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NCT Number: NCT02437409

Acute Recanalization of Thrombo-Embolic Ischemic Stroke With pREset (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

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Key information

Conditions

Stroke Brain Diseases Cardiovascular Diseases Central Nervous System Diseases Cerebrovascular Disorders Ischemia Nervous System Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms Vascular Diseases

Age range

18 year–85 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Katharinenhospital, Stuttgart, Baden-Wurttemberg, Germany

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

pREset thrombectomy retriever

Device

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

Primary outcomes

  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;

    • = 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

Secondary outcomes

  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:

    • 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

  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

Sponsors and collaborators

Lead sponsor

Phenox GmbH

Industry

Registry information

Acronym: ARTESp

Important dates

Study start
2013
Primary completion
2015
Study completion
2015
First posted
May 7, 2015
Registry last updated
Aug 23, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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