Trials / Completed
CompletedNCT04311086
SPYRAL DYSTAL Renal Denervation Global Clinical Study
Global Clinical Study of Renal Denervation in the Distal Main and First Order Branch Renal Arteries Using the Symplicity Spyral™ Multi-electrode Renal Denervation System (SPYRAL DYSTAL)
- Status
- Completed
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 128 (actual)
- Sponsor
- Medtronic Vascular · Industry
- Sex
- All
- Age
- 20 Years – 80 Years
- Healthy volunteers
- Not accepted
Summary
The objective of this single arm interventional study is to determine if renal denervation performed in the distal main and first order branch renal arteries is as effective in reducing blood pressure as the procedural approach used in the SPYRAL HTN-OFF MED clinical study.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DEVICE | Renal Denervation (Symplicity Spyral™) | Device: Symplicity Spyral™ multi-electrode renal denervation system. After a renal angiography according to standard procedures, subjects are treated with the renal denervation procedure. |
Timeline
- Start date
- 2020-06-12
- Primary completion
- 2022-12-22
- Completion
- 2022-12-22
- First posted
- 2020-03-17
- Last updated
- 2024-04-17
- Results posted
- 2024-04-17
Locations
8 sites across 4 countries: United States, Germany, Greece, United Kingdom
Regulatory
- FDA-regulated device study
Source: ClinicalTrials.gov record NCT04311086. Inclusion in this directory is not an endorsement.