NCT05352425

Effect of the MobiusHD® in Renal Hemodialysis Subjects With Uncontrolled Hypertension

A Study Assessing the Effect of the MobiusHD® Implant in Renal Hemodialysis Subjects Presented With Uncontrolled Hypertension

• Status: Withdrawn
• Phase: N/A
• Study type: Interventional
• Enrollment: 0 (actual)
• Sponsor: Vascular Dynamics, Inc. · Industry
• Sex: All
• Age: 21 Years
• Healthy volunteers: Not accepted

Summary

This is a prospective, multi-center, open-label clinical trial intended to evaluate the safety and benefit of the MobiusHD® system in renal hemodialysis subjects with uncontrolled hypertension.

Detailed description

Renal hemodialysis patients with uncontrolled hypertension will be considered for the study. Subjects who meet initial screening requirements will undergo non-invasive imaging of the carotid anatomy to assess adequacy of the anatomy to allow placement of the MobiusHD® device. Eligible subjects will receive an implant placed in the internal carotid artery. Following implantation of the device, subjects will be followed for 60 months.

Conditions

• Uncontrolled Hypertension

Interventions

Type	Name	Description
DEVICE	MobiusHD	The MobiusHD® device is a nickel-titanium device that is implanted in the internal carotid sinus using a minimally invasive approach.

Timeline

• Start date: 2022-05-31
• Primary completion: 2022-10-10
• Completion: 2022-10-10
• First posted: 2022-04-28
• Last updated: 2023-05-10

Regulatory

• FDA-regulated device study