Spyral InSight Study

Recruiting now · Not applicable

Conditions studied: Hypertension, Vascular Diseases, Cardiovascular Diseases

In brief

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.

Key facts

Study ID

NCT07013929

Run by

Medtronic Vascular

People needed

19

Starts

2025-06-09

Expected to finish

2027-07-01

Last updated by the study team

2026-05-04

Who can join

Age: 20 and older, up to 70. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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
• Individual is taking SGLT2 inhibitors or GLP-1 agonists
• Individual requires chronic oxygen support or mechanical ventilation
• Primary pulmonary hypertension.
• Secondary cause of hypertension
• Pregnant, nursing or planning to become pregnant during the study.
• Individual has a documented condition that would prohibit or interfere with ability to obtain an accurate blood pressure measurement
• Individual is currently taking anti-mineralocorticoid drugs.

Where it is running

• Hippokration General Hospital of Athens — Athens, Greece (enrolling)
• University Hospital Galway — Galway, Ireland (enrolling)

Full record on ClinicalTrials.gov

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