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

Primary Purpose

Hypertension, Resistant Hypertension

Status
Active
Phase
Not Applicable
Locations
International
Study Type
Interventional
Intervention
MobiusHD
Sham Implantation
Sponsored by
Vascular Dynamics, Inc.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Hypertension focused on measuring Hypertension, Resistant Hypertension, Baroreceptor, BAT

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Emory University Hospital Midtown
  • Southern Illinois University
  • St. Vincent Heart Center of Indiana
  • Ochsner Medical Center
  • The Carl & Edyth Lindner Center for Research & Education at The Christ Hospital
  • CHU Nancy Centre Coeur et Vaisseaux

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Sham Comparator

Arm Label

MobiusHD Implantation

Sham Implantation

Arm Description

MobiusHD Implantation

Sham Implantation

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Full Information

First Posted
May 30, 2017
Last Updated
May 9, 2023
Sponsor
Vascular Dynamics, Inc.
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1. Study Identification

Unique Protocol Identification Number
NCT03179800
Brief Title
CALM- 2 - Controlling and Lowering Blood Pressure With the MobiusHD™
Acronym
CALM-2
Official Title
CALM- 2 - Controlling and Lowering Blood Pressure With the MobiusHD™
Study Type
Interventional

2. Study Status

Record Verification Date
May 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
October 19, 2017 (Actual)
Primary Completion Date
May 2025 (Anticipated)
Study Completion Date
May 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Vascular Dynamics, Inc.

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
Yes
Device Product Not Approved or Cleared by U.S. FDA
Yes
Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hypertension, Resistant Hypertension
Keywords
Hypertension, Resistant Hypertension, Baroreceptor, BAT

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
ParticipantCare ProviderOutcomes Assessor
Allocation
Randomized
Enrollment
300 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
MobiusHD Implantation
Arm Type
Experimental
Arm Description
MobiusHD Implantation
Arm Title
Sham Implantation
Arm Type
Sham Comparator
Arm Description
Sham Implantation
Intervention Type
Device
Intervention Name(s)
MobiusHD
Intervention Description
The MobiusHD device is a self-expanding nitinol implant that is delivered intravascularly to the internal carotid sinus via the delivery catheter.
Intervention Type
Other
Intervention Name(s)
Sham Implantation
Intervention Description
Sham Implantation
Primary Outcome Measure Information:
Title
Primary Effectiveness Endpoint - Change in mean 24-hr sABP from baseline to 180-day
Description
The primary effectiveness endpoint is change in mean 24-hr ambulatory systolic blood pressure (24hr sABP) from baseline to the 180-day visit.
Time Frame
180-day
Other Pre-specified Outcome Measures:
Title
Safety Assessments - Composite measured at 90-day
Description
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.
Time Frame
90-day

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Bryan Williams, MD
Organizational Affiliation
University College, London
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Gregg Stone, MD
Organizational Affiliation
Cardiovascular Research and Education Columbia University Medical Center
Official's Role
Study Chair
Facility Information:
Facility Name
Emory University Hospital Midtown
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30308
Country
United States
Facility Name
Southern Illinois University
City
Springfield
State/Province
Illinois
ZIP/Postal Code
62702
Country
United States
Facility Name
St. Vincent Heart Center of Indiana
City
Indianapolis
State/Province
Indiana
ZIP/Postal Code
46290
Country
United States
Facility Name
Ochsner Medical Center
City
New Orleans
State/Province
Louisiana
ZIP/Postal Code
70121
Country
United States
Facility Name
The Carl & Edyth Lindner Center for Research & Education at The Christ Hospital
City
Cincinnati
State/Province
Ohio
ZIP/Postal Code
45219
Country
United States
Facility Name
CHU Nancy Centre Coeur et Vaisseaux
City
Nancy
ZIP/Postal Code
54035
Country
France

12. IPD Sharing Statement

Citations:
PubMed Identifier
30407514
Citation
Calhoun DA, Schiffrin EL, Flack JM. Resistant Hypertension: An Update. Am J Hypertens. 2019 Jan 1;32(1):1-3. doi: 10.1093/ajh/hpy156. No abstract available.
Results Reference
derived
Links:
URL
http://www.vasculardynamics.com/
Description
Related Info

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

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