Continued Safety and Performance of the TIVUS System

Study Overview
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Brief Summary
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The TIVUS II is a prospective, multicenter, non-randomized, open-label clinical study of the safety and performance of the TIVUS™ System consisting of three (3) concurrent cohorts: TIVUS™ Severe Resistant HTN Cohort TIVUS™ Moderate Resistant HTN Cohort TIVUS™ Failed RF Therapy Cohort

Official Title
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Clinical Evaluation of the Therapeutic Intra-Vascular Ultrasound (TIVUS™) System for Renal Denervation in Patients With Resistant Hypertension

Conditions
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Hypertension, Resistant to Conventional Therapy

Intervention / Treatment
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* Device: TIVUS


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patient is ≥ 18 and ≤ 80 years of age For Cohort A: Documented office systolic blood pressure > 160 mmHg (> 150 mmHg for diabetic patients); For Cohort B: Documented office systolic blood pressure > 140 mmHg (> 130 mmHg for diabetic patients); For Cohort C: Documented office systolic blood pressure > 150 mmHg (> 140 mmHg for diabetic patients) Documented 24 hour systolic ABPM > 135 mmHg Adherence to a stable drug regimen For patients in Cohort C only: Documented renal denervation procedure with any RF technology 12 months or more prior to screening Suitable renal artery anatomy Male or non-pregnant / non-lactating female Patient understands the nature of the procedure and provides written informed consent Patient is willing and able to comply with the specified study requirements and follow-up evaluations Exclusion Criteria: eGFR < 45mL/min/1.73m2 Documented primary pulmonary hypertension Patient experienced >1 episode of orthostatic hypotension coupled with syncope Documented indicator of a secondary renal hypertension History of myocardial infarction, unstable angina pectoris, or a cerebrovascular accident within 6 months Planned major surgery or cardiovascular intervention in the next 6 months Surgery or cardiovascular intervention in the previous 3 months Hemodynamically significant valvular heart disease Severe debilitating lung disease Patient on anticoagulant therapy that cannot be temporarily withheld for performing catheterization Patient has a single functioning kidney Documented thrombocytopenia, clotting disorders or aortic aneurysms Moribund patient, or patient with comorbidities limiting life expectancy to less than one year Contraindication to recommended study medications or intravascular contrast material that cannot be adequately controlled with pre-medication Concurrent enrollment in another trial Main renal arteries < 4 mm in lumen diameter or < 20 mm in length Aorto-renal angle that prevents a safe cannulation of the renal artery Severe common femoral artery, common and/or external iliac artery, renal, iliac or aortic calcification or tortuosity that may compromise the safe performance and completion of the procedure Hemodynamically or anatomically significant renal artery abnormality or stenosis in either renal artery Any renal artery stenosis > 50% by visual assessment Any renal artery aneurysm in either renal artery A history of prior renal artery balloon angioplasty or stenting (for patients in Cohort A and B only, also a history of prior renal denervation at any time)

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Severe Resistant HTN<br>Patients presenting with resistant hypertension and office systolic blood pressure of 160 mmHg (150 mmHg for DM) or greater | Device: TIVUS<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in office Systolic Blood Pressure (SBP) from baseline to 6-month |  | 6 month | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Procedural complications |  | 30 day | 
| Major Adverse Events (MAE) |  | 1 year | 
| Preservation of renal function |  | 1 year | 
| Cardiovascular complications |  | 1 year | 
| Blood pressure reduction |  | 1 year |