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RECRUITING
NCT06907147
NA

SPYRAL GEMINI Pilot Study

Sponsor: Medtronic Vascular

View on ClinicalTrials.gov

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

Interventions

DEVICE

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