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

NCT03179800 · Status: ACTIVE_NOT_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 300

Last updated 2024-07-18

No results posted yet for this study

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.

Conditions

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

Sponsors & Collaborators

  • Vascular Dynamics, Inc.

    lead INDUSTRY

Principal Investigators

  • Bryan Williams, MD · University College, London

  • Gregg Stone, MD · Cardiovascular Research and Education Columbia University Medical Center

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2017-10-19
Primary Completion
2025-05-31
Completion
2025-05-31
FDA Device
Yes

Countries

  • United States
  • France

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03179800 on ClinicalTrials.gov