Trials / Completed
CompletedNCT02439749
SPYRAL PIVOTAL - SPYRAL HTN-OFF MED Study
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)
- Status
- Completed
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 366 (actual)
- Sponsor
- Medtronic Vascular · Industry
- Sex
- All
- Age
- 20 Years – 80 Years
- Healthy volunteers
- Not accepted
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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DEVICE | Symplicity Spyral™ multi-electrode renal denervation system | After a renal angiography according to standard procedures, subjects remain blinded and are immediately treated with the renal denervation procedure after randomization. |
| PROCEDURE | Sham Procedure | 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. |
Timeline
- Start date
- 2015-06-01
- Primary completion
- 2020-04-30
- Completion
- 2023-10-25
- First posted
- 2015-05-12
- Last updated
- 2025-03-28
- Results posted
- 2021-05-27
Locations
47 sites across 9 countries: United States, Australia, Austria, Canada, Germany, Greece, Ireland, Japan, United Kingdom
Regulatory
- FDA-regulated device study
Source: ClinicalTrials.gov record NCT02439749. Inclusion in this directory is not an endorsement.