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Trial record 1 of 1 for:    NCT04457479
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APERIO® HYBRID Thrombectomy Device for Flow Restoration in Vessels of Patients Experiencing Acute Ischemic Stroke

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04457479
Recruitment Status : Active, not recruiting
First Posted : July 7, 2020
Last Update Posted : July 7, 2020
Sponsor:
Information provided by (Responsible Party):
Acandis GmbH

Study Description
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Brief Summary:
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 Thrombectomy Device in clinical practice. APERIO® Hybrid Thrombectomy Device will be used within its approved indication.

Condition or disease
Acute Stroke

Detailed Description:

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: 13 participating centers in Germany planned

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

Estimated Enrolment: 430 patients treated with APERIO® HYBRID Thrombectomy

Device as a result of an acute stroke

Follow up: 3 months

Estimated Final Assessment: End of 2022

Study Design
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Study Type : Observational [Patient Registry]
Estimated Enrollment : 430 participants
Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration: 3 Months
Official Title: APERIO® HYBRID Thrombectomy Device for Flow Restoration in Vessels of Patients Experiencing Acute Ischemic Stroke
Actual Study Start Date : July 1, 2020
Estimated Primary Completion Date : December 2022
Estimated Study Completion Date : January 2023
Groups and Cohorts
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Outcome Measures
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Primary Outcome Measures :
  1. Technical success [ Time Frame: until 24 hours after intervention ]
    mTICI ≥ 2b APERIO® HYBRID

  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 Outcome Measures :
  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)


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
All patients treated with APERIO® HYBRID Thrombectomy Device as a result of an acute stroke Patient age < 18 years Pre stroke mRS ≥ 3
Criteria

Inclusion Criteria:

- All patients treated with APERIO® HYBRID Thrombectomy Device as a result of an acute stroke.

Exclusion Criteria:

  • Patient age < 18 years
  • Pre stroke mRS ≥ 3
Contacts and Locations
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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): NCT04457479


Locations
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Germany
Evangelisches Krankenhaus Oldenburg
Oldenburg, Germany, 26122
Sponsors and Collaborators
Acandis GmbH
More Information
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Responsible Party: Acandis GmbH
ClinicalTrials.gov Identifier: NCT04457479    
Other Study ID Numbers: HYBRID
First Posted: July 7, 2020    Key Record Dates
Last Update Posted: July 7, 2020
Last Verified: July 2020

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Stroke
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
 Nervous System Diseases
Vascular Diseases
Cardiovascular Diseases