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

January 25, 2021 updated by: Boston Scientific Corporation

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

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
51

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

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

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
OBSERVATIONAL: Change (Mean Reduction) in Average 24-hour Ambulatory Systolic Blood Pressure (ASBP) Through 8 Weeks
Time Frame: 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

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Number of Hospitalizations Due to Severe Hypotension/Syncope
Time Frame: Through 6 months
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
Time Frame: 4 weeks
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
Time Frame: 4 weeks
Number of renal artery dissection or perforation requiring intervention through 4 weeks.
4 weeks
Vascular Complications
Time Frame: 4 weeks
Number of vascular complications through 4 weeks.
4 weeks
Significant New Renal Artery Stenosis
Time Frame: 6 months
Number of significant new renal artery stenosis events through 6 months.
6 months
Number of Subjects Utilizing Anti-hypertensive Medications
Time Frame: 3 months
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
Time Frame: 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
Time Frame: 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
Time Frame: 6 months
Number of subjects utilizing anti-hypertensive medications at 6 months
6 months
Mean Reduction in Average 24-Hour Ambulatory Systolic Blood Pressure
Time Frame: 12 Months
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
Time Frame: 12 Months
Mean reduction in average 24-hour ambulatory diastolic blood pressure at 12 months
12 Months
All-Cause Death
Time Frame: 24 Months
Number of all causes of death through 24 months
24 Months
Number of Participants With Renal Failure
Time Frame: 24 Months
Number of renal failure events through 24 months
24 Months
Number of Participants With Hypertensive Crisis
Time Frame: 24 Months
Number of hypertensive crisis events through 24 months
24 Months
Mean Reduction in Average Office-based Systolic Blood Pressure
Time Frame: 24 Months
Mean Reduction in Average office-based systolic blood pressure through 24 months
24 Months
Mean Reduction in Average Office-based Diastolic Blood Pressure
Time Frame: 24 Months
Mean Reduction in Office-based diastolic blood pressure through 24 months
24 Months
Percent of Subjects at Target Blood Pressure
Time Frame: 24 Months
Percent of subjects at target blood pressure through 24 months
24 Months
Congestive Heart Failure
Time Frame: 24 Months
Number of subjects with congestive heart failure through 24 months
24 Months
Myocardial Infarction
Time Frame: 24 Months
Number of subjects who experience myocardial infarction through 24 months
24 Months
Stroke
Time Frame: 24 Months
Number of subjects experiencing stroke through 24 months
24 Months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Boston Scientific Corporation

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Michael Weber, MD, SUNY Downstate College of Medicine
  • Principal Investigator: Martin B Leon, MD, Columbia University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
April 1, 2015

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
September 7, 2017

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
August 2, 2019

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
March 13, 2015

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 18, 2015

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
March 19, 2015

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
February 11, 2021

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
January 25, 2021

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
January 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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