BENITIONSClinical Trial Intelligence

SPYRAL HTN-ON MED Study of Renal Denervation With the Symplicity Spyral™ Multi-electrode Renal Denervation System

N/A Completed NCT02439775

ConditionHypertension, Vascular Diseases, Cardiovascular Diseases
PhaseN/A
SponsorMedtronic Vascular
StatusCompleted
Enrollment337 participants
InterventionsSymplicity Spyral™ multi-electrode renal denervation system, Sham Procedure
Start dateJul 22, 2015
Completion dateAug 18, 2022
Results postedSep 15, 2023

Summary

The purpose of this study is to test the hypothesis that renal denervation decreases blood pressure and is safe when studied in the presence of up to three standard antihypertensive medications.

Change in Systolic Blood Pressure as Measured by 24-hour Ambulatory Blood Pressure Monitoring (ABPM)

From baseline to 6 months post-procedure · mm Hg

Renal Denervation-6.5 ± 10.7 mm Hg
Sham Procedure-4.5 ± 10.3 mm Hg

Acute and Chronic Safety by Evaluating Incidence of Major Adverse Events

From Baseline to 1 month post-procedure (6 months for new renal artery stenosis) · Participants

Renal Denervation204 Participants
Sham Procedure130 Participants
Renal Denervation2 Participants
Sham Procedure1 Participants

Open in BENITIONS View on ClinicalTrials.gov

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