The Peregrine Post-Market Study for the Treatment of Hypertension
Condition: Hypertension
MeSH terms: Hypertension
Study type: Interventional

Summary: 
      The Ablative Solutions, Inc. Peregrine System Infusion Catheter is a catheter-based device
      which is intended to be used to ablate the afferent and efferent sympathetic nerves serving
      the kidneys. The catheter is inserted via the femoral artery, steered into the renal artery,
      and then delivers, by infusion from its distal end, a neurolytic agent. This targets the
      nerve bundles, which are in the adventitia - a sheath surrounding the artery. The aim is to
      reduce blood pressure in cases of hypertension, including seriously elevated blood pressure
      which does not respond to drug treatment. This study will evaluate the safety and performance
      of the device.
    

Detailed description: 
      There is strong evidence in the published literature that the renal nerves are important
      contributors to hypertension, and that their ablation does not have adverse side-effects.

      The literature provides technical, clinical and scientific evidence supporting the use of
      perivascular renal denervation for a carefully defined patient group.

      An existing device (the Medtronic Symplicity catheter) was initially shown to be safe and
      effective for achieving perivascular renal denervation by delivery of radio-frequency energy.
      The results of early nonrandomized clinical studies (HTN-1, HTN-2) found that perivascular
      renal denervation by radio-frequency energy delivery was an effective therapy, associated
      with very low risks. In other contexts, denervation can also be safely and effectively
      achieved by neurolytic agents.

      The ASI Peregrine System™ Infusion Catheter and the denervation procedure in general is
      similar enough to the Medtronic Symplicity catheter to enable the use of published data to
      establish the validity of the design concept of the Peregrine System and estimate the likely
      levels of risk of side effects. It can be concluded from the literature that the ASI
      Peregrine System™ will achieve percutaneous renal denervation with a low risk of procedural
      complications (comparable to accepted percutaneous interventional therapies) and without
      long-term impairment of renal artery or kidney function or other serious adverse events.

      Previous premarket clinical trials have provided support for the safe and effective use of
      the Peregrine Catheter for the treatment of patients with hypertension. The Peregrine System
      Infusion Catheter is currently CE marked and the indication for use is "The Peregrine System™
      Infusion Catheter is intended for the infusion of a neurolytic agent to achieve a reduction
      in systemic blood pressure in hypertensive patients." Based upon the literature and previous
      clinical data, chemical denervation is an appropriate treatment for the specified study
      population of adults who have hypertension despite taking at least 3 anti-hypertensive drugs
      of different classes including at least one diuretic.

      The objectives of this post-market study are to collect additional safety and performance
      data pertaining to renal denervation by using dehydrated alcohol as a chemical neurolytic
      agent delivered into the adventitial/peri-adventitial area of the renal arteries for the
      purpose of renal denervation, using the Peregrine System™ Infusion Catheter, in patients with
      hypertension.

      In order for the study to be valid, only one chemical neurolytic agent can be used. The
      Coordinating Investigator has chosen to use dehydrated alcohol (not less than 95% by volume)
      for therapeutic neurolysis, therefore all participating sites will use this agent.
    

Intervention name(s): Peregrine System Infusion Catheter
Intervention type(s): Device
Intervention description(s): The Peregrine Catheter is inserted bilaterally into the renal arteries and a specified amount of a neurolytic agent is inserted into the vessel walls.
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment