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

Boston Scientific

Status

Completed

Conditions

Hypertension

Treatments

Device: Renal Denervation (Vessix)

Device: Renal Angiography

Study type

Interventional

Funder types

Industry

Identifiers

NCT02392351

S2333

Details and patient eligibility

About

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).

Full description

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

Enrollment

51 patients

Sex

All

Ages

18 to 75 years old

Volunteers

No Healthy Volunteers

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