NCT03179800

CALM- 2 - Controlling and Lowering Blood Pressure With the MobiusHD™

• Status: Active Not Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 300 (estimated)
• Sponsor: Vascular Dynamics, Inc. · Industry
• Sex: All
• Age: 18 Years – 80 Years
• Healthy volunteers: Not accepted

Summary

The objective of this study is to evaluate the safety and effectiveness of the MobiusHD System in a prospective, randomized, double-blind, sham-controlled multi-center pivotal study.

Detailed description

The objective of this study is to evaluate the safety and effectiveness of the MobiusHD System in a prospective, randomized, double-blind, sham-controlled multi-center pivotal study. Patients with resistant hypertension who remain uncontrolled despite pharmacologic treatment with maximum tolerated, guideline-directed anti-hypertensive pharmacologic therapy will be evaluated.

Conditions

• Hypertension
• Resistant Hypertension

Interventions

Type	Name	Description
DEVICE	MobiusHD	The MobiusHD device is a self-expanding nitinol implant that is delivered intravascularly to the internal carotid sinus via the delivery catheter.
OTHER	Sham Implantation	Sham Implantation

Timeline

• Start date: 2017-10-19
• Primary completion: 2025-05-01
• Completion: 2025-05-01
• First posted: 2017-06-07
• Last updated: 2024-07-18

Locations

6 sites across 2 countries: United States, France

Regulatory

• FDA-regulated device study