HypertensionRADIANCE-IINCT03614260
The RADIANCE II Pivotal Study: A Study of the ReCor Medical Paradise System in Stage II Hypertension
A study testing Paradise Renal Denervation System and Renal Angiogram in people with Hypertension and Vascular Diseases, run by ReCor Medical, Inc. at 47 sites in 8 countries.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Hypertension, Vascular Diseases, Cardiovascular Diseases
- What is being tested?
- Paradise Renal Denervation System and Renal Angiogram
- Type of treatment
- Medical device, Surgery or procedure
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 224 participants
- Where
- 47 sitesin 8 countries
- Study dates
- 14 Dec 2018to Jul 2029
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 11Show fewer
- 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 locations and contacts
47 sites in 8 countries.
47 sites in 8 countries
United States28 sites
Emory University Hospital Midtown
Atlanta, Georgia, 30308
Cardiology PC
Birmingham, Alabama, 35211
The Brigham and Women's Hospital
Boston, Massachusetts, 02120
Bridgeport Hospital
Bridgeport, Connecticut, 06610
Deborah Heart & Lung Center
Browns Mills, New Jersey, 08015
The University of North Carolina at Chapel Hill
Chapel Hill, North Carolina, 27599
Medical University of South Carolina
Charleston, South Carolina, 29425
Northwestern University
Chicago, Illinois, 60611
Cleveland Clinic
Cleveland, Ohio, 44195
The Cardiac and Vascular Institute
Gainsville, Florida, 32605
Hackensack University
Hackensack, New Jersey, 07601
Saint Luke's Health System
Kansas City, Missouri, 64111
Cedars Sinai Medical Center
Los Angeles, California, 940048
The University of Tennessee Health Science Center
Memphis, Tennessee, 38163
Minneapolis Heart Institute Foundation
Minneapolis, Minnesota, 55407
Vanderbilt University
Nashville, Tennessee, 37232
Ochsner Heart and Vascular Institute
New Orleans, Louisiana, 70121
Columbia University Medical Center/NYPH
New York, New York, 10032
Northwell Health Inc.
New York, New York, 10075
University of Pennsylvania Health System
Philadelphia, Pennsylvania, 19104
University of Pittsburgh Medical Center
Pittsburgh, Pennsylvania, 15213
Renown Regional Medical Center
Reno, Nevada, 89502
University of Utah
Salt Lake City, Utah, 84132
Swedish Medical Center
Seattle, Washington, 98122
Southern Illinois University
Springfield, Illinois, 62794
Stamford Hospital
Stamford, Connecticut, 06904
Munson Medical Center
Traverse City, Michigan, 49684
MedStar Washington
Washington D.C., District of Columbia, 20010
Germany6 sites
University Clinic Erlangen
Erlangen, D-91054
University Clinic of Saarland - Homburg
Homburg, D-66421
Klinikum Karlsruhe GmbH
Karlsruhe, 76133
Klinikum Konstanz
Konstanz, D-78464
Herzzentrum Leipzig GmbH
Leipzig, D-04289
Sana Kliniken Lübeck GmbH
Lübeck, D-23560
United Kingdom6 sites
The Cardiothoracic Centre Basildon University Hospital
Basildon, Essex, SS16 5NL
University Hospitals Dorset NHS Foundation Trust
Bournemouth, BH7 7DW
Kent & Canterbury Hospital
Canterbury, CT1 3NG
University Hospital Wales
Cardiff
St Bartholomew's Hospital
London, EC1A 7BE
Freeman Hospital
Newcastle upon Tyne, NE7 7DN
France3 sites
Hôpital Saint André
Bordeaux, 33000
CHRU de Lille
Lille, 59000
Hôpital Européen Georges-Pompidou (HEGP)
Paris, 75015
About this study
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
- Being tested
- Paradise Renal Denervation System, Renal Angiogram
- Keywords
- Denervation, Resistant Hypertension, Essential Hypertension, Uncontrolled Hypertension
- Medical subject headings
- Hypertension, Vascular Diseases, Cardiovascular Diseases, Essential Hypertension
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Paradise Renal Denervation SystemDevice
Also called Renal Angiogram, Renal Denervation
Following renal angiogram according to standard procedures, subjects remain blinded and are immediately treated with the renal denervation procedure after randomization.
Renal AngiogramProcedure or surgery
Following renal angiogram to standard procedures, subjects remain blinded and renal angiogram is considered the sham procedure.
| Study group | Role | What they receive |
|---|---|---|
| Renal Denervation | Experimental | Renal Angiogram and Renal Denervation (Paradise Renal Denervation System) Receives: Device: Paradise Renal Denervation System |
| Sham Control | Sham comparator | Renal Angiogram Receives: Procedure: Renal Angiogram |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Average Daytime Ambulatory Systolic BP
The primary efficacy outcome is the mean change in daytime ambulatory systolic blood pressure at 2 months
Measured: From baseline to 2 months post-procedure
Percentage of Participants With Major Adverse Events (MAE)
The primary safety composite outcome of major adverse events included death, kidney failure, and major embolic, vascular, cardiovascular, cerebrovascular, and hypertensive events at 30 days.
Measured: From baseline to 30 days post-procedure
Secondary outcomes (7)
Change in Average 24-hr Ambulatory Systolic BP
Change in average 24-hr ambulatory systolic blood pressure
Measured: From baseline to 2 months post-procedure
Change in Average Office Systolic BP
Change in average office systolic blood pressure
Measured: From baseline to 2 months post-procedure
Change in Average Home Systolic BP
Change in average home systolic blood pressure
Measured: From baseline to 2 months post-procedure
Change in Average Daytime Ambulatory Diastolic BP
Change in average daytime ambulatory diastolic blood pressure
Measured: From baseline to 2 months post-procedure
Change in Average 24-hr Ambulatory Diastolic BP
Change in average 24-hr ambulatory diastolic blood pressure
Measured: From baseline to 2 months post-procedure
Change in Average Office Diastolic BP
Change in average office diastolic blood pressure
Measured: From baseline to 2 months post-procedure
Change in Average Home Diastolic BP
Change in average home diastolic blood pressure
Measured: From baseline to 2 months post-procedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Aug 2018
- Study start14 Dec 2018
- Primary completion21 Dec 2022
- Study completionJul 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for HypertensionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 224 participants (actual)
Sponsor and investigators
- Lead sponsor
- ReCor Medical, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Ajay Kirtane, MD, SM, Principal investigator, Columbia University Medical Center/New York-Presbyterian Hospital and the Cardiovascular Research FoundationProf. Michel Azizi, MD, PhD, Principal investigator, Professor of Vascular Medicine, Hypertension Dept. and Clinical Investigation Center, Hôpital Européen Georges Pompidou
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03614260
- Sponsor's protocol ID
- RADIANCE II Study
- Acronym
- RADIANCE-II
- Status last verified
- Sep 2026
- First submitted
- 30 Jul 2018
- Last updated
- 24 Sep 2026
- Results posted
- Yes, on ClinicalTrials.gov
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
Publications
Azizi M, Saxena M, Wang Y, Jenkins JS, Devireddy C, Rader F, Fisher NDL, Schmieder RE, Mahfoud F, Lindsey J, Sanghvi K, Todoran TM, Pacella J, Flack J, Daemen J, Sharp ASP, Lurz P, Bloch MJ, Weber MA, Lobo MD, Basile J, Claude L, Reeve-Stoffer H, McClure CK, Kirtane AJ; RADIANCE II Investigators and Collaborators. Endovascular Ultrasound Renal Denervation to Treat Hypertension: The RADIANCE II Randomized Clinical Trial. JAMA. 2023 Feb 28;329(8):651-661. doi: 10.1001/jama.2023.0713.
PubMed 36853250Bytyqi V, Kannenkeril D, Striepe K, Bosch A, Karg MV, Schmid A, Schiffer M, Uder M, Schmieder RE. Predicting blood pressure response to renal denervation based on a new approach. J Hypertens. 2025 Mar 1;43(3):413-419. doi: 10.1097/HJH.0000000000003918. Epub 2024 Oct 29.
PubMed 39526682Azizi M, Sharp ASP, Fisher NDL, Weber MA, Lobo MD, Daemen J, Lurz P, Mahfoud F, Schmieder RE, Basile J, Bloch MJ, Saxena M, Wang Y, Sanghvi K, Jenkins JS, Devireddy C, Rader F, Gosse P, Claude L, Augustin DA, McClure CK, Kirtane AJ; RADIANCE Investigators. Patient-Level Pooled Analysis of Endovascular Ultrasound Renal Denervation or a Sham Procedure 6 Months After Medication Escalation: The RADIANCE Clinical Trial Program. Circulation. 2024 Mar 5;149(10):747-759. doi: 10.1161/CIRCULATIONAHA.123.066941. Epub 2023 Oct 26.
PubMed 37883784Kirtane AJ, Sharp ASP, Mahfoud F, Fisher NDL, Schmieder RE, Daemen J, Lobo MD, Lurz P, Basile J, Bloch MJ, Weber MA, Saxena M, Wang Y, Sanghvi K, Jenkins JS, Devireddy C, Rader F, Gosse P, Sapoval M, Barman NC, Claude L, Augustin D, Thackeray L, Mullin CM, Azizi M; RADIANCE Investigators and Collaborators. Patient-Level Pooled Analysis of Ultrasound Renal Denervation in the Sham-Controlled RADIANCE II, RADIANCE-HTN SOLO, and RADIANCE-HTN TRIO Trials. JAMA Cardiol. 2023 May 1;8(5):464-473. doi: 10.1001/jamacardio.2023.0338.
PubMed 36853627
Study at a glance
From the registry record, last updated by the sponsor on 24 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The RADIANCE II Pivotal Study: A Study of the ReCor Medical Paradise System in Stage II Hypertension
- ClinicalTrials.gov ID
- NCT03614260
- Acronym / sponsor ID
- RADIANCE-II / RADIANCE II Study
- Conditions
- Hypertension, Vascular Diseases, Cardiovascular Diseases
- Keywords
- Denervation, Resistant Hypertension, Essential Hypertension, Uncontrolled Hypertension
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 224 participants (actual)
- Lead sponsor
- ReCor Medical, Inc.Industry (pharma, biotech, devices)
- Study start
- 14 Dec 2018 (actual)
- Primary completion
- 21 Dec 2022 (actual)
- Study completion
- Jul 2029 (estimated)
- First posted
- 3 Aug 2018 (actual)
- Results
- Posted 24 Sep 2026
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Renal Denervation | Experimental | Device: Paradise Renal Denervation SystemRenal Angiogram and Renal Denervation (Paradise Renal Denervation System) |
| Sham Control | Sham comparator | Procedure: Renal AngiogramRenal Angiogram |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (11 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Paradise Renal Denervation SystemAlso: Renal Angiogram, Renal DenervationFollowing renal angiogram according to standard procedures, subjects remain blinded and are immediately treated with the renal denervation procedure after randomization. | Device | Renal Denervation |
| Renal AngiogramFollowing renal angiogram to standard procedures, subjects remain blinded and renal angiogram is considered the sham procedure. | Procedure or surgery | Sham Control |
Primary outcome
Change in Average Daytime Ambulatory Systolic BP
Time frame: From baseline to 2 months post-procedure
The primary efficacy outcome is the mean change in daytime ambulatory systolic blood pressure at 2 months
Percentage of Participants With Major Adverse Events (MAE)
Time frame: From baseline to 30 days post-procedure
The primary safety composite outcome of major adverse events included death, kidney failure, and major embolic, vascular, cardiovascular, cerebrovascular, and hypertensive events at 30 days.
7 secondary outcomes
Change in Average 24-hr Ambulatory Systolic BP
Time frame: From baseline to 2 months post-procedure
Change in Average Office Systolic BP
Time frame: From baseline to 2 months post-procedure
Change in Average Home Systolic BP
Time frame: From baseline to 2 months post-procedure
Change in Average Daytime Ambulatory Diastolic BP
Time frame: From baseline to 2 months post-procedure
Change in Average 24-hr Ambulatory Diastolic BP
Time frame: From baseline to 2 months post-procedure
Change in Average Office Diastolic BP
Time frame: From baseline to 2 months post-procedure
Change in Average Home Diastolic BP
Time frame: From baseline to 2 months post-procedure
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Sep 2026.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Results publication: PubMed 36853250Azizi M, Saxena M, Wang Y, Jenkins JS, Devireddy C, Rader F, Fisher NDL, Schmieder RE, Mahfoud F, Lindsey J, Sanghvi K, Todoran TM, Pacella J, Flack J, Daemen J, Sharp ASP, Lurz P, Bloch MJ, Weber MA, Lobo MD, Basile J, Claude L, Reeve-Stoffer H, McClure CK, Kirtane AJ; RADIANCE II Investigators and Collaborators. Endovascular Ultrasound Renal Denervation to Treat Hypertension: The RADIANCE II Randomized Clinical Trial. JAMA. 2023 Feb 28;329(8):651-661. doi: 10.1001/jama.2023.0713.
- Derived from this study: PubMed 39526682Bytyqi V, Kannenkeril D, Striepe K, Bosch A, Karg MV, Schmid A, Schiffer M, Uder M, Schmieder RE. Predicting blood pressure response to renal denervation based on a new approach. J Hypertens. 2025 Mar 1;43(3):413-419. doi: 10.1097/HJH.0000000000003918. Epub 2024 Oct 29.
- Derived from this study: PubMed 37883784Azizi M, Sharp ASP, Fisher NDL, Weber MA, Lobo MD, Daemen J, Lurz P, Mahfoud F, Schmieder RE, Basile J, Bloch MJ, Saxena M, Wang Y, Sanghvi K, Jenkins JS, Devireddy C, Rader F, Gosse P, Claude L, Augustin DA, McClure CK, Kirtane AJ; RADIANCE Investigators. Patient-Level Pooled Analysis of Endovascular Ultrasound Renal Denervation or a Sham Procedure 6 Months After Medication Escalation: The RADIANCE Clinical Trial Program. Circulation. 2024 Mar 5;149(10):747-759. doi: 10.1161/CIRCULATIONAHA.123.066941. Epub 2023 Oct 26.
- Derived from this study: PubMed 36853627Kirtane AJ, Sharp ASP, Mahfoud F, Fisher NDL, Schmieder RE, Daemen J, Lobo MD, Lurz P, Basile J, Bloch MJ, Weber MA, Saxena M, Wang Y, Sanghvi K, Jenkins JS, Devireddy C, Rader F, Gosse P, Sapoval M, Barman NC, Claude L, Augustin D, Thackeray L, Mullin CM, Azizi M; RADIANCE Investigators and Collaborators. Patient-Level Pooled Analysis of Ultrasound Renal Denervation in the Sham-Controlled RADIANCE II, RADIANCE-HTN SOLO, and RADIANCE-HTN TRIO Trials. JAMA Cardiol. 2023 May 1;8(5):464-473. doi: 10.1001/jamacardio.2023.0338.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ajay Kirtane, MD, SM principal investigator
Columbia University Medical Center/New York-Presbyterian Hospital and the Cardiovascular Research Foundation
Prof. Michel Azizi, MD, PhD principal investigator
Professor of Vascular Medicine, Hypertension Dept. and Clinical Investigation Center, Hôpital Européen Georges Pompidou
47 sites in 8 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Paradise Renal Denervation System and Renal Angiogram in people with Hypertension and Vascular Diseases, run by ReCor Medical, Inc. at 47 sites in 8 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 24 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 47 sites in United States, Germany, United Kingdom, France, Belgium and 3 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 24 Sep 2026). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Average Daytime Ambulatory Systolic BP (time frame: From baseline to 2 months post-procedure). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03614260, which also lists 4 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Sep 2026.