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

 
 
 
 
 
 
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PROTOCOL SUMMARY 
TITLE: 
A Post-Market Study of Transcatheter Perivascular Renal 
Denervation for the Treatment of Hypertension using the 
Ablative Solutions Inc. Peregrine System™ Infusion Catheter 
SHORT TITLE: 
The Peregrine Post-Market Study 
PROTOCOL ID: 
CR0001 
INVESTIGATIONAL 
PRODUCT: 
Peregrine System™ Infusion Catheter 
INDICATION: 
Hypertension 
ClinicalTrials.gov ID: 
NCT02570113 
PHASE: 
Post market clinical follow up study 
SPONSOR: 
Ablative Solutions, Inc. 
6203 San Ignacio Avenue, Suite 110 
San Jose, CA 95119, US 
COORDINATING 
INVESTIGATORS: 
Prof. Dr. med. Horst Sievert 
PROTOCOL VERSION: 
Rev K 
DATE: 
16 April 2018 
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INVESTIGATIONAL PRODUCT 
Name of Product 
Peregrine System™ Infusion Catheter 
CLINICAL CONDITION/INDICATION 
Hypertension 
Protocol ID 
CR0001 
Protocol Title 
A Post-Market Study of Transcatheter Perivascular Renal 
Denervation for the Treatment of Hypertension using the Ablative 
Solutions Inc. Peregrine System™ Infusion Catheter 
Short Title 
The Peregrine Post-Market Study 
Study Phase 
Post market clinical follow up study 
PLANNED STUDY PERIOD 
Initiation 
November 2015 
Study Completion 
May 2019 
Duration 
Approximately 3.5 years 
STUDY OBJECTIVES AND PURPOSE 
Study Purpose 
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 Catheter, in patients with hypertension. 
Objective  
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 Catheter, in patients with hypertension. 
 
STUDY DESIGN 
Study Type/ Classification/ 
Discipline 
Post market clinical follow up study for safety and performance 
(ambulatory blood pressure monitoring [ABPM], office blood pressure)  
Study Indication Type 
Treatment 
 
 

 
 
 
 
 
 
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Study Design 
This post-market study is a prospective, single arm, open label, multicenter trial. Up 
to 60 subjects with hypertension will be treated with 0.6 mL of dehydrated alcohol 
as the neurolytic agent per renal artery. The data of the first 5 treated subjects in the 
study (including renal duplex ultrasound) will be assessed at the 1-month follow-up 
by the Data Safety Monitoring Board (DSMB). If no safety concern arises, treatment 
with 0.6 mL of alcohol will continue according to the protocol. 
 
Contenting subjects will be assessed for eligibility and baseline data collected. 
Subjects will attend the study site for the day of procedure. Subjects will be 
discharged from the study site per the physician’s judgment. Subjects must be 
maintained on his/her baseline anti-hypertensive medications at the same doses 
through the 6 months follow up visit unless the study subject has symptomatic 
hypotension requiring anti-hypertensive medication reduction.  Planned increases in 
anti-hypertensive medications must be in alignment with JNC-8 and/or European 
Hypertension Guidelines and with approval from the sponsor. 
 
Follow-up visits will be performed at 7 days, 1 month, 3 months, 6 months and 12 
months post-procedure. 
Study 
Geography/ 
Number of 
Planned 
Investigational 
Sites 
Europe: up to 10 sites in Europe. 
Number of 
Groups/ Arms/ 
Cohorts 
1 group 
 
Number of 
Subjects  
Up to 60 
Planned 
Duration of 
Subject 
Participation 
Up to 12 months 
INVESTIGATIONAL PRODUCT 
Product 
Peregrine System™ Infusion Catheter used to deliver a neurolytic agent (such as 
dehydrated alcohol) to the perivascular area of the renal arteries to ablate the afferent 
and efferent sympathetic nerves serving the kidneys 
Dose: 0.6 mL alcohol per treated renal artery. 
Mode of administration: Direct infusion to the perivascular space, during an 
endovascular procedure  
SUBJECT SELECTION 
Subjects will be enrolled in the study at the time they sign the informed consent form. No study-specific 
procedures will be performed until after the subject has provided written informed consent. 
 
 

 
 
 
 
 
 
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Subject Inclusion Criteria 
Subjects must meet ALL of the following inclusion criteria to receive the percutaneous procedure: 
1. Adult subject, age 18-80, male or female 
2. Subject has a target treatment vasculature diameter of ≥4 mm and ≤ 7 mm and length of ≥5 mm 
3. Subject has 3 measurements with a mean of office Systolic Blood Pressure of ≥150 mmHg AND 
office Diastolic Blood Pressure of ≥85 mmHg 
4. Subject has a 24-hour mean systolic Ambulatory Blood Pressure Measurement (ABPM) ≥135 
mm Hg with ≥70% valid readings (as determined by measurement device) 
5. Subject with hypertension is receiving and adhering to a stable medication regimen of at least 3 
anti-hypertensive medications of different classes (for at least 4 consecutive weeks), one of 
which must be a diuretic 
6. Subject agrees to have all study procedures performed, to comply with medication regimen and 
is able and willing to comply with all study follow-up visits 
7. Subject has provided written informed consent 
 
Exclusion Criteria 
Any subject who meets ANY of the following exclusion criteria will not receive the percutaneous 
interventional procedure: 
1. Subject has a contraindication known for conventional percutaneous interventional procedures 
such as: 
• 
intolerance for antiplatelet/anticoagulant therapy 
• 
known allergy to contrast media 
• 
bleeding disorders (such as bleeding diathesis, thrombocytopenia and severe anemia) 
2. Subject has documented severe untreated obstructive sleep apnea (Apnea Hypopnea Index 
[AHI] ≥30 per hour) 
3. Subjects with nephrotic syndrome 
4. Subjects on immunosuppressive medications or immunosuppressive doses of steroids 
5. Subject has type 1 diabetes mellitus 
6. Subject is pregnant or nursing or planning to become pregnant 
7. Subject has an estimated glomerular filtration rate (eGFR) ≤20 mL/min/1.73m2, based on the 
Chronic Kidney Disease Epidemiology Collaboration (CKD-EPI) equation 
8. Subject has imaging-assessed renal artery anatomy abnormalities or variations based on 
Investigator’s evaluation of the screening images [i.e. magnetic resonance 
angiogram/angiography (MRA)/ computed tomography angiogram/angiography (CTA) 
examination and/or renal angiography]) meeting one of the following criteria: 
• 
Renal artery stenosis >60% of the normal diameter segment (diameter stenosis, compared to 
the angiographically normal proximal or distal segment) 

 
 
 
 
 
 
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• 
Any renal artery abnormality or disease that, per the physician assessment, precludes the safe 
insertion of the guiding catheter (such as but not limited to severe renal artery aneurysm, 
excessive tortuosity, severe renal artery calcification) 
• 
Previous renal angioplasty associated with stenting or other implants, that, per the physician’s 
assessment, precludes the safe deployment of the Peregrine catheter components in the target 
treatment segment of the renal artery 
9. Subject has a history of nephrectomy, a single kidney or kidney tumor, or urinary tract 
obstruction (with potential for hydronephrosis) 
10. Subject is known to have a non-functioning kidney or unequal renal size (>2 cm difference in 
renal length between kidneys associated with a chronic kidney disease or a deterioration of the 
kidney function) 
11. Subject has a renal transplant 
12. Subject has a history of myocardial infarction, unstable angina pectoris, or stroke/transient 
ischemic attack (TIA) within the last six months from planned procedure 
13. Subject has hemodynamically significant valvular heart disease 
14. Subject has heart failure (New York Heart Association [NYHA] III or IV) or has an ejection 
fraction ≤30% 
15. Subject with chronic atrial fibrillation 
16. Subjects who are allergic or intolerant of the neurolytic agent (such as dehydrated alcohol) 
17. Any contraindication to the imaging as required per the protocol 
18. Subject has a life expectancy of <12 months 
19. Subject is currently enrolled in other potentially confounding research, i.e., another therapeutic 
or interventional research trial. Subjects enrolled in observational registries may still be eligible