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SPYRAL GEMINI Pilot Study
Sponsor: Medtronic Vascular
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.
Official title: Global Pilot Study of rEnal and Hepatic coMbINed denervatIon in Subjects With Uncontrolled Hypertension With and Without High Cardiovascular Risk
Key Details
Gender
All
Age Range
18 Years - 80 Years
Study Type
INTERVENTIONAL
Enrollment
175
Start Date
2025-05-01
Completion Date
2029-12-22
Last Updated
2026-03-02
Healthy Volunteers
No
Conditions
Interventions
Multi-Organ Denervation Gemini System
After angiography according to standard procedures, subjects are treated with renal denervation followed by hepatic denervation.
Locations (13)
Stanford Hospital and Clinics
Stanford, California, United States
Piedmont Heart Institute
Atlanta, Georgia, United States
Beth Israel Deaconess Medical Center
Boston, Massachusetts, United States
Henry Ford Providence Hospital
Southfield, Michigan, United States
North Mississippi Medical Center
Tupelo, Mississippi, United States
Renown Regional Medical Center
Reno, Nevada, United States
Virtua Our Lady of Lourdes Hospital
Camden, New Jersey, United States
Baylor Heart & Vascular Hospital
Dallas, Texas, United States
UT Health East Texas
Tyler, Texas, United States
Royal Perth Hospital (Dobney Hypertension Centre)
Perth, Australia
Hippokration General Hospital
Athens, Greece
University Hospital of Galway
Galway, Ireland
University Hospital Basel
Basel, Switzerland