Trials / Recruiting
RecruitingNCT02827032
Controlling and Lowering Blood Pressure With the MobiusHD™
Controlling and Lowering Blood Pressure With the MobiusHD™ - Defining Efficacy Markers
- Status
- Recruiting
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 200 (estimated)
- Sponsor
- Vascular Dynamics, Inc. · Industry
- Sex
- All
- Age
- 18 Years – 80 Years
- Healthy volunteers
- Not accepted
Summary
To perform post-market surveillance and evaluate the performance of the MobiusHD System in subjects with primary resistant hypertension.
Detailed description
The CALM-DIEM Trial is an open-label, prospective, multicenter study for patients who have been selected for treatment with the MobiusHD.
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. |
Timeline
- Start date
- 2016-07-01
- Primary completion
- 2024-12-01
- Completion
- 2026-06-01
- First posted
- 2016-07-11
- Last updated
- 2023-10-06
Locations
22 sites across 3 countries: Germany, Netherlands, United Kingdom
Regulatory
- FDA-regulated device study
Source: ClinicalTrials.gov record NCT02827032. Inclusion in this directory is not an endorsement.