SPYRAL GEMINI Pilot Study

Last updated: May 12, 2026
Sponsor: Medtronic Vascular
Overall Status: Active - Recruiting

Phase

N/A

Condition

Diabetes And Hypertension

Kidney Disease

Kidney Failure

Treatment

Multi-Organ Denervation Gemini System

Clinical Study ID

NCT06907147
MDT23034
  • Ages 18-80
  • All Genders

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.

Eligibility Criteria

Inclusion

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 anoffice DBP ≥ 90 mmHg.

  3. 24-hour average SBP ≥140 mmHg and <170 mmHg measured by ABPM at Baseline.

Exclusion

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 anyhistory 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 anaccurate 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 Design

Total Participants: 175
Treatment Group(s): 1
Primary Treatment: Multi-Organ Denervation Gemini System
Phase:
Study Start date:
May 01, 2025
Estimated Completion Date:
December 22, 2029

Study 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).

Connect with a study center

  • Dobney Hypertension Centre

    Perth, 6000
    Australia

    Active - Recruiting

  • Royal Perth Hospital (Dobney Hypertension Centre)

    Perth, 6000
    Australia

    Active - Recruiting

  • Royal Perth Hospital (Dobney Hypertension Centre)

    Perth 2063523, 6000
    Australia

    Site Not Available

  • Universität des Saarlandes

    Homburg, 66421
    Germany

    Active - Recruiting

  • Hippokration General Hospital

    Athens, 11527
    Greece

    Active - Recruiting

  • Hippokration General Hospital

    Athens 264371, 11527
    Greece

    Site Not Available

  • University Hospital of Galway

    Galway, H91 YR71
    Ireland

    Active - Recruiting

  • University Hospital of Galway

    Galway 2964180, H91 YR71
    Ireland

    Site Not Available

  • University Hospital Basel

    Basel, 4031
    Switzerland

    Active - Recruiting

  • University Hospital Basel

    Basel 2661604, 4031
    Switzerland

    Site Not Available

  • Stanford Hospital and Clinics

    Stanford, California 94305
    United States

    Active - Recruiting

  • Stanford Hospital and Clinics

    Stanford 5398563, California 5332921 94305
    United States

    Site Not Available

  • Orlando Health Heart & Vascular Institute

    Orlando, Florida 32806
    United States

    Active - Recruiting

  • BayCare Health System Mease Countryside Hospital

    Safety Harbor, Florida 34695
    United States

    Active - Recruiting

  • Piedmont Heart Institute

    Atlanta, Georgia 30309-1281
    United States

    Active - Recruiting

  • Piedmont Heart Institute

    Atlanta 4180439, Georgia 4197000 30309-1281
    United States

    Site Not Available

  • Beth Israel Deaconess Medical Center

    Boston, Massachusetts 02215
    United States

    Active - Recruiting

  • Beth Israel Deaconess Medical Center

    Boston 4930956, Massachusetts 6254926 02215
    United States

    Site Not Available

  • Henry Ford Providence Hospital

    Southfield, Michigan 48075-4818
    United States

    Active - Recruiting

  • Henry Ford Providence Hospital

    Southfield 5010636, Michigan 5001836 48075-4818
    United States

    Site Not Available

  • North Mississippi Medical Center

    Tupelo, Mississippi 38801-4934
    United States

    Active - Recruiting

  • North Mississippi Medical Center

    Tupelo 4448903, Mississippi 4436296 38801-4934
    United States

    Site Not Available

  • Renown Regional Medical Center

    Reno, Nevada 89502
    United States

    Active - Recruiting

  • Renown Regional Medical Center

    Reno 5511077, Nevada 5509151 89502
    United States

    Site Not Available

  • Virtua Our Lady of Lourdes Hospital

    Camden, New Jersey 08103
    United States

    Active - Recruiting

  • Virtua Our Lady of Lourdes Hospital

    Camden 4501018, New Jersey 5101760 08103
    United States

    Site Not Available

  • Baylor Heart & Vascular Hospital

    Dallas, Texas 75226
    United States

    Active - Recruiting

  • UT Health East Texas

    Tyler, Texas 75701
    United States

    Active - Recruiting

  • Baylor Heart & Vascular Hospital

    Dallas 4684888, Texas 4736286 75226
    United States

    Site Not Available

  • UT Health East Texas

    Tyler 4738214, Texas 4736286 75701
    United States

    Site Not Available

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