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CALM- 2 - Controlling and Lowering Blood Pressure With the MobiusHD™
Sponsor: Vascular Dynamics, Inc.
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.
Key Details
Gender
All
Age Range
18 Years - 80 Years
Study Type
INTERVENTIONAL
Enrollment
300
Start Date
2017-10-19
Completion Date
2025-05
Last Updated
2024-07-18
Healthy Volunteers
No
Conditions
Interventions
MobiusHD
The MobiusHD device is a self-expanding nitinol implant that is delivered intravascularly to the internal carotid sinus via the delivery catheter.
Sham Implantation
Sham Implantation
Locations (6)
Emory University Hospital Midtown
Atlanta, Georgia, United States
Southern Illinois University
Springfield, Illinois, United States
St. Vincent Heart Center of Indiana
Indianapolis, Indiana, United States
Ochsner Medical Center
New Orleans, Louisiana, United States
The Carl & Edyth Lindner Center for Research & Education at The Christ Hospital
Cincinnati, Ohio, United States
CHU Nancy Centre Coeur et Vaisseaux
Nancy, France