SPYRAL GEMINI Pilot Study

Recruiting now · Not applicable

Conditions studied: Hypertension, Vascular Diseases, Cardiovascular Diseases, Chronic Kidney Diseases, Diabetes Mellitus

In brief

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.

Key facts

Study ID

NCT06907147

Run by

Medtronic Vascular

People needed

175

Starts

2025-05-01

Expected to finish

2029-12-22

Last updated by the study team

2026-06-24

Who can join

Age: 18 and older, up to 80. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• All Subjects (both cohorts):
• ≥18 and ≤80 years of age.
• Diagnosed with HTN and has a baseline office SBP ≥150 mmHg and <180 mmHg and an office DBP ≥ 90 mmHg.
• 24-hour average SBP ≥140 mmHg and <170 mmHg measured by ABPM at Baseline.

You may not qualify if…

• Individual lacks appropriate renal artery OR common hepatic artery anatomy.
• Prior renal or hepatic denervation.
• History of NYHA Class III or IV heart failure within 6 months of screening visit.
• Stroke or transient ischemic attack (TIA) within 6 months of screening visit or any history of stroke leading to permanent disability.
• Documented Type 1 diabetes or use of insulin within 6 months.
• Secondary cause of hypertension.
• Documented condition that would prohibit or interfere with ability to obtain an accurate blood pressure measurement.
• Estimated glomerular filtration rate (eGFR) of <40
• Pregnant, nursing or planning to become pregnant during the study.
• Primary pulmonary arterial hypertension.
• History or evidence of active / suspected chronic liver or biliary disease.
• Current or chronic pancreatitis.

Where it is running

• Stanford Hospital and Clinics — Stanford, California, United States (enrolling)
• Orlando Health Heart & Vascular Institute — Orlando, Florida, United States (enrolling)
• BayCare Health System Mease Countryside Hospital — Safety Harbor, Florida, United States (enrolling)
• Piedmont Heart Institute — Atlanta, Georgia, United States (enrolling)
• Beth Israel Deaconess Medical Center — Boston, Massachusetts, United States (enrolling)
• Henry Ford Providence Hospital — Southfield, Michigan, United States (enrolling)
• North Mississippi Medical Center — Tupelo, Mississippi, United States (enrolling)
• Renown Regional Medical Center — Reno, Nevada, United States (enrolling)
• Virtua Our Lady of Lourdes Hospital — Camden, New Jersey, United States (enrolling)
• University of North Carolina (UNC) Memorial Hospital — Chapel Hill, North Carolina, United States (enrolling)
• Baylor Heart & Vascular Hospital — Dallas, Texas, United States (enrolling)
• UT Health East Texas — Tyler, Texas, United States (enrolling)
• Royal Perth Hospital (Dobney Hypertension Centre) — Perth, Australia (enrolling)
• University Hospital Erlangen — Erlangen, Germany (enrolling)
• Universität des Saarlandes — Homburg, Germany (enrolling)
• Hippokration General Hospital — Athens, Greece (enrolling)
• University Hospital of Galway — Galway, Ireland (enrolling)
• University Hospital Basel — Basel, Switzerland (enrolling)

Full record on ClinicalTrials.gov

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