investigators: Principal Investigator: Wolfgang Reith, Prof., Universitätsklinikum des Saarlands

Publications and helpful links

General Publications

• 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.

Helpful Links

• phenox GmbH

Study record dates

Study Major Dates

• Study Start: February 1, 2013
• Primary Completion (Actual): March 1, 2015
• Study Completion (Actual): August 1, 2015

Study Registration Dates

• First Submitted: April 28, 2015
• First Submitted That Met QC Criteria: May 4, 2015
• First Posted (Estimate): May 7, 2015

Study Record Updates

• Last Update Posted (Actual): August 23, 2017
• Last Update Submitted That Met QC Criteria: July 19, 2017
• Last Verified: July 1, 2017

More Information

Terms related to this study

• Keywords: Ischemic, Acute
• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Stroke; Ischemic Stroke
• Other Study ID Numbers: T01-072012