Controlling And Lowering blood pressure with the MobiusHD device: STudying effects in A Randomized Trial.

Screening:
1. Aged 18-70 years;
2. Diagnosed with resistant hypertension;
3. A mean systolic 24-hour ambulatory blood pressure of 135-170 mmHg following at least 30 days on a stable antihypertensive medication regimen (no changes in medications or dose).;Baseline:
1. A mean systolic 24-hour ambulatory blood pressure of 135-170 mmHg after washout of all antihypertensive medications.

Screening:
1. An inability to provide written informed consent;
2. Taking more than 4 antihypertensive medications;
3. Taking medications co-indicated for hypertension and a comorbidity that cannot be safely stopped for the antihypertensive medication washout periods (examples include beta-blockers) or taking other medications that cause hypotension (i.e. SGLT2 inhibitors for the treatment of diabetes mellitus) that cannot be safely switched/stopped;
4. Currently taking centrally acting agonists such as clonidine, moxonidine, or methyl dopa;
5. White coat hypertension, defined as >20% difference between an average of 3 consecutive systolic OBP measurements and mean systolic 24-hour ABP;
6. Patient with a history of hypertensive crisis in the past 6 months;
7. Known or clinically suspected baroreflex failure or autonomic neuropathy;
8. Known significant aortoiliac or common femoral artery disease that will prohibit safe femoral access, or determination upon femoral pulse assessment and examination of inguinal anatomy that femoral access is contraindicated;
9. Hypertension secondary to an identifiable cause other than treated sleep apnea (e.g., hyperaldosteronism, renal artery stenosis, pheochromocytoma, Cushing's syndrome, coarctation of the aorta, hyper- or hypothyroidism and intracranial tumor);
10. Treatable cause of hypertension including, but not limited to, improper BP measurement, volume overload and pseudotolerance (excessive sodium intake, volume retention from kidney disease, inadequate diuretic therapy), drug-induced or other causes (non-adherence, inadequate doses, inappropriate combinations, NSAIDs, COX-2 inhibitors, cocaine, amphetamines, or other drugs, sympathomimetics, oral contraceptives (confirmed cause of hypertension), adrenocortical steroids, cyclosporine, tacrolimus, erythropoietin, excessive licorice (including some chewing tobacco), ephedra, ma haung, bitter orange; and excessive alcohol intake;
11. Arm circumference >46 cm and/or BMI >=40 kg/m2;
12. Chronic atrial fibrillation, or intermittent atrial fibrillation with one or more episode(s) within the last twelve (12) months;
13. History of bleeding complications with dual antiplatelet therapy in the past, or has known uncorrected bleeding diathesis, or has history of Heparin Induced Thrombocytopenia (HIT);
14. Current or planned use of chronic anticoagulation therapy, including vitamin K antagonists and novel oral anticoagulants (apixaban, rivaroxaban, dabigatran and edoxaban).
15. Peptic ulcer disease with documented active ulcer, or gastrointestinal bleeding within the last year;
16. History of allergy to nickel, or allergy to contrast media that cannot be managed medically;
17. Persistent symptomatic orthostatic hypotension (>20/10 mmHg after 5 minutes of standing upright);
18. Syncope documented to be related to changes in BP within the last six (6) months;
19. History of myocardial infarction, or unstable angina within the past six (6) months;
20. History of cerebral vascular accident within the past year, and NIHSS >5 or mRS >1, or any prior stroke with permanent neurologic defect or any intracranial bleed;
21. Chronic kidney disease (Glomerular filtration rate (GFR) calculated by the Modification of Diet in Renal Disease equation <45 ml/min);
22. Prior carotid surgery, therapeutic radiation, or endovascular stent placement in either carotid region;
23. Severe valvular or structural heart disease (excluding left ventricular hypertrophy);
24. Severe chronic obstructive pulmonary disease, severe asthma or severe pulmonary hypertension (Pulmonary Artery Systolic Pressure PASP>70 mmHg or Pulmonary Vascular Resistance PVR >4.0 Woods Units, not correctable with intravenous diuretics or vasodilator therapy), or any pulmonary disease in which it is expected that the patient cannot lay down without experiencing dyspnea for the duration of the procedure and post-procedural care;
25. NYHA class III or IV heart failure or known reduced left ventricular function (ejection fraction (EF) <30%);
26. Uncontrolled diabetes mellitus with HbA1c >=10 %;
27. Clinical suspicion or history of vasculitis or other condition causing vasculitis (e.g. autoimmune disorders);
28. Active infection within the last month requiring antibiotics;
29. Uncontrolled co-morbid medical condition, including mental health issues, that would adversely affect participation in the trial (including adherence with all follow-up procedures);
30. Co-morbid condition that reduces life expectancy to less than one (1) year;
31. Planned surgery or other procedure within the next six (6) months requiring cessation of antiplatelet medications;
32. Pregnant or lactating females. For females of child-bearing potential, a positive mandatory pregnancy test within seven (7) days of the pre-randomization screening or refusal to use a medically accepted method of birth control for the duration of the screening period and trial;
33. Presence of visible atherosclerotic plaque or areas of intimal thickness (IMT) of >1500 micron in the region of the carotid bifurcation (15 mm proximal and 15 mm distal to the ICA ostium), determined at a central core laboratory;
34. Significant obstructive vascular disease, calcification or plaque of aortic arch and great vessels by ultrasound, CTA or MRA;
35. Renal artery stenosis >50% or systolic gradient >10 mmHg in borderline cases diagnosed by renal artery imaging in the 36 months prior to signature of informed consent. Acceptable renal artery imaging modalities include renal duplex, MRA, CTA, and selective or non-selective renal angiography depending on trial site diagnostic standards;
36. Internal carotid artery (ICA) lumen diameters <4.5 mm or >12.5 mm within the planned location of the implant placement via CTA or MRA. Evidence of landing zone restrictions, such as inadequate length, vessel tapering, and/or vessel curvature that would preclude safe placement of the implant;
37. Enrolled in a concurrent clinical trial of an investigational drug or device that has not yet reached its primary endpoint or may otherwise interfere in study processes or endpoints;
38. Unable or unwilling to fulfill the protocol follow-up requirements;
39. Subject is a prisoner or member of other vulnerable population. ;Day of Procedure - Angiographic:
1. Evidence of any carotid plaque, ulceration or any stenosis on selective carotid angiography performed in orthogonal views. ICA luminal diameter <5 mm or >11.75 mm within the planned location of the device placement;
2. Any angiographic evidence of plaque or ulceration in the aortic arch and/or the supra-aortic vasculature;
3. Inappropriate anatomy of the carotid bifurcation for deployment of the MobiusHD, including, but not limited to, tortuosity of the extracranial vessels and significant angulation of the common carotid artery bifurcation;
4. Type III arch or horizontal takeoff of the left carotid from the innominate and any significant calcification of the carotid bulb.