The Peregrine Post-Market Study for the Treatment of Hypertension

Inclusion Criteria

• Adult subject, age 18-80, male or female;
• Subject has a target treatment vasculature diameter of ≥4 mm and ≤ 7 mm and length of ≥5 mm;
• Subject has 3 measurements with a mean of office Systolic Blood Pressure of

≥150 mmHg AND office Diastolic Blood Pressure of ≥85 mmHg;

• Subject has a 24-hour mean systolic Ambulatory Blood Pressure Measurement (ABPM) ≥135 mm Hg with ≥70% valid readings (as determined by measurement device);
• 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;
• 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;
• Subject has provided written informed consent.

Exclusion Criteria

• 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)
• Subject has documented severe untreated obstructive sleep apnea (Apnea Hypopnea Index [AHI] ≥30 per hour);
• Subjects with nephrotic syndrome;
• Subjects on immunosuppressive medications or immunosuppressive doses of steroids;
• Subject has type 1 diabetes mellitus;
• Subject is pregnant or nursing or planning to become pregnant;
• Subject has an eGFR ≤20 mL/min/1.73m2

, based on the CKD-EPI equation;

• Subject has imaging-assessed renal artery anatomy abnormalities or variations based on Investigator's evaluation of the screening images [i.e. MRA/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);
• 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;
• Subject has a history of nephrectomy, a single kidney or kidney tumor, or urinary tract obstruction (with potential for hydronephrosis);
• 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);
• Subject has a renal transplant;
• Subject has a history of myocardial infarction, unstable angina pectoris, or stroke/TIA within the last six months from planned procedure;
• Subject has hemodynamically significant valvular heart disease;
• Subject has heart failure (NYHA III or IV) or has an ejection fraction ≤30%;
• Subject with chronic atrial fibrillation;
• Subjects who are allergic or intolerant of the neurolytic agent (such as dehydrated alcohol);
• Any contraindication to the imaging as required per the protocol;
• Subject has a life expectancy of <12 months;
• 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.