CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 45 enrolled
Drug / intervention
Peregrine System Infusion Catheterdevice
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT02570113
NCT02570113N/ACompleted
CompareCT.gov

A Post-Market Study of Transcatheter Perivascular Renal Denervation for the Treatment of Hypertension Using the Ablative Solutions Inc. Peregrine System™ Infusion Catheter

Ablative Solutions, Inc.·interventional·Posted Oct 7, 2015·Updated Sep 28, 2023

In Brief

A clinical study evaluating Peregrine System Infusion Catheter for Hypertension. Completed, enrolled 45 participants across 10 sites in 4 countries.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsHypertension
CountriesBelgium, Czechia, Germany, Poland
Collaborators--

Timeline

N/ACompletedFinished
20162017201820192020202120222023202420252026
First PostedOct 7, 2015
Enrollment StartNov 1, 2015
Primary CompletionFeb 1, 2019
Study CompletionJul 1, 2019
TodayJul 2, 2026
Enrollment to primary: 3.3 yearsPosted 10.7 years ago

Interventions

Peregrine System Infusion Catheterdevice

The Peregrine Catheter is inserted bilaterally into the renal arteries and a specified amount of a neurolytic agent is inserted into the vessel walls.