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Trial record 1 of 1 for:    NCT04479020
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REcanalization of Distal Cerebral Vessels In Acute Stroke Using ApeRio®

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ClinicalTrials.gov Identifier: NCT04479020
Recruitment Status : Recruiting
First Posted : July 21, 2020
Last Update Posted : June 29, 2021
Sponsor:
Information provided by (Responsible Party):
Acandis GmbH

Study Description
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Brief Summary:
The purpose of the REVISAR PMCF is to collect data in clinical practice of the APERIO® and APERIO® Hybrid(17) Thrombectomy Device, which are intended to restore blood flow in the neurovasculature by removing thrombus in patients experiencing ischemic stroke. Recanalization status will be assessed at the end of the procedure using the modified TICI (Thrombolysis in cerebral infarction) score.

Condition or disease Intervention/treatment
Acute Stroke Device: Mechanical Thrombectomy

Detailed Description:

Study Type: prospective, multicenter, single-arm, open-label Participants: 10 participating centers in Germany planned PI: Dr. Franziska Dorn, University Hospital Bonn, Germany Estimated Enrolment: A minimum of 130 patients treated with the APERIO® or APERIO® Hybrid(17) Thrombectomy Device due to thrombotic occlusions in a distal vessel of the anterior and posterior circulation (postbifurcal MCA, ACA, PCA)

Follow up: 3 months Estimated Final Assessment: End of 2022

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® and APERIO® Hybrid(17) Thrombectomy Device inin a distal vessel of the anterior and posterior circulation (postbifurcal MCA, ACA, PCA). Aperio® and Aperio® Hybrid(17) Thrombectomy Device will be used within its approved indication.

Study Design
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Study Type : Observational [Patient Registry]
Estimated Enrollment : 130 participants
Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration: 3 Months
Official Title: REcanalization of Distal Cerebral Vessels In Acute Stroke Using ApeRio®
Actual Study Start Date : July 1, 2020
Estimated Primary Completion Date : December 2021
Estimated Study Completion Date : January 2022

Resource links provided by the National Library of Medicine


Groups and Cohorts
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Intervention Details:
  • Device: Mechanical Thrombectomy
    Mechanical thrombectomy requiring the use an APERIO® or APERIO® Hybrid(17) Thrombectomy device due to an thrombotic occlusion in a distal vessel of the anterior and posterior circulation (postbifurcal MCA, ACA, PCA)

Outcome Measures
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Primary Outcome Measures :
  1. Primary efficacy endpoint [ Time Frame: Immediatley after interventional procedure ]
    Successful arterial recanalization of occluded target vessel measured by mTICI score of 2b or 3 following the use of the APERIO® and APERIO® Hybrid(17) Thrombectomy Device without any symptomatic intracranial hemorrhage and rescue therapy within 3 passes per Device mTICI describes the response of thrombolytic therapy in ischemic stroke. Higashida et al. 2003: Grade 0: no perfusion Grade 1: penetration with minimal perfusion Grade 2: partial perfusion Grade 2A: only partial filling (less than two-thirds) 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

  2. Primary safety endpoint [ Time Frame: 48 hours ]
    • Symptomatic intracranial hemorrhage (sICH): ICH in periprocedural (<48 hours) CT associated with worsening of NIHSS by ≥ 4 points within 48 hours.

  3. Primary safety endpoint [ Time Frame: 90 days ]
    Rates of device and procedure related (serious) adverse events ((S)AEs)

  4. Primary Safety endpoint [ Time Frame: 90 days ]
    Mortality


Secondary Outcome Measures :
  1. Good neurological outcome [ Time Frame: 90 days ]

    mRS (modified Ranking Scale)= 0-2

    0 No Symptoms

    1. No significant disability, despite symptoms, able to perform all usual duties and activities
    2. Slight disability; unable to perform all previous activities but able to look after own affairs without assistance
    3. Moderate disability; requires some help, but able to walk without assistance
    4. Moderately severe disability; unable to walk without assistance and unable to attend to own bodily needs without assistance
    5. Severe disability bedridden incontinent and requires constant nursing care and attention
    6. Patient died


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
Patients treated with an APERIO® or APERIO® Hybrid(17) Thrombectomy Device due to a thrombotic occlusion in distal vessel of the anterior and posterior circulation (postbifurcal MCA, ACA, PCA).
Criteria

Inclusion Criteria:

  • Any patient treated with the APERIO® or APERIO® Hybrid(17) Thrombectomy Device due to occlusion in distal vessel of the anterior and posterior circulation (postbifurcal MCA, ACA, PCA) according to IFU
  • Age ≥ 18 years

Exclusion Criteria:

  • pre stroke mRS ≥ 3
  • Any contraindication according to IFU
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): NCT04479020


Contacts
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Contact: Franziska Dorn, Prof. Dr. med. +49 (0) 228-287-16505 Franziska.Dorn@ukbonn.de

Locations
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Germany
Schlosspark Klinik Charlottenburg Recruiting
Berlin, Germany
Contact: Annette Förschler, Dr. med.         
Universitätsklinikum Bonn Recruiting
Bonn, Germany, 53127
Contact: Franziska Dorn, Prof. Dr. med.         
Universitätsklinikum Düsseldorf Recruiting
Düsseldorf, Germany
Contact: Bernd Turowski, Prof. Dr.         
Klinikum Fulda gAG Recruiting
Fulda, Germany
Contact: Kallenberg Kai, PD. Dr.         
Universitätsmedizin Göttingen Recruiting
Göttingen, Germany
Contact: Marielle Ernst, PD Dr. med.         
Universitätsklinikum Köln Recruiting
Köln, Germany
Contact: Christoph Kabbasch, Dr.         
Universitätsklinikum Magdeburg A. ö. R. Recruiting
Magdeburg, Germany
Contact: Daniel Behme, PD. Dr. med.         
Johannes Wesling Klinikum Minden Recruiting
Minden, Germany
Contact: Borggrefe Jan, Prof. Dr. med.         
Klinikum der Universität München Recruiting
München, Germany, 80336
Contact: Thomas Liebig, Prof.Dr. med.         
radprax Neurozentrum Solingen Recruiting
Solingen, Germany, 42697
Contact: Hannes Nordmeyer, Dr. med.         
Sponsors and Collaborators
Acandis GmbH
More Information
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Responsible Party: Acandis GmbH
ClinicalTrials.gov Identifier: NCT04479020    
Other Study ID Numbers: REVISAR Revision 3.2
First Posted: July 21, 2020    Key Record Dates
Last Update Posted: June 29, 2021
Last Verified: June 2021

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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