The purpose of the Spyral InSight Early Clinical Feasibility Study is to characterize the physiological response to renal nerve stimulation (RNS) in humans prior to and post renal denervation.
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All-cause mortality
Timeframe: Through study completion, from enrollment to 12-month follow-up
End-stage renal disease
Timeframe: Through study completion, from enrollment to 12-month follow-up
Myocardial infarction
Timeframe: Through study completion, from enrollment to 12-month follow-up
Incidence of stroke
Timeframe: Through study completion, from enrollment to 12-month follow-up
Hospitalization for hypertensive crisis not related to non-adherence with medications
Timeframe: Through study completion, from enrollment to 12-month follow-up
Significant embolic event resulting in end-organ damage
Timeframe: Through study completion, from enrollment to 12-month follow-up
Renal artery intervention
Timeframe: Through study completion, from enrollment to 12-month follow-up
New renal artery stenosis >70%, confirmed by angiography and as determined by the angiographic core lab
Timeframe: Through study completion, from enrollment to 12-month follow-up
Vascular complications
Timeframe: Through study completion, from enrollment to 12-month follow-up
Major bleeding according to TIMI definition
Timeframe: Through study completion, from enrollment to 12-month follow-up
Prolonged renal vasoconstriction requiring intervention
Timeframe: Through study completion, from enrollment to 12-month follow-up
Contrast induced nephropathy
Timeframe: Through study completion, from enrollment to 12-month follow-up