HypertensionSPYRAL GEMININCT06907147
SPYRAL GEMINI Pilot Study
A study testing Multi-Organ Denervation Gemini System in people with Hypertension and Vascular Diseases, run by Medtronic Vascular at 18 sites in 6 countries.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Hypertension, Vascular Diseases, Cardiovascular Diseases
- What is being tested?
- Multi-Organ Denervation Gemini System
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 175 participants
- Where
- 18 sitesin 6 countries
- Study dates
- 1 May 2025to 22 Dec 2029
- Phase
- Interventional
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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 join
- 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.
Show all 12Show fewer
- Documented condition that would prohibit or interfere with ability to obtain an accurate blood pressure measurement.
- Estimated glomerular filtration rate (eGFR) of <40
- Pregnant, nursing or planning to become pregnant during the study.
- Primary pulmonary arterial hypertension.
- History or evidence of active / suspected chronic liver or biliary disease.
- Current or chronic pancreatitis.
Trial locations and contacts
18 sites in 6 countries. Contact the study team or a site near you to ask about taking part.
18 sites in 6 countries
United States12 sites, 12 recruiting
- Recruiting
Piedmont Heart Institute
Atlanta, Georgia, 30309-1281
David Kandzari, MD, 404-605-2800, david.kandzari@piedmont.org
Wendy Noland, 404-605-3561, wendy.noland1@piedmont.org
- Recruiting
Beth Israel Deaconess Medical Center
Boston, Massachusetts, 02215
Jenifer Kaufman, DNP, 617-632-8956, jmkaufma@bidmc.harvard.edu
Jacob Luetje, 617-632-7484, jluetje@bidmc.harvard.edu
- Recruiting
Virtua Our Lady of Lourdes Hospital
Camden, New Jersey, 08103
Kristin Broderick, BS, 609-969-1175, kbroderick@virtua.org
Kintur Sanghvi, MD
- Recruiting
University of North Carolina (UNC) Memorial Hospital
Chapel Hill, North Carolina, 27599
George Stouffer, MD, 984-974-7244, rick_stouffer@med.unc.edu
George Stouffer, MD
- Recruiting
Baylor Heart & Vascular Hospital
Dallas, Texas, 75226
Merielle H. Boatman, MBA, 214-820-2273, merielle.boatman@bswhealth.org
Cara East, MD
- Recruiting
Orlando Health Heart & Vascular Institute
Orlando, Florida, 32806
Farhan J. Khawaja, MD, 321-841-6444, farhan.khawaja@orlandohealth.com
George Ngo, DNP, MBA, PMSM, 321-843-9657, George.Ngo@orlandohealth.com
- Recruiting
Renown Regional Medical Center
Reno, Nevada, 89502
Kristen Gurnea, MPH, kristen.gurnea@renown.org
Lisa English, BS, lisa.english@renown.org
- Recruiting
BayCare Health System Mease Countryside Hospital
Safety Harbor, Florida, 34695
Kristy Roakes, 727-724-8611, kristy.roakes@baycare.org
Edith Rowson, 727-724-2032, edith.rowson@baycare.org
- Recruiting
Henry Ford Providence Hospital
Southfield, Michigan, 48075-4818
Yulia Abidov, 248-849-5328, yabidov1@hfhs.org
David Shukri, MD
- Recruiting
Stanford Hospital and Clinics
Stanford, California, 94305
Maria Perlas, 650-723-2094, mperlas@stanford.edu
Isabella Ko, 650-497-2367, idko@stanford.edu
- Recruiting
North Mississippi Medical Center
Tupelo, Mississippi, 38801-4934
Brittany Cook, 662-620-6853, brittany.cook@nmhs.net
Barry Bertolet, MD
- Recruiting
UT Health East Texas
Tyler, Texas, 75701
Elizabeth Seal, BSc, CCRC, 903-510-7291, elizabeth.seal@uthet.com
Frank Navetta, MD
Germany2 sites, 2 recruiting
- Recruiting
University Hospital Erlangen
Erlangen, 91054
Roland E. Schmieder, MD, +49- 9131 8539002, roland.schmieder@uk-erlangen.de
Dennis Kannenkeril, MD, +49-9131 8536207, dennis.kannenkeril@uk-erlangen.de
- Recruiting
Universität des Saarlandes
Homburg, 66421
Tamara Bakuradze, MD, +496841 16 23309, tamara.bakuradze@uks.eu
Saarraangan Kulenthiran, MD, saarraaken.kulenthiran@uks.eu
Australia1 site, 1 recruiting
- Recruiting
Royal Perth Hospital (Dobney Hypertension Centre)
Perth, 6000
Markus Schlaich, MD, +61 9224 0382, markus.schlaich@uwa.edu.au
Anu Joyson, +61 9224 0390, anu.joyson@uwa.edu.au
Greece1 site, 1 recruiting
- Recruiting
Hippokration General Hospital
Athens, 11527
Konstantinos Tsioufis, MD, 00302132088025, ktsioufis@gmail.com
Konstantinos Tsioufis, MD
Ireland1 site, 1 recruiting
- Recruiting
University Hospital of Galway
Galway, H91 YR71
Aideen O 'Doherty, +353091493918, odoherty@universityofgalway.ie
Faisal Sharif, MD
Switzerland1 site, 1 recruiting
- Recruiting
University Hospital Basel
Basel, 4031
Lucas Lauder, MD, 0041 61 32 83402, lucas.lauder@usb.ch
Lucas Lauder, MD
About this study
Official title: Global Pilot Study of rEnal and Hepatic coMbINed denervatIon in Subjects With Uncontrolled Hypertension With and Without High Cardiovascular Risk
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.
Read the detailed description
This study is exploratory in nature and will evaluate procedural and long-term safety of multi-organ denervation (MDN) and provide preliminary efficacy data in two parallel single arm cohorts:
- Gemini Pilot Off Med: MDN for Hypertension Off Anti-hypertensive Meds and,
- Gemini Pilot On Med: MDN for Hypertension and High Cardiovascular Risk On Anti-hypertensive Meds
There is no pre-specified primary endpoint; however, the data will be used for hypothesis generation to be evaluated and confirmed in subsequent clinical investigation(s).
- Conditions
- Hypertension, Vascular Diseases, Cardiovascular Diseases, Chronic Kidney Diseases, Diabetes Mellitus
- Being tested
- Multi-Organ Denervation Gemini System
- Keywords
- Renal Insufficiency, Chronic Disease, Disease Attributes, Pathologic Processes, Kidney Diseases, Hypertension, Cardiovascular Diseases, Vascular Diseases, Denervation, Renal Denervation, Hepatic Denervation
- Medical subject headings
- Hypertension, Vascular Diseases, Cardiovascular Diseases, Renal Insufficiency, Chronic, Diabetes Mellitus, Renal Insufficiency, Chronic Disease, Disease Attributes
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Multi-Organ Denervation Gemini SystemDevice
After angiography according to standard procedures, subjects are treated with renal denervation followed by hepatic denervation.
| Study group | Role | What they receive |
|---|---|---|
| Gemini Pilot Off Med: Multi-Organ Denervation for Hypertension Off Anti-hypertensive Meds | Experimental | Not described Receives: Device: Multi-Organ Denervation Gemini System |
| Gemini Pilot On Med: MDN for Hypertension and High Cardiovascular Risk On Anti-hypertensive Meds. | Experimental | Not described Receives: Device: Multi-Organ Denervation Gemini System |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in office blood pressure
Measured: From baseline to 36 months post-procedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Apr 2025
- Study start1 May 2025
- Primary completion22 Dec 2029 (estimated)
- Study completion22 Dec 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HypertensionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Model description
- Two parallel single-arm assignment
- Masking
- None (open label)
- Enrolment
- 175 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Medtronic Vascular
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06907147
- Sponsor's protocol ID
- MDT23034
- Acronym
- SPYRAL GEMINI
- Status last verified
- Oct 2026
- First submitted
- 10 Mar 2025
- Last updated
- 20 Oct 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No: There is not a plan to make IPD available.