Evaluation of Safety and Efficacy of the Accero® (Heal) Stent for Intracranial Aneurysm Treatment

September 8, 2023 updated by: Acandis GmbH
This study is intended to show that the application of the Accero® (heal) stent is safe within the given indication.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Estimated)

130

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 Locations

  • Germany
      • Berlin, Germany, 12351
        • Recruiting
        • Vivantes - Klinikum Neukölln Institut für klinische und interventionelle Neuroradiologie
        • Contact:
          • Dr. Alexander Bock
      • Hamburg, Germany, 20246
        • Recruiting
        • Klinik und Poliklinik für Neuroradiologische Diagnostik und Intervention, Universitätsklinikum Hamburg-Eppendorf
        • Contact:
          • Dr. Maxim Bester
      • Meppen, Germany, 49716
        • Recruiting
        • Krankenhaus Ludmillenstift, Abteilung für Radiologie, Neuroradiologie und Nuklearmedizin
        • Contact:
          • Ekin Celik, Dr.
      • Recklinghausen, Germany, 45657
        • Recruiting
        • KLINIKUM VEST GMBH Knappschaftskrankenhaus Klinik für Radiologie und Neuroradiologie
        • Contact:
          • Christian Loehr, Dr.

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

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

All patients treated with Accero® (heal) Stent

Description

Inclusion Criteria:

All patients treated with Accero® (heal) Stent according to IFU

Exclusion Criteria:

  • mRS > 2
  • Hunt and Hess >3 (in patients with subarachnoid hemorrhage-SAH)

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: Case-Only
  • Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Raymond Roy Classification
Time Frame: 6 months after treatment
Assessment of Raymond Roy Classification
6 months after treatment
Raymond Roy Classification
Time Frame: 12 months after treatment
Assessment of Raymond Roy Classification
12 months after treatment
Raymond Roy Classification
Time Frame: 24 months after treatment
Assessment of Raymond Roy Classification
24 months after treatment
Raymond Roy Classification
Time Frame: 36 months after treatment
Assessment of Raymond Roy Classification
36 months after treatment

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
modified Rankin Scale (mRS)
Time Frame: 6 months after treatment

Assessment of modified Rankin Scale

Modified Rankin Scale (mRS) is a commonly used scale for measuring the degree of disability or dependence in the daily activities.

The scale runs from 0-6:

0 - No symptoms.

  1. - No significant disability. Able to carry out all usual activities, despite some symptoms.
  2. - Slight disability. Able to look after own affairs without assistance, but unable to carry out all previous activities.
  3. - Moderate disability. Requires some help, but able to walk unassisted.
  4. - Moderately severe disability. Unable to attend to own bodily needs without assistance, and unable to walk unassisted.
  5. - Severe disability. Requires constant nursing care and attention, bedridden, incontinent.
  6. - Dead.
6 months after treatment
modified Rankin Scale (mRS)
Time Frame: 12 months after treatment

Assessment of modified Rankin Scale

Modified Rankin Scale (mRS) is a commonly used scale for measuring the degree of disability or dependence in the daily activities.

The scale runs from 0-6:

0 - No symptoms.

  1. - No significant disability. Able to carry out all usual activities, despite some symptoms.
  2. - Slight disability. Able to look after own affairs without assistance, but unable to carry out all previous activities.
  3. - Moderate disability. Requires some help, but able to walk unassisted.
  4. - Moderately severe disability. Unable to attend to own bodily needs without assistance, and unable to walk unassisted.
  5. - Severe disability. Requires constant nursing care and attention, bedridden, incontinent.
  6. - Dead.
12 months after treatment
modified Rankin Scale (mRS)
Time Frame: 24 months after treatment

Assessment of modified Rankin Scale

Modified Rankin Scale (mRS) is a commonly used scale for measuring the degree of disability or dependence in the daily activities.

The scale runs from 0-6:

0 - No symptoms.

  1. - No significant disability. Able to carry out all usual activities, despite some symptoms.
  2. - Slight disability. Able to look after own affairs without assistance, but unable to carry out all previous activities.
  3. - Moderate disability. Requires some help, but able to walk unassisted.
  4. - Moderately severe disability. Unable to attend to own bodily needs without assistance, and unable to walk unassisted.
  5. - Severe disability. Requires constant nursing care and attention, bedridden, incontinent.
  6. - Dead.
24 months after treatment
modified Rankin Scale (mRS)
Time Frame: 36 months after treatment

Assessment of modified Rankin Scale

Modified Rankin Scale (mRS) is a commonly used scale for measuring the degree of disability or dependence in the daily activities.

The scale runs from 0-6:

0 - No symptoms.

  1. - No significant disability. Able to carry out all usual activities, despite some symptoms.
  2. - Slight disability. Able to look after own affairs without assistance, but unable to carry out all previous activities.
  3. - Moderate disability. Requires some help, but able to walk unassisted.
  4. - Moderately severe disability. Unable to attend to own bodily needs without assistance, and unable to walk unassisted.
  5. - Severe disability. Requires constant nursing care and attention, bedridden, incontinent.
  6. - Dead.
36 months after treatment

Collaborators and Investigators

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

Sponsor

Acandis GmbH

Investigators

  • Principal Investigator: Maxim Bester, PD. Dr., Klinik und Poliklinik für Neuroradiologische Diagnostik und Intervention, Universitätsklinikum Hamburg-Eppendorf

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)

July 23, 2019

Primary Completion (Estimated)

September 1, 2026

Study Completion (Estimated)

December 31, 2026

Study Registration Dates

First Submitted

May 16, 2019

First Submitted That Met QC Criteria

May 17, 2019

First Posted (Actual)

May 21, 2019

Study Record Updates

Last Update Posted (Actual)

September 11, 2023

Last Update Submitted That Met QC Criteria

September 8, 2023

Last Verified

September 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 1041-1

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

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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