Spyral InSight Study
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age20-70
SponsorMedtronic Vascular
About this trial
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.
Eligibility criteria
Qualifiers
20 - 70 years of age
Office SBP ≥150 mmHg and <180 mmHg and DBP ≥90 mmHg
Individual is prescribed with one, two, or three antihypertensive medication classes
24-hour ABPM average of SBP ≥135 and <170 mmHg at Baseline
Disqualifiers
Prior renal denervation.
Individual lacks appropriate renal artery Anatomy
Has a renal artery stent
Individual has an estimated glomerular filtration rate (eGFR) of <60 mL/min/1.73m2
Trial design
Treatments tested in this trial
- Renal nerve stimulation
Treatment groups
19 Participants
are divided into 1 treatment groupLocations
2Greece
Hippokration General Hospital of Athens11527, Athens Greece
Ireland
University Hospital GalwayH91 YR71, Galway Ireland
Sponsors and collaborators
Medtronic Vascular
Lead sponsor
Source ClinicalTrials.gov