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

Boston Scientific Corporation51 enrolled

Overview

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).

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

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

SINGLE

Enrollment

Conditions

Hypertension

Interventions

Renal Denervation (Vessix)DEVICE

Percutaneous renal denervation using the Vessix Reduce™ Catheter and Vessix™ Generator

Renal AngiographyDEVICE

Percutaneous renal angiography

Eligibility

Sex: ALLMin age: 18 YearsMax age: 75 Years

Medical Language ↔ Plain English

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

Locations (12)

Cardiology, PC

Birmingham, Alabama, United States

Cedars - Sinai Medical Center

Los Angeles, California, United States

Mount Sinai Medical Center

Miami Beach, Florida, United States

Outcomes

Primary Outcomes

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)

Time frame: Through 8 weeks

Secondary Outcomes

Number of Hospitalizations Due to Severe Hypotension/Syncope

Number of hospitalizations due to severe hypotension/syncope through 6 months.

Time frame: 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.

Time frame: 4 weeks

Renal Artery Dissection or Perforation Requiring Intervention

Number of renal artery dissection or perforation requiring intervention through 4 weeks.

Time frame: 4 weeks

Vascular Complications

Number of vascular complications through 4 weeks.

Time frame: 4 weeks

Significant New Renal Artery Stenosis

Number of significant new renal artery stenosis events through 6 months.

Time frame: 6 months

Number of Subjects Utilizing Anti-hypertensive Medications

Number of subjects utilizing anti-hypertensive medications at 3 months.

Data from ClinicalTrials.gov

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