Renal Denervation Using the Vessix Renal Denervation System for the Treatment of Hypertension (REDUCE HTN:REINFORCE)

Prospective, multicenter, single blinded, randomized, controlled, pilot study. Subjects will
be randomized to renal denervation treatment or masked renal angiogram procedure (2:1).

Inclusion Criteria:

- Age ≥18 and ≤75 years

- OSBP ≥150 mmHg and ≤180 mmHg based on an average of 3 office-based blood pressure
measurements

- Average 24-hour ASBP ≥135 mmHg and ≤170 mmHg

- For each kidney, a main renal artery, with or without accessory renal arteries, with
diameter ≥3.0 mm and ≤7.0 mm and length ≥20.0 mm

- Agrees to have all study procedures performed, and is competent and willing to provide
written, informed consent

Exclusion Criteria:

- Stenosis >30% or renal artery aneurysm in either renal artery

- Fibromuscular dysplasia (FMD)

- Known causes of secondary HTN

- Type 1 diabetes mellitus

- eGFR <40 mL/min/1.73m2

- Known ejection fraction of <30% or heart failure that required hospitalization in the
previous 6 months

- Severe valvular heart disease

- ≥1 episode(s) of orthostatic hypotension not related to medication changes (reduction
of SBP of ≥20 mmHg or DBP of ≥10 mmHg within three minutes of standing) coupled with
symptoms within the past year or during screening