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Active, Not Recruiting

NCT Number: NCT05017935

RADIANCE Continued Access Protocol

RADIANCE CAP is a non-randomized study designed to allow for continued access to ultrasound renal denervation therapy via the Paradise System, and to allow for the on-going collection of safety and effectiveness data in subjects with uncontrolled hypertension despite the prescription of antihypertensive medications.

Active, Not Recruiting

This study is active but is not currently recruiting participants.

Key information

Conditions

Hypertension Cardiovascular Diseases Essential Hypertension Hypertension Resistant to Conventional Therapy Hypertension, Resistant to Conventional Therapy Vascular Diseases

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Cardiovascular Institute of San Diego, Chula Vista, California, United States

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Average office BP ≥140/90 mmHg at screening visit despite taking stables doses of antihypertensive medications for at least 4 weeks prior to consent
  • Documented daytime ABP ≥135/85 mmHg following 4 week run-in/standardization period on antihypertensive medication regimen

Exclusion criteria

  • Renal artery anatomy ineligible for treatment
  • Secondary hypertension not including sleep apnea
  • Type I diabetes mellitus or uncontrolled Type II diabetes (defined as plasma HbA1c ≥9.0%)
  • eGFR <40
  • Brachial circumference ≥42 cm
  • Any history of cerebrovascular event or severe cardiovascular event within 3 months prior to consent
  • Documented repeat (>1) hospitalization for hypertensive crisis within 3 months prior to consent
  • Documented confirmed episode(s) of unstable angina within 3 months prior to consent
  • 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

Renal Denervation

Device

Renal angiogram and renal denervation (Paradise ultrasound Renal Denervation System)

Primary outcomes

  1. Incidence of Adverse Events

    Time frame: From baseline to 60 months

  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/night-time ambulatory systolic BP

    Time frame: From baseline to 2 months post procedure

  2. Change in average daytime/24-hr/night-time ambulatory systolic BP

    Time frame: From Baseline to Months 6 and 12 post procedure

  3. Change in average office systolic/diastolic BP

    Time frame: From Baseline to Months 2, 6, 12, 24, 36, 48, and 60 post procedure

  4. Change in average home systolic/diastolic BP

    Time frame: From Baseline to Months 2, 6, 12, 24, 36, 48, and 60 post procedure

  5. Change in average 24-hr/night-time ambulatory diastolic BP

    Time frame: From baseline to Months 2, 6, and 12 post procedure

Sponsors and collaborators

Lead sponsor

ReCor Medical, Inc.

Industry

Registry information

Official study title

RADIANCE Continued Access Protocol (RADIANCE CAP): A Study of the ReCor Medical Paradise System in Clinical Hypertension

Acronym: RADIANCE CAP

Important dates

Study start
2022
Primary completion
2028
Study completion
2028
First posted
Aug 24, 2021
Registry last updated
Jun 17, 2024

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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