MobiusHD Device for High Blood Pressure
(CALM-2 Trial)

Recruiting in Palo Alto (17 mi)

+39 other locations

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Academic

Waitlist Available

Sponsor: Vascular Dynamics, Inc.

No Placebo Group

Approved in 2 Jurisdictions

Trial Summary

What is the purpose of this trial?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.

Eligibility Criteria

This trial is for adults with high blood pressure that's stayed high (145-200 mmHg) despite taking up to 5 different blood pressure meds, including a specific combo of an ACE inhibitor or angiotensin receptor blocker, calcium channel blocker, and diuretic. People can't join if their carotid artery anatomy isn't right for the MobiusHD device based on special X-ray tests.

Inclusion Criteria

My blood pressure is high despite taking a mix of up to 5 blood pressure medications.

Exclusion Criteria

Your carotid arteries are not suitable for treatment with the MobiusHD based on a special type of x-ray called carotid angiography.

Participant Groups

The CALM-2 study is testing how safe and effective the MobiusHD System is at lowering blood pressure compared to a fake procedure. Participants won't know which one they get in this controlled study where treatments are assigned randomly.

2Treatment groups

Experimental Treatment

Placebo Group

Group I: MobiusHD ImplantationExperimental Treatment1 Intervention

MobiusHD Implantation

Group II: Sham ImplantationPlacebo Group1 Intervention

Sham Implantation

MobiusHD is already approved in European Union, United States for the following indications:

🇪🇺 Approved in European Union as MobiusHD for: