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SPYRAL PIVOTAL - SPYRAL HTN-OFF MED Study

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ClinicalTrials.gov Identifier: NCT02439749
Recruitment Status : Recruiting
First Posted : May 12, 2015
Last Update Posted : July 6, 2018
Sponsor:
Information provided by (Responsible Party):
Medtronic Vascular

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.

Condition or disease Intervention/treatment Phase
Hypertension Vascular Diseases Cardiovascular Diseases Device: Symplicity Spyral™ multi-electrode renal denervation system Procedure: Sham Procedure Not Applicable

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 433 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
Official Title: 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)
Actual Study Start Date : June 2015
Estimated Primary Completion Date : June 2020
Estimated Study Completion Date : December 2022

Arm Intervention/treatment
Experimental: Renal Denervation
Renal angiography and Renal Denervation (Symplicity Spyral™ multi-electrode renal denervation system)
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

Sham Comparator: Sham Procedure
Renal angiography
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




Primary Outcome Measures :
  1. Acute and chronic safety by evaluating incidence of Major Adverse Events [ Time Frame: From baseline to 1 month post-procedure (6 months for new renal artery stenosis) ]
  2. Change in systolic blood pressure as measured by 24-hour Ambulatory Blood Pressure Monitoring (ABPM) [ Time Frame: From baseline to 3 months post-procedure ]

Secondary Outcome Measures :
  1. Change in office systolic blood pressure [ Time Frame: From baseline to 36 months post-procedure ]
  2. Significant embolic event resulting in end-organ damage [ Time Frame: From baseline to 1 month post-procedure ]
  3. Renal artery perforation requiring intervention [ Time Frame: From baseline to 1 month post-procedure ]
  4. Renal artery dissection requiring intervention [ Time Frame: From baseline to 1 month post-procedure ]
  5. Vascular complications [ Time Frame: From baseline to 1 month post-procedure ]
  6. End-stage renal disease [ Time Frame: From baseline to 36 months post-procedure ]
  7. ≥40% decline in eGFR [ Time Frame: From baseline to 36 months post-procedure ]
  8. New myocardial infarction [ Time Frame: From baseline to 36 months post-procedure ]
  9. New stroke [ Time Frame: From baseline to 36 months post-procedure ]
  10. Renal artery re-intervention [ Time Frame: From baseline to 36 months post-procedure ]
  11. Major bleeding according to TIMI definition [ Time Frame: From baseline to 36 months post-procedure ]
  12. Increase in serum creatinine > 50% [ Time Frame: From baseline to 36 months post-procedure ]
  13. New renal artery stenosis > 70% [ Time Frame: From baseline to 36 months post-procedure ]
  14. Hospitalization for hypertensive crisis not related to confirmed nonadherence with medications or the protocol [ Time Frame: From baseline to 36 months post-procedure ]
  15. All-cause mortality [ Time Frame: From baseline to 36 month post-procedure ]
  16. Change in systolic blood pressure as measured by 24-hour ABPM [ Time Frame: From baseline to 36 month post-procedure ]
  17. Incidence of achieving target office systolic blood pressure (SBP <140 mmHg) [ Time Frame: From 1 month to 36 months post-procedure ]
  18. Change in office diastolic blood pressure [ Time Frame: From baseline to 36 months post-procedure ]
  19. Change in diastolic blood pressure as measured by 24-hour ABPM [ Time Frame: From baseline to 36 months post-procedure ]


Information from the National Library of Medicine

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Ages Eligible for Study:   20 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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 experienced a myocardial infarction, unstable angina pectoris, syncope, or a cerebrovascular accident within three months of the screening period, or has widespread atherosclerosis, with documented intravascular thrombosis or unstable plaques.
  • Individual works night shifts.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02439749


Contacts

  Show 33 Study Locations
Sponsors and Collaborators
Medtronic Vascular
Investigators
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

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Medtronic Vascular
ClinicalTrials.gov Identifier: NCT02439749     History of Changes
Other Study ID Numbers: SPYRAL HTN-OFF MED
First Posted: May 12, 2015    Key Record Dates
Last Update Posted: July 6, 2018
Last Verified: July 2018

Keywords provided by Medtronic Vascular:
Uncontrolled hypertension
Renal denervation

Additional relevant MeSH terms:
Hypertension
Cardiovascular Diseases
Vascular Diseases