CALM-FIM_EUR - CONTROLLING AND LOWERING BLOOD PRESSURE WITH THE MOBIUSHD* - A PROSPECTIVE MULTICENTER SAFETY STUDY

Completed

Conditions: Resistant Hypertension
Drug resistant high blood pressure
Refractory Hypertension

Registration Number: NL-OMON45177

Lead Sponsor: Vascular Dynamics, Inc. Clinical Research

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Completed

Sex: Not specified

Target Recruitment: 24

Inclusion Criteria

Baseline Screening Visit 1 - (Day 0 - 14) - Assessed on Day 14
1. Provided written informed consent;
2. >= 18 years of age and <= 80 years of age;
3. Office cuff SBP >= 160 mmHg measured per protocol instructions (Appendix IV) following at least one (1) month of maximally tolerated therapy with at least three (3) anti-hypertensive medications, of which at least one (1) must be a diuretic unless patient has history of intolerance, ineffectiveness or contraindications. Any combination medications will be counted per the active ingredient. (For example, Zestoretic (Lisinopril +HCTZ) equals two (2) anti-hypertensive medications);
4. Carotid duplex studies demonstrating no obstructive carotid disease or plaque
5. Renal artery imaging performed within the last 12 months showing no evidence of renal artery stenosis. Acceptable imaging modalities include renal duplex, magnetic resonance angiography, CT angiography, and selective or nonselective renal angiography depending on trial site diagnostic standards. In the absence of adequate imaging testing this inclusion criteria could also be met by obtaining a renal duplex prior to enrollment, or by performing nonselective renal angiography at the time of device implantation.
6. Compliant with medications (self-reported); and
7. For females (with child-bearing potential), a negative pregnancy test, and the use of a medically accepted method of birth control for the duration of the trial.;Baseline Screening Visit 2 - (Day 15 - 30) - Assessed on Day 30
1. No significant obstructive vascular disease or plaque on CTA or MRA of the aortic arch and great vessels;
2. Continued adherence to hypertension medications without anticipated changes; and
3. Continued office cuff SBP >= 160 mmHg despite at least one (1) month of maximally tolerated therapy with at least three (3) anti-hypertensive medications, of which at least one (1) must be a diuretic unless patient has history of intolerance, ineffectiveness or contraindications. Any combination medications will be counted per the active ingredient. (For example, Zestoretic (Lisinopril+HCTZ) equals two (2) anti-hypertensive medications).;Day of Procedure -
1. Continued adherence to hypertension medications without anticipated changes.

Exclusion Criteria

Baseline Screening Visit 1 - (Day 0 - 14) - Assessed on Day 14
1.Known or clinically suspected baroreflex failure or autonomic neuropathy;
2.Hypertension secondary to an identifiable and treatable cause other than sleep apnea;
3.Arm circumference greater than 46cm and/or BMI >= 40;
4.Chronic atrial fibrillation or recurrent atrial fibrillation with episode within the last 12 months;
5.Vulnerable plaque or ulceration of any size in the carotid artery or aortic arch;
6.History of bleeding complications with dual anti-platelet therapy in the past or has known uncorrectable bleeding diathesis;
7.Current use of additional anticoagulation therapy. (Examples include vitamin K antagonists like warfarin, direct thrombin inhibitors, direct factor Xa inhibitors, thrombin IIa inhibitors like apixaban, rivaroxaban, dabigatran and etexilate;
8.Peptic ulcer disease with documented active ulcer or bleeding within the last year.
9.History of allergy to contrast dye that cannot be managed medically;
10.History of orthostatic hypotension;
11.History of syncope within the last six (6) months;
12.History of myocardial infarction or unstable angina within the past three (3) months;
13.History of cerebral vascular accident (stroke or TIA) within the past year;
14.Severe chronic kidney disease (calculated GFR < 30 ml/min);
15.Prior surgery, radiation, or endovascular stent placement in either carotid region;
16.Clinically significant structural valvular cardiac disease;
17.Moderate to severe reactive airway disease, chronic obstructive pulmonary disease, or primary pulmonary hypertension;
18.Uncompensated congestive heart failure or known severe reduction in left ventricular function (EF < 30%);
19.Uncontrolled co-morbid medical condition that would adversely affect participation in the trial;
20.Non-controlled diabetes mellitus;
21.Active infection within the last month;
22.Co-morbid condition that reduces life expectancy to less than one (1) year;
23.Mental health issues that would prohibit the subject*s availability to meet the Protocol requirements;
24.Currently taking an imidazoline receptor agonist or central sympathetic treatment;
25.Enrolled in a concurrent clinical trial;
26.Unable or unwilling to fulfill the protocol follow-up requirements;
27.Subject is a prisoner or member of other protected population;
28.Planned surgery or other procedure within the next six (6) months; or
29.Deep venous thrombosis (DVT) within the last year or documented recurrent DVT.;Baseline Screening Visit 2 - (Day 15 - 30) - Assessed on Day 30
1.ICA lumen diameters < 5 mm or > 11.75 mm.
2.Carotid hypersensitivity detected by carotid massage or typical history, as described in the Protocol (Appendix V); or
3.Significant aortoiliac or common femoral artery disease that will prohibit safe femoral access
4. Mean 24-hour ambulatory blood pressure < 130/80 mmHg.;Day of Procedure - Angiographic
1. Evidence of plaque, ulceration or any stenosis by angiographic evaluation in
orthogonal views of the carotid artery. Lumen diameters will be assessed to exclude
subjects with ICA lumen diameters smaller than 5 mm or larger than 11.75 mm.
2. Any plaque or ulceration on the arch angiogram involving the aortic arch and/or the
origin of the great vessels;
3. Inappropriate anatomy of the carotid bifurcation for deployment of the MobiusH

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>Safety: Incidence of serious adverse events (SAEs) and unanticipated adverse<br /><br>device effects (UADE) reported for the study population from implantation<br /><br>through six (6) months of follow-up. </p><br>

Secondary Outcome Measures