CALM- 2 - Controlling and Lowering Blood Pressure With the MobiusHD™ (CALM-2)
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ClinicalTrials.gov Identifier: NCT03179800 |
Recruitment Status :
Active, not recruiting
First Posted : June 7, 2017
Last Update Posted : January 7, 2020
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Hypertension Resistant Hypertension | Device: MobiusHD Other: Sham Implantation | Not Applicable |
Study Type : | Interventional (Clinical Trial) |
Estimated Enrollment : | 300 participants |
Allocation: | Randomized |
Intervention Model: | Crossover Assignment |
Masking: | Triple (Participant, Care Provider, Outcomes Assessor) |
Primary Purpose: | Treatment |
Official Title: | CALM- 2 - Controlling and Lowering Blood Pressure With the MobiusHD™ |
Actual Study Start Date : | October 19, 2017 |
Estimated Primary Completion Date : | May 2021 |
Estimated Study Completion Date : | May 2026 |

Arm | Intervention/treatment |
---|---|
Experimental: MobiusHD Implantation
MobiusHD Implantation
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Device: MobiusHD
The MobiusHD device is a self-expanding nitinol implant that is delivered intravascularly to the internal carotid sinus via the delivery catheter. |
Sham Comparator: Sham Implantation
Sham Implantation
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Other: Sham Implantation
Sham Implantation |
- Primary Effectiveness Endpoint - Change in mean 24-hr sABP from baseline to 180-day [ Time Frame: 180-day ]The primary effectiveness endpoint is change in mean 24-hr ambulatory systolic blood pressure (24hr sABP) from baseline to the 180-day visit.
- Safety Assessments - Composite measured at 90-day [ Time Frame: 90-day ]Composite measure of death, MI, stroke, device embolization, carotid occlusion, new ipsilateral carotid stenosis requiring surgical or percutaneous intervention, or Bleeding Academic Research Consortium (BARC) 3 or 5 bleeding events as adjudicated by CEC from randomization through the 90-day visit. All adverse events.

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Ages Eligible for Study: | 18 Years to 80 Years (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- Mean 24 hour ambulatory systolic blood pressure ≥145 mmHg and ≤200 mmHg and stable for at least 8 weeks on a maximally tolerated guideline directed, (JNC8) or their equivalent when those listed are not available dosing regimen consisting of up to 5 antihypertensive medications, with a minimum required dosing regimen of an "A+C+D" antihypertensive medication regimen, where "A" is an angiotensin-converting enzyme Inhibitor or an angiotensin receptor blocker, "C" is a calcium channel blocker, and "D" is a diuretic.
Exclusion Criteria:
- Inadequacy of the carotid anatomy for treatment with the MobiusHD based on carotid angiography.

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03179800

Study Chair: | Bryan Williams, MD | University College, London | |
Study Chair: | Gregg Stone, MD | Cardiovascular Research and Education Columbia University Medical Center |
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: | Vascular Dynamics, Inc. |
ClinicalTrials.gov Identifier: | NCT03179800 |
Other Study ID Numbers: |
CRD0447 |
First Posted: | June 7, 2017 Key Record Dates |
Last Update Posted: | January 7, 2020 |
Last Verified: | January 2020 |
Studies a U.S. FDA-regulated Drug Product: | No |
Studies a U.S. FDA-regulated Device Product: | Yes |
Device Product Not Approved or Cleared by U.S. FDA: | Yes |
Hypertension Resistant Hypertension Baroreceptor BAT |
Hypertension Vascular Diseases Cardiovascular Diseases |