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

Not Applicable

Active, not recruiting

• Conditions: Cardiovascular Diseases; Vascular Diseases; Hypertension

• Registration Number: NCT03614260
• Lead Sponsor: ReCor Medical, Inc.

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2018-07-30
• Study First Submitted QC: 2018-07-30
• Study First Posted: 2018-08-03
• Study Start: 2018-12-14
• Primary Completion: 2022-12-21
• Status Verified: 2025-04
• Last Update Submitted: 2025-04-01
• Last Update Posted: 2025-04-04
• Study Completion: 2027-07

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 225

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Change in average daytime ambulatory systolic BP	From baseline to 2 months post-procedure
Incidence of Major Adverse Events (MAE)	From baseline to 30 days post-procedure

Secondary Outcome Measures

Name	Time	Method
Change in average 24-hr ambulatory diastolic BP	From baseline to 2 months post-procedure
Change in average office systolic BP	From baseline to 2 months post-procedure
Change in average daytime ambulatory diastolic BP	From baseline to 2 months post-procedure
Change in average office diastolic BP	From baseline to 2 months post-procedure
Change in average 24-hr ambulatory systolic BP	From baseline to 2 months post-procedure
Change in average home systolic BP	From baseline to 2 months post-procedure
Change in average home diastolic BP	From baseline to 2 months post-procedure

Trial Locations

Locations (47)

Cardiology PC; 🇺🇸 Birmingham, Alabama, United States

Cedars Sinai Medical Center; 🇺🇸 Los Angeles, California, United States

Bridgeport Hospital; 🇺🇸 Bridgeport, Connecticut, United States

Stamford Hospital; 🇺🇸 Stamford, Connecticut, United States

MedStar Washington; 🇺🇸 Washington, District of Columbia, United States

The Cardiac and Vascular Institute; 🇺🇸 Gainesville, Florida, United States

Emory University Hospital Midtown; 🇺🇸 Atlanta, Georgia, United States

Northwestern University; 🇺🇸 Chicago, Illinois, United States

Southern Illinois University; 🇺🇸 Springfield, Illinois, United States

Ochsner Heart and Vascular Institute; 🇺🇸 New Orleans, Louisiana, United States

Scroll for more (37 remaining)