Spyral InSight Study

Launched by MEDTRONIC VASCULAR · Jun 2, 2025

Keywords

ClinConnect Summary

The Spyral InSight Study is a clinical trial designed to explore how renal nerve stimulation (RNS) affects blood pressure in people with hypertension, which is a condition that causes high blood pressure. The study will look at how this treatment works before and after a procedure called renal denervation, which aims to help lower blood pressure. This trial is not yet recruiting participants, but when it starts, it will include individuals aged 20 to 70 who have high blood pressure and are currently taking one to three different medications to manage it.

To be eligible for the study, participants should have a specific range of blood pressure readings, both in the doctor’s office and over a 24-hour period. However, some people may not qualify if they have had certain medical conditions or treatments, such as previous renal denervation or specific kidney issues. Participants can expect to be closely monitored throughout the study to assess how their bodies respond to the treatment. This trial represents an important step in understanding new ways to manage high blood pressure effectively.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • 1. 20 - 70 years of age
• • 2. Office SBP ≥150 mmHg and \<180 mmHg and DBP ≥90 mmHg
• • 3. Individual is prescribed with one, two, or three antihypertensive medication classes
• • 4. 24-hour ABPM average of SBP ≥135 and \<170 mmHg at Baseline
• Exclusion Criteria:
• • 1. Prior renal denervation.
• • 2. Individual lacks appropriate renal artery Anatomy
• • 3. Has a renal artery stent
• • 4. Individual has an estimated glomerular filtration rate (eGFR) of \<60 mL/min/1.73m2
• • 5. Individual is taking SGLT2 inhibitors or GLP-1 agonists
• • 6. Individual requires chronic oxygen support or mechanical ventilation
• • 7. Primary pulmonary hypertension.
• • 8. Secondary cause of hypertension
• • 9. Pregnant, nursing or planning to become pregnant during the study.
• • 10. Individual has a documented condition that would prohibit or interfere with ability to obtain an accurate blood pressure measurement
• • 11. Individual is currently taking anti-mineralocorticoid drugs.