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

NCT02392351 | Completed Results DMC FDA Device

• 1 other identifier: S2333
• Study Type: interventional
• Target: 51
• Locations: 1 country
• Sites: 12

Brief Summary

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).

Conditions

Hypertension

Keywords

Hypertension; Renal Denervation

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (20)

• Number of Hospitalizations Due to Severe Hypotension/Syncope

  Through 6 months

• Significant Embolic Event Resulting in End-organ Damage or Intervention to Prevent it

  4 weeks

• Renal Artery Dissection or Perforation Requiring Intervention

  4 weeks

• Vascular Complications

  4 weeks

• Significant New Renal Artery Stenosis

  6 months

Study Arms (2)

Renal Denervation

EXPERIMENTAL

Percutaneous renal denervation using the Vessix Reduce™ Catheter and Vessix™ Generator (Vessix Renal Denervation System).

Device: Renal Denervation (Vessix)

Masked Procedure

SHAM COMPARATOR

Percutaneous renal angiography

Device: Renal Angiography

Interventions

Renal Denervation (Vessix) DEVICE

Percutaneous renal denervation using the Vessix Reduce™ Catheter and Vessix™ Generator

Also known as: Vessix Reduce™ Catheter and Vessix™ Generator, Vessix Renal Denervation System

Renal Denervation

Renal Angiography DEVICE

Percutaneous renal angiography

Also known as: Renal Angiogram

Masked Procedure

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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

Sponsors & Collaborators

• Boston Scientific Corporation: lead

Study Sites (12)

Cardiology, PC

Birmingham, Alabama, 35211, United States

Location

Cedars - Sinai Medical Center

Los Angeles, California, 90048, United States

Location

Mount Sinai Medical Center

Miami Beach, Florida, 33140, United States

Location

Cardiovascular Institute of the South

Houma, Louisiana, 70360, United States

Location

University of Maryland

Baltimore, Maryland, 21201, United States

Location

Tufts Medical Center

Boston, Massachusetts, 02111, United States

Location

Columbia University Medical Center

New York, New York, 10032, United States

Location

Albert Einstein Medical Center

Philadelphia, Pennsylvania, 19141, United States

Location

Wellmont CVA Heart Institute

Kingsport, Tennessee, 37660, United States

Location

Dallas Medical Center

Dallas, Texas, 75006, United States

Location

Cardiovascular Research Institute of Dallas

Dallas, Texas, 75231, United States

Location

Aspirus Heart and Vascular Institute

Wausau, Wisconsin, 54401, United States

Location

Related Publications (1)

• 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.

  PMID: 32081240 DERIVED

MeSH Terms

Conditions

Hypertension

Condition Hierarchy (Ancestors)

Vascular Diseases; Cardiovascular Diseases

Results Point of Contact

• Title: Clinical Trial Manager
• Organization: Boston Scientific

nicole.kilburn@bsci.com

970-294-4082

Study Officials

• Martin B Leon, MD

  Columbia University

  PRINCIPAL INVESTIGATOR

• Michael Weber, MD

  SUNY Downstate College of Medicine

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 13, 2015
• First Posted: March 19, 2015
• Study Start: April 1, 2015
• Primary Completion: September 7, 2017
• Study Completion: August 2, 2019
• Last Updated: February 11, 2021
• Results First Posted: October 4, 2019

Record last verified: 2021-01

Locations

US (12)