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Clinical Trials/NCT02439749
NCT02439749CompletedNot Applicable

Global Clinical Study of Renal Denervation With the Symplicity Spyral™ Multi-electrode Renal Denervation System in Patients With Uncontrolled Hypertension in the Absence of Antihypertensive Medications (SPYRAL PIVOTAL - SPYRAL HTN-OFF MED)

Medtronic Vascular91 sites in 9 countries366 target enrollmentStarted: June 1, 2015Last updated:
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Conditions

Trial Snapshot

Phase
Not Applicable
Status
Completed
Sponsor
Enrollment
366
Locations
91
Primary Endpoint
Number of Participants With Major Adverse Events (MAE) Defined as a Composite of Events.
Study OverviewStudy DesignEligibility CriteriaOutcomesInvestigatorsSitesRecords & IdentifiersSimilar Trials

Study Overview

Brief Summary

The purpose of this study is to test the hypothesis that renal denervation decreases blood pressure and is safe when studied in the absence of antihypertensive medications.

Study Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel
Primary Purpose
Treatment
Masking
Single (Participant)

Eligibility Criteria

Ages
20 Years to 80 Years (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
No

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 lacks appropriate renal artery anatomy.
  • •Individual has estimated glomerular filtration rate (eGFR) of <
  • •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.

Outcomes

Primary Outcomes

Number of Participants With Major Adverse Events (MAE) Defined as a Composite of Events.

Time Frame: From baseline to 1 month post-procedure (6 months for new renal artery stenosis)

All-cause mortality End-stage Renal Disease (ESRD) Significant embolic event resulting in end-organ damage Renal artery perforation requiring intervention Renal artery dissection requiring intervention Vascular complications Hospitalization for hypertensive crisis not related to confirmed non-adherence with medications or the protocol New renal artery stenosis \>70% (6 months for new renal artery stenosis)

Baseline Adjusted Change (Using Analysis of Covariance) in Systolic Blood Pressure as Measured by 24-hour Ambulatory Blood Pressure Monitoring

Time Frame: From baseline to 3 months post-procedure

The outcome measure is the change in ambulatory systolic blood pressure from baseline to 3-month. The unadjusted treatment difference between renal denervation and sham control groups is -3.9 mmHg. The baseline adjusted treatment difference is -3.9 mmHg.

Secondary Outcomes

  • New Stroke(From baseline to 3 months post randomization)
  • Number of Participants With Renal Artery Re-intervention(From baseline to 36 months post randomization)
  • Number of Participants With Major Bleeding According to TIMI Definition(From baseline to 36 months post randomization)
  • Number of Participants With Increase in Serum Creatinine(From baseline to 1 month post-procedure)
  • Number of Participants With Hospitalization for Hypertensive Crisis With Medications or the Protocol(From baseline to 1 month post-procedure)
  • Change in Office Systolic Blood Pressure(From baseline to 36 months post procedure)
  • Change in Office Diastolic Blood Pressure(From baseline to 36 months post-procedure)
  • Number of Participants Achieving Target Office Systolic Blood Pressure(From baseline to 3 months post procedure)
  • Baseline Adjusted Change (Using Analysis of Covariance) in Office Systolic Blood Pressure(From baseline to 3 months post-procedure)
  • Number of Participants With All-cause Mortality(From baseline to 36 months post-randomization)
  • Number of Participants With ≥40% Decline in eGFR(From baseline to 36 months post randomization)
  • Number of Participants With End-Stage Renal Disease (ESRD)(From baseline to 36 months post randomization)
  • Number of Participants With New Myocardial Infarction(From baseline to 36 months post randomization)
  • Increase in Serum Creatinine(From baseline to 3 months post randomization)
  • Number of Participants With Hospitalization for Hypertensive Crisis(From baseline to 36 months post randomization)
  • Change in Diastolic Blood Pressure as Measured by 24-hour ABPM(From baseline to 36 months post-procedure)
  • Number of Participants With New Renal Artery Stenosis > 70%(From baseline to 36 months post randomization)
  • Change in Systolic Blood Pressure as Measured by 24-hour ABPM(From baseline to 36 month post-procedure)
  • Number of Participants With Incidence of Achieving Target Office Systolic Blood Pressure (SBP <140) mmHg)(From baseline to 36 months post-procedure)
  • Number of Participants With New Stroke(From baseline to 36 months post randomization)
  • Number of Participants With an Increase in Serum Creatinine(From baseline to 36 months post randomization)
  • Number of Participants With Significant Embolic Event Resulting in End-organ Damage(From baseline to 1 month post-procedure)
  • Number of Participants With Renal Artery Perforation Requiring Intervention(From baseline to 1 month post-procedure)
  • Renal Artery Dissection(From baseline to 1 month post-procedure)
  • Number of Participants With Vascular Complications(From baseline to 1 month post-procedure)
  • Number of Participants With End-stage Renal Disease(From baseline to 1 month post-procedure)
  • Number of Participants With Decline in eGFR(From baseline to 1 month post-procedure)
  • Myocardial Infarction(From baseline to 1 month post-procedure)

Investigators

Sponsor
Medtronic Vascular
Sponsor Class
Industry
Responsible Party
Sponsor

Study Sites (91)

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