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Clinical Trials in Ireland / NCT06907147
Recruiting Not applicable

SPYRAL GEMINI Pilot Study

NCT06907147 · tracked via the Priya Life Science Ireland tracker
Sponsor
Medtronic Vascular
Phase
Not applicable
Started
2025-05-01
Last updated
2026-06-24

Condition(s) studied

HypertensionVascular DiseasesCardiovascular DiseasesChronic Kidney DiseasesDiabetes Mellitus

Investigational drug(s) / intervention(s)

Multi-Organ Denervation Gemini System

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

Study 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

Sex
ALL
Min age
18 Years
Max age
80 Years
Healthy volunteers
No
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.

Primary outcome measure(s)

Trial sites (18)

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

More Medtronic Vascular trials in Ireland

Other trials for the same condition

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06907147 on ClinicalTrials.gov ↗ ← All trials in Ireland