CALM- 2 - Controlling and Lowering Blood Pressure With the MobiusHD™ (CALM-2)
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The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. |
| ClinicalTrials.gov Identifier: NCT03179800 |
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Recruitment Status :
Active, not recruiting
First Posted : June 7, 2017
Last Update Posted : January 7, 2020
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Sponsor:
Vascular Dynamics, Inc.
Information provided by (Responsible Party):
Vascular Dynamics, Inc.
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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 |
|---|---|---|
| Hypertension Resistant Hypertension | Device: MobiusHD Other: Sham Implantation | Not Applicable |
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 Type : | Interventional (Clinical Trial) |
| Estimated 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 : | October 19, 2017 |
| Estimated Primary Completion Date : | May 2021 |
| Estimated Study Completion Date : | May 2026 |
Resource links provided by the National Library of Medicine
MedlinePlus Genetics related topics:
Hypertension
| Arm | Intervention/treatment |
|---|---|
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Experimental: MobiusHD Implantation
MobiusHD Implantation
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Device: MobiusHD
The MobiusHD device is a self-expanding nitinol implant that is delivered intravascularly to the internal carotid sinus via the delivery catheter. |
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Sham Comparator: Sham Implantation
Sham Implantation
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Other: Sham Implantation
Sham Implantation |
Primary Outcome Measures :
- Primary Effectiveness Endpoint - Change in mean 24-hr sABP from baseline to 180-day [ Time Frame: 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 [ Time Frame: 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.
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| Ages Eligible for Study: | 18 Years to 80 Years (Adult, Older Adult) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
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.
Information from the National Library of Medicine
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03179800
Locations
Show 40 study locations
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 |
Additional Information:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
| Responsible Party: | Vascular Dynamics, Inc. |
| ClinicalTrials.gov Identifier: | NCT03179800 |
| Other Study ID Numbers: |
CRD0447 |
| First Posted: | June 7, 2017 Key Record Dates |
| Last Update Posted: | January 7, 2020 |
| Last Verified: | January 2020 |
| 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 |
Keywords provided by Vascular Dynamics, Inc.:
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Hypertension Resistant Hypertension Baroreceptor BAT |
Additional relevant MeSH terms:
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Hypertension Vascular Diseases Cardiovascular Diseases |