RecruitingNot Applicable

Spyral InSight Study

Greece, Ireland19 participantsStarted 2025-06-09

Plain-language summary

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.

Who can participate

Age range

20 Years – 70 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

. 20 - 70 years of age
. Office SBP ≥150 mmHg and \<180 mmHg and DBP ≥90 mmHg
. Individual is prescribed with one, two, or three antihypertensive medication classes
. 24-hour ABPM average of SBP ≥135 and \<170 mmHg at Baseline

Exclusion criteria

. Prior renal denervation.
. Individual lacks appropriate renal artery Anatomy
. Has a renal artery stent
. Individual has an estimated glomerular filtration rate (eGFR) of \<60 mL/min/1.73m2
. Individual is taking SGLT2 inhibitors or GLP-1 agonists
. Individual requires chronic oxygen support or mechanical ventilation
. Primary pulmonary hypertension.
. Secondary cause of hypertension

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

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

Trial details

NCT IDNCT07013929

SponsorMedtronic Vascular

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2027-02-28

Contact for this trial

Sjors Wijnands

+31 6 1113 5502 sjors.wijnands@medtronic.com

View on ClinicalTrials.gov More Hypertension trials

Who can participate

Age range

20 Years – 70 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

. 20 - 70 years of age
. Office SBP ≥150 mmHg and \<180 mmHg and DBP ≥90 mmHg
. Individual is prescribed with one, two, or three antihypertensive medication classes
. 24-hour ABPM average of SBP ≥135 and \<170 mmHg at Baseline

Exclusion criteria

. Prior renal denervation.
. Individual lacks appropriate renal artery Anatomy
. Has a renal artery stent
. Individual has an estimated glomerular filtration rate (eGFR) of \<60 mL/min/1.73m2
. Individual is taking SGLT2 inhibitors or GLP-1 agonists
. Individual requires chronic oxygen support or mechanical ventilation
. Primary pulmonary hypertension.
. Secondary cause of hypertension

What they're measuring

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