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

A Boston Scientific Clinical Trial of Renal Denervation Using the Vessix Reduce™ Catheter and Vessix™ Generator for the Treatment of HyperTensioN: REINFORCE

The REDUCE HTN: REINFORCE study is being conducted to determine whether the Vessix Reduce™ Catheter and Vessix™ Generator for the treatment of uncontrolled hypertension (off-treatment office systolic blood pressure ≥150 mmHg and ≤180 mmHg) shows acceptable performance at 8 weeks when compared to a masked procedure (renal angiogram).

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