HypertensionPhase 3RADARNCT07083765
Renal Artery Denervation Assessment Without Antihypertensive Medication Regimen (RADAR)
A Phase 3 study testing Dehydrated Alcohol Injection, USP in people with Hypertension and Hypertension,Essential, run by Ablative Solutions, Inc. at 1 site in United States.
Trial summary
To obtain an assessment of the efficacy and safety of renal denervation by dehydrated alcohol injection, USP administered via the Peregrine System™ Infusion Catheter in hypertensive subjects in the absence of antihypertensive medications. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Hypertension, Hypertension,Essential
- What is being tested?
- Dehydrated Alcohol Injection, USP
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 202 participants
- Where
- 1 siteUnited States
- Study dates
- Oct 2026to Feb 2029
- Phase
- Phase 3
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 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Has 2 office blood pressure measurements with a mean office systolic blood pressure (SBP) of ≥150 mmHg and ≤180 mmHg, AND a mean office diastolic blood pressure (DBP) of ≥90 mmHg.
- Documented history of uncontrolled hypertension and is currently taking 0, 1, or 2 antihypertensive medications.
- Is willing to discontinue any current antihypertensive medications for at least 13 weeks (5-week pre-procedure and 8-week post-procedure).
- Has a mean 24-hour ambulatory SBP of ≥140 mmHg and ≤170 mmHg with required valid readings.
Who cannot join
- Has renal artery anatomy abnormalities.
- Has previously undergone renal denervation.
- Has an estimated glomerular filtration rate (eGFR) of ≤45 mL/min/1.73 m2, based on the Chronic Kidney Disease Epidemiology Collaboration (CKD-EPI) equation; or is on chronic renal replacement therapy.
- Has documented untreated sleep apnea.
- Has any of the following conditions: severe cardiac valve stenosis, heart failure (New York Heart Association [NYHA] Class III or IV), chronic atrial fibrillation (defined as at least one documented episode in the 12 months before study entry), and known primary pulmonary hypertension (>60 mmHg pulmonary artery or right ventricular systolic pressure).
- Is pregnant or lactating at the time of enrollment or planning to become pregnant during the trial time period (female subjects only).
- Is being treated chronically (e.g. daily use) with NSAIDs, immunosuppressive medications, or immunosuppressive doses of steroids. Aspirin therapy and nasal pulmonary inhalants are allowed.
- Has a history of myocardial infarction, unstable angina pectoris, or stroke/TIA within 6 months prior to the planned procedure.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site
Tennova Turkey Creek Medical Center
Knoxville, Tennessee, 37934
About this study
Official title: A Prospective Multicenter, Blinded, Sham Procedure-Controlled Trial of Renal Denervation Using the Dehydrated Alcohol Injection, USP Administered With the Peregrine System™ Infusion Catheter in Subjects With Hypertension, in the Absence of Antihypertensive Medications
To obtain an assessment of the efficacy and safety of renal denervation by dehydrated alcohol injection, USP administered via the Peregrine System™ Infusion Catheter in hypertensive subjects in the absence of antihypertensive medications.
Read the detailed description
This Phase 3, prospective, randomized, blinded, sham procedure-controlled, multicenter study will assess the efficacy and safety of renal denervation by alcohol-mediated neurolysis using the Peregrine Catheter in hypertensive subjects in the absence of antihypertensive medications. Subjects with a documented history of uncontrolled hypertension who are taking 0, 1, or 2 antihypertensive medications at enrollment will be recruited. After providing written informed consent, subjects will undergo screening assessments to assess eligibility for the study. Eligible subjects will then enter a run-in period during which they will take no antihypertensive medications. Subjects who continue to be eligible at the end of the run-in period will complete the study Baseline visit and remain without taking antihypertensive medications. Subjects who continue to be eligible after the completion of the Baseline visit will attend the study site and will be randomized to either the Treatment Arm (renal denervation using the Peregrine Catheter) or the Sham Control Arm (renal angiography only).
After study unblinding, crossover from the Sham Control Arm to the Treatment Arm may be allowed, at the discretion of the treating investigator.
- Conditions
- Hypertension, Hypertension,Essential
- Being tested
- Dehydrated Alcohol Injection, USP, Sham procedure
- Keywords
- Renal denervation, Neurolysis
- Medical subject headings
- Hypertension, Essential Hypertension
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Dehydrated Alcohol Injection, USPDrug
Also called Alcohol
Alcohol is directly infused/delivered to the adventitial and periadventitial space of the renal arteries
Sham procedureProcedure or surgery
Endovascular, renal angiography
| Study group | Role | What they receive |
|---|---|---|
| Treatment Arm | Experimental | Renal denervation performed with dehydrated alcohol injection, USP administered via the Peregrine System™ Infusion Catheter. Receives: Drug: Dehydrated Alcohol Injection, USP |
| Sham Control Arm | Sham comparator | Only renal angiography performed Receives: Procedure: Sham procedure |
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes in Systolic Ambulatory Blood Pressure at 8 weeks
Change from baseline in mean 24-hour ambulatory systolic blood pressure
Measured: Baseline to 8 weeks post-treatment
Secondary outcomes (22)
Change in Office SBP at 8 Weeks
Change from Baseline in mean office SBP to Week 8
Measured: Baseline to 8 weeks post-treatment
Change in Office DBP at 8 Weeks
Change from Baseline in mean office DBP to Week 8
Measured: Baseline to 8 weeks post-treatment
Changes in Diastolic Ambulatory Blood Pressure at 8 Weeks
Change from baseline in mean 24-hour ambulatory diastolic blood pressure at 8 weeks post-procedure
Measured: Baseline to 8 weeks post-treatment
Changes in Systolic Ambulatory Blood Pressure at 6 Months
Change from baseline in mean 24-hour ambulatory systolic blood pressure at 6 months post-procedure
Measured: Baseline to 6 months post-treatment
Changes in Diastolic Ambulatory Blood Pressure at 6 Months
Change from baseline in mean 24-hour ambulatory diastolic blood pressure at 6 months post-procedure
Measured: Baseline to 6 months post-treatment
Changes in Mean Daytime Ambulatory SBP at 8 Weeks
Change from baseline in mean daytime systolic blood pressure at 8 weeks post-procedure
Measured: Baseline to 8 weeks post-treatment
Changes in Mean Daytime Ambulatory SBP at 6 Months
Change from baseline in mean daytime systolic blood pressure at 6 months post-procedure
Measured: Baseline to 6 months post-treatment
Changes in Mean Daytime Ambulatory DBP at 8 Weeks
Change from baseline in mean daytime diastolic blood pressure at 8 weeks post-procedure
Measured: Baseline to 8 weeks post-treatment
Changes in Mean Daytime Ambulatory DBP at 6 Months
Change from baseline in mean daytime diastolic blood pressure at 6 months post-procedure
Measured: Baseline to 6 months post-treatment
Changes in Mean Nighttime Ambulatory SBP at 8 Weeks
Change from baseline in mean nighttime systolic blood pressure at 8 weeks post-procedure
Measured: Baseline to 8 weeks post-treatment
Changes in Mean Nighttime Ambulatory SBP at 6 Months
Change from baseline in mean nighttime systolic blood pressure at 6 months post-procedure
Measured: Baseline to 6 months post-treatment
Changes in Mean Nighttime Ambulatory DBP at 8 Weeks
Change from baseline in mean nighttime diastolic blood pressure at 8 weeks post-procedure
Measured: Baseline to 8 weeks post-treatment
Changes in Mean Nighttime Ambulatory DBP at 6 Months
Change from baseline in mean nighttime DBP at 6 months post-procedure
Measured: Baseline to 6 months post-treatment
Change in Office SBP at 6 Months
Change from Baseline in mean office SBP at 6 months post-procedure
Measured: Baseline to 6 months post-treatment
Change in Office DBP at 6 Months
Change from Baseline in mean office DBP to Week 8 at 6 months post-procedure
Measured: Baseline to 6 months post-treatment
Use of Antihypertensive Medication(s) at 8 Weeks
Use of antihypertensive medication at 8 weeks post-procedure
Measured: 8 weeks post-treatment
Use of antihypertensive medication(s) from 8 Weeks to 6 Months
Change in use of antihypertensive medication(s) from 8 Weeks to 6 Months post procedure (titrated according to standardized formula to maintain a target SBP of <140 mmHg and ≥90 mmHg)
Measured: 6 months post-treatment
Number of Participants With Major Adverse Events (MAEs)
Number of participants with major adverse events (MAEs) 30 days post-procedure
Measured: 30 days post-treatment
Change in Home SBP at 8 Weeks
Change from Baseline in mean home SBP at 8 weeks post-procedure
Measured: 8 weeks post-treatment
Change in Home SBP at 6 months
Change from Baseline in mean home SBP at 6 months post-procedure
Measured: 6 months post-treatment
Change in Home DBP at 8 Weeks
Change from Baseline in mean home DBP at 8 weeks post-procedure
Measured: 8 weeks post-treatment
Change in Home DBP at 6 months
Change from Baseline in mean home DBP at 6 months post-procedure
Measured: 6 months post-treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Jul 2025
- Study startOct 2026 (estimated)
- Primary completionMay 2028 (estimated)
- Study completionFeb 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Treatment arm: renal denervation performed with dehydrated alcohol injection, USP administered via the Peregrine System™ Infusion Catheter. Sham Control Arm: only renal angiography performed
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 202 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ablative Solutions, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Michael Weber, MD, Study chair, SUNY Downstate Medical Center and College of MedicineDavid Kandzari, MD, Study chair, Piedmont HealthcareFelix Mahfoud, Prof.Dr. med, Study chair, University of BaselAtul Pathak, Prof., Study chair, Princess Grace Hospital, MonacoGregg Stone, MD, Principal investigator, The Mount Sinai Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07083765
- Sponsor's protocol ID
- CR0041
- Acronym
- RADAR
- Status last verified
- Aug 2026
- First submitted
- 12 May 2025
- Last updated
- 20 Aug 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- Yes