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Clinical Trial Details — Status: Active, not recruiting

Administrative data

NCT number NCT03179800
Other study ID # CRD0447
Secondary ID
Status Active, not recruiting
Phase N/A
First received
Last updated
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
Health authority
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.

Study Design


Related Conditions & MeSH terms


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
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