Actively Recruiting

Age: 18Years +
All Genders
NCT05543447

DERIVO® 2heal® Study: Clinical Safety and Efficacy of the DERIVO® 2heal® Embolisation Device

Led by Acandis GmbH · Updated on 2025-09-04

158

Participants Needed

17

Research Sites

206 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

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.

CONDITIONS

Official Title

DERIVO® 2heal® Study: Clinical Safety and Efficacy of the DERIVO® 2heal® Embolisation Device

Who Can Participate

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Patient to be treated with DERIVO4heal4 Embolisation Device for intracranial aneurysm as per instructions for use
  • Age greater than 18 years
  • Signed informed consent form
  • Scheduled to be treated for only one target aneurysm or multiple aneurysms in the same target zone with one DERIVO4heal4 device
  • Effective use of antiplatelet medication confirmed by testing according to local standards
Not Eligible

You will not qualify if you...

  • Previously treated aneurysms with flow diverter, stent, or WEB device
  • Patient with ruptured aneurysm in the acute bleeding phase
  • Pre-treatment disability with modified Rankin Scale score greater than 2
  • Aneurysms related to pre-existing arteriosclerotic vascular disease in the target vessel
  • Contraindication to antiplatelet medication
  • Female patients who are pregnant, breastfeeding, or planning pregnancy during the study
  • Participation in another clinical study

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 17 locations

1

Universitätsklinikum Augsburg

Augsburg, Germany

Actively Recruiting

2

Charité - Universitätsmedizin Berlin

Berlin, Germany

Actively Recruiting

3

Klinikum Bremerhaven-Reinkenheide

Bremerhaven, Germany

Actively Recruiting

4

Universitätsklinikum Köln

Cologne, Germany

Actively Recruiting

5

Universitätsklinikum Carl Gustav Carus Dresden

Dresden, Germany

Actively Recruiting

6

Universitätsklinikum Düsseldorf

Düsseldorf, Germany

Actively Recruiting

7

Universitätsklinikum Essen

Essen, Germany

Actively Recruiting

8

Krankenhaus Nordwest Frankfurt

Frankfurt am Main, Germany

Actively Recruiting

9

Universitätsmedizin Halle

Halle, Germany

Actively Recruiting

10

Universitätsklinikum Hamburg-Eppendorf

Hamburg, Germany

Actively Recruiting

11

Westpfalz-Klinikum Kaiserslautern

Kaiserslautern, Germany

Actively Recruiting

12

Universitätsklinikum Magdeburg

Magdeburg, Germany

Actively Recruiting

13

Mühlenkreiskliniken | Johannes Wesling Klinikum Minden

Minden, Germany

Actively Recruiting

14

Ludwig-Maximilians-Universität München

München, Germany

Actively Recruiting

15

Technische Universität München

München, Germany

Actively Recruiting

16

Klinikum Vest - Knappschaftskrankenhaus Recklinghausen

Recklinghausen, Germany

Actively Recruiting

17

Städtisches Klinikum Solingen

Solingen, Germany

Actively Recruiting

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Research Team

A

Acandis GmbH

CONTACT

How is the study designed?

Study Type

OBSERVATIONAL

Masking

N/A

Allocation

N/A

Model

N/A

Primary Purpose

N/A

Number of Arms

0

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