HypertensionSpyral InSightNCT07013929
Spyral InSight Study
A study testing Renal nerve stimulation in people with Hypertension and Vascular Diseases, run by Medtronic Vascular at 2 sites in 2 countries.
Trial 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. Read more about this study
- Who is it for?
- Ages 20 to 70 years
- Conditions the study is for
- Hypertension, Vascular Diseases, Cardiovascular Diseases
- What is being tested?
- Renal nerve stimulation
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 19 participants
- Where
- 2 sitesin 2 countries
- Study dates
- 9 Jun 2025to 1 Jul 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
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- 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.
Trial locations and contacts
2 sites in 2 countries. Contact the study team or a site near you to ask about taking part.
2 sites in 2 countries
Greece1 site, 1 recruiting
- Recruiting
Hippokration General Hospital of Athens
Athens, 11527
Konstantinos Tsioufis, MD, 00302132088025, ktsioufis@gmail.com
Konstantinos Tsioufis, MD
Ireland1 site, 1 recruiting
- Recruiting
University Hospital Galway
Galway, H91 YR71
Eileen Coen, +353 86 145 5568, eileen.coen@nuigalway.ie
Faisal Sharif, MD
About this study
Official title: Spyral InSight Early Clinical Feasibility 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.
Read the 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.
- Conditions
- Hypertension, Vascular Diseases, Cardiovascular Diseases
- Being tested
- Renal nerve stimulation
- Keywords
- Hypertension, Cardiovascular Diseases, Vascular Diseases, Denervation, Renal Denervation
- Medical subject headings
- Hypertension, Vascular Diseases, Cardiovascular Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Renal nerve stimulationDevice
Renal nerve stimulation will be performed prior to and post renal denervation.
| Study group | Role | What they receive |
|---|---|---|
| Renal nerve stimulation performed prior to and post renal artery denervation (RDN) | Experimental | Not described Receives: Device: Renal nerve stimulation |
What is being measured
The primary outcome is the main question the study is designed to answer.
All-cause mortality
Measured: Through study completion, from enrollment to 12-month follow-up
End-stage renal disease
Measured: Through study completion, from enrollment to 12-month follow-up
Myocardial infarction
Measured: Through study completion, from enrollment to 12-month follow-up
Incidence of stroke
Measured: Through study completion, from enrollment to 12-month follow-up
Hospitalization for hypertensive crisis not related to non-adherence with medications
Measured: Through study completion, from enrollment to 12-month follow-up
Significant embolic event resulting in end-organ damage
Measured: Through study completion, from enrollment to 12-month follow-up
Renal artery intervention
Measured: 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
Measured: Through study completion, from enrollment to 12-month follow-up
Vascular complications
Measured: Through study completion, from enrollment to 12-month follow-up
Major bleeding according to TIMI definition
Measured: Through study completion, from enrollment to 12-month follow-up
Prolonged renal vasoconstriction requiring intervention
Measured: Through study completion, from enrollment to 12-month follow-up
Contrast induced nephropathy
Measured: Through study completion, from enrollment to 12-month follow-up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Jun 2025
- Study start9 Jun 2025
- Primary completion28 Feb 2027 (estimated)
- Study completion1 Jul 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HypertensionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 19 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Medtronic Vascular
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07013929
- Sponsor's protocol ID
- MDT24037
- Acronym
- Spyral InSight
- Status last verified
- Oct 2026
- First submitted
- 18 Apr 2025
- Last updated
- 20 Oct 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: There is not a plan to make IPD available.
Study at a glance
From the registry record, last updated by the sponsor on 20 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Spyral InSight Early Clinical Feasibility Study
- ClinicalTrials.gov ID
- NCT07013929
- Acronym / sponsor ID
- Spyral InSight / MDT24037
- Conditions
- Hypertension, Vascular Diseases, Cardiovascular Diseases
- Keywords
- Hypertension, Cardiovascular Diseases, Vascular Diseases, Denervation, Renal Denervation
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 19 participants (estimated)
- Lead sponsor
- Medtronic VascularIndustry (pharma, biotech, devices)
- Study start
- 9 Jun 2025 (actual)
- Primary completion
- 28 Feb 2027 (estimated)
- Study completion
- 1 Jul 2027 (estimated)
- First posted
- 10 Jun 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Renal nerve stimulation performed prior to and post renal artery denervation (RDN) | Experimental | Device: Renal nerve stimulation |
Who may qualify
- Ages
- 20 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (11 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Renal nerve stimulationRenal nerve stimulation will be performed prior to and post renal denervation. | Device | Renal nerve stimulation performed prior to and post renal artery denervation (RDN) |
Primary outcome
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
Prolonged renal vasoconstriction requiring intervention
Time frame: Through study completion, from enrollment to 12-month follow-up
Contrast induced nephropathy
Time frame: Through study completion, from enrollment to 12-month follow-up
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Oct 2026.
- Individual participant dataSharing planned: No. There is not a plan to make IPD available.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
2 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Renal nerve stimulation in people with Hypertension and Vascular Diseases, run by Medtronic Vascular at 2 sites in 2 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 20 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Greece, Ireland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Sjors Wijnands (+31 6 1113 5502, sjors.wijnands@medtronic.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
All-cause mortality (time frame: Through study completion, from enrollment to 12-month follow-up). The study lists 12 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Oct 2026.