Global Clinical Study of Renal Denervation in the distal main and first order branch renal arteries using the Symplicity SpyralTM multi-electrode renal denervation system (SPYRAL DYSTAL)

1. Individual is * 20 and * 80 years old at time of enrollment (consent).
2. Individual has an office systolic blood pressure (SBP) * 150 mmHg and < 180
mmHg and an office diastolic blood pressure (DBP) * 90 mmHg measured at
Screening Visit 2, according to the guidelines in Appendix 16.5.
3. Individual has a valid 24-hour Ambulatory Blood Pressure Monitoring (ABPM)
average SBP *140 mmHg and < 170 mmHg measured at Screening Visit 2, according
to guidelines in Appendix 16.5
a) ABPM is considered valid if the number of successful daytime readings
captured is * 21 and the number of successful nighttime readings captured *12.
4. Individual agrees to have all study procedures performed, and is competent
and willing to provide written, informed consent to participate in this
clinical study.
5. Individual is willing to discontinue current antihypertensive medications at
Screening Visit 1 through the 3-month post-procedure visit.

1. Individual has one or more of the following conditions: stable or unstable
angina within 3 months of enrollment, myocardial infarction within 3 months of
enrollment; heart failure, cerebrovascular accident or transient ischemic
attack, or atrial fibrillation at any time. Patients are permitted to take
aspirin or clopidogrel for cardiovascular risk reduction. Patients who received
catheter or surgical treatment for Atrial Fibrillation and are in sinus rhythm
are not excluded.
2. Individual has undergone prior renal denervation.
3. Individual has at least one main renal artery with a diameter of less than
3mm or greater than 8mm.
4. Presence of FMD (defined as visible beading of the artery on angiography).
5. Has >50% stenosis in any treatable vessel.
6. Has a renal artery stent placed <3 months prior to the denervation procedure.
7. Presence of a renal artery aneurysm defined as any localized increase in the
diameter of the vessel.
8. Disease not allowing any treatment in the main renal artery.
9. Individual has an estimated glomerular filtration rate (eGFR) of <45
mL/min/1.73m2, using the 4 variable MDRD calculation (in mL/min per 1.73 m2 =
175 x SerumCr-1.154 x age-0.203 x 1.212 (if patient is black) x 0.742 (if
female).
10. Individual has documented type 1 diabetes mellitus or poorly-controlled
type 2 diabetes mellitus with glycosylated hemoglobin greater than 8.0%. (If
the glycosylated hemoglobin in the patient*s records is >3 months old (from the
date of Screening Visit 2), or history of uncontrolled blood sugars raises
concern, it is required to analyze glycosylated hemoglobin as part of Screening
Visit 2 labs.)
11. Individual is taking SGLT2 inhibitor or GLP-1 agonists that have been
prescribed <90 days prior to SV1 or who does not plan on remaining on these
drugs for the duration of the trial.
12. Individual has had *1 episode(s) of orthostatic hypotension not related to
medication changes within the past year or has a reduction of SBP *20 mmHg or
DBP *10 mmHg within 3 minutes of standing coupled with symptoms during the
screening process (at SV2).
13. Individual requires chronic oxygen support or mechanical ventilation other
than nocturnal respiratory support for sleep apnea (e.g. CPAP, BiPAP).
14. Individual with a history of narcotic drug abuse, is currently on
Methadone, or who has used narcotic drugs more than once in the month prior to
Screening Visit 1.
15. Individual had documented primary pulmonary hypertension.
16. Individual has untreated secondary cause of hypertension (either known or
suspected) or is taking drugs that increase sympathetic tone that could
contribute to hypertension.
17. Individual has frequent intermittent or chronic pain that results in
treatment with non-steroidal anti-inflammatory drugs (NSAIDs) for two or more
days per week over the month prior to Screening Visit 2.
18. Individual with HIV on anti-retroviral drug therapy without documentation
that hypertension preceded initiation of anti-retroviral drug treatment.
19. Individual has a scheduled or planned surgery that, in the opinion of the
Investigator, may affect study endpoints.
20. Individual has a documented condition that would prohibit or interfere with
ability to obtain an accurate blood pressure measurement using the
protocol-specified automatic/office blood pressure monitor (e.g., upper arm
circumference outside cuff size ranges available by geography or arrhythmia
such as atrial fibrillation that interferes with automatic monitor*s pulse
sensing and prohibits an accurate measurement).
21. Individual works night shifts.
22. Individual has severe cardiac valve stenosis for which, in the opinion of
the investigator, a significant reduction of blood pressure is contraindicated.
23. Individual has a documented confounding medical condition, which in the
opinion of the investigator, may adversely affect the safety of the participant
(e.g. patients with clinically significant peripheral vascular disease, aortic
aneurysm, bleeding disorders such as thrombocytopenia, hemophilia, or
significant anemia).
24. Individual is pregnant, nursing or planning to become pregnant during the
course of the study follow-up. (Note: Pre-menopausal female participants must
have a negative serum or urine human chorionic gonadotropin (hCG) pregnancy
test prior to angiography).
25. Individual has a known unresolved history of drug use or alcohol
dependency, lacks the ability to comprehend or follow instructions, or would be
unlikely or unable, in the opinion of the investigator, to comply with study
follow-up requirements.
26. Individual is currently enrolled in a concurrent investigational drug or
device study, unless approved by the study sponsor. (Note: For the purpose of
this protocol, participants involved in extended follow-up studies for products
that were investigational but are currently commercially available are not
considered enrolled in an investigational study).
27. Individual is currently taking anti-mineralocorticoid drugs. (Note:
Subjects may be enrolled as long as anti-mineralocorticoid drugs are weaned off
at least 8 weeks prior to Screening Visit 1).
28. Individual has an active peptic ulcer or gastrointestinal (GI) bleeding
within the prior six months from consent.
29. Individual has a history of bleeding diathesis or coagulopathy or will
refuse blood transfusions.
30. Individual has polycystic kidney disease, unilateral kidney, atrophic
kidney, or history of renal transplant.