Trials / Terminated
TerminatedNCT02804087
Controlling And Lowering Blood Pressure With the MobiusHDTM Device
CALM-START - Controlling And Lowering Blood Pressure With the MobiusHDTM Device: STudying Effects in A Randomized Trial
- Status
- Terminated
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 4 (actual)
- Sponsor
- Vascular Dynamics, Inc. · Industry
- Sex
- All
- Age
- 18 Years – 70 Years
- Healthy volunteers
- Not accepted
Summary
To evaluate the safety and performance of the MobiusHD system in subjects with resistant hypertension.
Detailed description
This is a prospective, randomized, double-blind, sham-controlled, multi-center post market study investigating the efficacy and safety of MobiusHD System, and the efficacy of the MobiusHD device in lowering mean systolic 24-hour ABP in subjects with resistant hypertension.
Conditions
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
- 2017-08-24
- Primary completion
- 2021-06-30
- Completion
- 2021-07-21
- First posted
- 2016-06-17
- Last updated
- 2023-10-10
Locations
4 sites across 1 country: Netherlands
Regulatory
- FDA-regulated device study
Source: ClinicalTrials.gov record NCT02804087. Inclusion in this directory is not an endorsement.