What is high blood pressure?
High blood pressure (a value equal to or greater than 140/90 mmHg (8)) is a common condition in which the force of the blood flowing through the arteries is too high. High blood pressure causes the heart to work much harder while pumping blood throughout the body, putting strain on arteries, which can eventually lead to other health problems such as heart attack, stroke, and loss of vision.
The sympathetic nerve system plays an important role in maintaining the body’s balance – including regulating healthy blood pressure – sending messages between the brain and organs. If, however, the nerves are overactive and send too many signals, this can contribute to high blood pressure. Physicians have demonstrated that interrupting nerve pathways contributing to overactive signaling can help in reducing blood pressure.(10,11)
What is the purpose of the TARGET BP I Clinical Trial?
The purpose of the trial is to investigate the safety and efficacy of the Peregrine System™ Kit in the treatment of patients with uncontrolled hypertension who are taking 2-5 anti-hypertensive medications.
How long does the trial last?
Patients will be asked to make office visits to be seen by study investigators both before and after the procedure, in order to monitor the effects of the treatment on blood pressure over time. The procedure itself should require no more than one overnight stay. The last follow-up visit for the trial will take place three years after the procedure.
What is the Peregrine System Kit?
The Peregrine System Kit is used during a minimally invasive procedure that will be performed under mild sedation. The Peregrine Kit includes the Peregrine Catheter and Ablative Solutions medical alcohol. The Peregrine Catheter will be inserted through a small incision in the groin and guided up to the renal (kidney) arteries using angiography (like an X-ray). The system will deliver a small dose of Ablative Solutions medical alcohol to the region just outside the artery where the sympathetic nerves are located, to deactivate the over-signaling of these nerves.
Why is the trial randomized?
The TARGET BP I Clinical Trial is randomized between a treatment arm and a control arm - which means that some patients will receive the investigational Peregrine Kit, while patients in the control arm will receive a diagnostic procedure, but no treatment with the Peregrine Kit. All patients will be actively monitored and managed by the study investigators. Patients will not know which study arm they are in. The reason for this trial design is that it could help to clarify how effectively the procedure reduces blood pressure as compared to other factors, such as the benefits of active blood-pressure monitoring as a participant in the trial.
Has the Peregrine Kit been studied before? Where can I find the data?
The Peregrine Kit is currently being studied in another trial in Europe, the TARGET BP OFF-MED Clinical Trial, which will involve 90 patients. Results from another European study of the CE-marked Peregrine System Infusion Catheter, which is part of the investigational Peregrine Kit, were presented in March 2019.
Patients may be eligible for the TARGET BP I Clinical Trial if:
between the ages of 18 and 80
taking 2-5 antihypertensive medications
with an average blood pressure equal to or greater than 150 mmHg systolic / 90 mmHg diastolic
To learn more about the trial and answer trial eligibility screening questions, please click on the link below. Based on responses, you may be directed to a nearby clinical trial site for further information. No personal data will be gathered from your responses to the questions.