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

ReCor Medical logo

ReCor Medical

Status

Active, not recruiting

Conditions

Hypertension
Cardiovascular Diseases
Vascular Diseases

Treatments

Procedure: Renal Angiogram
Device: Paradise Renal Denervation System

Study type

Interventional

Funder types

Industry

Identifiers

NCT03614260
RADIANCE II Study

Details and patient eligibility

About

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.

Enrollment

225 estimated patients

Sex

All

Ages

18 to 75 years old

Volunteers

No Healthy Volunteers

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

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Double Blind

225 participants in 2 patient groups

Renal Denervation
Experimental group
Description:
Renal Angiogram and Renal Denervation (Paradise Renal Denervation System)
Treatment:
Device: Paradise Renal Denervation System
Sham Control
Sham Comparator group
Description:
Renal Angiogram
Treatment:
Procedure: Renal Angiogram

Trial contacts and locations

48

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Data sourced from clinicaltrials.gov

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