TARGET BP I Clinical Trial

Ablative Solutions

Status and phase: Active, not recruiting; Phase 3

Conditions: Hypertension

Treatments: Drug: Dehydrated alcohol; Device: Peregrine System Kit (Sham Procedure)

Study type: Interventional

Funder types: Industry

Identifiers

NCT02910414

CR0002

Details and patient eligibility

About

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.

Full 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.

Enrollment: 300 patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. 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.
2. Has a mean 24-hour ambulatory SBP of ≥135 mmHg and ≤170 mmHg with ≥70% valid readings

Exclusion criteria

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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300 participants in 2 patient groups

Treated with Peregrine System Kit

Experimental group

Description:

The experimental group will receive an infusion of Dehydrated Alcohol Injection, USP into the perivascular space of the renal arteries with the Peregrine Catheter. A total of 0.6mL of the alcohol will be delivered to the perivascular space of each renal artery. The drug will only be delivered once to each renal artery during the treatment procedure.

Treatment:

Drug: Dehydrated alcohol

Renal Angiography Only (Sham Procedure)

Sham Comparator group

Description:

The sham control group will only have diagnostic renal angiography performed. There will be no insertion of the Peregrine Catheter and no alcohol infusion (i.e. no renal denervation).

Treatment:

Device: Peregrine System Kit (Sham Procedure)