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Trial record 1 of 1 for:    02439749
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SPYRAL PIVOTAL - SPYRAL HTN-OFF MED Study

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02439749
Recruitment Status : Active, not recruiting
First Posted : May 12, 2015
Results First Posted : May 27, 2021
Last Update Posted : November 1, 2021
Sponsor:
Information provided by (Responsible Party):
Medtronic Vascular

Tracking Information
First Submitted Date  ICMJE April 28, 2015
First Posted Date  ICMJE May 12, 2015
Results First Submitted Date  ICMJE April 30, 2021
Results First Posted Date  ICMJE May 27, 2021
Last Update Posted Date November 1, 2021
Actual Study Start Date  ICMJE June 2015
Actual Primary Completion Date April 30, 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: June 10, 2021)
  • Number of Participants With Major Adverse Events (MAE) Defined as a Composite of Events. [ Time Frame: From baseline to 1 month post-procedure ]
    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, however endpoint data is reported to 3 months only)
  • 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.
Original Primary Outcome Measures  ICMJE
 (submitted: May 6, 2015)
  • Acute and chronic safety by evaluating incidence of Major Adverse Events [ Time Frame: From baseline to 36 months post-procedure ]
  • Change in systolic blood pressure as measured by 24-hour Ambulatory Blood Pressure Monitoring (ABPM) [ Time Frame: From baseline to 36 months post-procedure ]
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: June 10, 2021)
  • Baseline Adjusted Change (Using Analysis of Covariance) in Office Systolic Blood Pressure [ Time Frame: From baseline to 3 months post-procedure ]
    The outcome measure is the change in office systolic blood pressure from baseline to 3-month. The unadjusted treatment difference between renal denervation and sham control groups is -7.0 mmHg. The baseline adjusted treatment difference is -6.9 mmHg.
  • Number of Participants With Significant Embolic Event Resulting in End-organ Damage [ Time Frame: From baseline to 1 month post-procedure ]
    Significant embolic event resulting in end-organ damage (e.g. kidney/bowel infarct, lower extremity ulceration or gangrene, or doubling of serum creatinine documented by at least two measurements at least 21 days apart)
  • Number of Participants With Renal Artery Perforation Requiring Intervention [ Time Frame: From baseline to 1 month post-procedure ]
    Renal artery perforation requiring intervention
  • Renal Artery Dissection [ Time Frame: From baseline to 1 month post-procedure ]
    Number of Participants with Renal artery dissection requiring intervention
  • Number of Participants With Vascular Complications [ Time Frame: From baseline to 1 month post-procedure ]
    Vascular complications (e.g., clinically significant groin hematoma, arteriovenous fistula, pseudoaneurysm, excessive bleeding) requiring surgical repair, interventional procedure, thrombin injection, or blood transfusion (requiring more than 2 units of packed red blood cells within any 24 hour period during the first 7 days post renal denervation procedure).
  • Number of Participants With End-stage Renal Disease [ Time Frame: From baseline to 1 month post-procedure ]
    defined as two or more eGFR measurements < 15 mL/min/1.73m2 at least 21 days apart and requiring dialysis for one of more of the following:
    • Volume management refractory to diuretics
    • Hyperkalemia unmanageable by diet and diuretics
    • Acidosis bicarbonate <18 unmanageable with HCO3 supplements
    • Symptoms of uremia, nausea, vomiting
  • Number of Participants With Decline in eGFR [ Time Frame: From baseline to 1 month post-procedure ]
    ≥40% decline in eGFR
  • Myocardial Infarction [ Time Frame: From baseline to 1 month post-procedure ]
    Number of Participants with New myocardial infarction
  • New Stroke [ Time Frame: From baseline to 1 month post-procedure ]
    Number of Participants with New stroke
  • Number of Participants With Renal Artery Re-intervention [ Time Frame: From baseline to 1 month post-procedure ]
    Renal artery re-intervention
  • Number of Participants With Major Bleeding According to TIMI Definition [ Time Frame: From baseline to 1 month post-procedure ]
    Major bleeding according to TIMI definition (i.e. intracranial hemorrhage, ≥5g/dl decrease in hemoglobin concentration, a ≥15% absolute decrease in hematocrit, or death due to bleeding within 7 days of the procedure).
  • Number of Participants With Increase in Serum Creatinine [ Time Frame: From baseline to 1 month post-procedure ]
    Increase in serum creatinine > 50% from screening visit 2.
  • Number of Participants With New Renal Artery Stenosis > 70% [ Time Frame: From baseline to 6 month post-procedure ]
    Confirmed by angiography and as determined by the angiographic core laboratory.
  • Number of Participants With Hospitalization for Hypertensive Crisis With Medications or the Protocol [ Time Frame: From baseline to 1 month post-procedure ]
    Hospitalization for hypertensive crisis not related to confirmed non-adherence with medications or the protocol.
  • Number of Participants With All-cause Mortality [ Time Frame: From baseline to 3 months post-procedure ]
    All-cause mortality
  • Number of Participants With Change in Systolic Blood Pressure as Measured by 24-hour ABPM [ Time Frame: From baseline to 36 month post-procedure ]
  • Number of Participants With Incidence of Achieving Target Office Systolic Blood Pressure (SBP <140 mmHg) [ Time Frame: From 1 month to 36 months post-procedure ]
  • Number of Participants With Change in Office Diastolic Blood Pressure [ Time Frame: From baseline to 36 months post-procedure ]
    Change in office diastolic blood pressure
  • Number of Participants With Change in Diastolic Blood Pressure as Measured by 24-hour ABPM [ Time Frame: From baseline to 36 months post-procedure ]
    Change in diastolic blood pressure as measured by 24-hour ABPM
  • Number of Participants With End-Stage Renal Disease (ESRD) [ Time Frame: From baseline to 3 months post randomization ]
    Defined as two or more eGFR measurements < 15 mL/min/1.73m2 at least 21 days apart and requiring dialysis for one of more of the following:
    • Volume management refractory to diuretics
    • Hyperkalemia unmanageable by diet and diuretics
    • Acidosis bicarbonate <18 unmanageable with HCO3 supplements
    • Symptoms of uremia, nausea, vomiting
  • Number of Participants With ≥40% Decline in eGFR [ Time Frame: From baseline to 3 months post randomization ]
    ≥40% Decline in eGFR
  • Number of Participants With New Myocardial Infarction [ Time Frame: From baseline to 3 months post randomization ]
    New Myocardial Infarction
  • New Stroke [ Time Frame: From baseline to 3 months post randomization ]
    Number of Participants with New Stroke
  • Number of Participants With Renal Artery Re-intervention [ Time Frame: From baseline to 3 months post randomization ]
    Renal Artery Re-intervention
  • Number of Participants With Major Bleeding According to TIMI Definition [ Time Frame: From baseline to 3 months post randomization ]
    Major bleeding according to TIMI definition (i.e. intracranial hemorrhage, ≥5g/dl decrease in hemoglobin concentration, a ≥15% absolute decrease in hematocrit, or death due to bleeding within 7 days of the procedure).
  • Increase in Serum Creatinine [ Time Frame: From baseline to 3 months post randomization ]
    Number of Participants with Increase in Serum Creatinine > 50% from screening visit 2.
  • Number of Participants With Hospitalization for Hypertensive Crisis [ Time Frame: From baseline to 3 months post randomization ]
    Hospitalization for Hypertensive Crisis Not Related to Confirmed Nonadherence With Medications or the Protocol
  • Change in Office Systolic Blood Pressure [ Time Frame: From baseline to 1 month post procedure ]
    Change in office systolic blood pressure from baseline (Screening Visit 2) to 1-month
  • Number of Participants Achieving Target Office Systolic Blood Pressure [ Time Frame: From baseline to 1 month post procedure ]
    Incidence of achieving target office systolic blood pressure (SBP <140 mmHg)
  • Number of Participants Achieving Target Office Systolic Blood Pressure [ Time Frame: From baseline to 3 months post procedure ]
    Incidence of Achieving Target Office Systolic Blood Pressure (SBP <140 mmHg)
  • Change in Office Diastolic Blood Pressure [ Time Frame: From baseline to 1 month post procedure ]
    Change in office diastolic blood pressure from baseline (Screening Visit 2)
  • Change in Office Diastolic Blood Pressure [ Time Frame: From baseline to 3 months post procedure ]
    Change in Office Diastolic Blood Pressure From Baseline (Screening Visit 2) to 3-months
  • Change in Diastolic Blood Pressure as Measured by 24-hour Ambulatory Blood Pressure Monitoring (ABPM) [ Time Frame: From baseline to 3 months post procedure ]
    Change in diastolic blood pressure from baseline (screening visit 2) to 3-month as measured by 24-hour Ambulatory Blood Pressure Monitoring (ABPM).
Original Secondary Outcome Measures  ICMJE
 (submitted: May 6, 2015)
  • Change in office systolic blood pressure [ Time Frame: From baseline to 36 months post-procedure ]
  • Incidence of achieving target office systolic blood pressure (SBP<140 mmHg or <130 mmHg for patients with diabetes or renal disease) [ Time Frame: From 1 month to 36 months post-procedure ]
  • Change in office diastolic blood pressure [ Time Frame: From baseline to 36 months post-procedure ]
  • Change in diastolic blood pressure as measured by 24-hour ABPM [ Time Frame: From baseline to 36 months post-procedure ]
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE SPYRAL PIVOTAL - SPYRAL HTN-OFF MED Study
Official Title  ICMJE 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)
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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
Condition  ICMJE
  • Hypertension
  • Vascular Diseases
  • Cardiovascular Diseases
Intervention  ICMJE
  • Device: Symplicity Spyral™ multi-electrode renal denervation system
    After a renal angiography according to standard procedures, subjects remain blinded and are immediately treated with the renal denervation procedure after randomization.
    Other Names:
    • Renal angiography
    • Renal Denervation
  • Procedure: Sham Procedure
    After a renal angiography according to standard procedures, subjects remain blinded and remain on the catheterization lab table for at least 20 minutes prior to introducer sheath removal.
    Other Name: Renal angiography
Study Arms  ICMJE
  • Experimental: Renal Denervation
    Renal angiography and Renal Denervation (Symplicity Spyral™ multi-electrode renal denervation system)
    Intervention: Device: Symplicity Spyral™ multi-electrode renal denervation system
  • Sham Comparator: Sham Procedure
    Renal angiography
    Intervention: Procedure: Sham Procedure
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Active, not recruiting
Actual Enrollment  ICMJE
 (submitted: March 31, 2020)
366
Original Estimated Enrollment  ICMJE
 (submitted: May 6, 2015)
120
Estimated Study Completion Date  ICMJE March 2023
Actual Primary Completion Date April 30, 2020   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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 <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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 20 Years to 80 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Australia,   Austria,   Canada,   Germany,   Greece,   Ireland,   Japan,   United Kingdom,   United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02439749
Other Study ID Numbers  ICMJE SPYRAL HTN-OFF MED
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Device Product: Yes
Device Product Not Approved or Cleared by U.S. FDA: Yes
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Medtronic Vascular
Study Sponsor  ICMJE Medtronic Vascular
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Raymond Townsend, MD University of Pennsylvania
Principal Investigator: David Kandzari, MD Piedmont Hospital
Principal Investigator: Michael Böhm, MD Universitätskliniken des Saarlandes
Principal Investigator: Kazuomi Kario, MD Jichi Medical University
PRS Account Medtronic Vascular
Verification Date October 2021

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP