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RecruitingNCT06907147SPYRAL GEMINIUpdated Oct 20, 2026

SPYRAL GEMINI Pilot Study

An interventional study of Multi-Organ Denervation Gemini System in Hypertension, Vascular Diseases and Cardiovascular Diseases, sponsored by Medtronic Vascular. Recruiting at 18 sites in 6 countries. Open to participants aged 18 Years to 80 Years. Per ClinicalTrials.gov, last updated 2026-10-20.

Sponsored by Medtronic Vascular (part of Medtronic) · Not applicable, Interventional, and Treatment

From the registry’s dates

  • Started May 2025; still recruiting 1 year 6 months later.
Phase
Not applicable
Study type
Interventional
Enrollment
175
Allocation
Non-randomized
Ages
18 Years to 80 Years
Sex
All
01

Study 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 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).

02

Conditions studied

  • Hypertension
  • Vascular Diseases
  • Cardiovascular Diseases
  • Chronic Kidney Diseases
  • Diabetes Mellitus

Keywords

  • Renal Insufficiency
  • Chronic Disease
  • Disease Attributes
  • Pathologic Processes
  • Kidney Diseases
  • Hypertension
  • Cardiovascular Diseases
  • Vascular Diseases
  • Denervation
  • Renal Denervation
  • Hepatic Denervation
03

In context

Hypertension

6,114 studies on the registry are indexed under Hypertension; 912 are open to participants now.

This study's planned enrollment of 175 is above the median of 100 across 4,575 interventional studies indexed under Hypertension.

Browse Hypertension studies →

Lead sponsor

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.

Browse Medtronic Vascular studies →All Medtronic studies →

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 80 Years
Sexes eligible
All
Accepts healthy volunteers
No

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.

Inclusion criteria

All Subjects (both cohorts):

  1. ≥18 and ≤80 years of age.
  2. Diagnosed with HTN and has a baseline office SBP ≥150 mmHg and \<180 mmHg and an office DBP ≥ 90 mmHg.
  3. 24-hour average SBP ≥140 mmHg and \<170 mmHg measured by ABPM at Baseline.

Exclusion criteria

Exclusion Criteria:

  1. Individual lacks appropriate renal artery OR common hepatic artery anatomy.
  2. Prior renal or hepatic denervation.
  3. History of Class III or IV heart failure within 6 months of screening visit.
  4. Stroke or (TIA) within 6 months of screening visit or any history of stroke leading to permanent disability.
  5. Documented Type 1 diabetes or use of insulin within 6 months.
  6. Secondary cause of hypertension.
  7. Documented condition that would prohibit or interfere with ability to obtain an accurate blood pressure measurement.
  8. Estimated (eGFR) of \<40
  9. Pregnant, nursing or planning to become pregnant during the study.
  10. Primary pulmonary arterial hypertension.
  11. History or evidence of active / suspected chronic liver or biliary disease.
  12. Current or chronic pancreatitis.
Terms in these criteria, in plain language(3)

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.

NYHA class (heart failure)

The New York Heart Association’s four classes of how much heart failure limits physical activity.

I
No limits: ordinary activity causes no undue tiredness or breathlessness.
II
Slight limits: comfortable at rest, ordinary activity causes symptoms.
III
Marked limits: comfortable at rest, less than ordinary activity causes symptoms.
IV
Symptoms even at rest; any activity makes them worse.

Studies set their own limit — many outside heart failure leave out class III–IV, while heart failure studies may ask for a particular class. Check the class this study names.

TIA (transient ischaemic attack)

A “mini-stroke”: temporary stroke-like symptoms caused by reduced blood flow to part of the brain, spinal cord or eye, without signs of a new stroke on a scan.

Stroke symptoms need emergency care at once, even if they go away.

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.

05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Non-randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
175 participants (estimated)

Study arms

  • Experimental
    Gemini Pilot Off Med: Multi-Organ Denervation for Hypertension Off Anti-hypertensive Meds

    Device: Multi-Organ Denervation Gemini System

  • Experimental
    Gemini Pilot On Med: MDN for Hypertension and High Cardiovascular Risk On Anti-hypertensive Meds.

    Device: Multi-Organ Denervation Gemini System

Interventions

  • DeviceMulti-Organ Denervation Gemini System

    After angiography according to standard procedures, subjects are treated with renal denervation followed by hepatic denervation.

06

What researchers measure

Primary outcomes

  1. Change in office blood pressure

    Time frame: From baseline to 36 months post-procedure

Other outcomes

  1. Change in 24-hour ambulatory blood pressure

    Change in blood pressure from baseline as measured by 24-hour Ambulatory Blood Pressure Monitoring (ABPM) at 3-and 6-months post-procedure

    Time frame: From baseline to 3 and 6 months post-procedure

  2. Change in daytime blood pressure

    Change in daytime blood pressure from baseline as measured by 24-hour Ambulatory Blood Pressure Monitoring (ABPM) at 3- and 6-months post-procedure

    Time frame: From baseline to 3 and 6 months post-procedure

  3. Change in nighttime blood pressure

    Change in nighttime blood pressure from baseline as measured by 24-hour Ambulatory Blood Pressure Monitoring (ABPM) at 3- and 6-months post-procedure

    Time frame: From baseline to 3 and 6 months post-procedure

  4. Change in office blood pressure

    Change in office blood pressure from baseline at 1-, 3-, 6-, 12-, 24- and 36-months post-procedure

    Time frame: From baseline to 1, 3, 6, 12, 24 and 36 months post-procedure

  5. Change in home blood pressure (HBP)

    Change in home blood pressure (HBP) from baseline at 1-, 3-, 6-, 12-, 24- and 36-months post-procedure

    Time frame: From baseline to 1, 3, 6, 12, 24 and 36 months post-procedure

  6. Incidence of achieving target office systolic blood pressure (SBP<140 mmHg)

    Incidence of achieving target office systolic blood pressure (SBP\<140 mmHg) at 1-, 3-, 6-, 12-, 24- and 36-months post-procedure

    Time frame: From baseline to 1, 3, 6, 12, 24 and 36 months post-procedure

  7. All-cause mortality

    Time frame: From pre-procedure to immediately after the procedure, 1, 3, 6, 12, 24 and 36 months post-procedure

  8. Significant embolic event resulting in end-organ damage

    Time frame: From pre-procedure to immediately after the procedure, 1, 3, 6, 12, 24 and 36 months post-procedure

  9. Vascular complications

    Time frame: From pre-procedure to immediately after the procedure, 1, 3, 6, 12, 24 and 36 months post-procedure

  10. Hospitalization for hypertensive crisis not related to non-adherence with medications or the protocol

    Time frame: From pre-procedure to immediately after the procedure, 1, 3, 6, 12, 24 and 36 months post-procedure

  11. Major bleeding requiring transfusion

    Time frame: From pre-procedure to immediately after the procedure, 1, 3, 6, 12, 24 and 36 months post-procedure

  12. Hepatic Arterial Damage requiring intervention (i.e., perforation, dissection, occlusion, aneurysm)

    Time frame: From pre-procedure to immediately after the procedure, 1, 3, 6, 12, 24 and 36 months post-procedure

  13. Hepatic artery thrombosis

    Time frame: From pre-procedure to immediately after the procedure, 1, 3, 6, 12, 24 and 36 months post-procedure

  14. New Hepatic Stenosis >70%, confirmed by angiography

    Time frame: From pre-procedure to immediately after the procedure, 1, 3, 6, 12, 24 and 36 months post-procedure

  15. Aminotransferase Elevation(s) >3x the upper limit of normal

    Time frame: From pre-procedure to immediately after the procedure, 1, 3, 6, 12, 24 and 36 months post-procedure

  16. Myocardial Infarction

    Time frame: From pre-procedure to immediately after the procedure, 1, 3, 6, 12, 24 and 36 months post-procedure

  17. Stroke

    Time frame: From pre-procedure to immediately after the procedure, 1, 3, 6, 12, 24 and 36 months post-procedure

  18. Renal artery re-intervention

    Time frame: From pre-procedure to immediately after the procedure, 1, 3, 6, 12, 24 and 36 months post-procedure

  19. New renal artery stenosis >70% confirmed by angiography

    Time frame: From pre-procedure to immediately after the procedure, 1, 3, 6, 12, 24 and 36 months post-procedure

  20. End Stage Renal Disease

    Time frame: From pre-procedure to immediately after the procedure, 1, 3, 6, 12, 24 and 36 months post-procedure

  21. Increase in serum creatinine >50% from Baseline

    Time frame: From pre-procedure to immediately after the procedure, 1, 3, 6, 12, 24 and 36 months post-procedure

  22. Any of the following requiring intervention or hospitalization: Pancreatitis, Biliary stricture, New onset biliary dyskinesia, Acute cholecystitis, Sphincter of Oddi dysfunction

    Time frame: From pre-procedure to immediately after the procedure, 1, 3, 6, 12, 24 and 36 months post-procedure

07

Study locations

18 of 18 sites recruiting
08

References and documents

Individual participant data

Plan to share: No — There is not a plan to make IPD available.

No publications or documents are linked to this record.

09

Timeline

1 registry update since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Started May 2025 (actual). Primary completion is estimated for Dec 2029, 55 months after the start.

Of 95 industry-sponsored interventional studies with no phase under Hypertension, half reached primary completion within 34 months of starting (the median), counting those still running; a quarter within 12 and three quarters within 55. This study's planned 55 months is above that.

Counting every sponsor, half of 1,498 studies reached it within 23 months; a quarter within 10 and three quarters within 41.

How these figures are worked out, and which studies are left out of them.

Registered
Mar 10, 2025
First posted
Apr 2, 2025
StartActual
May 1, 2025
Primary completionEst.
Dec 22, 2029
CompletionEst.
Dec 22, 2029
Last update
Oct 20, 2026
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
Minor edits
Nothing that changes what the study is or who can join. Edited: verification date
1 update, last Oct 20, 2026
Show all 1 update
  1. Oct 20, 2026
    Minor edits only
    + 1 other change: verification date

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 ↗

10

Registry details

Key details

Study ID
NCT06907147
Lead sponsor
Medtronic Vascular
Responsible party
Sponsor
First posted
Apr 2, 2025
Start date
May 1, 2025
Primary completion
Dec 22, 2029 (estimated)
Completion
Dec 22, 2029 (estimated)
Last update
Oct 20, 2026

Study contacts

Cecile Mahoney
Contact
Cecile.C.Mahoney@medtronic.com
+17635051057

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
Yes
View the source record on ClinicalTrials.gov ↗

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