Actively Recruiting
Spyral InSight Study
Led by Medtronic Vascular · Updated on 2026-05-04
19
Participants Needed
2
Research Sites
107 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
The purpose of the Spyral InSight Early Clinical Feasibility Study is to characterize the physiological response to renal nerve stimulation (RNS) in humans prior to and post renal denervation.
CONDITIONS
Official Title
Spyral InSight Study
Who Can Participate
Eligibility Criteria
You may qualify if you...
- 20 to 70 years of age
- Office systolic blood pressure (SBP) between 150 and less than 180 mmHg and diastolic blood pressure (DBP) of at least 90 mmHg
- Currently prescribed one, two, or three classes of antihypertensive medications
- 24-hour ambulatory blood pressure monitoring (ABPM) average SBP between 135 and less than 170 mmHg at baseline
You will not qualify if you...
- Prior renal denervation procedure
- Inappropriate renal artery anatomy
- Presence of a renal artery stent
- Estimated glomerular filtration rate (eGFR) less than 60 mL/min/1.73m2
- Currently taking SGLT2 inhibitors or GLP-1 agonists
- Requires chronic oxygen support or mechanical ventilation
- Diagnosed with primary pulmonary hypertension
- Secondary causes of hypertension
- Pregnant, nursing, or planning pregnancy during the study
- Conditions preventing accurate blood pressure measurement
- Currently taking anti-mineralocorticoid medications
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 2 locations
1
Hippokration General Hospital of Athens
Athens, Greece, 11527
Actively Recruiting
2
University Hospital Galway
Galway, Ireland, H91 YR71
Actively Recruiting
Research Team
S
Sjors Wijnands
CONTACT
M
Marianne Wanten
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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