The Peregrine Post-Market Study for the Treatment of Hypertension
|Study Design:||Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
|Official Title:||A Post-Market Study of Transcatheter Perivascular Renal Denervation for the Treatment of Hypertension Using the Ablative Solutions Inc. Peregrine System™ Infusion Catheter|
- Number of Subjects with Treatment Related Adverse Events [ Time Frame: 1-month ]
The primary safety endpoint is defined by the absence of any of the following events as adjudicated by the CEC through 1-month post procedure:
- Peri-procedural major vascular complications;
- Major Bleeding as defined by the TIMI Bleeding Classification;
- Acute Kidney Injury (AKI) within 1 month of the procedure
- Peri-procedural death (within 1 month of the procedure)
- Reduction of 24-hour Mean Ambulatory Systolic Blood Pressure [ Time Frame: 6 months ]The primary performance endpoint is defined as a reduction of 24-hour mean ambulatory systolic blood pressure following treatment at 6 months, as compared to baseline.
- Proportion of subjects with a decline in eGFR by >25% [ Time Frame: 6 months ]Proportion of subjects with a decline in eGFR by >25% from baseline to 6-month follow-up;
- Change in serum creatinine [ Time Frame: 6 months ]Change in serum creatinine from baseline to 6-month follow-up
- New renal arterial stenosis > 60% [ Time Frame: 6 months ]New renal arterial stenosis > 60% from the baseline at the 6-month follow-up, to be confirmed by the same imaging method used at baseline.
- Proportion of subjects with stroke or Transient Ischemic Attack (TIA) [ Time Frame: 1 month ]Stroke or TIA within 1 month of the procedure
- Myocardial Infarction (MI) [ Time Frame: 1 month ]. Myocardial Infarction (MI) within 1 month of the procedure
- Major Adverse Events (MAE) [ Time Frame: 6 months ]
Major Adverse Events (MAE) through 6-month post-procedure. MAE is defined as the occurrence of any of the following:
- All-cause death
- End stage renal failure
- Significant embolic event resulting in end-organ damage or requiring intervention to prevent it
- Major Vascular Complications
- Significant new renal artery stenosis (>60% diameter stenosis)
- Hypertensive crisis
- Severe hypotension/syncope
- Changes in antihypertensive medications [ Time Frame: 7-day, 1, 3, 6 and 12 months ]Changes in antihypertensive medications at 7-day, 1, 3, 6 and 12 months post procedure;
- Changes in systolic and diastolic clinic/office blood pressure [ Time Frame: 7-day, 1, 3, 6 and 12 months ]Changes in systolic and diastolic clinic/office blood pressure following treatment compared to baseline, assessed at 7-day, 1, 3, 6 and 12 months post-procedure.
- Changes in systolic and diastolic 24-hour mean daytime and nighttime ambulatory blood pressure [ Time Frame: 1, 3, 6 and 12-months ]Changes in systolic and diastolic 24-hour mean daytime and nighttime ambulatory blood pressure, assessed at 1, 3, 6 and 12-month post-procedure.
- Changes in diastolic 24-hour mean ambulatory blood pressure [ Time Frame: 1, 3, 6 and 12-months ]Changes in systolic and diastolic 24-hour mean ambulatory blood pressure assessed at 1, 3, 6 and 12-month post-procedure.
|Study Start Date:||November 2015|
|Estimated Study Completion Date:||September 2018|
|Estimated Primary Completion Date:||March 2018 (Final data collection date for primary outcome measure)|
Experimental: Renal Denervation by Neurolysis
Infusion of 0.6 ml of dehydrated alcohol (not less than 95% by volume) into the peri-adventitial space of the renal artery, to achieve renal denervation by neurolysis, via three simultaneous deployed needles, situated at the distal end of the Peregrine System Infusion Catheter.
Device: Peregrine System Infusion Catheter
The Peregrine Catheter is inserted bilaterally into the renal arteries and a specified amount of a neurolytic agent is inserted into the vessel walls.
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 usethis agent.
Please refer to this study by its ClinicalTrials.gov identifier: NCT02570113
|Contact: Horst Sievert, MD||0049 email@example.com|
|Contact: Ali Kakavand, PhD||+1 650 575 firstname.lastname@example.org|
|Cliniques Universitaires Saint-Luc||Recruiting|
|Brussels, Belgium, 1200|
|Contact: Alexandre Persu, MD PhD +32 2 764 25 33|
|Na Homolce Hospital||Active, not recruiting|
|Prague, Czech Republic, 150 30|
|Berlin, Germany, 12203|
|Contact: Maximilian de Bucourt, MD 0049 304 5062 7085|
|Universitätsklinik Erlangen Klinik für Nephrologie/Hypertensiologie||Recruiting|
|Erlangen, Germany, 91054|
|Contact: Roland E Schmieder, Prof. Dr. med. +49 9131 85 36245|
|Elisabeth-Krankenhaus Essen GmbH||Recruiting|
|Essen, Germany, 45138|
|Contact: Thomas Schmitz, MD +49 201 897 3200|
|CardioVasculares Centrum (CVC) Frankfurt||Recruiting|
|Frankfurt, Germany, 60389|
|Contact: Horst Sievert, MD 0049 46031340|
|Universitats-Herzzentrum/University Heart Center Klinik fur Kardiologie und Angiologie||Recruiting|
|Freiburg, Germany, 79106|
|Contact: Andreas Zirlik, MD 0049 76127034415|
|Klinik fur Innere Medizin III||Recruiting|
|Homburg, Germany, 66421|
|Contact: Felix Mahfoud, MD PhD +49 6841 16 15911|
|Oddzial Kardiologii Inwazyjnej||Active, not recruiting|
|Tychy, Poland, 43-100|
|Oddizal Kardiologiczno-Angiologiczny PAKS||Active, not recruiting|
|Ustron, Poland, 43-450|
|Principal Investigator:||Horst Sievert, MD||CardioVasculares Centrum (CVC) Frankfurt|