Clinical trial

SPYRAL PIVOTAL - SPYRAL HTN-OFF MED Study

NCT02439749 · Medtronic Vascular, Industry · Completed

Key facts

NCT number NCT02439749
Title SPYRAL PIVOTAL - SPYRAL HTN-OFF MED Study
Official title 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)
Lead sponsor Medtronic Vascular, Industry
Status Completed
Study type Interventional
Conditions Hypertension, Vascular Diseases, Cardiovascular Diseases
Intervention type Device, Procedure
Interventions Symplicity Spyral™ multi-electrode renal denervation system, Sham Procedure
Enrollment 366
Start date Jun 1, 2015
Primary completion Apr 30, 2020
Completion Oct 25, 2023
First posted May 12, 2015
Last update posted Mar 28, 2025
Countries Australia, Austria, Canada, Germany, Greece, Ireland, Japan, United Kingdom, United States

At a glance

  • 10–99 Study sites
  • Yes Results posted
  • None Linked FDA submissions

Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.

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