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SPYRAL DYSTAL Renal Denervation Global Clinical Study

Primary Purpose

Hypertension, Vascular Diseases, Cardiovascular Diseases

Status
Completed
Phase
Not Applicable
Locations
International
Study Type
Interventional
Intervention
Renal Denervation (Symplicity Spyral™)
Sponsored by
Medtronic Vascular
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Hypertension focused on measuring Uncontrolled hypertension, Renal denervation

Eligibility Criteria

20 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Stanford Hospital and Clinics
  • Piedmont Heart Institute
  • Baylor Heart & Vascular Hospital
  • Universitaetsklinikum Erlangen
  • Universitaetsklinikum des Saarlandes
  • Herzzentrum Leipzig
  • Hippokration General Hospital of Athens
  • University Hospital of Wales

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Renal Denervation

Arm Description

Renal angiography and Renal Denervation (Symplicity Spyral™ multi-electrode renal denervation system)

Outcomes

Primary Outcome Measures

Change in systolic blood pressure (SBP) from baseline as measured by 24-hour Ambulatory Blood Pressure Monitoring (ABPM)

Secondary Outcome Measures

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

Full Information

First Posted
March 12, 2020
Last Updated
October 10, 2023
Sponsor
Medtronic Vascular
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1. Study Identification

Unique Protocol Identification Number
NCT04311086
Brief Title
SPYRAL DYSTAL Renal Denervation Global Clinical Study
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)
Study Type
Interventional

2. Study Status

Record Verification Date
October 2023
Overall Recruitment Status
Completed
Study Start Date
June 12, 2020 (Actual)
Primary Completion Date
December 22, 2022 (Actual)
Study Completion Date
December 22, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Medtronic Vascular

4. Oversight

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
Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hypertension, Vascular Diseases, Cardiovascular Diseases
Keywords
Uncontrolled hypertension, Renal denervation

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
128 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Renal Denervation
Arm Type
Experimental
Arm Description
Renal angiography and Renal Denervation (Symplicity Spyral™ multi-electrode renal denervation system)
Intervention Type
Device
Intervention Name(s)
Renal Denervation (Symplicity Spyral™)
Other Intervention Name(s)
Renal Angiography, Renal Denervation
Intervention Description
Device: Symplicity Spyral™ multi-electrode renal denervation system. After a renal angiography according to standard procedures, subjects are treated with the renal denervation procedure.
Primary Outcome Measure Information:
Title
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
Secondary Outcome Measure Information:
Title
Change in office systolic blood pressure
Time Frame
From baseline to 12 months post-procedure
Title
Change in office diastolic blood pressure
Time Frame
From baseline to 12 months post-procedure
Title
Change in office diastolic blood pressure baseline as measured by 24-hour ABPM
Time Frame
From baseline to 12 months post-procedure
Title
Incidence of achieving target office BP
Time Frame
From baseline to 12 months post-procedure
Title
Comparison of BP reduction pattern over 24 hours of ABPM
Time Frame
From baseline to 12 months post-procedure
Title
Procedural characteristics (e.g. Procedure time, contrast media usage, etc.)
Time Frame
Baseline
Title
Acute and chronic safety by evaluating incidence of Major Adverse Events
Time Frame
From baseline to 12 months post-procedure
Title
Incidence of Myocardial Infarction
Time Frame
From baseline to 12 months post-procedure
Title
Incidence of Stroke
Time Frame
From baseline to 12 months post-procedure
Title
Incidence of Renal artery re-intervention
Time Frame
From baseline to 12 months post-procedure
Title
Incidence of Major bleeding according to TIMI definition
Time Frame
From baseline to 12 months post-procedure
Title
Incidence of Increase in serum creatinine >50%
Time Frame
From baseline to 12 months post-procedure

10. Eligibility

Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
David P Lee, MD
Organizational Affiliation
Stanford University
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Andrew Sharp, MD
Organizational Affiliation
University Hospital of Wales
Official's Role
Principal Investigator
Facility Information:
Facility Name
Stanford Hospital and Clinics
City
Stanford
State/Province
California
ZIP/Postal Code
94305
Country
United States
Facility Name
Piedmont Heart Institute
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30309
Country
United States
Facility Name
Baylor Heart & Vascular Hospital
City
Dallas
State/Province
Texas
ZIP/Postal Code
75226
Country
United States
Facility Name
Universitaetsklinikum Erlangen
City
Erlangen
Country
Germany
Facility Name
Universitaetsklinikum des Saarlandes
City
Homburg
Country
Germany
Facility Name
Herzzentrum Leipzig
City
Leipzig
Country
Germany
Facility Name
Hippokration General Hospital of Athens
City
Athens
Country
Greece
Facility Name
University Hospital of Wales
City
Cardiff
Country
United Kingdom

12. IPD Sharing Statement

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