SPYRAL GEMINI Pilot Study

Trial ID or NCT#

NCT06907147

Status

recruiting iconRECRUITING

Purpose

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.

Official Title

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

Eligibility Criteria

Ages Eligible for Study: 18 to 80
Sexes Eligible for Study: ALL
Accepts Healthy Volunteers: No
Inclusion Criteria:
  1. All Subjects (both cohorts):
    1. 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.
  2. Exclusion Criteria:
    1. 1. Individual lacks appropriate renal artery OR common hepatic artery anatomy.2. Prior renal or hepatic denervation.3. Prior stroke or transient ischemic attack (TIA).4. Documented Type 1 diabetes or use of insulin or sulfonylureas within 6 months.5. Secondary cause of hypertension.6. Documented condition that would prohibit or interfere with ability to obtain an accurate blood pressure measurement.7. Estimated glomerular filtration rate (eGFR) of \<408. Pregnant, nursing or planning to become pregnant during the study.9. Primary pulmonary arterial hypertension.10. History or evidence of active / suspected chronic liver or biliary disease.11. Current or chronic pancreatitis.
Exclusion Criteria:
  1. 1. Individual lacks appropriate renal artery OR common hepatic artery anatomy.2. Prior renal or hepatic denervation.3. Prior stroke or transient ischemic attack (TIA).4. Documented Type 1 diabetes or use of insulin or sulfonylureas within 6 months.5. Secondary cause of hypertension.6. Documented condition that would prohibit or interfere with ability to obtain an accurate blood pressure measurement.7. Estimated glomerular filtration rate (eGFR) of \<408. Pregnant, nursing or planning to become pregnant during the study.9. Primary pulmonary arterial hypertension.10. History or evidence of active / suspected chronic liver or biliary disease.11. Current or chronic pancreatitis.
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Investigator(s)

Nataliya Kovalchuk
David Lee, MD
David Lee, MD
Cardiologist, Interventional cardiologist
Professor of Medicine (Cardiovascular Medicine)

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Contact

Cecile Mahoney
+17635051057

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View on ClinicalTrials.gov