CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 337 enrolled / 337 target
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/NCT02439775
NCT02439775N/ACompletedMonitor (2.6/mo)Completion was 46mo ago
CompareCT.gov

Global Clinical Study of Renal Denervation With the Symplicity Spyral™ Multi-electrode Renal Denervation System in Patients With Uncontrolled Hypertension on Standard Medical Therapy (SPYRAL HTN-ON MED)

Medtronic Vascular·interventional·Posted May 12, 2015·Updated Jun 11, 2026

In Brief

A clinical study evaluating Symplicity Spyral™ multi-electrode renal denervation system and Sham Procedure for Hypertension and 2 related conditions. Completed, enrolled 337 participants across 56 sites in 10 countries.

Signals

Enrolling slower than its timeline implies

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 presence of up to three standard antihypertensive medications.

Study Details

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

Timeline

N/ACompletedFinished
20162017201820192020202120222023202420252026
First PostedMay 12, 2015
Enrollment StartJul 22, 2015
Primary CompletionAug 18, 2022
Study CompletionAug 14, 2025
TodayJul 2, 2026
Enrollment to primary: 7.1 yearsPosted 11.1 years ago

Arms & Interventions

Renal Denervationexperimental

Renal angiography and Renal Denervation (Symplicity Spyral™ multi-electrode renal denervation system)

Device: Symplicity Spyral™ multi-electrode renal denervation system
Sham Proceduresham_comparator

Renal angiography

Procedure: Sham Procedure

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.