Actively Recruiting
SPYRAL GEMINI Pilot Study
Led by Medtronic Vascular · Updated on 2026-05-14
175
Participants Needed
16
Research Sites
242 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
SPYRAL GEMINI Pilot Study
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age between 18 and 80 years
- Diagnosed with hypertension with baseline office systolic blood pressure (SBP) between 150 mmHg and less than 180 mmHg
- Office diastolic blood pressure (DBP) of at least 90 mmHg
- 24-hour average SBP between 140 mmHg and less than 170 mmHg measured by ambulatory blood pressure monitoring (ABPM) at baseline
You will not qualify if you...
- Lack of appropriate renal artery or common hepatic artery anatomy
- Prior renal or hepatic denervation
- History of New York Heart Association (NYHA) Class III or IV heart failure within 6 months before screening
- Stroke or transient ischemic attack (TIA) within 6 months before screening or any stroke causing permanent disability
- Documented Type 1 diabetes or insulin use within 6 months
- Secondary cause of hypertension
- Condition preventing accurate blood pressure measurement
- Estimated glomerular filtration rate (eGFR) less than 40
- Pregnant, nursing, or planning pregnancy during the study
- Primary pulmonary arterial hypertension
- History or signs of active or suspected chronic liver or biliary disease
- Current or chronic pancreatitis
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 16 locations
1
Stanford Hospital and Clinics
Stanford, California, United States, 94305
Actively Recruiting
2
Orlando Health Heart & Vascular Institute
Orlando, Florida, United States, 32806
Actively Recruiting
3
BayCare Health System Mease Countryside Hospital
Safety Harbor, Florida, United States, 34695
Actively Recruiting
4
Piedmont Heart Institute
Atlanta, Georgia, United States, 30309-1281
Actively Recruiting
5
Beth Israel Deaconess Medical Center
Boston, Massachusetts, United States, 02215
Actively Recruiting
6
Henry Ford Providence Hospital
Southfield, Michigan, United States, 48075-4818
Actively Recruiting
7
North Mississippi Medical Center
Tupelo, Mississippi, United States, 38801-4934
Actively Recruiting
8
Renown Regional Medical Center
Reno, Nevada, United States, 89502
Actively Recruiting
9
Virtua Our Lady of Lourdes Hospital
Camden, New Jersey, United States, 08103
Actively Recruiting
10
Baylor Heart & Vascular Hospital
Dallas, Texas, United States, 75226
Actively Recruiting
11
UT Health East Texas
Tyler, Texas, United States, 75701
Actively Recruiting
12
Royal Perth Hospital (Dobney Hypertension Centre)
Perth, Australia, 6000
Actively Recruiting
13
Universität des Saarlandes
Homburg, Germany, 66421
Actively Recruiting
14
Hippokration General Hospital
Athens, Greece, 11527
Actively Recruiting
15
University Hospital of Galway
Galway, Ireland, H91 YR71
Actively Recruiting
16
University Hospital Basel
Basel, Switzerland, 4031
Actively Recruiting
Research Team
C
Cecile Mahoney
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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