Actively Recruiting
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
Eligibility Criteria
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
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
Trial Site Locations
Total: 17 locations
1
Universitätsklinikum Augsburg
Augsburg, Germany
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2
Charité - Universitätsmedizin Berlin
Berlin, Germany
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3
Klinikum Bremerhaven-Reinkenheide
Bremerhaven, Germany
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4
Universitätsklinikum Köln
Cologne, Germany
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5
Universitätsklinikum Carl Gustav Carus Dresden
Dresden, Germany
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6
Universitätsklinikum Düsseldorf
Düsseldorf, Germany
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7
Universitätsklinikum Essen
Essen, Germany
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8
Krankenhaus Nordwest Frankfurt
Frankfurt am Main, Germany
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9
Universitätsmedizin Halle
Halle, Germany
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10
Universitätsklinikum Hamburg-Eppendorf
Hamburg, Germany
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11
Westpfalz-Klinikum Kaiserslautern
Kaiserslautern, Germany
Actively Recruiting
12
Universitätsklinikum Magdeburg
Magdeburg, Germany
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13
Mühlenkreiskliniken | Johannes Wesling Klinikum Minden
Minden, Germany
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14
Ludwig-Maximilians-Universität München
München, Germany
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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
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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