Renal Denervation Using the Vessix Renal Denervation System for the Treatment of Hypertension (REDUCE HTN:REINFORCE)
NCT ID: NCT02392351
Last Updated: 2021-02-11
Study Results
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View full resultsBasic Information
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COMPLETED
NA
51 participants
INTERVENTIONAL
2015-04-30
2019-08-02
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
SINGLE
Study Groups
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Renal Denervation
Percutaneous renal denervation using the Vessix Reduce™ Catheter and Vessix™ Generator (Vessix Renal Denervation System).
Renal Denervation (Vessix)
Percutaneous renal denervation using the Vessix Reduce™ Catheter and Vessix™ Generator
Masked Procedure
Percutaneous renal angiography
Renal Angiography
Percutaneous renal angiography
Interventions
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Renal Denervation (Vessix)
Percutaneous renal denervation using the Vessix Reduce™ Catheter and Vessix™ Generator
Renal Angiography
Percutaneous renal angiography
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
* 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
18 Years
75 Years
ALL
No
Sponsors
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Boston Scientific Corporation
INDUSTRY
Responsible Party
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Principal Investigators
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Martin B Leon, MD
Role: PRINCIPAL_INVESTIGATOR
Columbia University
Michael Weber, MD
Role: PRINCIPAL_INVESTIGATOR
SUNY Downstate College of Medicine
Locations
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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
Countries
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References
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Weber MA, Kirtane AJ, Weir MR, Radhakrishnan J, Das T, Berk M, Mendelsohn F, Bouchard A, Larrain G, Haase M, Diaz-Cartelle J, Leon MB. The REDUCE HTN: REINFORCE: Randomized, Sham-Controlled Trial of Bipolar Radiofrequency Renal Denervation for the Treatment of Hypertension. JACC Cardiovasc Interv. 2020 Feb 24;13(4):461-470. doi: 10.1016/j.jcin.2019.10.061.
Provided Documents
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Document Type: Study Protocol and Statistical Analysis Plan
Other Identifiers
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S2333
Identifier Type: -
Identifier Source: org_study_id
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