SPYRAL DYSTAL Renal Denervation Global Clinical Study

Study Overview
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Brief Summary
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The objective of this single arm interventional study is to determine if renal denervation performed in the distal main and first order branch renal arteries is as effective in reducing blood pressure as the procedural approach used in the SPYRAL HTN-OFF MED clinical study.

Official Title
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Global Clinical Study of Renal Denervation in the Distal Main and First Order Branch Renal Arteries Using the Symplicity Spyral™ Multi-electrode Renal Denervation System (SPYRAL DYSTAL)

Conditions
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Hypertension, Vascular Diseases, Cardiovascular Diseases

Intervention / Treatment
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* Device: Renal Denervation (Symplicity Spyral™)


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: - Individual has office systolic blood pressure (SBP) ≥ 150 mmHg and <180 mmHg and a diastolic blood pressure (DBP) ≥ 90 mmHg after being off medications. Individual has 24-hour Ambulatory Blood Pressure Monitoring (ABPM) average SBP ≥ 140 mmHg and < 170 mmHg. Individual is willing to discontinue current antihypertensive medications Exclusion Criteria: Individual has estimated glomerular filtration rate (eGFR) of <45. Individual has type 1 diabetes mellitus or poorly-controlled type 2 diabetes mellitus. Individual has one or more episodes of orthostatic hypotension. Individual requires chronic oxygen support or mechanical ventilation other than nocturnal respiratory support for sleep apnea. Individual has primary pulmonary hypertension. Individual is pregnant, nursing or planning to become pregnant. Individual has frequent intermittent or chronic pain that results in treatment with nonsteroidal anti-inflammatory drugs (NSAIDs) for two or more days per week over the month prior to enrollment. Individual has stable or unstable angina within 3 months of enrollment, myocardial infarction within 3 months of enrollment; heart failure, cerebrovascular accident or transient ischemic attack, or atrial fibrillation at any time. Individual works night shifts.

Ages Eligible for Study
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Minimum Age: 20 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Renal Denervation<br>Renal angiography and Renal Denervation (Symplicity Spyral™ multi-electrode renal denervation system) | Device: Renal Denervation (Symplicity Spyral™)<br>* Device: Symplicity Spyral™ multi-electrode renal denervation system. After a renal angiography according to standard procedures, subjects are treated with the renal denervation procedure.<br>* Other names: Renal Denervation;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in systolic blood pressure (SBP) from baseline as measured by 24-hour Ambulatory Blood Pressure Monitoring (ABPM) |  | From baseline to 12 months post-procedure | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in office systolic blood pressure |  | From baseline to 12 months post-procedure | 
| Change in office diastolic blood pressure |  | From baseline to 12 months post-procedure | 
| Change in office diastolic blood pressure baseline as measured by 24-hour ABPM |  | From baseline to 12 months post-procedure | 
| Incidence of achieving target office BP |  | From baseline to 12 months post-procedure | 
| Comparison of BP reduction pattern over 24 hours of ABPM |  | From baseline to 12 months post-procedure | 
| Procedural characteristics (e.g. Procedure time, contrast media usage, etc.) |  | Baseline | 
| Acute and chronic safety by evaluating incidence of Major Adverse Events |  | From baseline to 12 months post-procedure | 
| Incidence of Myocardial Infarction |  | From baseline to 12 months post-procedure | 
| Incidence of Stroke |  | From baseline to 12 months post-procedure | 
| Incidence of Renal artery re-intervention |  | From baseline to 12 months post-procedure | 
| Incidence of Major bleeding according to TIMI definition |  | From baseline to 12 months post-procedure | 
| Incidence of Increase in serum creatinine >50% |  | From baseline to 12 months post-procedure | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Uncontrolled hypertension, Renal denervation