---
title: CALM- 2 - Controlling and Lowering Blood Pressure With the MobiusHD™
nct_id: NCT03179800
overall_status: ACTIVE_NOT_RECRUITING
phase: NA
sponsor: Vascular Dynamics, Inc.
study_type: INTERVENTIONAL
primary_condition: Hypertension
countries: United States, France
canonical_url: "https://parkinsonspathways.com/agent/trials/NCT03179800.md"
clinicaltrials_gov: "https://clinicaltrials.gov/study/NCT03179800"
ct_last_update_post_date: 2024-07-18
last_seen_at: "2026-05-12T06:32:13.385Z"
source: ClinicalTrials.gov (mirrored, no enrichment)
---
# CALM- 2 - Controlling and Lowering Blood Pressure With the MobiusHD™

**NCT ID:** [NCT03179800](https://clinicaltrials.gov/study/NCT03179800)

## Key Facts

- **Status:** ACTIVE_NOT_RECRUITING
- **Phase:** NA
- **Study Type:** INTERVENTIONAL
- **Target Enrollment:** 300
- **Lead Sponsor:** Vascular Dynamics, Inc.
- **Conditions:** Hypertension, Resistant Hypertension
- **Start Date:** 2017-10-19
- **Completion Date:** 2025-05
- **CT.gov Last Update:** 2024-07-18

## Brief 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.

## Detailed Description

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. Patients with resistant hypertension who remain uncontrolled despite pharmacologic treatment with maximum tolerated, guideline-directed anti-hypertensive pharmacologic therapy will be evaluated.

## Eligibility

- **Minimum age:** 18 Years
- **Maximum age:** 80 Years
- **Sex:** ALL
- **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.
```

## Arms

- **MobiusHD Implantation** (EXPERIMENTAL) — MobiusHD Implantation
- **Sham Implantation** (SHAM_COMPARATOR) — Sham Implantation

## Interventions

- **MobiusHD** (DEVICE) — The MobiusHD device is a self-expanding nitinol implant that is delivered intravascularly to the internal carotid sinus via the delivery catheter.
- **Sham Implantation** (OTHER) — Sham Implantation

## Primary Outcomes

- **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.

## 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

## Recent Field Changes (last 30 days)

- `status.overallStatus` — added _(2026-05-12)_
- `status.primaryCompletionDate` — added _(2026-05-12)_
- `status.completionDate` — added _(2026-05-12)_
- `status.lastUpdatePostDate` — added _(2026-05-12)_
- `design.phases` — added _(2026-05-12)_
- `design.enrollmentCount` — added _(2026-05-12)_
- `eligibility.criteria` — added _(2026-05-12)_
- `eligibility.minAge` — added _(2026-05-12)_
- `eligibility.maxAge` — added _(2026-05-12)_
- `eligibility.sex` — added _(2026-05-12)_
- `outcomes.primary` — added _(2026-05-12)_
- `armsInterventions.arms` — added _(2026-05-12)_
- `armsInterventions.interventions` — added _(2026-05-12)_
- `sponsor.lead` — added _(2026-05-12)_
- `results.hasResults` — added _(2026-05-12)_
- `locations.emory university hospital midtown|atlanta|georgia|united states` — added _(2026-05-12)_
- `locations.southern illinois university|springfield|illinois|united states` — added _(2026-05-12)_
- `locations.st. vincent heart center of indiana|indianapolis|indiana|united states` — added _(2026-05-12)_
- `locations.ochsner medical center|new orleans|louisiana|united states` — added _(2026-05-12)_
- `locations.the carl & edyth lindner center for research & education at the christ hospital|cincinnati|ohio|united states` — added _(2026-05-12)_
- `locations.chu nancy centre coeur et vaisseaux|nancy||france` — added _(2026-05-12)_

---

*Canonical: https://parkinsonspathways.com/agent/trials/NCT03179800.md*  
*Source data (authoritative): https://clinicaltrials.gov/study/NCT03179800*  
*This page is a raw mirror with no AI summary, no editorial enrichment, and no Parkinson's-specific filtering.*