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
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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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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Birmingham, Alabama 35211
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Dallas, TX
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7 Medical Parkway
Dallas, Texas 75006
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Houma, Louisiana 70360
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Houma, LA
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Kingsport, Tennessee 37660
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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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