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Completed

NCT Number: NCT04457479

APERIO® HYBRID Thrombectomy Device for Flow Restoration in Vessels of Patients Experiencing Acute Ischemic Stroke

This is a prospective, multicenter, single-arm, open-label, national Post-Market Clinical Follow-up study to collect comprehensive information on technical and clinical success and safety of the use of APERIO® Hybrid(17/21) Thrombectomy Device in clinical practice. APERIO® Hybrid(17/21) Thrombectomy Device will be used within its approved indication.

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Key information

Conditions

Acute Stroke Brain Diseases Cardiovascular Diseases Central Nervous System Diseases Cerebrovascular Disorders Nervous System Diseases Stroke Vascular Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Evangelisches Krankenhaus Oldenburg

Oldenburg, 26122, Germany

About this study

German APERIO® Hybrid Post- Market Clinical Follow-up Study

APERIO® Hybrid PMCF Study- Thrombectomy device for flow restoration in vessels of patients experiencing acute ischemic stroke

Study Type: prospective, multicenter, single-armed, open-label

Participants: 8 participating centers in Germany

PI: Dr. Christian Mathys, Evangelisches Krankenhaus Oldenburg, Germany

Estimated Enrolment: 190 patients treated with APERIO® HYBRID(17/21) Thrombectomy Device as a result of an acute stroke

Follow up: 3 months

Estimated Final Assessment: Mid to End of 2023

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • All patients treated with APERIO® HYBRID and/or APERIO® Hybrid(17/21) Thrombectomy Device as a result of an acute stroke.

Exclusion criteria

  • Patient age < 18 years
  • Pre stroke mRS ≥ 3

Treatment and study plan

Primary outcomes

  1. Technical success

    Time frame: until 24 hours after intervention

    mTICI ≥ 2b after treatment with APERIO® HYBRID(17/21)

  2. Good clinical outcome at 90 days

    Time frame: 90 days after intervention

    Modified Rankin Scale (mRS) < 3 (mRS 1= no symptoms/ good outcome; mRS 6= Patient died/ worse outcome)

  3. Periprocural symptomatic intracranial hemorrhage (sICH):

    Time frame: until 24 hours after intervention

    ICH in postinterventional (<24 hours) CT associated with worsening of NIHSS by ≥ 4 points within 24 hours

Secondary outcomes

  1. Cerebrovascular events until hospital discharge:

    Time frame: between 24 hours after intervention and discharge from hospital

    • Intracranial haemorrhage (symptomatic / asymptomatic)
    • Death
    • TIA in the region of the target vessel
    • Non-disabling ischemic stroke (MRS 0-2) in the region of the target vessel
    • Disabling ischemic stroke (MRS 3-6) in the region of the target vessel
    • TIA outside the region of the target vessel
    • Non-disabling ischemic stroke (MRS 0-2) outside the region of the target vessel
    • Disabling ischemic stroke (MRS 3-6) outside the region of the target vessel

  2. Cerebrovascular events at 90 days

    Time frame: at 90 days

    • Intracranial haemorrhage (symptomatic / asymptomatic)
    • Death
    • TIA
    • Non-disabling ischemic stroke (MRS 0-2)
    • Disabling ischemic stroke (MRS 3-6)

Sponsors and collaborators

Lead sponsor

Acandis GmbH

Industry

Registry information

Important dates

Study start
2020
Primary completion
2023
Study completion
2023
First posted
Jul 7, 2020
Registry last updated
Aug 14, 2023

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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