NCT06907147

SPYRAL GEMINI Pilot Study

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

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 175 (estimated)
• Sponsor: Medtronic Vascular · Industry
• Sex: All
• Age: 18 Years – 80 Years
• Healthy volunteers: Not accepted

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.

Detailed description

This study is exploratory in nature and will evaluate procedural and long-term safety of multi-organ denervation (MDN) and provide preliminary efficacy data in two parallel single arm cohorts: * Gemini Pilot Off Med: MDN for Hypertension Off Anti-hypertensive Meds and, * Gemini Pilot On Med: MDN for Hypertension and High Cardiovascular Risk On Anti-hypertensive Meds There is no pre-specified primary endpoint; however, the data will be used for hypothesis generation to be evaluated and confirmed in subsequent clinical investigation(s).

Conditions

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

Interventions

Type	Name	Description
DEVICE	Multi-Organ Denervation Gemini System	After angiography according to standard procedures, subjects are treated with renal denervation followed by hepatic denervation.

Timeline

• Start date: 2025-05-01
• Primary completion: 2029-12-22
• Completion: 2029-12-22
• First posted: 2025-04-02
• Last updated: 2026-04-14

Locations

13 sites across 5 countries: United States, Australia, Greece, Ireland, Switzerland

Regulatory

• FDA-regulated device study