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

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ClinicalTrials.gov Identifier: NCT02437409
Recruitment Status : Completed
First Posted : May 7, 2015
Results First Posted : November 6, 2015
Last Update Posted : August 23, 2017
Sponsor:
Information provided by (Responsible Party):
Phenox GmbH

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


Condition or disease Intervention/treatment
Stroke 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.

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Study Type : Observational
Actual Enrollment : 115 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Acute Recanalization of Thrombo-Embolic Ischemic Stroke With pREset (ARTESp)
Study Start Date : February 2013
Actual Primary Completion Date : March 2015
Actual Study Completion Date : August 2015

Intervention Details:
  • Device: pREset thrombectomy retriever
    Interventional recanalization of acute cerebral vessel occlusions with the pREset thrombectomy system alone or in combination with intravenous or intraarterial thrombolytics (rt-PA).


Primary Outcome Measures :
  1. Neurological Condition of the Patient [ Time Frame: 90 days after treatment ]

    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


Secondary Outcome Measures :
  1. Neurological Condition of the Patient [ Time Frame: 24 to 72 hr after treatment ]

    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:

    1. Level of Conciousness (LOC) (0-3) 1a. LOC Questions (0-2) 1b. LOC Commands (0-2)
    2. Best Gaze (0-2)
    3. Visual (0-3)
    4. Facial palsy (0-3)
    5. Motor arm (0-4)
    6. Motor leg (0-4)
    7. Limb ataxia (0-2)
    8. Sensory (0-2)
    9. Best Language (0-3)
    10. Dysarthria (0-2)
    11. 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


  2. Intracranial Hemorrhage (ICH) [ Time Frame: 24 hr after treatment ]
    Intracranial hemorrhage was assessed via imaging material (e.g. Digital Subtraction Angiography - DSA or CT) as forwarded by the clinical sites.

  3. Time From Groin Puncture to Recanalization [ Time Frame: during intervention, up to 3 hr ]
  4. Recanalization of the Target Vessel [ Time Frame: at the end of intervention, up to 3 hr ]

    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.


  5. No. of Passages Needed to Reach the Final TICI Score With pREset [ Time Frame: during intervention, up to 3 hr ]


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years to 85 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
100 patients harboring an acute ischemic stroke in at least one of the major intracranial arteries
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02437409


Locations
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Germany
Katharinenhospital
Stuttgart, Baden-Württemberg, Germany, 70174
Klinikum rechts der Isar
München, Bayern, Germany, 81675
Universitätsklinikum Münster
Münster, Nordrhein-Westfalen, Germany, 48149
Universitätsklinikum des Saarlandes
Homburg, Saarland, Germany, 66424
Sponsors and Collaborators
Phenox GmbH
Investigators
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Principal Investigator: Wolfgang Reith, Prof. Universitätsklinikum des Saarlands
Additional Information:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Phenox GmbH
ClinicalTrials.gov Identifier: NCT02437409    
Other Study ID Numbers: T01-072012
First Posted: May 7, 2015    Key Record Dates
Results First Posted: November 6, 2015
Last Update Posted: August 23, 2017
Last Verified: July 2017
Keywords provided by Phenox GmbH:
Ischemic, Acute
Additional relevant MeSH terms:
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Stroke
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Vascular Diseases
Cardiovascular Diseases