Tests a device for uncontrolled high blood pressure in adults
Tests whether a multi-organ nerve procedure is safe and lowers blood pressure in adults.
Key facts
- Who runs it
- Medtronic Vascular
- Where
- Basel, SwitzerlandSee the siteAlso in 5 other countries, 17 sites
- Trial code
- Registry title
- SPYRAL GEMINI Pilot Study
- Status
- Recruiting
- People taking part
- 175 people, planned
- Started
- 1 May 2025
- Expected to end
- 22 Dec 2029
- Type of study
- Interventional, 2 groups
- Treatments tested
- Multi-Organ Denervation Gemini System
- Record updated
- 20 October 2026
Who can take part
AI summary
From the trial's eligibility criteria. Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.
The trial is looking for adults aged 18 to 80 with high blood pressure that is not controlled. It tests a device that treats nerves around the kidney and liver arteries.
- Age
- 18 to 80 years
- Sex
- All sexes can join.
- Disease stage
- Diagnosed high blood pressure. Office top number (SBP) 150 mmHg or more but under 180 mmHg, and office bottom number (DBP) 90 mmHg or more. 24-hour average SBP 140 mmHg or more but under 170 mmHg.
- Earlier treatment
- People who had a nerve treatment (denervation) of the kidney or liver arteries before cannot join.
Main reasons for not taking part
- Kidney or liver artery shape that does not fit the device
- Heart failure NYHA Class III or IV within 6 months
- Stroke or TIA within 6 months, or a stroke that left permanent disability
- Type 1 diabetes or insulin use within 6 months
- eGFR below 40, or pregnant, nursing or planning pregnancy
The registry criteria, word for word
Show all 16 criteriaShow less
Who can take part
- All Subjects (both cohorts):
- ≥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
Who cannot take part
- 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
- Primary pulmonary arterial hypertension
- History or evidence of active / suspected chronic liver or biliary disease
- Estimated glomerular filtration rate (eGFR) of <40
- Individual lacks appropriate renal artery OR common hepatic artery anatomy
- Pregnant, nursing or planning to become pregnant during the study
- Current or chronic pancreatitis
Check if you might fit
Answer for yourself. This is not a decision: only the study team can say whether you can take part.
- Are you between 18 and 80 years old?
Where in Switzerland
Also in 5 other countries, 17 sites
- University Hospital BaselBasel, SwitzerlandContact: Lucas Lauder, MDTaking people
About the trial
What the trial wants to find out
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.
The 2 groups in the trial
- Gemini Pilot Off Med: Multi-Organ Denervation for Hypertension Off Anti-hypertensive MedsTreatment being tested
Treatment: Multi-Organ Denervation Gemini System
- Gemini Pilot On Med: MDN for Hypertension and High Cardiovascular Risk On Anti-hypertensive Meds.Treatment being tested
Treatment: Multi-Organ Denervation Gemini System
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Contact the study team: see the registry record → Contacts and Locations
Print a page for my doctorData and sources
- Registry record
- Listed on ClinicalTrials.gov.
- Official title
- Global Pilot Study of rEnal and Hepatic coMbINed denervatIon in Subjects With Uncontrolled Hypertension With and Without High Cardiovascular Risk
- Plain-language title
- Tests a device for uncontrolled high blood pressure in adultsGenerated from the registry record. The registry title is the official one.
- AI summary
- From the trial's eligibility criteria. Read by machine on 12 November 2026.
- Fit questions
- Built from NCT06907147, who can take part
- Record updated
- 20 October 2026