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SPYRAL DYSTAL Clinical 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. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04311086
Recruitment Status : Recruiting
First Posted : March 17, 2020
Last Update Posted : October 26, 2020
Sponsor:
Information provided by (Responsible Party):
Medtronic Vascular

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Hypertension Vascular Diseases Cardiovascular Diseases Device: Renal Denervation (Symplicity Spyral™) Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 50 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: 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)
Actual Study Start Date : June 12, 2020
Estimated Primary Completion Date : March 14, 2021
Estimated Study Completion Date : April 30, 2022

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Renal Denervation
Renal angiography and Renal Denervation (Symplicity Spyral™ multi-electrode renal denervation system)
Device: Renal Denervation (Symplicity Spyral™)
Device: Symplicity Spyral™ multi-electrode renal denervation system. After a renal angiography according to standard procedures, subjects are treated with the renal denervation procedure.
Other Names:
  • Renal Angiography
  • Renal Denervation




Primary Outcome Measures :
  1. Change in systolic blood pressure (SBP) from baseline 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 systolic blood pressure (SBP) from baseline as measured by 24-hour Ambulatory Blood Pressure Monitoring (ABPM) [ Time Frame: From baseline to 12 months post-procedure ]
  2. Change in office systolic blood pressure [ Time Frame: From baseline to 12 months post-procedure ]
  3. Change in office diastolic blood pressure [ Time Frame: From baseline to 12 months post-procedure ]
  4. Change in office diastolic blood pressure baseline as measured by 24-hour ABPM [ Time Frame: From baseline to 12 months post-procedure ]
  5. Incidence of achieving target office BP [ Time Frame: From baseline to 12 months post-procedure ]
  6. Comparison of BP reduction pattern over 24 hours of ABPM [ Time Frame: From baseline to 12 months post-procedure ]
  7. Procedural characteristics (e.g. Procedure time, contrast media usage, etc.) [ Time Frame: Baseline ]
  8. Acute and chronic safety by evaluating incidence of Major Adverse Events [ Time Frame: From baseline to 12 months post-procedure ]
  9. Incidence of Myocardial Infarction [ Time Frame: From baseline to 12 months post-procedure ]
  10. Incidence of Stroke [ Time Frame: From baseline to 12 months post-procedure ]
  11. Incidence of Renal artery re-intervention [ Time Frame: From baseline to 12 months post-procedure ]
  12. Incidence of Major bleeding according to TIMI definition [ Time Frame: From baseline to 12 months post-procedure ]
  13. Incidence of Increase in serum creatinine >50% [ Time Frame: From baseline to 12 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 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.

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): NCT04311086


Contacts
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Contact: M Wanten +17075250111 rs.spyraldystal@medtronic.com

Locations
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United States, California
Stanford Hospital and Clinics Recruiting
Stanford, California, United States, 94305
Contact: David P Lee, MD         
United States, Georgia
Piedmont Heart Institute Recruiting
Atlanta, Georgia, United States, 30309
Contact: David Kandzari, MD         
United States, Texas
Baylor Heart & Vascular Hospital Recruiting
Dallas, Texas, United States, 75226
Contact: James Choi, MD         
Germany
Universitaetsklinikum Erlangen Recruiting
Erlangen, Germany
Contact: Roland Schmieder, MD         
Justus-Liebig-Universität Gießen Not yet recruiting
Gießen, Germany
Contact: Oliver Dörr, MD         
Universitaetsklinikum des Saarlandes Recruiting
Homburg, Germany
Contact: Felix Mahfoud, MD         
Herzzentrum Leipzig Recruiting
Leipzig, Germany
Contact: Philipp Lurz, MD         
Greece
Hippokration General Hospital of Athens Recruiting
Athens, Greece
Contact: Konstantinos Tsioufis, MD         
Italy
Ospedale di Verona Borgo Trento Recruiting
Verona, Italy
Contact: Flavio Ribichini, MD         
Netherlands
Erasmus Medical Center Withdrawn
Rotterdam, Netherlands
United Kingdom
University Hospital of Wales Not yet recruiting
Cardiff, United Kingdom
Contact: Andrew Sharp, MD         
Oxford University Hospitals NHS Trust - John Radcliffe Hospital Not yet recruiting
Oxford, United Kingdom
Contact: Adrian Banning, MD         
Sponsors and Collaborators
Medtronic Vascular
Investigators
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Principal Investigator: David P Lee, MD Stanford University
Principal Investigator: Andrew Sharp, MD University Hospital of Wales
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Responsible Party: Medtronic Vascular
ClinicalTrials.gov Identifier: NCT04311086    
Other Study ID Numbers: SPYRAL DYSTAL
First Posted: March 17, 2020    Key Record Dates
Last Update Posted: October 26, 2020
Last Verified: October 2020

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Device Product Not Approved or Cleared by U.S. FDA: Yes
Keywords provided by Medtronic Vascular:
Uncontrolled hypertension
Renal denervation
Additional relevant MeSH terms:
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Hypertension
Cardiovascular Diseases
Vascular Diseases