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SPYRAL GEMINI Pilot Study

Global Pilot Study of rEnal and Hepatic coMbINed denervatIon in Subjects With Uncontrolled Hypertension With and Without High Cardiovascular Risk

Who can join

As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.

Age
18 Years to 80 Years
Sex
All sexes
Healthy volunteers
Not accepted
Compensation
Not stated

Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.

What to expect

No one can promise a trial will help you personally — that is what the research is trying to find out.

What participation involves

Not stated in the study description — ask the study team about visits and procedures.

Compensation
Not stated
  • Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
  • Participants are monitored closely by the research team throughout the study.
  • Some participants may receive access to an investigational treatment, which is still being studied.
  • Your participation helps researchers learn whether this approach could help future patients.

About this study

In plain language

This study tests whether the Gemini System is safe and can lower blood pressure by interrupting nerve signals to more than one organ. It is for adults with uncontrolled high blood pressure, with or without a high risk of heart and blood vessel problems.

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.

Compensation is read from the study's own description and may be missing — always confirm with the study team.

Eligibility

Who can join

  • You are 18 to 80 years old.
  • You have high blood pressure. At the starting office visit, your top number is at least 150 but below 180, and your bottom number is at least 90.
  • Your average top blood pressure number over 24 hours is at least 140 but below 170, measured with a blood pressure monitor.

Who can't join

  • Your kidney artery or main liver artery is not suitable for treatment, or you have already had treatment to interrupt nerves to the kidneys or liver.
  • You had severe heart failure (NYHA class III or IV), a stroke, or a mini-stroke in the past 6 months, or any stroke that caused lasting disability.
  • You have type 1 diabetes or have used insulin in the past 6 months.
  • Your high blood pressure has another underlying cause.
  • You have a condition that prevents accurate blood pressure readings, or your kidney filtering test result (eGFR) is below 40.
  • You are pregnant, breastfeeding, or planning to become pregnant during the study.
  • You have primary pulmonary arterial hypertension, a type of high blood pressure in the lung arteries.
  • You have signs or a history of active or suspected long-term liver or bile duct disease, or current or long-term pancreatitis (swelling of the pancreas).

Simplified for readability. The official criteria below are what the study team uses.

Official eligibility criteria

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.

Study sites (12)

CA

FL

GA

MA

MI

MS

NC

NJ

NV

TX