Clinical Studies

Aneurysm Bridging

ACCERO® (PMCF) ACCERO® (PMCF)

Evaluation of Safety and Efficacy of the ACCERO® Stent for Intracranial Aneurysm Treatment

PI:
Dr. Maxim Bester, University Hospital Hamburg-Eppendorf, Germany
Sponsor: ACANDIS GmbH, Pforzheim, Germany
Device: ACCERO® Stent
Clinical trials.gov identifier: NCT03957382
Study Type: Prospective, one-armed, open-label, multicentre, national registry
Objective:
Evaluation of the safety and efficacy of the ACCERO® Stent in stent-assisted intracranial aneurysm treatment
(Est.) Enrolment: 130 patients
Status: Active, enroling

 


Flow Diversion

DERIVO® (PMCF) DERIVO® (PMCF)

Post Market Clinical Follow-up of the DERIVO® Embolisation Device

PI:
Prof. Dr. Christian Taschner, University Hospital Freiburg, Germany
Sponsor: ACANDIS GmbH, Pforzheim, Germany
Device: DERIVO® Embolisation Device
Clinical trials.gov identifier: -
DRKS identifier: DRKS00006103
Study Type: Observational, prospective, multicentre
Objective:
The study objective is to assess the safety and effectiveness of the DERIVO® Embolisation Device with respect to long-term clinical and angiographic outcomes.
Enrolment: 96 subjects in 12 sites (Germany, Poland)
Status: Complete
Results:
Follow up: 18 months
mRs: After 14.8 ± 5.2 months
Occlusion: After 12.4 ± 5.84 months: 89 %
Mortality: 0 %
Morbidity: 3 %