A Pivotal, Multicenter, Blinded, Sham Procedure-Controlled Trial of Renal Denervation by the Peregrine System™ Kit, in Subjects With Hypertension
Description
Brief Summary
The TARGET BP I Trial is a randomized, blinded, multi-center, international, sham-procedure
controlled trial, comparing renal denervation performed with the Peregrine System Kit in the
treatment group to the sham control group (without renal denervation - no alcohol infusion).
Subjects will be randomized in a 1:1 fashion to treatment versus sham control via central
randomization.
Detailed Description
The TARGET BP I Trial is a randomized, blinded, multi-center, international, sham-procedure
controlled trial, comparing renal denervation performed with the Peregrine System Kit in the
treatment group to the sham control group (without renal denervation - no alcohol infusion).
Subjects will be randomized in a 1:1 fashion to treatment versus sham control via central
randomization.
The TARGET BP I clinical trial uses a percutaneous catheter to deliver very small amounts of
alcohol (neurolytic agent). The patient population for this trial is comparable to those used
in other renal denervation studies, but also incorporates lessons learned from recent trials
of renal denervation. This is to enable the study of an optimized patient population who
stands to benefit from the intervention, in a manner that reduces possible study bias.
This trial is intended to evaluate the safety and efficacy of the Peregrine Catheter when
used to deliver a 0.6 mL volume of alcohol to the perivascular area of the respective renal
arteries while patients are adequately managed with oral antihypertensive medications.
Phase
N/AInclusion and Exclusion Criteria
- Has 3 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 when receiving 2 to 5 antihypertensive medications.
- Has a mean 24-hour ambulatory SBP of ≥135 mmHg and ≤170 mmHg with ≥70% valid readings
- Subject has renal artery anatomy abnormalities.
- Subject 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.
- Subject has documented sleep apnea.
- Subject has any of the following conditions: severe cardiac valve stenosis, heart failure (New York Heart Association [NYHA] Class III or IV), chronic atrial fibrillation, and known primary pulmonary hypertension (>60 mmHg pulmonary artery or right ventricular systolic pressure).
- Subject is pregnant or lactating at the time of enrollment or planning to become pregnant during the trial time period (female subjects only).
- Subject 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.
- Subject has a history of myocardial infarction, unstable angina pectoris, or stroke/TIA within 6 months prior to the planned procedure.
Sites
Please contact the trial administrator to learn more about where you can participate in this trial. Please use the contact form on the right side.
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