N/A N=51 Randomized Single-blind Treatment

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

Hypertension

Bottom Line

View on ClinicalTrials.gov: NCT02392351 ↗

Enrolled (actual)

Serious AEs

19.6%

Results posted

Oct 2019

Primary outcome: Primary: OBSERVATIONAL: Change (Mean Reduction) in Average 24-hour Ambulatory Systolic Blood Pressure (ASBP) Through 8 Weeks — -5.3; -8.5 mmHg

Study Design & Population

Study type: Interventional
Phase: N/A
Interventions: Renal Denervation (Vessix) (Device); Renal Angiography (Device)
Age: Adult, Older Adult · 18+ yrs
Sex: All
Sponsor: Boston Scientific Corporation
Primary completion: Sep 2017

Outcome Measures

Outcome	Result	p-value
PRIMARY OBSERVATIONAL: Change (Mean Reduction) in Average 24-hour Ambulatory Systolic Blood Pressure (ASBP) Through 8 Weeks	-5.3; -8.5	—
SECONDARY Number of Hospitalizations Due to Severe Hypotension/Syncope	0; 0	—
SECONDARY Significant Embolic Event Resulting in End-organ Damage or Intervention to Prevent it	0; 0	—
SECONDARY Renal Artery Dissection or Perforation Requiring Intervention	0; 0	—
SECONDARY Vascular Complications	0; 0	—
SECONDARY Significant New Renal Artery Stenosis	0; 0	—
SECONDARY Number of Subjects Utilizing Anti-hypertensive Medications	26; 14	—
SECONDARY Mean Reduction in Average 24-hour Ambulatory Systolic Blood Pressure at 6 Months	-16.7; -9.5	—
SECONDARY Mean Reduction in Average 24-hour Ambulatory Diastolic Blood Pressure Through 6 Months	-9.1; -5.5	—
SECONDARY Number of Subjects Utilizing Anti-hypertensive Medications	26; 14	—
SECONDARY Mean Reduction in Average 24-Hour Ambulatory Systolic Blood Pressure	-18.2; -14.3	—
SECONDARY Mean Reduction in Average 24-hour Ambulatory Diastolic Blood Pressure	-11.0; -9.0	—
SECONDARY All-Cause Death	0; 0	—
SECONDARY Number of Participants With Renal Failure	2; 0	—
SECONDARY Number of Participants With Hypertensive Crisis	1; 0	—
SECONDARY Mean Reduction in Average Office-based Systolic Blood Pressure	-19.7; -25.7	—
SECONDARY Mean Reduction in Average Office-based Diastolic Blood Pressure	-9.5; -9.8	—
SECONDARY Percent of Subjects at Target Blood Pressure	12; 5	—
SECONDARY Congestive Heart Failure	1; 0	—
SECONDARY Myocardial Infarction	0; 0	—
SECONDARY Stroke	0; 0	—

Summary

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).

Eligibility Criteria

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

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT02392351). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.