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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 trial)
CAUTION: Investigational device. Limited by U.S. law to investigational use.
The SPYRAL Off-Med pivotal trial met its secondary efficacy endpoint, showing clinically significant blood pressure reductions at three months.1* The powered efficacy endpoints for the trial were:
Zero major adverse events† through three months in the RDN treatment arm.1
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 trial)
Acute and chronic safety by evaluating incidence of major adverse events from baseline to one month post-procedure or six months for new renal artery stenosis
Change in systolic blood pressure as measured by 24-hour ambulatory blood pressure monitoring (ABPM) from baseline to three months post-procedure
More details are available at clinicaltrials.gov
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CAUTION. Investigational device. Limited by U.S. law to investigational use.
An analysis of covariance model was used adjusting for baseline blood pressure.
Death, stroke, end-stage renal disease, or MI.
ANCOVA Adjusted.
Böhm M, Kario K, Kandzari DE, et al. Efficacy of catheter-based renal denervation in the absence of antihypertensive medications (SPYRAL HTN-OFF MED Pivotal): a multicentre, randomised, sham-controlled trial. Lancet 2020; Published online March 29, 2020. DOI: 10.1016/S0140-6736(20)30554-7.
Only for patients discontinuing anti-hypertensive medications.
According to scheduling.
Drug testing to ensure no medications are present.
Optional follow-up at weeks 6 and/or 10 if the patient is not controlled.
Only for patients with BP ≥140 mm Hg at 3M.
Drug testing to ensure prescribed medications are present (if on drug).
6 and 12 month renal imaging.