CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 366 enrolled
Drug / intervention
Symplicity Spyral™ multi-electrode renal denervation system +1 moredevice
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT02439749
NCT02439749N/ACompleted
CompareCT.gov

Global Clinical Study of Renal Denervation With the Symplicity Spyral™ Multi-electrode Renal Denervation System in Patients With Uncontrolled Hypertension in the Absence of Antihypertensive Medications (SPYRAL PIVOTAL - SPYRAL HTN-OFF MED)

Medtronic Vascular·interventional·Posted May 12, 2015·Updated Mar 28, 2025

In Brief

A clinical study evaluating Symplicity Spyral™ multi-electrode renal denervation system and Sham Procedure for Hypertension and 2 related conditions. Completed, enrolled 366 participants across 47 sites in 9 countries.

Detailed Summary

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

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsHypertension, Vascular Diseases, Cardiovascular Diseases
CountriesAustralia, Austria, Canada, Germany, Greece, Ireland, Japan, United Kingdom, United States
Collaborators--

Timeline

N/ACompletedFinished
20162017201820192020202120222023202420252026
First PostedMay 12, 2015
Enrollment StartJun 1, 2015
Primary CompletionApr 30, 2020
Study CompletionOct 25, 2023
TodayJul 2, 2026
Enrollment to primary: 4.9 yearsPosted 11.1 years ago

Interventions

Symplicity Spyral™ multi-electrode renal denervation systemdevice

After a renal angiography according to standard procedures, subjects remain blinded and are immediately treated with the renal denervation procedure after randomization.

Sham Procedureprocedure

After a renal angiography according to standard procedures, subjects remain blinded and remain on the catheterization lab table for at least 20 minutes prior to introducer sheath removal.