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Completed

NCT Number: NCT02392351

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

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Key information

Conditions

Hypertension Cardiovascular Diseases Vascular Diseases

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Cardiology, PC, Birmingham, Alabama, United States

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About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Renal Denervation (Vessix)

Device

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

Other names: Vessix Reduce™ Catheter and Vessix™ Generator, Vessix Renal Denervation System

Renal Angiography

Device

Percutaneous renal angiography

Other names: Renal Angiogram

Primary outcomes

  1. 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)

Secondary outcomes

  1. Number of Hospitalizations Due to Severe Hypotension/Syncope

    Time frame: Through 6 months

    Number of hospitalizations due to severe hypotension/syncope through 6 months.

  2. 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.

  3. Renal Artery Dissection or Perforation Requiring Intervention

    Time frame: 4 weeks

    Number of renal artery dissection or perforation requiring intervention through 4 weeks.

  4. Vascular Complications

    Time frame: 4 weeks

    Number of vascular complications through 4 weeks.

  5. Significant New Renal Artery Stenosis

    Time frame: 6 months

    Number of significant new renal artery stenosis events through 6 months.

  6. Number of Subjects Utilizing Anti-hypertensive Medications

    Time frame: 3 months

    Number of subjects utilizing anti-hypertensive medications at 3 months.

  7. 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

  8. 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.

  9. Number of Subjects Utilizing Anti-hypertensive Medications

    Time frame: 6 months

    Number of subjects utilizing anti-hypertensive medications at 6 months

  10. 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

  11. 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. All-Cause Death

    Time frame: 24 Months

    Number of all causes of death through 24 months

  13. Number of Participants With Renal Failure

    Time frame: 24 Months

    Number of renal failure events through 24 months

  14. Number of Participants With Hypertensive Crisis

    Time frame: 24 Months

    Number of hypertensive crisis events through 24 months

  15. 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

  16. Mean Reduction in Average Office-based Diastolic Blood Pressure

    Time frame: 24 Months

    Mean Reduction in Office-based diastolic blood pressure through 24 months

  17. Percent of Subjects at Target Blood Pressure

    Time frame: 24 Months

    Percent of subjects at target blood pressure through 24 months

  18. Congestive Heart Failure

    Time frame: 24 Months

    Number of subjects with congestive heart failure through 24 months

  19. Myocardial Infarction

    Time frame: 24 Months

    Number of subjects who experience myocardial infarction through 24 months

  20. Stroke

    Time frame: 24 Months

    Number of subjects experiencing stroke through 24 months

Sponsors and collaborators

Lead sponsor

Boston Scientific Corporation

Industry

Registry information

Official study title

A Boston Scientific Clinical Trial of Renal Denervation Using the Vessix Reduce™ Catheter and Vessix™ Generator for the Treatment of HyperTensioN: REINFORCE

Important dates

Study start
2015
Primary completion
2017
Study completion
2019
First posted
Mar 19, 2015
Registry last updated
Feb 11, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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