RADIANCE Continued Access Protocol (RADIANCE CAP)

ReCor Medical

Status

Active, not recruiting

Conditions

Hypertension

Hypertension, Resistant to Conventional Therapy

Cardiovascular Diseases

Vascular Diseases

Treatments

Device: Renal Denervation

Study type

Interventional

Funder types

Industry

Identifiers

NCT05017935

CLN-0932

Details and patient eligibility

About

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.

Enrollment

300 estimated patients

Sex

All

Ages

18 to 75 years old

Volunteers

No Healthy Volunteers

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