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

Hypertension Clinical Trial

— CALM-2  

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT03179800
• Other study ID #: CRD0447
• Status: Active, not recruiting
• Phase: N/A
• Start date: October 19, 2017
• Est. completion date: May 2025

Study information

• Verified date: May 2023
• Source: Vascular Dynamics, Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 300
• Est. completion date: May 2025
• Est. primary completion date: May 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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.

Related Conditions & MeSH terms

• Hypertension
• Resistant Hypertension

Intervention

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

Locations

Country	Name	City	State
France	CHU Nancy Centre Coeur et Vaisseaux	Nancy
United States	Emory University Hospital Midtown	Atlanta	Georgia
United States	The Carl & Edyth Lindner Center for Research & Education at The Christ Hospital	Cincinnati	Ohio
United States	St. Vincent Heart Center of Indiana	Indianapolis	Indiana
United States	Ochsner Medical Center	New Orleans	Louisiana
United States	Southern Illinois University	Springfield	Illinois

Sponsors (1)

Lead Sponsor	Collaborator
Vascular Dynamics, Inc.

Countries where clinical trial is conducted

United States,  France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Safety Assessments - Composite measured at 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.	90-day
Primary	Primary Effectiveness Endpoint - Change in mean 24-hr sABP from baseline to 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.	180-day

External Links

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