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Active, Not Recruiting

NCT Number: NCT03614260

The RADIANCE II Pivotal Study: A Study of the ReCor Medical Paradise System in Stage II Hypertension

The objective of the RADIANCE II Pivotal study is to demonstrate the effectiveness and safety of the Paradise System in subjects with Stage 2 hypertension on 0-2 medications at the time of consent. Prior to randomization, subjects will be hypertensive in the absence of hypertension medication.

Active, Not Recruiting

This study is active but is not currently recruiting participants.

Key information

Conditions

Hypertension Cardiovascular Diseases Essential Hypertension Vascular Diseases

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Centre Hospitalier Universitaire Saint-Pierre, Brussels, Belgium

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Previously or currently prescribed antihypertensive therapy
  • Average office BP ≥ 140/90 mmHg <180/120 mmHg while stable for at least 4 weeks on 0-2 classes of antihypertensive medication
  • Documented daytime ABP ≥ 135/85 mmHg and < 170/105 mmHg after 4-week washout/run-in period

Exclusion criteria

  • Lacks appropriate renal artery anatomy for treatment
  • Known, uncorrected causes of secondary hypertension other than sleep apnea
  • Type I diabetes mellitus or uncontrolled Type II diabetes
  • eGFR of <40
  • Brachial circumference ≥ 42 cm
  • Any history of cerebrovascular event or severe cardiovascular event, or history of stable or unstable angina within 12 months prior to consent
  • Repeat (>1) hospitalization for hypertensive crisis within 12 months prior to screening period, or any hospitalization for hypertensive crisis within 3 months prior to screening period
  • Chronic oxygen support or mechanical ventilation other than nocturnal respiratory support for sleep apnea
  • Primary pulmonary hypertension
  • Night shift workers
  • Pregnant, nursing or planning to become pregnant

Treatment and study plan

Paradise Renal Denervation System

Device

Following renal angiogram according to standard procedures, subjects remain blinded and are immediately treated with the renal denervation procedure after randomization.

Other names: Renal Angiogram, Renal Denervation

Renal Angiogram

Procedure

Following renal angiogram to standard procedures, subjects remain blinded and renal angiogram is considered the sham procedure.

Primary outcomes

  1. Incidence of Major Adverse Events (MAE)

    Time frame: From baseline to 30 days post-procedure

  2. Change in average daytime ambulatory systolic BP

    Time frame: From baseline to 2 months post-procedure

Secondary outcomes

  1. Change in average 24-hr ambulatory systolic BP

    Time frame: From baseline to 2 months post-procedure

  2. Change in average office systolic BP

    Time frame: From baseline to 2 months post-procedure

  3. Change in average home systolic BP

    Time frame: From baseline to 2 months post-procedure

  4. Change in average daytime ambulatory diastolic BP

    Time frame: From baseline to 2 months post-procedure

  5. Change in average 24-hr ambulatory diastolic BP

    Time frame: From baseline to 2 months post-procedure

  6. Change in average office diastolic BP

    Time frame: From baseline to 2 months post-procedure

  7. Change in average home diastolic BP

    Time frame: From baseline to 2 months post-procedure

Sponsors and collaborators

Lead sponsor

ReCor Medical, Inc.

Industry

Registry information

Acronym: RADIANCE-II

Important dates

Study start
2018
Primary completion
2022
Study completion
2027
First posted
Aug 3, 2018
Registry last updated
Apr 4, 2025

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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