AcandiS Stenting of Intracranial STENosis - regisTry (ASSISTENT)

Acandis

Status: Enrolling

Conditions: Intracranial Stenosis

Treatments: Device: Credo® Stent, NeuroSpeed® PTA balloon catheter

Study type: Observational

Funder types: Industry

Identifiers

NCT03902444

ASSISTENT

Details and patient eligibility

About

ASSISTENT is designed to collect comprehensive information on technical and clinical safety of the use of Credo® stent together with the NeuroSpeed® PTA balloon catheter in clinical practice in an open registry.

Full description

ASSISTENT is subdivided into two components. The first part only requires recording of data acquired in routine clinical practice during the treatment of patients with intracranial stenosis with the self-expandable Credo® stent until discharge. This comprises demographic data, data concerning the qualifying clinical event, limited data on medical history and medication, information about the intervention including technical success and periprocedural complications or events, and information about events and clinical status during the in-hospital treatment until hospital discharge.

The second part of the registry consists of a follow-up visit 30 days after the interventional procedure which will be conducted outside of clinical practice.

Enrollment: 150 estimated patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Treatment with Credo® for symptomatic atherosclerotic intracranial artery stenosis (see product IFU)

Exclusion criteria

• There are no specific exclusion criteria (see product IFU)

Trial design

150 participants in 1 patient group

Credo® Stent and NeuroSpeed® PTA balloon catheter

Description:

Patients treated with Credo® Stent and NeuroSpeed® PTA balloon catheter in the clinical routine

Treatment:

Device: Credo® Stent, NeuroSpeed® PTA balloon catheter