Trial Search Results

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

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.

Stanford is currently not accepting patients for this trial.

Lead Sponsor:

Vascular Dynamics, Inc.

Stanford Investigator(s):

Intervention(s):

  • Device: MobiusHD
  • Other: Sham Implantation

Phase:

N/A

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.

Ages Eligible for Study

18 Years - 80 Years

Genders Eligible for Study

All

Not currently accepting new patients for this trial

Contact Information

Stanford University
School of Medicine
300 Pasteur Drive
Stanford, CA 94305
Recruiting