NCT03902444

AcandiS Stenting of Intracranial STENosis - regisTry

• Status: Unknown
• Phase: —
• Study type: Observational
• Enrollment: 150 (estimated)
• Sponsor: Acandis GmbH · Industry
• Sex: All
• Age: 18 Years – 80 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed 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.

Conditions

• Intracranial Stenosis

Interventions

Type	Name	Description
DEVICE	Credo® Stent, NeuroSpeed® PTA balloon catheter	a self-expanding stent is used together with a PTA balloon catheter

Timeline

• Start date: 2016-05-01
• Primary completion: 2025-03-01
• Completion: 2025-10-01
• First posted: 2019-04-04
• Last updated: 2023-02-01

Locations

16 sites across 1 country: Germany