RecruitingNot ApplicableNCT06907147

SPYRAL GEMINI Pilot Study

Global Pilot Study of rEnal and Hepatic coMbINed denervatIon in Subjects With Uncontrolled Hypertension With and Without High Cardiovascular Risk


Sponsor

Medtronic Vascular

Enrollment

175 participants

Start Date

May 1, 2025

Study Type

INTERVENTIONAL

Conditions

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

Min Age: 18 YearsMax Age: 80 Years

Plain Language Summary

Simplified for easier understanding

This study is testing a procedure called renal denervation — where nerves around the kidney and liver arteries are disrupted using a catheter — to lower blood pressure in people whose high blood pressure is not controlled with medications. **You may be eligible if...** - You are between 18 and 80 years old - You have high blood pressure with a systolic reading (top number) of 150–179 mmHg in the office - Your 24-hour average blood pressure monitoring also shows elevated readings **You may NOT be eligible if...** - Your blood vessels are not suitable for the procedure - You have had a prior stroke or TIA (mini-stroke) - You have type 1 diabetes or use insulin or certain diabetes medications - Your high blood pressure has a known secondary cause - Your kidney function is significantly impaired - You are pregnant, nursing, or planning to become pregnant Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DEVICEMulti-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

View Full Details on ClinicalTrials.gov

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NCT06907147


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