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

Description

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 consentedure (renal angiogram).

Study Start Date

April 2015

Estimated Completion Date

May 2019

Interventions

  • Device: Renal Denervation (Vessix)
  • Device: Renal Angiography

Specialties

  • Nephrology: Hypertension
  • Physician Assistant: Nephrology

MeSH Terms

  • Hypertension

Study ID

Boston Scientific Corporation -- S2333

Status

Unknown

Trial ID

NCT02392351

Study Type

Interventional

Trial Phase

Phase 2

Enrollment Quota

100

Sponsor

Boston Scientific Corporation

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

Gender

Both

Ages

18 Years to 75 Years

Accepts Healthy Volunteers

No

Study Locations and Contact Information (13)

Study Location Distance Name Phone Email
Columbia University Medical Center - New York, New York 44.8 miles Ajay Kirtane MD None None
OhioHealth Research Institute - Columbus, Ohio 519.7 miles Gary Ansel MD None None
Wellmont CVA Heart Institute - Kingsport, Tennessee 596.1 miles David Metzger MD None None
The Lindner Clinical Trial Center - Cincinnati, Ohio 613.2 miles Dean Kereiakes MD None None
Piedmont Hospital - Atlanta, Georgia 798.5 miles David E Kandzari MD None None
Aspirus Heart and Vascular Institute - Wausau, Wisconsin 867.6 miles German Larrain MD None None
Prairie Heart Institute - Springfield, Illinois 867.9 miles Nilesh Goswami MD None None
Cardiology PC - Birmingham, Alabama 919.9 miles Farrell Mendelsohn MD None None
Mayo Clinic - Rochester, Minnesota 997.5 miles Gary Schwartz MD None None
Baptist Hospital of Miami - Miami, Florida 1,152.7 miles Barry Katzen MD None None
Cardiovascular Institute of the South - Houma, Louisiana 1,271.0 miles Craig Walker MD None None
Cardiovascular Research Institute of Dallas - Dallas, Texas 1,416.1 miles Tony Das MD None None
Saint Joseph Hospital - Tustin, California 2,476.5 miles Joel M Neutel MD None None

ClinicalTrialsLocator.com provides clinical trial listings in an easy to view format. All clinical trial information is pulled directly from ClinicalTrials.gov. This website does not guarantee acceptance into any clinical trial, and is not responsible for adverse events that may be incurred from a clinical trial.