RecruitingNot ApplicableNCT06907147
SPYRAL GEMINI Pilot Study
Global Pilot Study of rEnal and Hepatic coMbINed denervatIon in Subjects With Uncontrolled Hypertension With and Without High Cardiovascular Risk
Sponsor
Medtronic Vascular
Enrollment
175 participants
Start Date
May 1, 2025
Study Type
INTERVENTIONAL
Conditions
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
Min Age: 18 YearsMax Age: 80 Years
Inclusion Criteria4
- 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.
- hour average SBP ≥140 mmHg and \<170 mmHg measured by ABPM at Baseline.
Exclusion Criteria11
- Individual lacks appropriate renal artery OR common hepatic artery anatomy.
- Prior renal or hepatic denervation.
- Prior stroke or transient ischemic attack (TIA).
- Documented Type 1 diabetes or use of insulin or sulfonylureas 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.
Interventions
DEVICEMulti-Organ Denervation Gemini System
After angiography according to standard procedures, subjects are treated with renal denervation followed by hepatic denervation.
Locations(13)
View Full Details on ClinicalTrials.gov
For the most up-to-date information, visit the official listing.
NCT06907147
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