Spyral InSight Early Clinical Feasibility Study
Trial Snapshot
- Phase
- Not Applicable
- Status
- Recruiting
- Sponsor
- Enrollment
- 19
- Locations
- 3
- Primary Endpoint
- End-stage renal disease
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Single Group
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 20 Years to 70 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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.
Arms & Interventions
Renal nerve stimulation performed prior to and post renal artery denervation (RDN)
Intervention: Renal nerve stimulation (Device)
Outcomes
Primary Outcomes
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
All-cause mortality
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
Secondary Outcomes
No secondary outcomes reported