The Peregrine Study: A Safety and Performance Study of Renal Denervation
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 typically 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 resistant hypertension - seriously elevated blood
      pressure which does not respond to drug treatment.
    

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 Ardian Symplicity catheter) has been shown to be safe and effective
      for achieving perivascular renal denervation by delivery of radiofrequency energy.
      Perivascular renal denervation by radio-frequency energy delivery is an effective therapy,
      associated with very low risks. In other contexts, denervation can also be safely and
      effectively achieved by neurolytic agents.

      The objectives of the study are to evaluate the safety and performance of renal denervation
      by a chemical neurolytic agent delivered into the advential/ periadventitial area of the
      renal arteries for the purpose of neurolysis, using the Peregrine System Infusion Catheter,
      in patients with refractory hypertension.

      The ASI Peregrine System Infusion Catheter is similar enough to the Ardian 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 from 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.

      Chemical denervation is an appropriate treatment for the specified study population of adults
      who have resistant hypertension despite taking at least 3 anti-hypertensive drugs of
      different classes including at least one diuretic. 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 (96 - 98% by volume) for therapeutic neurolysis, therefore all
      participating sites will use this agent. This clinical investigation is intended to provide
      clinical data that demonstrates the safety and performance of the ASI Peregrine System
      Infusion Catheter.
    

Intervention name(s): The Peregrine System Infusion Catheter
Intervention type(s): Device
Intervention description(s): The ASI catheter is inserted bilaterally into the renal arteries and a specified amount of a neurolytic agent is inserted into the vessel walls.
Other intervention name(s): Renal denervation using a neurolytic agent
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: safety, performance, hypertension, renal denervation