Health TrialsbyHealthPanel

Renal Artery Denervation Assessment Without Antihypertensive Medication Regimen (RADAR)

ConditionsHypertensionHypertension,Essential
Trial statusNot yet recruiting
Trial phasePhase 3
Trial typeInterventional
Biological sexAll
Age18-80
SponsorAblative Solutions, Inc.

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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.

Disqualifiers

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.

Trial design

Design model

Parallel

Treatments tested in this trial

  • Dehydrated Alcohol Injection, USP

    Drug

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

  • Sham procedure

    Procedure/Surgery

    Endovascular, renal angiography

Treatment groups

202 Participants
are divided into 2 treatment groups
Group A: Treatment ArmExperimental treatment 1 intervention
Group B: Sham Control ArmSham comparator 1 intervention

Trial outcomes

Primary outcomes

1

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

1

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
2

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
3

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
4

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

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Ablative Solutions, Inc.

Lead sponsor

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: