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

Completed · Not applicable

Conditions studied: Hypertension

In brief

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).

Key facts

Study ID

NCT02392351

Run by

Boston Scientific Corporation

People needed

51

Starts

2015-04-01

Expected to finish

2019-08-02

Last updated by the study team

2021-02-11

Who can join

Age: 18 and older, up to 75. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• Cardiology, PC — Birmingham, Alabama, United States
• Cedars - Sinai Medical Center — Los Angeles, California, United States
• Mount Sinai Medical Center — Miami Beach, Florida, United States
• Cardiovascular Institute of the South — Houma, Louisiana, United States
• University of Maryland — Baltimore, Maryland, United States
• Tufts Medical Center — Boston, Massachusetts, United States
• Columbia University Medical Center — New York, New York, United States
• Albert Einstein Medical Center — Philadelphia, Pennsylvania, United States
• Wellmont CVA Heart Institute — Kingsport, Tennessee, United States
• Dallas Medical Center — Dallas, Texas, United States
• Cardiovascular Research Institute of Dallas — Dallas, Texas, United States
• Aspirus Heart and Vascular Institute — Wausau, Wisconsin, United States

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.