Spyral InSight Study

NCT07013929 | Recruiting DMC

• 1 other identifier: MDT24037
• Study Type: interventional
• Target: 19
• Locations: 2 countries
• Sites: 2

Brief Summary

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

Hypertension; Vascular Diseases; Cardiovascular Diseases

Keywords

Hypertension; Cardiovascular Diseases; Vascular Diseases; Denervation; Renal Denervation

Outcome Measures

Primary Outcomes (12)

• All-cause mortality

  Through study completion, from enrollment to 12-month follow-up

• End-stage renal disease

  Through study completion, from enrollment to 12-month follow-up

• Myocardial infarction

  Through study completion, from enrollment to 12-month follow-up

• Incidence of stroke

  Through study completion, from enrollment to 12-month follow-up

• Hospitalization for hypertensive crisis not related to non-adherence with medications

  Through study completion, from enrollment to 12-month follow-up

• Significant embolic event resulting in end-organ damage

  Through study completion, from enrollment to 12-month follow-up

• Renal artery intervention

  Through study completion, from enrollment to 12-month follow-up

• New renal artery stenosis >70%, confirmed by angiography and as determined by the angiographic core lab

  Through study completion, from enrollment to 12-month follow-up

• Vascular complications

  Through study completion, from enrollment to 12-month follow-up

• Major bleeding according to TIMI definition

  Through study completion, from enrollment to 12-month follow-up

• Prolonged renal vasoconstriction requiring intervention

  Through study completion, from enrollment to 12-month follow-up

• Contrast induced nephropathy

  Through study completion, from enrollment to 12-month follow-up

Study Arms (1)

Renal nerve stimulation performed prior to and post renal artery denervation (RDN)

EXPERIMENTAL

Device: Renal nerve stimulation

Interventions

Renal nerve stimulation DEVICE

Renal nerve stimulation will be performed prior to and post renal denervation.

Renal nerve stimulation performed prior to and post renal artery denervation (RDN)

Eligibility Criteria

• Age: 20 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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
• 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.

Sponsors & Collaborators

• Medtronic Vascular: lead

Study Sites (2)

Hippokration General Hospital of Athens

Athens, 11527, Greece

RECRUITING

University Hospital Galway

Galway, H91 YR71, Ireland

RECRUITING

MeSH Terms

Conditions

Hypertension; Vascular Diseases; Cardiovascular Diseases

Central Study Contacts

Sjors Wijnands

CONTACT

+31 6 1113 5502; sjors.wijnands@medtronic.com

Marianne Wanten

CONTACT

+31 613703414; marianne.wanten@medtronic.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 18, 2025
• First Posted: June 10, 2025
• Study Start: June 9, 2025
• Primary Completion (Estimated): February 28, 2027
• Study Completion (Estimated): July 1, 2027
• Last Updated: May 4, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

GR (1); IE (1)