NCT06907147 · Medtronic Vascular
SPYRAL GEMINI Pilot Study
(SPYRAL GEMINI)
What this study 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.
View original scientific description
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.
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
Inclusion criteria
- 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 criteria
- Individual lacks appropriate renal artery OR common hepatic artery anatomy.
- Prior renal or hepatic denervation.
- History of NYHA Class III or IV heart failure within 6 months of screening visit.
- Stroke or transient ischemic attack (TIA) within 6 months of screening visit or any history of stroke leading to permanent disability.
- Documented Type 1 diabetes or use of insulin 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.
Where
- Stanford, California
- Orlando, Florida
- Safety Harbor, Florida
- Atlanta, Georgia
- Boston, Massachusetts
- Southfield, Michigan
- Tupelo, Mississippi
- Reno, Nevada
- Camden, New Jersey
- Chapel Hill, North Carolina
- Dallas, Texas
- Tyler, Texas
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Jun 24, 2026 · Source of record for eligibility and locations