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

Status unconfirmed · Not applicable · Has a placebo group

Conditions studied: Hypertension, Resistant Hypertension

In brief

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.

Key facts

Study ID

NCT03179800

Run by

Vascular Dynamics, Inc.

People needed

300

Starts

2017-10-19

Expected to finish

2025-05-01

Last updated by the study team

2024-07-18

Who can join

Age: 18 and older, up to 80. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• Inadequacy of the carotid anatomy for treatment with the MobiusHD based on carotid angiography.

Where it is running

• 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

Full record on ClinicalTrials.gov

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