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

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).

Study Overview

• Status: Completed
• Conditions: Hypertension
• Intervention / Treatment: Device: Renal Denervation (Vessix); Device: Renal Angiography

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).

• Study Type: Interventional
• Enrollment (Actual): 51
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Alabama
    • Birmingham, Alabama, United States, 35211
      • Cardiology, PC
  • California
    • Los Angeles, California, United States, 90048
      • Cedars - Sinai Medical Center
  • Florida
    • Miami Beach, Florida, United States, 33140
      • Mount Sinai Medical Center
  • Louisiana
    • Houma, Louisiana, United States, 70360
      • Cardiovascular Institute of the South
  • Maryland
    • Baltimore, Maryland, United States, 21201
      • University of Maryland
  • Massachusetts
    • Boston, Massachusetts, United States, 02111
      • Tufts Medical Center
  • New York
    • New York, New York, United States, 10032
      • Columbia University Medical Center
  • Pennsylvania
    • Philadelphia, Pennsylvania, United States, 19141
      • Albert Einstein Medical Center
  • Tennessee
    • Kingsport, Tennessee, United States, 37660
      • Wellmont CVA Heart Institute
  • Texas
    • Dallas, Texas, United States, 75231
      • Cardiovascular Research Institute of Dallas
    • Dallas, Texas, United States, 75006
      • Dallas Medical Center
  • Wisconsin
    • Wausau, Wisconsin, United States, 54401
      • Aspirus Heart and Vascular Institute

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 75 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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 Renal Denervation System; Vessix Reduce™ Catheter and Vessix™ Generator
Sham Comparator: Masked Procedure; Percutaneous renal angiography	Device: Renal Angiography; Percutaneous renal angiography; Other Names: Renal Angiogram

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
OBSERVATIONAL: Change (Mean Reduction) in Average 24-hour Ambulatory Systolic Blood Pressure (ASBP) Through 8 Weeks	Change (mean reduction) in average 24-hour Ambulatory Systolic Blood Pressure (ASBP) through 8 weeks post randomization in subjects treated with renal denervation (Test) and subjects treated with masked procedure (Control)	Through 8 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of Hospitalizations Due to Severe Hypotension/Syncope	Number of hospitalizations due to severe hypotension/syncope through 6 months.	Through 6 months
Significant Embolic Event Resulting in End-organ Damage or Intervention to Prevent it	Number of subjects experiencing a significant embolic event resulting in end-organ damage or intervention to prevent end-organ damage through 4 weeks.	4 weeks
Renal Artery Dissection or Perforation Requiring Intervention	Number of renal artery dissection or perforation requiring intervention through 4 weeks.	4 weeks
Vascular Complications	Number of vascular complications through 4 weeks.	4 weeks
Significant New Renal Artery Stenosis	Number of significant new renal artery stenosis events through 6 months.	6 months
Number of Subjects Utilizing Anti-hypertensive Medications	Number of subjects utilizing anti-hypertensive medications at 3 months.	3 months
Mean Reduction in Average 24-hour Ambulatory Systolic Blood Pressure at 6 Months	Change (mean reduction) in the average 24-hour ambulatory systolic blood pressure at 6 months compared to baseline	6 Months
Mean Reduction in Average 24-hour Ambulatory Diastolic Blood Pressure Through 6 Months	Change (mean reduction) in average 24-hour ambulatory diastolic blood pressure at 6 months compared to baseline.	6 Months
Number of Subjects Utilizing Anti-hypertensive Medications	Number of subjects utilizing anti-hypertensive medications at 6 months	6 months
Mean Reduction in Average 24-Hour Ambulatory Systolic Blood Pressure	Mean Reduction in Average 24-Hour Ambulatory systolic blood pressure at 12 months	12 Months
Mean Reduction in Average 24-hour Ambulatory Diastolic Blood Pressure	Mean reduction in average 24-hour ambulatory diastolic blood pressure at 12 months	12 Months
All-Cause Death	Number of all causes of death through 24 months	24 Months
Number of Participants With Renal Failure	Number of renal failure events through 24 months	24 Months
Number of Participants With Hypertensive Crisis	Number of hypertensive crisis events through 24 months	24 Months
Mean Reduction in Average Office-based Systolic Blood Pressure	Mean Reduction in Average office-based systolic blood pressure through 24 months	24 Months
Mean Reduction in Average Office-based Diastolic Blood Pressure	Mean Reduction in Office-based diastolic blood pressure through 24 months	24 Months
Percent of Subjects at Target Blood Pressure	Percent of subjects at target blood pressure through 24 months	24 Months
Congestive Heart Failure	Number of subjects with congestive heart failure through 24 months	24 Months
Myocardial Infarction	Number of subjects who experience myocardial infarction through 24 months	24 Months
Stroke	Number of subjects experiencing stroke through 24 months	24 Months

Collaborators and Investigators

• Sponsor: Boston Scientific Corporation
• Investigators: Principal Investigator: Michael Weber, MD, SUNY Downstate College of Medicine; Principal Investigator: Martin B Leon, MD, Columbia University

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start: April 1, 2015
• Primary Completion (Actual): September 7, 2017
• Study Completion (Actual): August 2, 2019

Study Registration Dates

• First Submitted: March 13, 2015
• First Submitted That Met QC Criteria: March 18, 2015
• First Posted (Estimate): March 19, 2015

Study Record Updates

• Last Update Posted (Actual): February 11, 2021
• Last Update Submitted That Met QC Criteria: January 25, 2021
• Last Verified: January 1, 2021

More Information

Terms related to this study

• Keywords: Hypertension; Renal Denervation
• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Hypertension
• Other Study ID Numbers: S2333

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes