CALM- 2 - Controlling and Lowering Blood Pressure With the MobiusHD™ (CALM-2)
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|ClinicalTrials.gov Identifier: NCT03179800|
Recruitment Status : Active, not recruiting
First Posted : June 7, 2017
Last Update Posted : January 7, 2020
|Condition or disease||Intervention/treatment||Phase|
|Hypertension Resistant Hypertension||Device: MobiusHD Other: Sham Implantation||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||300 participants|
|Intervention Model:||Crossover Assignment|
|Masking:||Triple (Participant, Care Provider, Outcomes Assessor)|
|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|
Experimental: MobiusHD Implantation
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
Other: Sham Implantation
- 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.
- 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.
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
|Study Chair:||Bryan Williams, MD||University College, London|
|Study Chair:||Gregg Stone, MD||Cardiovascular Research and Education Columbia University Medical Center|