SPYRAL GEMINI Pilot Study (SPYRAL GEMINI)

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.

Study Overview

• Status: Recruiting
• Conditions: Cardiovascular Diseases; Vascular Diseases; Hypertension; Diabetes Mellitus; Chronic Kidney Diseases
• Intervention / Treatment: Device: Multi-Organ Denervation Gemini System

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).

• Study Type: Interventional
• Enrollment (Estimated): 175
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Cecile Mahoney; Phone Number: +17635051057; Email: Cecile.C.Mahoney@medtronic.com

Study Locations

• Australia
  • Perth, Australia, 6000
    • Recruiting
    • Royal Perth Hospital (Dobney Hypertension Centre)
    • Principal Investigator: Markus Schlaich, MD
    • Contact: Markus Schlaich, MD; Phone Number: +61 9224 0382; Email: markus.schlaich@uwa.edu.au
    • Contact: Anu Joyson; Phone Number: +61 9224 0390; Email: anu.joyson@uwa.edu.au
    • Sub-Investigator: Carl Johann Schultz, MD
• Germany
  • Homburg, Germany, 66421
    • Recruiting
    • Universität des Saarlandes
    • Contact: Tamara Bakuradze, MD; Phone Number: +496841 16 23309; Email: tamara.bakuradze@uks.eu
    • Contact: Saarraangan Kulenthiran, MD; Email: saarraaken.kulenthiran@uks.eu
    • Principal Investigator: Michael Böhm, Prof.
    • Sub-Investigator: Saarraangan Kulenthiran, MD
• Greece
  • Athens, Greece, 11527
    • Recruiting
    • Hippokration General Hospital
    • Contact: Konstantinos Tsioufis, MD; Phone Number: 00302132088025; Email: ktsioufis@gmail.com
    • Principal Investigator: Konstantinos Tsioufis, MD
• Ireland
  • Galway, Ireland, H91 YR71
    • Recruiting
    • University Hospital of Galway
    • Principal Investigator: Faisal Sharif, MD
    • Contact: Aideen O 'Doherty; Phone Number: +353091493918; Email: odoherty@universityofgalway.ie
• Switzerland
  • Basel, Switzerland, 4031
    • Recruiting
    • University Hospital Basel
    • Contact: Lucas Lauder, MD; Phone Number: 0041 61 32 83402; Email: lucas.lauder@usb.ch
    • Principal Investigator: Lucas Lauder, MD
• United States
  • California
    • Stanford, California, United States, 94305
      • Recruiting
      • Stanford Hospital and Clinics
      • Contact: Maria Perlas; Phone Number: 650-723-2094; Email: mperlas@stanford.edu
      • Contact: Isabella Ko; Phone Number: 650-497-2367; Email: idko@stanford.edu
      • Principal Investigator: David Patrick Lee, MD
  • Florida
    • Orlando, Florida, United States, 32806
      • Recruiting
      • Orlando Health Heart & Vascular Institute
      • Principal Investigator: Farhan J. Khawaja, MD
      • Contact: Farhan J. Khawaja, MD; Phone Number: 321-841-6444; Email: farhan.khawaja@orlandohealth.com
      • Contact: George Ngo, DNP, MBA, PMSM; Phone Number: 321-843-9657; Email: George.Ngo@orlandohealth.com
    • Safety Harbor, Florida, United States, 34695
      • Recruiting
      • BayCare Health System Mease Countryside Hospital
      • Principal Investigator: Parag Patel, MD
      • Contact: Kristy Roakes; Phone Number: 727-724-8611; Email: kristy.roakes@baycare.org
      • Contact: Edith Rowson; Phone Number: 727-724-2032; Email: edith.rowson@baycare.org
  • Georgia
    • Atlanta, Georgia, United States, 30309-1281
      • Recruiting
      • Piedmont Heart Institute
      • Principal Investigator: David Kandzari, MD
      • Contact: David Kandzari, MD; Phone Number: 404-605-2800; Email: david.kandzari@piedmont.org
      • Contact: Wendy Noland; Phone Number: 404-605-3561; Email: wendy.noland1@piedmont.org
  • Massachusetts
    • Boston, Massachusetts, United States, 02215
      • Recruiting
      • Beth Israel Deaconess Medical Center
      • Principal Investigator: Eric Secemsky, MD
      • Sub-Investigator: Anna Krawisz, MD
      • Contact: Jacob Luetje; Phone Number: 617-632-7484; Email: jluetje@bidmc.harvard.edu
      • Contact: Jenifer Kaufman, DNP; Phone Number: 617-632-8956; Email: jmkaufma@bidmc.harvard.edu
  • Michigan
    • Southfield, Michigan, United States, 48075-4818
      • Recruiting
      • Henry Ford Providence Hospital
      • Contact: Yulia Abidov; Phone Number: 248-849-5328; Email: yabidov1@hfhs.org
      • Principal Investigator: David Shukri, MD
  • Mississippi
    • Tupelo, Mississippi, United States, 38801-4934
      • Recruiting
      • North Mississippi Medical Center
      • Principal Investigator: Barry Bertolet, MD
      • Contact: Brittany Cook; Phone Number: 662-620-6853; Email: brittany.cook@nmhs.net
      • Sub-Investigator: Benjamin Blossom, MD
      • Sub-Investigator: Jonathan Blossom, MD
  • Nevada
    • Reno, Nevada, United States, 89502
      • Recruiting
      • Renown Regional Medical Center
      • Principal Investigator: Michael Bloch, MD
      • Contact: Kristen Gurnea, MPH; Email: kristen.gurnea@renown.org
      • Contact: Lisa English, BS; Email: lisa.english@renown.org
  • New Jersey
    • Camden, New Jersey, United States, 08103
      • Recruiting
      • Virtua Our Lady of Lourdes Hospital
      • Principal Investigator: Kintur Sanghvi, MD
      • Contact: Kristin Broderick, BS; Phone Number: 609-969-1175; Email: kbroderick@virtua.org
  • Texas
    • Dallas, Texas, United States, 75226
      • Recruiting
      • Baylor Heart & Vascular Hospital
      • Principal Investigator: Cara East, MD
      • Contact: Merielle H. Boatman, MBA; Phone Number: 214-820-2273; Email: merielle.boatman@bswhealth.org
    • Tyler, Texas, United States, 75701
      • Recruiting
      • UT Health East Texas
      • Principal Investigator: Frank Navetta, MD
      • Contact: Elizabeth Seal, BSc, CCRC; Phone Number: 903-510-7291; Email: elizabeth.seal@uthet.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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:

1. Individual lacks appropriate renal artery OR common hepatic artery anatomy.
2. Prior renal or hepatic denervation.
3. History of NYHA Class III or IV heart failure within 6 months of screening visit.
4. Stroke or transient ischemic attack (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 glomerular filtration rate (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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Gemini Pilot Off Med: Multi-Organ Denervation for Hypertension Off Anti-hypertensive Meds	Device: Multi-Organ Denervation Gemini System; After angiography according to standard procedures, subjects are treated with renal denervation followed by hepatic denervation.
Experimental: Gemini Pilot On Med: MDN for Hypertension and High Cardiovascular Risk On Anti-hypertensive Meds.	Device: Multi-Organ Denervation Gemini System; After angiography according to standard procedures, subjects are treated with renal denervation followed by hepatic denervation.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Change in office blood pressure	From baseline to 36 months post-procedure

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	From baseline to 3 and 6 months post-procedure
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	From baseline to 3 and 6 months post-procedure
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	From baseline to 3 and 6 months post-procedure
Change in office blood pressure	Change in office blood pressure from baseline at 1-, 3-, 6-, 12-, 24- and 36-months post-procedure	From baseline to 1, 3, 6, 12, 24 and 36 months post-procedure
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	From baseline to 1, 3, 6, 12, 24 and 36 months post-procedure
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	From baseline to 1, 3, 6, 12, 24 and 36 months post-procedure
All-cause mortality		From pre-procedure to immediately after the procedure, 1, 3, 6, 12, 24 and 36 months post-procedure
Significant embolic event resulting in end-organ damage		From pre-procedure to immediately after the procedure, 1, 3, 6, 12, 24 and 36 months post-procedure
Vascular complications		From pre-procedure to immediately after the procedure, 1, 3, 6, 12, 24 and 36 months post-procedure
Hospitalization for hypertensive crisis not related to non-adherence with medications or the protocol		From pre-procedure to immediately after the procedure, 1, 3, 6, 12, 24 and 36 months post-procedure
Major bleeding requiring transfusion		From pre-procedure to immediately after the procedure, 1, 3, 6, 12, 24 and 36 months post-procedure
Hepatic Arterial Damage requiring intervention (i.e., perforation, dissection, occlusion, aneurysm)		From pre-procedure to immediately after the procedure, 1, 3, 6, 12, 24 and 36 months post-procedure
Hepatic artery thrombosis		From pre-procedure to immediately after the procedure, 1, 3, 6, 12, 24 and 36 months post-procedure
New Hepatic Stenosis >70%, confirmed by angiography		From pre-procedure to immediately after the procedure, 1, 3, 6, 12, 24 and 36 months post-procedure
Aminotransferase Elevation(s) >3x the upper limit of normal		From pre-procedure to immediately after the procedure, 1, 3, 6, 12, 24 and 36 months post-procedure
Myocardial Infarction		From pre-procedure to immediately after the procedure, 1, 3, 6, 12, 24 and 36 months post-procedure
Stroke		From pre-procedure to immediately after the procedure, 1, 3, 6, 12, 24 and 36 months post-procedure
Renal artery re-intervention		From pre-procedure to immediately after the procedure, 1, 3, 6, 12, 24 and 36 months post-procedure
New renal artery stenosis >70% confirmed by angiography		From pre-procedure to immediately after the procedure, 1, 3, 6, 12, 24 and 36 months post-procedure
Increase in serum creatinine >50% from Baseline		From pre-procedure to immediately after the procedure, 1, 3, 6, 12, 24 and 36 months post-procedure
Any of the following requiring intervention or hospitalization: Pancreatitis, Biliary stricture, New onset biliary dyskinesia, Acute cholecystitis, Sphincter of Oddi dysfunction		From pre-procedure to immediately after the procedure, 1, 3, 6, 12, 24 and 36 months post-procedure
End Stage Renal Disease		From pre-procedure to immediately after the procedure, 1, 3, 6, 12, 24 and 36 months post-procedure

Collaborators and Investigators

• Sponsor: Medtronic Vascular

Study record dates

Study Major Dates

• Study Start (Actual): May 1, 2025
• Primary Completion (Estimated): December 22, 2029
• Study Completion (Estimated): December 22, 2029

Study Registration Dates

• First Submitted: March 10, 2025
• First Submitted That Met QC Criteria: March 31, 2025
• First Posted (Actual): April 2, 2025

Study Record Updates

• Last Update Posted (Actual): May 14, 2026
• Last Update Submitted That Met QC Criteria: May 12, 2026
• Last Verified: May 1, 2026

More Information

Terms related to this study

• Keywords: Pathologic Processes; Vascular Diseases; Cardiovascular Diseases; Hypertension; Renal Insufficiency; Kidney Diseases; Denervation; Chronic Disease; Disease Attributes; Renal Denervation; Hepatic Denervation
• Additional Relevant MeSH Terms: Urogenital Diseases; Endocrine System Diseases; Male Urogenital Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Metabolic Diseases; Glucose Metabolism Disorders; Pathological Conditions, Signs and Symptoms; Nutritional and Metabolic Diseases; Hypertension; Cardiovascular Diseases; Diabetes Mellitus; Vascular Diseases; Renal Insufficiency; Pathologic Processes; Disease Attributes; Kidney Diseases; Renal Insufficiency, Chronic; Chronic Disease
• Other Study ID Numbers: MDT23034

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: There is not a plan to make IPD available.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: No