RecruitingNot Applicable

SPYRAL GEMINI Pilot Study

United States, Australia, Germany175 participantsStarted 2025-05-01

Plain-language summary

The purpose of the SPYRAL GEMINI Pilot Study is to evaluate that multi-organ denervation with the Gemini System is safe and provide evidence of blood pressure reduction when studied in an uncontrolled hypertensive population with and without high cardiovascular risk.

Who can participate

Age range

18 Years – 80 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

. ≥18 and ≤80 years of age.
. Diagnosed with HTN and has a baseline office SBP ≥150 mmHg and \<180 mmHg and an office DBP ≥ 90 mmHg.
. 24-hour average SBP ≥140 mmHg and \<170 mmHg measured by ABPM at Baseline.

Exclusion criteria

. Individual lacks appropriate renal artery OR common hepatic artery anatomy.
. Prior renal or hepatic denervation.
. History of NYHA Class III or IV heart failure within 6 months of screening visit.
. Stroke or transient ischemic attack (TIA) within 6 months of screening visit or any history of stroke leading to permanent disability.
. Documented Type 1 diabetes or use of insulin within 6 months.
. Secondary cause of hypertension.
. Documented condition that would prohibit or interfere with ability to obtain an accurate blood pressure measurement.
. Estimated glomerular filtration rate (eGFR) of \<40

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

Change in office blood pressure

Timeframe: From baseline to 36 months post-procedure

Trial details

NCT IDNCT06907147

SponsorMedtronic Vascular

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2029-12-22

Contact for this trial

Cecile Mahoney

+17635051057 Cecile.C.Mahoney@medtronic.com

View on ClinicalTrials.gov More Hypertension trials