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StrokeARTESpNCT02437409

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

An observational study of Stroke, run by Phenox GmbH at 4 sites in Germany.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 to 85 years
Conditions the study is for
Stroke
What is being tested?
pREset thrombectomy retriever
How many people
115 participants
Where
4 sitesGermany
Study dates
Feb 2013to Aug 2015
Phase
Observational
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 85 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

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

Who may be able to join

  • 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.

Who cannot join

  • 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

Trial locations and contacts

4 sites in 1 country.

Germany4 sites

  • Universitätsklinikum des Saarlandes

    Homburg, Saarland, 66424

  • Klinikum rechts der Isar

    München, Bavaria, 81675

  • Universitätsklinikum Münster

    Münster, North Rhine-Westphalia, 48149

  • Katharinenhospital

    Stuttgart, Baden-Wurttemberg, 70174

Other trials in Germany

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.

*German: "Gesellschaft mit beschränkter Haftung", limited liability company

Read the 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.

Conditions
Stroke
Being tested
pREset thrombectomy retriever
Keywords
Ischemic, Acute
Medical subject headings
Stroke, Ischemia

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • pREset thrombectomy retrieverDevice

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

What is being measured

The primary outcome is the main question the study is designed to answer.

  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

    Measured: 90 days after treatment

Secondary outcomes (5)

  1. 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:

    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

    Measured: 24 to 72 hr after treatment

  2. Intracranial Hemorrhage (ICH)

    Intracranial hemorrhage was assessed via imaging material (e.g. Digital Subtraction Angiography - DSA or CT) as forwarded by the clinical sites.

    Measured: 24 hr after treatment

  3. Time From Groin Puncture to Recanalization

    Measured: during intervention, up to 3 hr

  4. 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.

    Measured: at the end of intervention, up to 3 hr

  5. No. of Passages Needed to Reach the Final TICI Score With pREset

    Measured: during intervention, up to 3 hr

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted7 May 2015 (estimated)
  2. Study startFeb 2013
  3. Primary completionMar 2015
  4. Study completionAug 2015

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Prospective
Enrolment
115 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02437409
Sponsor's protocol ID
T01-072012
Acronym
ARTESp
Status last verified
Jul 2017
First submitted
28 Apr 2015
Last updated
23 Aug 2017
Data monitoring committee
No

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.

    PubMed 27530601

Questions about this trial

What is this clinical trial studying?

An observational study of Stroke, run by Phenox GmbH at 4 sites in Germany.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 23 Aug 2017. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 4 sites in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 6 Nov 2015). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Neurological Condition of the Patient (time frame: 90 days after treatment). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02437409, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Aug 2017.

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