Hypertension Clinical Trial
— CALM-2Official title:
CALM- 2 - Controlling and Lowering Blood Pressure With the MobiusHD™
Verified date | May 2023 |
Source | Vascular Dynamics, Inc. |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
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. |
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 |
Lead Sponsor | Collaborator |
---|---|
Vascular Dynamics, Inc. |
United States, France,
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 |
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