SPYRAL GEMINI Pilot Study
Recruiting
N/A
Interventional Study
Hypertension
Vascular Diseases
Cardiovascular Diseases
Chronic Kidney Diseases
Diabetes Mellitus
No Placebo Group
Every participant receives an active treatment — no one gets a placebo.
At a Glance
- Age
- 18 – 80
- Sex
- Any
- Study type
- Interventional
- Purpose
- Treatment
- Participants needed
- 175 (estimated)
- Sponsor
- Medtronic Vascular · Industry
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About This Trial
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 …
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