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NCT Number: NCT07013929

Spyral InSight Study

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.

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Key information

Conditions

Hypertension Cardiovascular Diseases Vascular Diseases

Age range

20 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Hippokration General Hospital of Athens, Athens, Greece

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About this study

This study is exploratory in nature and an early-stage clinical assessment that will evaluate procedural and long-term safety of renal nerve stimulation (RNS) when performed prior to and post renal artery denervation (RDN) with the Symplicity Spyral system, with follow-up at 1, 3, 6 and 12 months.

There is no pre-specified primary endpoint. However, the objectives of the Spyral InSight ECF study are as follows:

  • To assess safety of RNS when performed prior to and post RDN.
  • To characterize and quantify the physiological response to renal nerve stimulation in humans undergoing renal denervation per approved labeling.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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

Exclusion criteria

  • 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.

Treatment and study plan

Renal nerve stimulation

Device

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

Primary outcomes

  1. All-cause mortality

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

  2. End-stage renal disease

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

  3. Myocardial infarction

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

  4. Incidence of stroke

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

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

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

  6. Significant embolic event resulting in end-organ damage

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

  7. Renal artery intervention

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

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

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

  9. Vascular complications

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

  10. Major bleeding according to TIMI definition

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

  11. Prolonged renal vasoconstriction requiring intervention

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

  12. Contrast induced nephropathy

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

Interested in participating?

Recruiting

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Sponsors and collaborators

Lead sponsor

Medtronic Vascular

Industry

Registry information

Official study title

Spyral InSight Early Clinical Feasibility Study

Acronym: Spyral InSight

Important dates

Study start
2025
Primary completion
2027
Study completion
2027
First posted
Jun 10, 2025
Registry last updated
May 4, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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