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Renal Denervation System
Renal Denervation for High Blood Pressure (RADIANCE-II Trial)
N/A
Waitlist Available
Led By Prof. Michel Azizi, MD, PhD
Research Sponsored by ReCor Medical, Inc.
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Previously or currently prescribed antihypertensive therapy
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up from baseline to 2 months post-procedure
Awards & highlights
RADIANCE-II Trial Summary
This trial is testing whether the Paradise System, a new treatment for hypertension, is effective and safe. The trial will enroll people who have Stage 2 hypertension and are not currently taking any medication for their hypertension.
Who is the study for?
This trial is for adults with Stage II hypertension, who have been on 0-2 blood pressure medications. They should have a documented high blood pressure range and can't be on chronic oxygen support or have severe cardiovascular issues. Pregnant individuals or those with uncontrolled diabetes are excluded.Check my eligibility
What is being tested?
The study tests the Paradise System's safety and effectiveness in lowering blood pressure compared to a renal angiogram procedure. Participants will either receive the Paradise treatment or undergo an angiogram without denervation.See study design
What are the potential side effects?
Potential side effects may include discomfort at the catheter insertion site, bruising, bleeding, kidney artery damage, elevated blood pressure post-procedure, and possible impacts on kidney function.
RADIANCE-II Trial Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I have been prescribed medication for high blood pressure.
RADIANCE-II Trial Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ from baseline to 2 months post-procedure
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~from baseline to 2 months post-procedure
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Change in average daytime ambulatory systolic BP
Incidence of Major Adverse Events (MAE)
Secondary outcome measures
Change in average 24-hr ambulatory diastolic BP
Change in average 24-hr ambulatory systolic BP
Change in average daytime ambulatory diastolic BP
+4 moreRADIANCE-II Trial Design
2Treatment groups
Experimental Treatment
Placebo Group
Group I: Renal DenervationExperimental Treatment1 Intervention
Renal Angiogram and Renal Denervation (Paradise Renal Denervation System)
Group II: Sham ControlPlacebo Group1 Intervention
Renal Angiogram
Find a Location
Who is running the clinical trial?
ReCor Medical, Inc.Lead Sponsor
10 Previous Clinical Trials
4,951 Total Patients Enrolled
Prof. Michel Azizi, MD, PhDPrincipal InvestigatorProfessor of Vascular Medicine, Hypertension Dept. and Clinical Investigation Center, Hôpital Européen Georges Pompidou
Ajay Kirtane, MD, SMPrincipal InvestigatorColumbia University Medical Center/New York-Presbyterian Hospital and the Cardiovascular Research Foundation
2 Previous Clinical Trials
2,305 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I have high blood pressure in the lungs.I have not had a stroke, severe heart event, or chest pain in the last year.I've been hospitalized more than once for high blood pressure crises in the last year.I need oxygen or a ventilator during the day, not just for sleep apnea at night.My kidney arteries are not suitable for treatment.I have Type I diabetes or my Type II diabetes is not under control.My kidney function is low.My blood pressure is between 135/85 and 170/105 mmHg after a 4-week period without medication.My blood pressure is between 140/90 and 179/119 mmHg, and I've been stable on up to 2 blood pressure medications for at least 4 weeks.I have high blood pressure not caused by sleep apnea or treated conditions.I have been prescribed medication for high blood pressure.
Research Study Groups:
This trial has the following groups:- Group 1: Renal Denervation
- Group 2: Sham Control
Awards:
This trial has 0 awards, including:Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Is this experiment accepting participants who are 45 years and older?
"Participants must meet the following criteria to be eligible for this trial: age 18 or older, and under 75 years old."
Answered by AI
Are there any US-based medical facilities presently participating in this research?
"At present, 33 clinical sites are taking part in this trial. These centres span from Kansas City to Stony Brook and New Orleans amongst other locales. To make the process more convenient for those interested in enrolling, selecting the clinic closest to you is recommended."
Answered by AI
Is enrollment still open for this scientific experiment?
"The experimental procedure is recruiting up to 225 individuals suffering from vascular diseases, aged 18-75. Of primary importance are those who have been prescribed antihypertensive therapy at some point in their life."
Answered by AI
Is patient enrollment currently available for this trial?
"According to clinicaltrials.gov, this study is no longer recruiting participants. This trial was initially posted on December 14th 2018 and underwent its latest edit on October 5th 2022. Although applicants are not being accepted for this specific medical research, there are 1193 other trials that currently need volunteers."
Answered by AI
Who else is applying?
What site did they apply to?
Renown Regional Medical Center
Saint Luke's Health System
What portion of applicants met pre-screening criteria?
Did not meet criteria
Met criteria
Why did patients apply to this trial?
I tried taking losartan but it doesn't seem to be working and I don't feel good after taking it, therefore I desperately need to get my blood pressure under control.
PatientReceived 1 prior treatment
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