NCT05543447

Brief Summary

To analyse the clinical safety and efficacy of the DERIVO® 2heal® Embolisation Device in the standard clinical routine of flow diversion treatment with respect to the mid- and long-term clinical and angiographic outcomes.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
158

participants targeted

Target at P50-P75 for all trials

Timeline
7mo left

Started Dec 2022

Longer than P75 for all trials

Geographic Reach
1 country

17 active sites

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress86%
Dec 2022Dec 2026

First Submitted

Initial submission to the registry

September 14, 2022

Completed
2 days until next milestone

First Posted

Study publicly available on registry

September 16, 2022

Completed
3 months until next milestone

Study Start

First participant enrolled

December 15, 2022

Completed
3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2025

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2026

Expected
Last Updated

September 4, 2025

Status Verified

December 1, 2024

Enrollment Period

3 years

First QC Date

September 14, 2022

Last Update Submit

August 27, 2025

Conditions

Intracranial AneurysmFlow Diverter

Keywords

AneurysmDERIVODERIVO 2 Heal

Outcome Measures

Primary Outcomes (3)

  • Primary efficacy endpoint

    • Rate of complete aneurysm occlusion

    6 weeks +/- 3weeks; 6months +/- 3 months; 12months +/-3months

  • Primary safety endpoint

    * Stroke/Death Occurrence Percentage of subjects with major stroke in the territory of treated artery or neurological death post-procedure * Rate of device-related \& procedure-related complications (e.g. ICH, in-stent stenosis, in-stent thrombosis)

    12month ± 3month

  • Primary clinical endpoint

    • Good Clinical outcome

    6 weeks ± 3weeks; 6months ± 3 months; 12months ± 3months

Secondary Outcomes (2)

  • Secondary efficacy endpoint

    Measured directly after treatment

  • Secondary safety endpoint

    12months ± 3months

Interventions

Flow Diverter Treatment with DERIVO 2 Heal Embolisation DeviceDEVICE

Flow diversion therapy fpr intracranial aneurysm treatment.

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

All patients who were selected for flow diversion therapy and will be treated with DERIVO® 2heal® Embolisation Device due to intracranial aneurysm according to clinical routine.

You may qualify if:

  • Patient to be treated with DERIVO® 2heal® Embolisation Device due to intracranial aneurysm according to IFU
  • Age \> 18 years
  • Signed Informed Consent Form
  • Patient scheduled to be treated for only one target aneurysm except multiple aneurysms located in the same target zone to be treated with one DERIVO® 2heal® Embolisation Device
  • Effective use of antiplatelet medication confirmed by applicable testing method according to local standard

You may not qualify if:

  • Previously treated aneurysms with flow diverter, stent or WEB device
  • Patient with a ruptured aneurysm in the acute phase of bleeding
  • Pre-treatment disability (mRS \> 2)
  • Aneurysms related to pre-existing arteriosclerotic vascular disease in the target vessel
  • Contraindication against treatment with anti-platelet medication
  • Female patient who is known to be pregnant or is breastfeeding or wishes to become pregnant during participation in the study
  • Participating in another study

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (17)

Universitätsklinikum Augsburg

Augsburg, Germany

RECRUITING

Charité - Universitätsmedizin Berlin

Berlin, Germany

RECRUITING

Klinikum Bremerhaven-Reinkenheide

Bremerhaven, Germany

RECRUITING

Universitätsklinikum Köln

Cologne, Germany

RECRUITING

Universitätsklinikum Carl Gustav Carus Dresden

Dresden, Germany

RECRUITING

Universitätsklinikum Düsseldorf

Düsseldorf, Germany

RECRUITING

Universitätsklinikum Essen

Essen, Germany

RECRUITING

Krankenhaus Nordwest Frankfurt

Frankfurt am Main, Germany

RECRUITING

Universitätsmedizin Halle

Halle, Germany

RECRUITING

Universitätsklinikum Hamburg-Eppendorf

Hamburg, Germany

RECRUITING

Westpfalz-Klinikum Kaiserslautern

Kaiserslautern, Germany

RECRUITING

Universitätsklinikum Magdeburg

Magdeburg, Germany

RECRUITING

Mühlenkreiskliniken | Johannes Wesling Klinikum Minden

Minden, Germany

RECRUITING

Ludwig-Maximilians-Universität München

München, Germany

RECRUITING

Technische Universität München

München, Germany

RECRUITING

Klinikum Vest - Knappschaftskrankenhaus Recklinghausen

Recklinghausen, Germany

RECRUITING

Städtisches Klinikum Solingen

Solingen, Germany

RECRUITING

MeSH Terms

Conditions

Intracranial AneurysmAneurysm

Condition Hierarchy (Ancestors)

Intracranial Arterial DiseasesCerebrovascular DisordersBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesVascular DiseasesCardiovascular Diseases

Study Officials

  • Behme Daniel, Prof.

    Universitätsklinikum Magdeburg

    STUDY DIRECTOR

Central Study Contacts

Acandis GmbH

CONTACT

Tel: +49 7231 155 00 0info@acandis.com

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
PROSPECTIVE
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 14, 2022

First Posted

September 16, 2022

Study Start

December 15, 2022

Primary Completion

December 1, 2025

Study Completion (Estimated)

December 1, 2026

Last Updated

September 4, 2025

Record last verified: 2024-12

Locations

DE(17)