Clinical Trial: The Peregrine Study: A Safety and Performance Study of Renal Denervation
Study Status: Active, not recruiting
Recruit Status: Active, not recruiting
Study Type: Interventional
Official Title: A Safety and Performance Study of Renal Denervation by Neurolysis Using the Ablative Solutions Inc. Peregrine System™ Infusion Catheter
Brief 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 Summary:
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 hypertens
Sponsor: Ablative Solutions, Inc.
Current Primary Outcome:
- Vessel dissection or perforation [ Time Frame: Immediate post procedure ]Vessel dissection or perforation on immediate post-procedural fluoroscopy
- Grade 3 or Grade 4 hemorrhage [ Time Frame: During or immediately after procedure ]Grade 3 hemorrhage requiring transfusion or Grade 4 hemorrhage
- Cerebrovascular accident [ Time Frame: Time of procedure ]Cerebrovascular accident at the time of procedure
- Myocardial infarction [ Time Frame: Time of procedure ]Myocardial infarction at the time of the procedure
- Sudden cardiac death [ Time Frame: Time of procedure ]Sudden cardiac death at the time of the procedure
- Reduction in the systolic blood pressure [ Time Frame: 6 months ]The primary performance endpoint is a reduction in the clinic systolicand diastolic blood pressure following treatment compared to baseline, assessed at 6 months.
Original Primary Outcome:
- Vessel dissection or perforation [ Time Frame: Immediate post procedure ]Vessel dissection or perforation on immediate post-procedural fluoroscopy
- Grade 3 or Grade 4 hemorrhage [ Time Frame: During or immediately after procedure ]Grade 3 hemorrhage requiring transfusion or Grade 4 hemorrhage
- Cerebrovascular accident [ Time Frame: Time of procedure ]Cerebrovascular accident at the time of procedure
- Myocardial infarction [ Time Frame: Time of procedure ]Myocardial infarction at the time of the procedure
- Sudden cardiac death [ Time Frame: Time of procedure ]Sudden cardiac death at the time of the procedure
- Reduction in the systolic blood pressure of at least 10% [ Time Frame: 3 months ]The primary performance endpoint is a reduction in the systolic blood pressure of at least 10%. This reduction should correspond to approximately 20 mm Hg less than the baseline value.
Current Secondary Outcome:
- Change in eGFR (reduction >25%) [ Time Frame: baseline to 6 months ]Proportion of patients with a decline in eGFR by >25% from baseline to 6 months follow-up
- New renal arterial stenosis >60% [ Time Frame: 6 months ]New renal arterial stenosis >60% from baseline confirmed by the same method used at baseline
- Mean change in serum creatinine [ Time Frame: post baseline visits at 7d,1 mo,3mo,6mo,12mo,24mo ]Change in serum creatinine
- Adverse events [ Time Frame: post baseline visits at 7d,1 mo,3mo,6mo,12mo,24moprocedure and each of the follow-up time periods ]Adverse events - device and non-device related
- Changes in antihypertensive medications [ Time Frame: post baseline visits at 7d,1 mo,3mo,6mo,12mo,24moeach of the follow-up visits ]
The addition of new antihypertensive drugs will be considered an intensification of the antihypertensive regimen.
Discontinuation of one or more of the baseline antihypertensive medications without an increase in dose of remaining drugs or addition of new drugs will be considered a reduction in antihypertensive drug regimen.
- Changes in ambulatory blood pressure measurements [ Time Frame: post baseline visits at 7d,1 mo,3mo,6mo,12mo,24mo ]Ambulatory blood pressures will be reported to determine if they follow a similar patter to the clinic blood pressures.
Original Secondary Outcome:
- Change in eGFR (reduction >25%) [ Time Frame: Two serial measurements at 6 months ]Change in eGFR (reduction >25% confirmed by at least 2 serial measurements at 6 months)
- New renal arterial stenosis >60% [ Time Frame: 6 months ]New renal arterial stenosis >60% confirmed by CT angiogram at 6 months
- Change in serum creatinine [ Time Frame: 3 months ]Change in serum creatinine
- Adverse events [ Time Frame: During procedure and at 3, 6 and 12 months ]Adverse events - device and non-device related
- Changes in antihypertensive medications [ Time Frame: 3, 6 and 12 months ]
The addition of new antihypertensive drugs will be considered an intensification of the antihypertensive regimen.
Discontinuation of one or more of the baseline antihypertensive medications without an increase in dose of remaining drugs or addition of new drugs will be considered a reduction in antihypertensive drug regimen.
- Changes in ambulatory blood pressure measurements [ Time Frame: 3, 6 and 12 months ]Ambulatory blood pressures will be reported to determine if they follow a similar patter to the clinic blood pressures.
Information By: Ablative Solutions, Inc.
Dates:
Date Received: May 27, 2014
Date Started: July 2014
Date Completion: July 2017
Last Updated: June 6, 2016
Last Verified: June 2016
