CALM-2: CALM- 2 - Controlling and Lowering Blood Pressure With the MobiusHD™
Sponsor
Vascular Dynamics, Inc. (Industry)
Overall Status
Active, not recruiting
CT.gov ID
NCT03179800
Collaborator
(none)
300
24
2
90.4
12.5
0.1
Study Details
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
N/A |
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.
Study Design
Study Type:
Interventional
Anticipated Enrollment
:
300 participants
Allocation:
Randomized
Intervention Model:
Crossover Assignment
Masking:
Triple (Participant, Care Provider, Outcomes Assessor)
Primary Purpose:
Treatment
Official Title:
CALM- 2 - Controlling and Lowering Blood Pressure With the MobiusHD™
Actual Study Start Date
:
Oct 19, 2017
Anticipated Primary Completion Date
:
May 1, 2025
Anticipated Study Completion Date
:
May 1, 2025
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: MobiusHD Implantation MobiusHD Implantation |
Device: MobiusHD
The MobiusHD device is a self-expanding nitinol implant that is delivered intravascularly to the internal carotid sinus via the delivery catheter.
|
| Sham Comparator: Sham Implantation Sham Implantation |
Other: Sham Implantation
Sham Implantation
|
Outcome Measures
Primary Outcome Measures
- Primary Effectiveness Endpoint - Change in mean 24-hr sABP from baseline to 180-day [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.
Other Outcome Measures
- Safety Assessments - Composite measured at 90-day [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.
Eligibility Criteria
Criteria
Ages Eligible for Study:
18 Years
to 80 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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.
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Cardiology PC | Birmingham | Alabama | United States | 35211 |
| 2 | University of Alabama, Birmingham | Birmingham | Alabama | United States | 35294 |
| 3 | Stanford University Hospital | Palo Alto | California | United States | 94304 |
| 4 | Emory University Hospital Midtown | Atlanta | Georgia | United States | 30308 |
| 5 | University of Chicago | Chicago | Illinois | United States | 60637 |
| 6 | Southern Illinois University | Springfield | Illinois | United States | 62702 |
| 7 | St. Vincent Heart Center of Indiana | Indianapolis | Indiana | United States | 46290 |
| 8 | Ochsner Medical Center | New Orleans | Louisiana | United States | 70121 |
| 9 | The Carl & Edyth Lindner Center for Research & Education at The Christ Hospital | Cincinnati | Ohio | United States | 45219 |
| 10 | Cleveland Clinic | Cleveland | Ohio | United States | 44195 |
| 11 | Einstein Medical Center | Philadelphia | Pennsylvania | United States | 19141 |
| 12 | CHU Nancy Centre Coeur et Vaisseaux | Nancy | France | 54035 | |
| 13 | Asklepios Klinik Hamburg | Hamburg | Germany | 22559 | |
| 14 | Universitätsklinikum des Saarlandes | Homburg | Germany | 66421 | |
| 15 | Klinikum der Universität München | München | Germany | 81377 | |
| 16 | Maastricht University Medical Centre | Maastricht | Netherlands | 6229 HX | |
| 17 | University Medical Center Utrecht | Utrecht | Netherlands | 3584 CX | |
| 18 | Golden Jubilee | Glasgow | Scotland | United Kingdom | G81 4DY |
| 19 | Queen Elizabeth Hospital | Birmingham | United Kingdom | B15 2GW | |
| 20 | Heartlands Hospital | Birmingham | United Kingdom | B95SS | |
| 21 | Royal Liverpool University Hospital | Liverpool | United Kingdom | L7 8XP | |
| 22 | St. Bart's Hospital | London | United Kingdom | EC1M 6BQ | |
| 23 | University London College Hospital | London | United Kingdom | W1T 7DN | |
| 24 | Manchester Royal Infirmary | Manchester | United Kingdom | M13 9WL |
Sponsors and Collaborators
- Vascular Dynamics, Inc.
Investigators
- Study Chair: Bryan Williams, MD, University College, London
- Study Chair: Gregg Stone, MD, Cardiovascular Research and Education Columbia University Medical Center
Study Documents (Full-Text)
None provided.More Information
Additional Information:
Publications
None provided.Responsible Party:
Vascular Dynamics, Inc.
ClinicalTrials.gov Identifier:
NCT03179800
Other Study ID Numbers:
- CRD0447
First Posted:
Jun 7, 2017
Last Update Posted:
Oct 6, 2021
Last Verified:
Oct 1, 2021
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
Yes
Keywords provided by Vascular Dynamics, Inc.
Additional relevant MeSH terms: