Clinical Studies
To prove the safety and efficacy of our products, we conduct numerous clinical studies worldwide. The results support market entry of new technologies and serve as a basis for further development of innovative solutions.
Below you will find an overview of our clinical studies.
Haemorrhagic Stroke
Aneurysm Bridging
Evaluation of Safety and Efficacy of the ACCERO® (heal) Stent for Intracranial Aneurysm Treatment
PI:
Dr. Maxim Bester, Universitätsklinikum Hamburg-Eppendorf, Germany
Sponsor:
ACANDIS GmbH, Pforzheim, Germany
Device:
ACCERO® (heal) 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® (heal) Stent in stent-assisted intracranial aneurysm treatment
(Est.) Enrollment:
130 patients
Status:
Active, enrolling
Flow Diversion
DERIVO® 2heal® Study: Clinical safety and Efficacy of the DERIVO® 2heal® Embolisation Device
Sponsor:
ACANDIS GmbH, Pforzheim, Germany
Device:
DERIVO® 2heal® Embolisation Device
Clinical trials.gov identifier:
NCT05543447
Study Type:
Observational, prospective, multicentre
Objective:
Evaluation of the clinical safety and efficacy of the DERIVO® 2heal® Embolisation Device in the standard clinical routine of flow diversion treatment with respect to mid- and long-term clinical and angiographic outcomes.
(Est.) Enrollment:
158 patients
Status:
Active, enrolling
Ischaemic Stroke
Mechanical Thrombectomy
Recanalization of Distal cerebral Vessels In Acute Stroke using ApeRio® - REVISAR
PL:
Prof. Dr. Franziska Dorn, Universitätsklinikum Bonn, Germany
Sponsor:
ACANDIS GmbH, Pforzheim, Germany
Device:
APERIO® Thrombectomy Device/ APERIO® Hybrid
Thrombectomy Device/ APERIO® Hybrid17 Thrombectomy Device
Clinical trials.gov identifier:
NCT04479020
Study Type:
Post-Market Clinical Follow-Up Study (PMCF), Prospective, one-armed, open-label, multicentre, national
Objective:
Evaluation of the safety and efficacy of the APERIO® and the APERIO Hybrid(17) Thrombectomy Device in distal vessel occlusions in the anterior and posterior circulation (postbifurcal MCA, ACA, PCA) requiring the use of an APERIO® or APERIO® Hybrid(17) Thrombectomy Device according to IFU.
(Est.) Enrollment:
130 patients
Status:
Active, enrollment completed
APERIO® HYBRID Thrombectomy device for flow restoration in vessels of patients experiencing acute ischaemic stroke - HYBRID
PL:
Dr. Christian Mathys, Evangelisches Krankenhaus Oldenburg, Germany
Sponsor:
ACANDIS GmbH, Pforzheim, Germany
Device:
APERIO® Thrombectomy Device/ APERIO® Hybrid17 Thrombectomy Device
Clinical trials.gov identifier:
NCT04457479
Study Type:
Post-Market Clinical Follow-up Study (PMCF), Prospective, one-armed, open-label, multicentre, national
Objective:
The investigation of potential residual risks associated with the use of the device and to update the clinical evaluation of the device in order to ensure the long-term safety and performance of the APERIO® Hybrid(17|21) Thrombectomy Device after its placing on the market
(Est.) Enrollment:
430 patients
Status:
Active, enrollment completed
Stenting of intracranial stenoses
Rescue Stenting with CREDO® Heal for Recanalisation after Unsuccessful Thrombectomy (RECHRUT)
PL:
Dr. Hannes Nordmeyer, Municipal Hospital Solingen, Germany
Sponsor:
ACANDIS GmbH, Pforzheim, Germany
Device:
CREDO® heal Stent with NeuroSpeed® PTA Balloon Catheter
Clinical trials.gov identifier:
NCT05345483
Study Type:
Observational, prospective, multicentre
Objective:
To investigate the efficacy and safety of acute permanent stenting of intracranial stenoses after unsuccessful recanalisation by thrombectomy in acute ischemic stroke with a large vessel occlusion (LVO) using the self-expanding, coated CREDO® heal Stent.
(Est.) Enrollment:
153 patients
Status:
Active, enrolling
Acandis Stenting of Intracranial Stenosis – registry (ASSISTENT)
PL:
Prof. Dr. Götz Thomalla (Neurology), Universitätsklinikum Hamburg-Eppendorf, Germany
Co PI:
Prof. Dr. Rene Chapot (Neuroradiology), Alfried Krupp Krankenhaus Essen-Rüttenscheid, Germany
Sponsor:
ACANDIS GmbH, Pforzheim, Germany
Device:
CREDO® Stent with NeuroSpeed® PTA Balloon Catheter
Clinical trials.gov identifier:
NCT03902444
Study Type:
Prospective, one-armed, open-label, multicentre, national registry
Objective:
To conduct a post market clinical follow-up (PMCF) study of the use of the self-expandable Credo® Stent together with the NeuroSpeed® PTA balloon catheter in clinical practice. To investigate potential residual risks associated with the use of the device and to update the clinical evaluation of the device in order to ensure the long- term safety and performance of the Credo® Stent after its placing on the market.
(Est.) Enrollment:
150 patients
Status:
Active, enrolling