Renal Denervation Using the Vessix Renal Denervation System for the Treatment of Hypertension (REDUCE HTN:REINFORCE)

Study Overview
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Brief Summary
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The REDUCE HTN: REINFORCE study is being conducted to determine whether the Vessix Reduce™ Catheter and Vessix™ Generator for the treatment of uncontrolled hypertension (off-treatment office systolic blood pressure ≥150 mmHg and ≤180 mmHg) shows acceptable performance at 8 weeks when compared to a masked procedure (renal angiogram).

Detailed Description
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Prospective, multicenter, single blinded, randomized, controlled, pilot study. Subjects will be randomized to renal denervation treatment or masked renal angiogram procedure (2:1).

Official Title
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A Boston Scientific Clinical Trial of Renal Denervation Using the Vessix Reduce™ Catheter and Vessix™ Generator for the Treatment of HyperTensioN: REINFORCE

Conditions
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Hypertension

Intervention / Treatment
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* Device: Renal Denervation (Vessix)
* Device: Renal Angiography


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Age ≥18 and ≤75 years OSBP ≥150 mmHg and ≤180 mmHg based on an average of 3 office-based blood pressure measurements Average 24-hour ASBP ≥135 mmHg and ≤170 mmHg For each kidney, a main renal artery, with or without accessory renal arteries, with diameter ≥3.0 mm and ≤7.0 mm and length ≥20.0 mm Agrees to have all study procedures performed, and is competent and willing to provide written, informed consent Exclusion Criteria: Stenosis >30% or renal artery aneurysm in either renal artery Fibromuscular dysplasia (FMD) Known causes of secondary HTN Type 1 diabetes mellitus eGFR <40 mL/min/1.73m2 Known ejection fraction of <30% or heart failure that required hospitalization in the previous 6 months Severe valvular heart disease ≥1 episode(s) of orthostatic hypotension not related to medication changes (reduction of SBP of ≥20 mmHg or DBP of ≥10 mmHg within three minutes of standing) coupled with symptoms within the past year or during screening

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 75 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
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Renal Denervation<br>Percutaneous renal denervation using the Vessix Reduce™ Catheter and Vessix™ Generator (Vessix Renal Denervation System). | Device: Renal Denervation (Vessix)<br>* Percutaneous renal denervation using the Vessix Reduce™ Catheter and Vessix™ Generator<br>* Other names: Vessix Renal Denervation System;|
| Sham Comparator: Masked Procedure<br>Percutaneous renal angiography | Device: Renal Angiography<br>* Percutaneous renal angiography<br>* Other names: Renal Angiogram;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| OBSERVATIONAL: Change (Mean Reduction) in Average 24-hour Ambulatory Systolic Blood Pressure (ASBP) Through 8 Weeks | Change (mean reduction) in average 24-hour Ambulatory Systolic Blood Pressure (ASBP) through 8 weeks post randomization in subjects treated with renal denervation (Test) and subjects treated with masked procedure (Control) | Through 8 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Hospitalizations Due to Severe Hypotension/Syncope | Number of hospitalizations due to severe hypotension/syncope through 6 months. | Through 6 months | 
| Significant Embolic Event Resulting in End-organ Damage or Intervention to Prevent it | Number of subjects experiencing a significant embolic event resulting in end-organ damage or intervention to prevent end-organ damage through 4 weeks. | 4 weeks | 
| Renal Artery Dissection or Perforation Requiring Intervention | Number of renal artery dissection or perforation requiring intervention through 4 weeks. | 4 weeks | 
| Vascular Complications | Number of vascular complications through 4 weeks. | 4 weeks | 
| Significant New Renal Artery Stenosis | Number of significant new renal artery stenosis events through 6 months. | 6 months | 
| Number of Subjects Utilizing Anti-hypertensive Medications | Number of subjects utilizing anti-hypertensive medications at 3 months. | 3 months | 
| Mean Reduction in Average 24-hour Ambulatory Systolic Blood Pressure at 6 Months | Change (mean reduction) in the average 24-hour ambulatory systolic blood pressure at 6 months compared to baseline | 6 Months | 
| Mean Reduction in Average 24-hour Ambulatory Diastolic Blood Pressure Through 6 Months | Change (mean reduction) in average 24-hour ambulatory diastolic blood pressure at 6 months compared to baseline. | 6 Months | 
| Number of Subjects Utilizing Anti-hypertensive Medications | Number of subjects utilizing anti-hypertensive medications at 6 months | 6 months | 
| Mean Reduction in Average 24-Hour Ambulatory Systolic Blood Pressure | Mean Reduction in Average 24-Hour Ambulatory systolic blood pressure at 12 months | 12 Months | 
| Mean Reduction in Average 24-hour Ambulatory Diastolic Blood Pressure | Mean reduction in average 24-hour ambulatory diastolic blood pressure at 12 months | 12 Months | 
| All-Cause Death | Number of all causes of death through 24 months | 24 Months | 
| Number of Participants With Renal Failure | Number of renal failure events through 24 months | 24 Months | 
| Number of Participants With Hypertensive Crisis | Number of hypertensive crisis events through 24 months | 24 Months | 
| Mean Reduction in Average Office-based Systolic Blood Pressure | Mean Reduction in Average office-based systolic blood pressure through 24 months | 24 Months | 
| Mean Reduction in Average Office-based Diastolic Blood Pressure | Mean Reduction in Office-based diastolic blood pressure through 24 months | 24 Months | 
| Percent of Subjects at Target Blood Pressure | Percent of subjects at target blood pressure through 24 months | 24 Months | 
| Congestive Heart Failure | Number of subjects with congestive heart failure through 24 months | 24 Months | 
| Myocardial Infarction | Number of subjects who experience myocardial infarction through 24 months | 24 Months | 
| Stroke | Number of subjects experiencing stroke through 24 months | 24 Months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Hypertension, Renal Denervation