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



Status:Active, not recruiting
Conditions:High Blood Pressure (Hypertension)
Therapuetic Areas:Cardiology / Vascular Diseases
Healthy:No
Age Range:18 - 75
Updated:4/17/2018
Start Date:April 2015
End Date:March 2021

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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

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).

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
We found this trial at
12
sites
Birmingham, Alabama 35211
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800 Washington St
Boston, Massachusetts 02111
(617) 636-5000
Tufts Medical Center Tufts Medical Center is an internationally-respected academic medical center – a teaching...
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Boston, MA
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8700 Beverly Blvd # 8211
Los Angeles, California 90048
(1-800-233-2771)
Cedars Sinai Med Ctr Cedars-Sinai is known for providing the highest quality patient care. Our...
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Los Angeles, CA
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Baltimore, Maryland 20742
(301) 405-1000
University of Maryland As a globally-connected university offering a world-class education, the University of Maryland...
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Baltimore, MD
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Dallas, TX
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7 Medical Parkway
Dallas, Texas 75006
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Dallas, TX
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Houma, Louisiana 70360
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Houma, LA
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Kingsport, Tennessee 37660
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Kingsport, TN
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Miami Beach, Florida 33140
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Miami Beach, FL
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630 W 168th St
New York, New York
212-305-2862
Columbia University Medical Center Situated on a 20-acre campus in Northern Manhattan and accounting for...
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New York, NY
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5501 Old York Road
Philadelphia, Pennsylvania 19141
215-456-7890
Albert Einstein Medical Center Einstein Healthcare Network is a private, not-for-profit organization with several major...
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Philadelphia, PA
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Wausau, Wisconsin 54401
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Wausau, WI
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