RecruitingNot Applicable

SPYRAL GEMINI Pilot Study

United States175 participantsStarted 2025-05-01

Plain-language 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 hypertensive population with and without high cardiovascular risk.

Who can participate

Age range18 Years – 80 Years

SexALL

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Inclusion criteria

✓. ≥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

What they're measuring

Change in office blood pressure

Timeframe: From baseline to 36 months post-procedure

Trial details

NCT IDNCT06907147

SponsorMedtronic Vascular

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2029-12-22

Contact for this trial

Cecile Mahoney

+17635051057 Cecile.C.Mahoney@medtronic.com

View on ClinicalTrials.gov More Hypertension trials