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ACTIVE NOT RECRUITING
NCT03179800
NA

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

Sponsor: Vascular Dynamics, Inc.

View on ClinicalTrials.gov

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

Interventions

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

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