Renal Artery Denervation Assessment Without Antihypertensive Medication Regimen (RADAR)

NCT07083765 | Suspended Phase 3 DMC FDA Drug FDA Device

• 1 other identifier: CR0041
• Study Type: interventional
• Target: 142
• Locations: 1 country
• Sites: 1

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.

Conditions

Hypertension; Hypertension,Essential

Keywords

Renal denervation; Neurolysis

Outcome Measures

Primary Outcomes (1)

• Changes in Systolic Ambulatory Blood Pressure at 8 weeks

  Change from baseline in mean 24-hour ambulatory systolic blood pressure

  Baseline to 8 weeks post-treatment

Secondary Outcomes (18)

• Change in Office SBP at 8 Weeks

  Baseline to 8 weeks post-treatment

• Change in Office DBP at 8 Weeks

  Baseline to 8 weeks post-treatment

• Changes in Diastolic Ambulatory Blood Pressure at 8 Weeks

  Baseline to 8 weeks post-treatment

• Changes in Systolic Ambulatory Blood Pressure at 6 Months

  Baseline to 6 months post-treatment

• Changes in Diastolic Ambulatory Blood Pressure at 6 Months

  Baseline to 6 months post-treatment

Study Arms (2)

Treatment Arm

EXPERIMENTAL

Renal denervation performed with dehydrated alcohol injection, USP administered via the Peregrine System™ Infusion Catheter.

Drug: Dehydrated Alcohol Injection, USP

Sham Control Arm

SHAM COMPARATOR

Only renal angiography performed

Procedure: Sham procedure

Interventions

Dehydrated Alcohol Injection, USP DRUG

Alcohol is directly infused/delivered to the adventitial and periadventitial space of the renal arteries

Also known as: Alcohol

Treatment Arm

Sham procedure PROCEDURE

Endovascular, renal angiography

Sham Control Arm

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Ablative Solutions, Inc.: lead

Study Sites (1)

Tennova Turkey Creek Medical Center

Knoxville, Tennessee, 37934, United States

Location

MeSH Terms

Conditions

Hypertension; Essential Hypertension

Interventions

Ethanol

Condition Hierarchy (Ancestors)

Vascular Diseases; Cardiovascular Diseases

Intervention Hierarchy (Ancestors)

Alcohols; Organic Chemicals

Study Officials

• Michael Weber, MD

  SUNY Downstate Medical Center and College of Medicine

  PRINCIPAL INVESTIGATOR

• David Kandzari, MD

  Piedmont Healthcare

  PRINCIPAL INVESTIGATOR

• Felix Mahfoud, Prof.Dr. med

  University of Basel

  PRINCIPAL INVESTIGATOR

• Atul Pathak, Prof.

  Princess Grace Hospital, Monaco

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Treatment arm: renal denervation performed with dehydrated alcohol injection, USP administered via the Peregrine System™ Infusion Catheter. Sham Control Arm: only renal angiography performed

Study Record Dates

• First Submitted: May 12, 2025
• First Posted: July 24, 2025
• Study Start: September 1, 2025
• Primary Completion (Estimated): June 1, 2027
• Study Completion (Estimated): October 31, 2027
• Last Updated: April 30, 2026

Record last verified: 2026-04

Locations

US (1)