A Safety and Performance Study of Renal Denervation by Neurolysis
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 injection 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.
Device: The Ablative Solutions Peregrine Infusion Catheter
Device: Injection of a neurolytic agent for denervation of the renal sympathetic nerves
|Study Design:||Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||A Safety and Performance Study of Renal Denervation by Neurolysis Using the Ablative Solutions Inc.Peregrine System™ Infusion Catheter; "The Peregrine Study"|
- Vessel dissection or perforation [ Time Frame: Immediate post procedure ] [ Designated as safety issue: Yes ]Vessel dissection or perforation on immediate post-procedural fluoroscopy
- Grade 3 or Grade 4 hemorrhage [ Time Frame: During or immediately after procedure ] [ Designated as safety issue: Yes ]Grade 3 hemorrhage requiring transfusion or Grade 4 hemorrhage
- Cerebrovascular accident [ Time Frame: Time of procedure ] [ Designated as safety issue: Yes ]Cerebrovascular accident at the time of procedure
- Myocardial infarction [ Time Frame: Time of procedure ] [ Designated as safety issue: Yes ]Myocardial infarction at the time of the procedure
- Sudden cardiac death [ Time Frame: Time of procedure ] [ Designated as safety issue: Yes ]Sudden cardiac death at the time of the procedure
- Reduction in the systolic blood pressure of at least 10% [ Time Frame: 3 months ] [ Designated as safety issue: No ]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.
- Change in eGFR (reduction >25%) [ Time Frame: Two serial measurements at 6 months ] [ Designated as safety issue: Yes ]Change in eGFR (reduction >25% confirmed by at least 2 serial measurements at 6 months)
- New renal arterial stenosis >60% [ Time Frame: 6 months ] [ Designated as safety issue: Yes ]New renal arterial stenosis >60% confirmed by CT angiogram at 6 months
- Change in serum creatinine [ Time Frame: 3 months ] [ Designated as safety issue: Yes ]Change in serum creatinine
- Adverse events [ Time Frame: During procedure and at 3, 6 and 12 months ] [ Designated as safety issue: Yes ]Adverse events - device and non-device related
- Changes in antihypertensive medications [ Time Frame: 3, 6 and 12 months ] [ Designated as safety issue: No ]
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 ] [ Designated as safety issue: No ]Ambulatory blood pressures will be reported to determine if they follow a similar patter to the clinic blood pressures.
|Study Start Date:||July 2014|
|Estimated Study Completion Date:||July 2017|
|Estimated Primary Completion Date:||December 2015 (Final data collection date for primary outcome measure)|
Device: The Ablative Solutions Peregrine Infusion Catheter
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 Name: Renal denervation using a neurolytic agentDevice: Injection of a neurolytic agent for denervation of the renal sympathetic nerves
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 (not less than 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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT02155790
|Contact: Wojtek Wojakowski, M.D.||+48 (604) 188 firstname.lastname@example.org|
|Contact: Krzysztof Milewski, M.D.||+48 (609) 109 email@example.com|
|American Heart of Poland||Recruiting|
|American Heart of Poland||Not yet recruiting|
|Principal Investigator:||Wojtek Wojakowski, M.D.||American Hospitals Poland|