Status:
RECRUITING
SPYRAL GEMINI Pilot Study
Lead Sponsor:
Medtronic Vascular
Conditions:
Hypertension
Vascular Diseases
Eligibility:
All Genders
18-80 years
Phase:
NA
Brief 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...
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: * Gemi...
Eligibility Criteria
Inclusion
- 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.
Exclusion
- 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.
Key Trial Info
Start Date :
May 1 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 22 2029
Estimated Enrollment :
175 Patients enrolled
Trial Details
Trial ID
NCT06907147
Start Date
May 1 2025
End Date
December 22 2029
Last Update
December 22 2025
Active Locations (10)
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1
Stanford Hospital and Clinics
Stanford, California, United States, 94305
2
Piedmont Heart Institute
Atlanta, Georgia, United States, 30309-1281
3
Henry Ford Providence Hospital
Southfield, Michigan, United States, 48075-4818
4
North Mississippi Medical Center
Tupelo, Mississippi, United States, 38801-4934