No Placebo Group
Every participant receives an active treatment — no one gets a placebo.
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Review the details below, then apply to join this clinical trial.
At a Glance
Age
18 – 80
Sex
Any
Study type
Interventional
Purpose
Treatment
Participants needed
175 (estimated)
Sponsor
Medtronic Vascular · Industry
Who this trial is looking for
This trial is looking for people with high blood pressure who are between 18 and 80 years old. Participants will receive a treatment aimed at lowering blood pressure.
Are You a Good Fit for This Trial?
Rules you outType 1 diabetesChronic liver diseasePancreatitis
You may be able to join if
I am between 18 and 80 years old.
I have been diagnosed with high blood pressure.
My blood pressure is 150-180 mmHg when measured in the office.
My 24-hour average blood pressure is 140-170 mmHg.
You may not be able to join if
I have had a stroke or mini-stroke in the past 6 months.
I have had severe heart failure in the past 6 months.
I have a kidney problem that might affect my blood pressure.
I am pregnant, nursing, or planning to become pregnant.
I have a history of liver disease.
I have type 1 diabetes or have used insulin in the last 6 months.
I have had pancreatitis.
I have a condition that affects blood pressure readings.
Summarized in plain language from this trial's official eligibility criteria.
The full criteria are further down this page — only the research team can
confirm whether you qualify.
Think this trial could be right for you?
Answer three quick questions written from this study's own rules to see if you may qualify. No account needed to find out.
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.
Trial Locations
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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 …
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.
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