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Trial record 1 of 1 for:    NCT02392351
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Renal Denervation Using the Vessix Renal Denervation System for the Treatment of Hypertension (REDUCE HTN:REINFORCE)

This study is ongoing, but not recruiting participants.
Sponsor:
ClinicalTrials.gov Identifier:
NCT02392351
First Posted: March 19, 2015
Last Update Posted: November 1, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Boston Scientific Corporation
  Purpose
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).

Condition Intervention Phase
Hypertension Device: Renal Denervation (Vessix) Device: Renal Angiography Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
Official Title: A Boston Scientific Clinical Trial of Renal Denervation Using the Vessix Reduce™ Catheter and Vessix™ Generator for the Treatment of HyperTensioN: REINFORCE

Further study details as provided by Boston Scientific Corporation:

Primary Outcome Measures:
  • Mean reduction in average 24-hour ambulatory systolic blood pressure [ Time Frame: 8 weeks ]

Secondary Outcome Measures:
  • All-Cause Death [ Time Frame: Through 36 months ]
  • Renal Failure [ Time Frame: Through 36 months ]
  • Hypertensive crisis [ Time Frame: Through 36 months ]
  • Hypotension/syncope [ Time Frame: Through 36mo ]
  • Significant embolic event resulting in end-organ damage or intervention to prevent it [ Time Frame: 4 weeks ]
  • Renal artery dissection or perforation requiring intervention [ Time Frame: 4 weeks ]
  • Vascular complications [ Time Frame: 4 weeks ]
  • Significant new renal artery stenosis [ Time Frame: 6 months ]
  • Office-based systolic blood pressure [ Time Frame: Through 36 months ]
  • Office-based diastolic blood pressure [ Time Frame: Through 36 months ]
  • Percent of subjects at target blood pressure [ Time Frame: Through 36 months ]
  • Congestive Heart Failure [ Time Frame: Through 36 months ]
  • Stroke [ Time Frame: Through 36 months ]
  • Myocardial Infarction [ Time Frame: Through 36 months ]
  • Mean number of anti-hypertensive medications [ Time Frame: 3mo, 6mo ]
  • Mean reduction in average 24-hour ambulatory systolic blood pressure [ Time Frame: 6mo, 12mo ]
  • Mean reduction in average 24-hour ambulatory diastolic blood pressure [ Time Frame: 6mo, 12mo ]

Enrollment: 51
Study Start Date: April 2015
Estimated Study Completion Date: March 2021
Estimated Primary Completion Date: February 2018 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Renal Denervation
Percutaneous renal denervation using the Vessix Reduce™ Catheter and Vessix™ Generator (Vessix Renal Denervation System).
Device: Renal Denervation (Vessix)
Percutaneous renal denervation using the Vessix Reduce™ Catheter and Vessix™ Generator
Other Names:
  • Vessix Reduce™ Catheter and Vessix™ Generator
  • Vessix Renal Denervation System
Sham Comparator: Masked Procedure
Percutaneous renal angiography
Device: Renal Angiography
Percutaneous renal angiography
Other Name: Renal Angiogram

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

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02392351


Locations
United States, Alabama
Cardiology, PC
Birmingham, Alabama, United States, 35211
United States, California
Cedars - Sinai Medical Center
Los Angeles, California, United States, 90048
United States, Florida
Mount Sinai Medical Center
Miami Beach, Florida, United States, 33140
United States, Georgia
Augusta University
Augusta, Georgia, United States, 30912
United States, Louisiana
Cardiovascular Institute of the South
Houma, Louisiana, United States, 70360
United States, Maryland
University of Maryland
Baltimore, Maryland, United States, 21201
United States, Massachusetts
Tufts Medical Center
Boston, Massachusetts, United States, 02111
United States, New York
Columbia University Medical Center
New York, New York, United States, 10032
United States, Pennsylvania
Albert Einstein Medical Center
Philadelphia, Pennsylvania, United States, 19141
United States, Tennessee
Wellmont CVA Heart Institute
Kingsport, Tennessee, United States, 37660
United States, Texas
Dallas Medical Center
Dallas, Texas, United States, 75006
Cardiovascular Research Institute of Dallas
Dallas, Texas, United States, 75231
United States, Wisconsin
Aspirus Heart and Vascular Institute
Wausau, Wisconsin, United States, 54401
Sponsors and Collaborators
Boston Scientific Corporation
Investigators
Principal Investigator: Martin B Leon, MD Columbia University
Principal Investigator: Michael Weber, MD SUNY Downstate College of Medicine
  More Information

Responsible Party: Boston Scientific Corporation
ClinicalTrials.gov Identifier: NCT02392351     History of Changes
Other Study ID Numbers: S2333
First Submitted: March 13, 2015
First Posted: March 19, 2015
Last Update Posted: November 1, 2017
Last Verified: October 2017

Keywords provided by Boston Scientific Corporation:
Hypertension
Renal Denervation

Additional relevant MeSH terms:
Hypertension
Vascular Diseases
Cardiovascular Diseases