Acute Recanalization of Thrombo-Embolic Ischemic Stroke With pREset (ARTESp)
ARTESp
1 other identifier
observational
115
1 country
4
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
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for all trials
Started Feb 2013
Typical duration for all trials
4 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
February 1, 2013
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 1, 2015
CompletedFirst Submitted
Initial submission to the registry
April 28, 2015
CompletedFirst Posted
Study publicly available on registry
May 7, 2015
CompletedStudy Completion
Last participant's last visit for all outcomes
August 1, 2015
CompletedResults Posted
Study results publicly available
November 6, 2015
CompletedAugust 23, 2017
July 1, 2017
2.1 years
April 28, 2015
September 3, 2015
July 19, 2017
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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; 1. = able to carry out all usual duties and activities; 2. = unable to carry out all previous activities, but able to look after own affairs without assistance; 3. = requiring some help, but able to walk without assistance; 4. = unable to walk without assistance and unable to attend to own bodily needs without assistance; 5. = bedridden, incontinent and requiring constant nursing care and attention; 6. = dead
90 days after treatment
Secondary Outcomes (5)
Neurological Condition of the Patient
24 to 72 hr after treatment
Intracranial Hemorrhage (ICH)
24 hr after treatment
Time From Groin Puncture to Recanalization
during intervention, up to 3 hr
Recanalization of the Target Vessel
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
Interventions
Interventional recanalization of acute cerebral vessel occlusions with the pREset thrombectomy system alone or in combination with intravenous or intraarterial thrombolytics (rt-PA).
Eligibility Criteria
100 patients harboring an acute ischemic stroke in at least one of the major intracranial arteries
You may qualify if:
- 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.
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Phenox GmbHlead
Study Sites (4)
Katharinenhospital
Stuttgart, Baden-Wurttemberg, 70174, Germany
Klinikum rechts der Isar
München, Bavaria, 81675, Germany
Universitätsklinikum Münster
Münster, North Rhine-Westphalia, 48149, Germany
Universitätsklinikum des Saarlandes
Homburg, Saarland, 66424, Germany
Related Publications (1)
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.
PMID: 27530601DERIVED
Related Links
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Results Point of Contact
- Title
- Clinical Affairs
- Organization
- phenox GmbH
Study Officials
- PRINCIPAL INVESTIGATOR
Wolfgang Reith, Prof.
Universitätsklinikum des Saarlands
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- OTHER
- Restrictive Agreement
- Yes
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
April 28, 2015
First Posted
May 7, 2015
Study Start
February 1, 2013
Primary Completion
March 1, 2015
Study Completion
August 1, 2015
Last Updated
August 23, 2017
Results First Posted
November 6, 2015
Record last verified: 2017-07