Recruiting

SPYRAL GEMINI Pilot Study

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.

ClinicalTrials.gov IDNCT06907147

PhaseNA

Enrollment175

SponsorMedtronic Vascular

Age18 Years – 80 Years

SexALL

I'm interested View official listing

Conditions studied

Hypertension, Vascular Diseases, Cardiovascular Diseases, Chronic Kidney Diseases, Diabetes Mellitus

About this study

Interventions

Device: Multi-Organ Denervation Gemini System — After angiography according to standard procedures, subjects are treated with renal denervation followed by hepatic denervation.

Primary outcomes

Change in office blood pressure (From baseline to 36 months post-procedure)

Eligibility information

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 locations

Stanford Hospital and Clinics, Stanford, California 94305 United States
Orlando Health Heart & Vascular Institute, Orlando, Florida 32806 United States
BayCare Health System Mease Countryside Hospital, Safety Harbor, Florida 34695 United States
Piedmont Heart Institute, Atlanta, Georgia 30309-1281 United States
Beth Israel Deaconess Medical Center, Boston, Massachusetts 02215 United States
Henry Ford Providence Hospital, Southfield, Michigan 48075-4818 United States
North Mississippi Medical Center, Tupelo, Mississippi 38801-4934 United States
Renown Regional Medical Center, Reno, Nevada 89502 United States
Virtua Our Lady of Lourdes Hospital, Camden, New Jersey 08103 United States
University of North Carolina (UNC) Memorial Hospital, Chapel Hill, North Carolina 27599 United States

Showing 10 of 18 reported sites. See the official listing for all locations.

Before you participate: Varda Clinical is an independent discovery tool, not the study sponsor or a medical provider. Eligibility can only be determined by the official study team. Discuss potential risks and benefits with a qualified healthcare professional.

Source: ClinicalTrials.gov. Record last refreshed by Varda Clinical: 2026-10-14.