Clinical Studies

Aneurysm Bridging

Endovascular treatment of wide-neck aneurysms presented a challenge for neurointerventionalists in the past. Aneurysm bridging has become an important treatment option for intracranial aneurysms in the past years. Good wall adaptation and sufficient coil retention are important and necessary features of the stents, being used for stent-assisted coiling procedures - for these procedures, laser-cut as well as braided stents can be used.
The ACCERO® PMCF study evaluates the safety and efficacy of the braided ACCERO® Stent for intracranial aneurysm treatment according to its intended use and under clinical treatment routine.

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

A new concept for the endovascular treatment of intracranial aneurysms is the implantation of stents that guide the blood flow away from the diseased vessel part. So called „endoluminal embolisation devices“ or „flow diverters“ have a compact mesh system and lead in the long term to a closure of the aneurysm by reconstruction of the original vessel wall and the change of haemodynamic conditions inside the aneurysm.
Flow diverters are well suited for the therapy of complex aneurysms like wide-neck, fusiform or giant aneurysms, which cannot be treated with other endovascular techniques.
As this treatment method has existed only for the past few years, it is important to gather and evaluate clinical data in the routine use in order to prove the safety and efficiency of this method in the clinical use.
Within the DERIVO® Embolisation Device PMCF study the treatment of intracranial aneurysms was assessed according to its intended use and under clinical treatment routine.

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 %