An interventional study of Renal nerve stimulation in Hypertension, Vascular Diseases and Cardiovascular Diseases, sponsored by Medtronic Vascular. Recruiting at 2 sites in 2 countries. Open to participants aged 20 Years to 70 Years. Per ClinicalTrials.gov, last updated 2026-10-20.
Sponsored by Medtronic Vascular (part of Medtronic) · Not applicable, Interventional, and Treatment
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.
This study is exploratory in nature and an early-stage clinical assessment that will evaluate procedural and long-term safety of renal nerve stimulation (RNS) when performed prior to and post renal artery denervation (RDN) with the Symplicity Spyral system, with follow-up at 1, 3, 6 and 12 months.
There is no pre-specified primary endpoint. However, the objectives of the Spyral InSight ECF study are as follows:
6,114 studies on the registry are indexed under Hypertension; 912 are open to participants now.
This study's planned enrollment of 19 is below the median of 100 across 4,575 interventional studies indexed under Hypertension.
Browse Hypertension studies →Medtronic Vascular is the lead sponsor of 60 studies on the registry; 7 are open to participants now.
Of its 6 completed or terminated interventional studies of FDA-regulated products, 6 (100%) have results posted.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
GFR (glomerular filtration rate) is how much blood the kidneys filter each minute. It is usually estimated from a blood test — eGFR, by formulas such as CKD-EPI or MDRD — and some studies ask for it to be measured directly instead. Usually given in mL/min/1.73 m².
Check the method, the units and the minimum the study states. A value of 90 or above is in the normal-or-high range, but kidney damage can show in other tests too.
GFR and eGFR (kidney filtering)
GFR (glomerular filtration rate) is how much blood the kidneys filter each minute. It is usually estimated from a blood test — eGFR, by formulas such as CKD-EPI or MDRD — and some studies ask for it to be measured directly instead. Usually given in mL/min/1.73 m².
Check the method, the units and the minimum the study states. A value of 90 or above is in the normal-or-high range, but kidney damage can show in other tests too.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Device: Renal nerve stimulation
Renal nerve stimulation will be performed prior to and post renal denervation.
All-cause mortality
Time frame: Through study completion, from enrollment to 12-month follow-up
End-stage renal disease
Time frame: Through study completion, from enrollment to 12-month follow-up
Myocardial infarction
Time frame: Through study completion, from enrollment to 12-month follow-up
Incidence of stroke
Time frame: Through study completion, from enrollment to 12-month follow-up
Hospitalization for hypertensive crisis not related to non-adherence with medications
Time frame: Through study completion, from enrollment to 12-month follow-up
Significant embolic event resulting in end-organ damage
Time frame: Through study completion, from enrollment to 12-month follow-up
Renal artery intervention
Time frame: 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
Time frame: Through study completion, from enrollment to 12-month follow-up
Vascular complications
Time frame: Through study completion, from enrollment to 12-month follow-up
Major bleeding according to TIMI definition
Time frame: Through study completion, from enrollment to 12-month follow-up
Prolonged renal vasoconstriction requiring intervention
Time frame: Through study completion, from enrollment to 12-month follow-up
Contrast induced nephropathy
Time frame: Through study completion, from enrollment to 12-month follow-up
Plan to share: No — There is not a plan to make IPD available.
No publications or documents are linked to this record.
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
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