Renal Artery Denervation Assessment Without Antihypertensive Medication Regimen (RADAR)

Ablative Solutions, Inc.142 enrolled

Overview

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.

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 Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

TRIPLE

Enrollment

142

Conditions

Hypertension Hypertension,Essential

Interventions

Dehydrated Alcohol Injection, USPDRUG

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

Sham procedurePROCEDURE

Endovascular, renal angiography

Eligibility

Sex: ALLMin age: 18 YearsMax age: 80 Years

Medical Language ↔ Plain English

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.

Locations (1)

Tennova Turkey Creek Medical Center

Knoxville, Tennessee, United States

Outcomes

Primary Outcomes

Changes in Systolic Ambulatory Blood Pressure at 8 weeks

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

Time frame: Baseline to 8 weeks post-treatment

Secondary Outcomes

Change in Office SBP at 8 Weeks

Change from Baseline in mean office SBP to Week 8

Time frame: Baseline to 8 weeks post-treatment

Change in Office DBP at 8 Weeks

Change from Baseline in mean office DBP to Week 8

Time frame: 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

Time frame: 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

Time frame: 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

Time frame: 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

Time frame: Baseline to 8 weeks post-treatment

Data from ClinicalTrials.gov

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