Clinical trial NCT07013929: Spyral InSight Study
Official title: Spyral InSight Early Clinical Feasibility Study
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Hypertension
Vascular Diseases
Cardiovascular Diseases
Keywords: Hypertension
Cardiovascular Diseases
Vascular Diseases
Denervation
Renal Denervation
Lead sponsor: Medtronic Vascular
Sponsor class: INDUSTRY
First posted: 2025-06-10
Enrollment: 19
Sex: ALL
Minimum age (years): 20
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

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.

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.

Primary outcomes:
measure: All-cause mortality
timeFrame: Through study completion, from enrollment to 12-month follow-up
measure: End-stage renal disease
timeFrame: Through study completion, from enrollment to 12-month follow-up
measure: Myocardial infarction
timeFrame: Through study completion, from enrollment to 12-month follow-up
measure: Incidence of stroke
timeFrame: Through study completion, from enrollment to 12-month follow-up
measure: Hospitalization for hypertensive crisis not related to non-adherence with medications
timeFrame: Through study completion, from enrollment to 12-month follow-up
measure: Significant embolic event resulting in end-organ damage
timeFrame: Through study completion, from enrollment to 12-month follow-up
measure: Renal artery intervention
timeFrame: Through study completion, from enrollment to 12-month follow-up
measure: New renal artery stenosis >70%, confirmed by angiography and as determined by the angiographic core lab
timeFrame: Through study completion, from enrollment to 12-month follow-up
measure: Vascular complications
timeFrame: Through study completion, from enrollment to 12-month follow-up
measure: Major bleeding according to TIMI definition
timeFrame: Through study completion, from enrollment to 12-month follow-up
measure: Prolonged renal vasoconstriction requiring intervention
timeFrame: Through study completion, from enrollment to 12-month follow-up
measure: Contrast induced nephropathy
timeFrame: Through study completion, from enrollment to 12-month follow-up
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References: