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NCT02439749 · ClinicalTrials.gov registry record · NA
SPYRAL PIVOTAL - SPYRAL HTN-OFF MED Study
A NA study, sponsored by Medtronic Vascular.
- Completed
- Registry status
- NA
- Development phase
- 366
- Enrollment target
NCT02439749: Completed NA study, sponsored by Medtronic Vascular.
NCT02439749 is a NA study that has completed, run by Medtronic Vascular. The registered enrollment target is 366 participants, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (74% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02439749, a NA study, has completed, sponsored by Medtronic Vascular.
- COMPLETED
- Registry status
- NA
- Development phase
- 366 participants
- Enrollment target
Study 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.
Primary Outcome
All-cause mortality End-stage Renal Disease (ESRD) Significant embolic event resulting in end-organ damage Renal artery perforation requiring intervention Renal artery dissection requiring intervention Vascular complications Hospitalization for hypertensive crisis not related to confirmed non-adherence with medications or the protocol New renal artery stenosis \>70% (6 months for new renal artery stenosis)
Interventions
- PROCEDURE Sham Procedure
- DEVICE Symplicity Spyral™ multi-electrode renal denervation system
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 366 participants |
| Start Date | 2015-06 |
| Est. Completion | 2023-10-25 |
| Phase | NA |
What the finished NCT02439749 record still lists
NCT02439749 is an interventional study that assigns participants to a tested intervention. The registered 366 participants enrollment target is mid-sized for trials with a published cap, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (74% lower).
The record links to 0 conditions, and to 2 interventions - of which Sham Procedure is the first listed.
NCT02439749 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT02439749 about?
NCT02439749 is a clinical study titled "SPYRAL PIVOTAL - SPYRAL HTN-OFF MED Study". 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.
What is the current status of trial NCT02439749?
This trial is currently completed. It is a NA study. The enrollment target is 366 participants. The study started on 2015-06. Estimated completion is 2023-10-25.
What interventions are being tested in trial NCT02439749?
The interventions under investigation include: Sham Procedure (PROCEDURE), Symplicity Spyral™ multi-electrode renal denervation system (DEVICE).
Who is sponsoring clinical trial NCT02439749?
This trial is sponsored by Medtronic Vascular, which has 26 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT02439749's enrollment target sits among peer trials
366 284th of 2000 higher than 1,717 of 2,000 other NA trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other NA trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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