REcanalization of Distal Cerebral Vessels in Acute Stroke Using ApeRio®

December 4, 2024 updated by: Acandis GmbH
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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

Study Type: prospective, multicenter, single-arm, open-label, national

Participants: 11 participating centers in Germany

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 in 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 Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
134

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

  • Germany
      • Berlin, Germany
        • Schlosspark Klinik Charlottenburg
      • Bonn, Germany, 53127
        • Universitatsklinikum Bonn
      • Düsseldorf, Germany
        • Universitatsklinikum Dusseldorf
      • Fulda, Germany
        • Klinikum Fulda gAG
      • Göttingen, Germany
        • Universitatsmedizin Gottingen
      • Homburg, Germany
        • Universitätsklinikum des Saarlandes
      • Köln, Germany
        • Universitatsklinikum Koln
      • Magdeburg, Germany
        • Universitätsklinikum Magdeburg A. ö. R.
      • Minden, Germany
        • Johannes Wesling Klinikum Minden
      • München, Germany, 80336
        • Klinikum der Universität München
      • Solingen, Germany, 42697
        • radprax Neurozentrum Solingen

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years and older (Adult, Older Adult)

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).

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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
Immediatley after interventional procedure
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.
48 hours
Primary safety endpoint
Time Frame: 90 days
Rates of device and procedure related (serious) adverse events ((S)AEs)
90 days
Primary Safety endpoint
Time Frame: 90 days
Mortality
90 days

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
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
90 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Acandis GmbH

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
July 1, 2020

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
January 30, 2024

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
May 1, 2024

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
July 2, 2020

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 16, 2020

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
July 21, 2020

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
December 6, 2024

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
December 4, 2024

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
December 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • REVISAR Revision 4.0

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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