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
This trial does not accept healthy volunteersQualifiers
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
Design model
Single group
Treatments tested in this trial
Renal nerve stimulation
DeviceRenal nerve stimulation will be performed prior to and post renal denervation.
Treatment groups
19 Participants
are divided into 1 treatment groupGroup A: Renal nerve stimulation performed prior to and post renal artery denervation (RDN)Experimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
All-cause mortality
Time frame
Through study completion, from enrollment to 12-month follow-up2
End-stage renal disease
Time frame
Through study completion, from enrollment to 12-month follow-up3
Myocardial infarction
Time frame
Through study completion, from enrollment to 12-month follow-up4
Incidence of stroke
Time frame
Through study completion, from enrollment to 12-month follow-upSponsors and contacts
Click on the lead sponsor to view all of their trials.
Source ClinicalTrials.gov