SPYRAL GEMINI Pilot Study

Launched by MEDTRONIC VASCULAR · Mar 31, 2025

Keywords

ClinConnect Summary

The SPYRAL GEMINI Pilot Study is a clinical trial designed to test a new treatment called multi-organ denervation using the Gemini System. This study aims to see if this treatment is safe and effective in lowering blood pressure in people who have high blood pressure (hypertension), regardless of their risk for heart and blood vessel diseases. The trial is not yet recruiting participants, but it is open to adults between the ages of 18 and 80 who have high blood pressure readings both in the office and through a 24-hour monitoring device.

To be eligible for the study, participants must have a specific range of blood pressure measurements and cannot have certain health issues, such as serious kidney problems or a history of specific strokes. If you or someone you know meets these criteria, participating in the trial may involve receiving the new treatment and regular monitoring of blood pressure. It's important to know that the study will help researchers learn more about this innovative approach to managing high blood pressure and could lead to new treatment options in the future.

Gender

ALL

Eligibility criteria

• 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. Prior stroke or transient ischemic attack (TIA).
• • 4. Documented Type 1 diabetes or use of insulin or sulfonylureas within 6 months.
• • 5. Secondary cause of hypertension.
• • 6. Documented condition that would prohibit or interfere with ability to obtain an accurate blood pressure measurement.
• • 7. Estimated glomerular filtration rate (eGFR) of \<40
• • 8. Pregnant, nursing or planning to become pregnant during the study.
• • 9. Primary pulmonary arterial hypertension.
• • 10. History or evidence of active / suspected chronic liver or biliary disease.
• • 11. Current or chronic pancreatitis.