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

ArmDescriptionAssigned Intervention
Experimental
Renal Denervation 		Renal Angiogram and Renal Denervation (Paradise Renal Denervation System)
  • Device: Paradise Renal Denervation System
    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
Sham Comparator
Sham Control 		Renal Angiogram
  • Procedure: Renal Angiogram
    Following renal angiogram to standard procedures, subjects remain blinded and renal angiogram is considered the sham procedure.

More Details

Status
Active, not recruiting
Sponsor
ReCor Medical, Inc.

Study Contact