The RADIANCE II Pivotal Study: A Study of the ReCor Medical Paradise System in Stage II Hypertension
Purpose
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.
Conditions
- Hypertension
- Vascular Diseases
- Cardiovascular Diseases
Eligibility
- Eligible Ages
- Between 18 Years and 75 Years
- Eligible Genders
- All
- Accepts Healthy Volunteers
- No
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
- Phase
- N/A
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel Assignment
- Primary Purpose
- Treatment
- Masking
- Double (Participant, Outcomes Assessor)
Arm Groups
Arm | Description | Assigned Intervention |
---|---|---|
Experimental Renal Denervation |
Renal Angiogram and Renal Denervation (Paradise Renal Denervation System) |
|
Sham Comparator Sham Control |
Renal Angiogram |
|
More Details
- Status
- Active, not recruiting
- Sponsor
- ReCor Medical, Inc.