Clinical Studies

Intracranial Stenosis Stenting

Endovascular treatment is considered as sole method for treating patients with stroke recurrence and impaired haemodynamic pattern despite medical treatment. Percutaneous intraluminal angioplasty (PTA) and stenting of intracerebral arteries presents a particular challenge due to tortuous, elongated vessel anatomies and calcified lesions. Additionally the risk of vascular dissection or rupture, in stent thrombosis and also lacunar stroke should be taken into consideration.
The ASSISTENT registry and the ACUTE trial are designed to investigate potential residual risks associated with NeuroSpeed® PTA Balloon Catheter and CREDO® Stent in order to ensure long-term safety and efficacy.

ASSISTENT (PMCF) - (Elective Stenting)

AcandiS Stenting of Intracranial STENosis – registry (ASSISTENT)

PI:
Prof. Dr. Götz Thomalla (Neurology), University Hospital Hamburg-Eppendorf, Germany
Co PI:
Prof. Dr. René Chapot (Neuroradiology), Alfried Krupp Hospital 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.) Enrolment: 150 patients
Status: Active, enroling

 

ACUTE (MPG) - (Acute Stenting)

Acandis CREDO® intracranial stent for unsuccessful recanalization after thrombectomy (ACUTE)

PI:
Prof. Dr. Götz Thomalla (Neurology), University Hospital Hamburg-Eppendorf, Germany
Dr. Paul Stracke (Neuroradiology), University Hospital Münster, Germany
Sponsor: ACANDIS GmbH, Pforzheim, Germany
Device: CREDO® Stent with NeuroSpeed® PTA Balloon Catheter
Clinical trials.gov identifier: NCT03955835
Study Type: Prospective, interventional treatment, single-arm, open-label, multicentre trial
Objective:
To evaluate the efficacy and safety of acute permanent stenting of symptomatic intracranial stenosis following unsuccessful recanalization by thrombectomy in acute ischemic stroke with large vessel occlusion using the self-expandable CREDO® Stent together with the NeuroSpeed® PTA balloon catheter.
(Est.) Enrolment: 143 patients
Status: Active, enroling