Renal Artery Denervation Assessment Without Antihypertensive Medication Regimen (RADAR)

Not Applicable

Not yet recruiting

• Conditions: Hypertension; Hypertension,Essential
• Interventions: Drug: Dehydrated Alcohol Injection, USP; Procedure: Sham procedure

• Registration Number: NCT07083765
• Lead Sponsor: Ablative Solutions, Inc.

Brief 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.

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.

Study Timeline

• Study First Submitted: 2025-05-12
• Status Verified: 2025-07
• Study First Submitted QC: 2025-07-17
• Last Update Submitted: 2025-07-17
• Study First Posted: 2025-07-24
• Last Update Posted: 2025-07-24
• Study Start: 2025-09-01
• Primary Completion: 2027-06
• Study Completion: 2027-10-31

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 142

Inclusion Criteria

1. 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.
2. Documented history of uncontrolled hypertension and is currently taking 1 or 2 antihypertensive medications.
3. Is willing to discontinue any current antihypertensive medications for at least 13 weeks (5-week pre-procedure and 8-week post-procedure).
4. Has a mean 24-hour ambulatory SBP of ≥140 mmHg and ≤170 mmHg with required valid readings.

Exclusion Criteria

1. Has renal artery anatomy abnormalities.
2. Has previously undergone renal denervation.
3. 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.
4. Has documented untreated sleep apnea.
5. 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).
6. Is pregnant or lactating at the time of enrollment or planning to become pregnant during the trial time period (female subjects only).
7. 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.
8. Has a history of myocardial infarction, unstable angina pectoris, or stroke/TIA within 6 months prior to the planned procedure.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Treatment Arm	Dehydrated Alcohol Injection, USP	Renal denervation performed with dehydrated alcohol injection, USP administered via the Peregrine System™ Infusion Catheter.
Sham Control Arm	Sham procedure	Only renal angiography performed

Primary Outcome Measures

Name	Time	Method
Changes in Systolic Ambulatory Blood Pressure at 8 weeks	Baseline to 8 weeks post-treatment	Change from baseline in mean 24-hour ambulatory systolic blood pressure

Secondary Outcome Measures

Name	Time	Method
Change in Office SBP at 8 Weeks	Baseline to 8 weeks post-treatment	Change from Baseline in mean office SBP to Week 8
Change in Office DBP at 8 Weeks	Baseline to 8 weeks post-treatment	Change from Baseline in mean office DBP to Week 8
Changes in Diastolic Ambulatory Blood Pressure at 8 Weeks	Baseline to 8 weeks post-treatment	Change from baseline in mean 24-hour ambulatory diastolic blood pressure at 8 weeks post-procedure
Changes in Systolic Ambulatory Blood Pressure at 6 Months	Baseline to 6 months post-treatment	Change from baseline in mean 24-hour ambulatory systolic blood pressure at 6 months post-procedure
Changes in Diastolic Ambulatory Blood Pressure at 6 Months	Baseline to 6 months post-treatment	Change from baseline in mean 24-hour ambulatory diastolic blood pressure at 6 months post-procedure
Changes in Mean Daytime Ambulatory SBP at 8 Weeks	Baseline to 8 weeks post-treatment	Change from baseline in mean daytime systolic blood pressure at 8 weeks post-procedure
Changes in Mean Daytime Ambulatory SBP at 6 Months	Baseline to 6 months post-treatment	Change from baseline in mean daytime systolic blood pressure at 6 months post-procedure
Changes in Mean Daytime Ambulatory DBP at 8 Weeks	Baseline to 8 weeks post-treatment	Change from baseline in mean daytime diastolic blood pressure at 8 weeks post-procedure
Changes in Mean Daytime Ambulatory DBP at 6 Months	Baseline to 6 months post-treatment	Change from baseline in mean daytime diastolic blood pressure at 6 months post-procedure
Changes in Mean Nighttime Ambulatory SBP at 8 Weeks	Baseline to 8 weeks post-treatment	Change from baseline in mean nighttime systolic blood pressure at 8 weeks post-procedure
Changes in Mean Nighttime Ambulatory SBP at 6 Months	Baseline to 6 months post-treatment	Change from baseline in mean nighttime systolic blood pressure at 6 months post-procedure
Changes in Mean Nighttime Ambulatory DBP at 8 Weeks	Baseline to 8 weeks post-treatment	Change from baseline in mean nighttime diastolic blood pressure at 8 weeks post-procedure
Changes in Mean Nighttime Ambulatory DBP at 6 Months	Baseline to 6 months post-treatment	Change from baseline in mean nighttime diastolic blood pressure at 6 months post-procedure
Change in Office SBP at 6 Months	Baseline to 6 months post-treatment	Change from Baseline in mean office DBP at 6 months post-procedure
Change in Office DBP at 6 Months	Baseline to 6 months post-treatment	Change from Baseline in mean office DBP to Week 8 at 6 months post-procedure
Use of Antihypertensive Medication(s) at 8 Weeks	8 weeks post-treatment	Use of antihypertensive medication at 8 weeks post-procedure
Use of antihypertensive medication(s) from 8 Weeks to 6 Months	6 months post-treatment	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)
Number of Participants With Major Adverse Events (MAEs)	30 days post-treatment	Number of participants with major adverse events (MAEs) 30 days post-procedure