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Recruiting NCT07013929

Spyral InSight Study

No phase Interventional Hypertension Vascular Diseases Cardiovascular Diseases

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Renal nerve stimulation.
Who it may be relevant to
Registry conditions: Hypertension, Vascular Diseases, Cardiovascular Diseases. Basic parameters: 20 years — 70 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Greece, Ireland
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

Spyral InSight Early Clinical Feasibility Study

Overview

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.

Detailed description

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.

Interventions

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

Primary outcome measures

  • All-cause mortality [Time frame: Through study completion, from enrollment to 12-month follow-up]
  • End-stage renal disease [Time frame: Through study completion, from enrollment to 12-month follow-up]
  • Myocardial infarction [Time frame: Through study completion, from enrollment to 12-month follow-up]
  • Incidence of stroke [Time frame: Through study completion, from enrollment to 12-month follow-up]
  • Hospitalization for hypertensive crisis not related to non-adherence with medications [Time frame: Through study completion, from enrollment to 12-month follow-up]
  • Significant embolic event resulting in end-organ damage [Time frame: Through study completion, from enrollment to 12-month follow-up]
  • Renal artery intervention [Time frame: 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 [Time frame: Through study completion, from enrollment to 12-month follow-up]
  • Vascular complications [Time frame: Through study completion, from enrollment to 12-month follow-up]
  • Major bleeding according to TIMI definition [Time frame: Through study completion, from enrollment to 12-month follow-up]

Eligibility criteria

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
N/A
Model
Single group
Masking
Open label
Primary purpose
Treatment

Study locations

Greece · 1 center
  • Hippokration General Hospital of Athens — Athens
Ireland · 1 center
  • University Hospital Galway — Galway

Identifiers

NCT: NCT07013929 · MDT24037

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗