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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT02439749




Registration number
NCT02439749
Ethics application status
Date submitted
28/04/2015
Date registered
12/05/2015
Date last updated
18/04/2024

Titles & IDs
Public title
SPYRAL PIVOTAL - SPYRAL HTN-OFF MED Study
Scientific 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)
Secondary ID [1] 0 0
SPYRAL HTN-OFF MED
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Hypertension 0 0
Vascular Diseases 0 0
Cardiovascular Diseases 0 0
Condition category
Condition code
Cardiovascular 0 0 0 0
Hypertension
Cardiovascular 0 0 0 0
Diseases of the vasculature and circulation including the lymphatic system

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Devices - Symplicity Spyral™ multi-electrode renal denervation system
Treatment: Surgery - Sham Procedure

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

Sham comparator: Sham Procedure - Renal angiography


Treatment: Devices: 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.

Treatment: Surgery: 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.
Intervention code [1] 0 0
Treatment: Devices
Intervention code [2] 0 0
Treatment: Surgery
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Number of Participants With Major Adverse Events (MAE) Defined as a Composite of Events.
Timepoint [1] 0 0
From baseline to 1 month post-procedure
Primary outcome [2] 0 0
Baseline Adjusted Change (Using Analysis of Covariance) in Systolic Blood Pressure as Measured by 24-hour Ambulatory Blood Pressure Monitoring
Timepoint [2] 0 0
From baseline to 3 months post-procedure
Secondary outcome [1] 0 0
Baseline Adjusted Change (Using Analysis of Covariance) in Office Systolic Blood Pressure
Timepoint [1] 0 0
From baseline to 3 months post-procedure
Secondary outcome [2] 0 0
Number of Participants With Significant Embolic Event Resulting in End-organ Damage
Timepoint [2] 0 0
From baseline to 1 month post-procedure
Secondary outcome [3] 0 0
Number of Participants With Renal Artery Perforation Requiring Intervention
Timepoint [3] 0 0
From baseline to 1 month post-procedure
Secondary outcome [4] 0 0
Renal Artery Dissection
Timepoint [4] 0 0
From baseline to 1 month post-procedure
Secondary outcome [5] 0 0
Number of Participants With Vascular Complications
Timepoint [5] 0 0
From baseline to 1 month post-procedure
Secondary outcome [6] 0 0
Number of Participants With End-stage Renal Disease
Timepoint [6] 0 0
From baseline to 1 month post-procedure
Secondary outcome [7] 0 0
Number of Participants With Decline in eGFR
Timepoint [7] 0 0
From baseline to 1 month post-procedure
Secondary outcome [8] 0 0
Myocardial Infarction
Timepoint [8] 0 0
From baseline to 1 month post-procedure
Secondary outcome [9] 0 0
New Stroke
Timepoint [9] 0 0
From baseline to 1 month post-procedure
Secondary outcome [10] 0 0
Number of Participants With Renal Artery Re-intervention
Timepoint [10] 0 0
From baseline to 1 month post-procedure
Secondary outcome [11] 0 0
Number of Participants With Major Bleeding According to TIMI Definition
Timepoint [11] 0 0
From baseline to 1 month post-procedure
Secondary outcome [12] 0 0
Number of Participants With Increase in Serum Creatinine
Timepoint [12] 0 0
From baseline to 1 month post-procedure
Secondary outcome [13] 0 0
Number of Participants With New Renal Artery Stenosis > 70%
Timepoint [13] 0 0
From baseline to 6 month post-procedure
Secondary outcome [14] 0 0
Number of Participants With Hospitalization for Hypertensive Crisis With Medications or the Protocol
Timepoint [14] 0 0
From baseline to 1 month post-procedure
Secondary outcome [15] 0 0
Number of Participants With All-cause Mortality
Timepoint [15] 0 0
From baseline to 3 months post-procedure
Secondary outcome [16] 0 0
Number of Participants With Change in Systolic Blood Pressure as Measured by 24-hour ABPM
Timepoint [16] 0 0
From baseline to 36 month post-procedure
Secondary outcome [17] 0 0
Number of Participants With Incidence of Achieving Target Office Systolic Blood Pressure (SBP <140 mmHg)
Timepoint [17] 0 0
From 1 month to 36 months post-procedure
Secondary outcome [18] 0 0
Number of Participants With Change in Office Diastolic Blood Pressure
Timepoint [18] 0 0
From baseline to 36 months post-procedure
Secondary outcome [19] 0 0
Number of Participants With Change in Diastolic Blood Pressure as Measured by 24-hour ABPM
Timepoint [19] 0 0
From baseline to 36 months post-procedure
Secondary outcome [20] 0 0
Number of Participants With End-Stage Renal Disease (ESRD)
Timepoint [20] 0 0
From baseline to 3 months post randomization
Secondary outcome [21] 0 0
Number of Participants With =40% Decline in eGFR
Timepoint [21] 0 0
From baseline to 3 months post randomization
Secondary outcome [22] 0 0
Number of Participants With New Myocardial Infarction
Timepoint [22] 0 0
From baseline to 3 months post randomization
Secondary outcome [23] 0 0
New Stroke
Timepoint [23] 0 0
From baseline to 3 months post randomization
Secondary outcome [24] 0 0
Number of Participants With Renal Artery Re-intervention
Timepoint [24] 0 0
From baseline to 3 months post randomization
Secondary outcome [25] 0 0
Number of Participants With Major Bleeding According to TIMI Definition
Timepoint [25] 0 0
From baseline to 3 months post randomization
Secondary outcome [26] 0 0
Increase in Serum Creatinine
Timepoint [26] 0 0
From baseline to 3 months post randomization
Secondary outcome [27] 0 0
Number of Participants With Hospitalization for Hypertensive Crisis
Timepoint [27] 0 0
From baseline to 3 months post randomization
Secondary outcome [28] 0 0
Change in Office Systolic Blood Pressure
Timepoint [28] 0 0
From baseline to 1 month post procedure
Secondary outcome [29] 0 0
Number of Participants Achieving Target Office Systolic Blood Pressure
Timepoint [29] 0 0
From baseline to 1 month post procedure
Secondary outcome [30] 0 0
Number of Participants Achieving Target Office Systolic Blood Pressure
Timepoint [30] 0 0
From baseline to 3 months post procedure
Secondary outcome [31] 0 0
Change in Office Diastolic Blood Pressure
Timepoint [31] 0 0
From baseline to 1 month post procedure
Secondary outcome [32] 0 0
Change in Office Diastolic Blood Pressure
Timepoint [32] 0 0
From baseline to 3 months post procedure
Secondary outcome [33] 0 0
Change in Diastolic Blood Pressure as Measured by 24-hour Ambulatory Blood Pressure Monitoring (ABPM)
Timepoint [33] 0 0
From baseline to 3 months post procedure

Eligibility
Key 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.
Minimum age
20 Years
Maximum age
80 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key 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.

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s


Intervention assignment
Parallel
Other design features
Phase
Not applicable
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
1/06/2015
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
25/10/2023
Sample size
Target
Accrual to date
Final
366
Recruitment in Australia
Recruitment state(s)
VIC
Recruitment hospital [1] 0 0
Alfred Hospital - Melbourne
Recruitment postcode(s) [1] 0 0
3004 - Melbourne
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
Alabama
Country [2] 0 0
United States of America
State/province [2] 0 0
Arizona
Country [3] 0 0
United States of America
State/province [3] 0 0
California
Country [4] 0 0
United States of America
State/province [4] 0 0
Connecticut
Country [5] 0 0
United States of America
State/province [5] 0 0
Florida
Country [6] 0 0
United States of America
State/province [6] 0 0
Georgia
Country [7] 0 0
United States of America
State/province [7] 0 0
Iowa
Country [8] 0 0
United States of America
State/province [8] 0 0
Kentucky
Country [9] 0 0
United States of America
State/province [9] 0 0
Michigan
Country [10] 0 0
United States of America
State/province [10] 0 0
Minnesota
Country [11] 0 0
United States of America
State/province [11] 0 0
Mississippi
Country [12] 0 0
United States of America
State/province [12] 0 0
Missouri
Country [13] 0 0
United States of America
State/province [13] 0 0
New Jersey
Country [14] 0 0
United States of America
State/province [14] 0 0
New York
Country [15] 0 0
United States of America
State/province [15] 0 0
North Carolina
Country [16] 0 0
United States of America
State/province [16] 0 0
Ohio
Country [17] 0 0
United States of America
State/province [17] 0 0
Pennsylvania
Country [18] 0 0
United States of America
State/province [18] 0 0
Rhode Island
Country [19] 0 0
United States of America
State/province [19] 0 0
South Carolina
Country [20] 0 0
United States of America
State/province [20] 0 0
Tennessee
Country [21] 0 0
United States of America
State/province [21] 0 0
Texas
Country [22] 0 0
United States of America
State/province [22] 0 0
West Virginia
Country [23] 0 0
United States of America
State/province [23] 0 0
Wisconsin
Country [24] 0 0
Austria
State/province [24] 0 0
Wels
Country [25] 0 0
Canada
State/province [25] 0 0
Ontario
Country [26] 0 0
Canada
State/province [26] 0 0
Quebec
Country [27] 0 0
Germany
State/province [27] 0 0
Bad Krozingen
Country [28] 0 0
Germany
State/province [28] 0 0
Erlangen
Country [29] 0 0
Germany
State/province [29] 0 0
Homburg
Country [30] 0 0
Germany
State/province [30] 0 0
Leipzig
Country [31] 0 0
Germany
State/province [31] 0 0
Lübeck
Country [32] 0 0
Greece
State/province [32] 0 0
Athens
Country [33] 0 0
Greece
State/province [33] 0 0
Thessaloniki
Country [34] 0 0
Ireland
State/province [34] 0 0
Galway
Country [35] 0 0
Japan
State/province [35] 0 0
Tochigi
Country [36] 0 0
Japan
State/province [36] 0 0
Tokyo
Country [37] 0 0
United Kingdom
State/province [37] 0 0
Cardiff
Country [38] 0 0
United Kingdom
State/province [38] 0 0
Exeter
Country [39] 0 0
United Kingdom
State/province [39] 0 0
London

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
Medtronic Vascular
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Raymond Townsend, MD
Address 0 0
University of Pennsylvania
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries

No information has been provided regarding IPD availability


What supporting documents are/will be available?




Results publications and other study-related documents

No documents have been uploaded by study researchers.

Results are available at https://clinicaltrials.gov/study/NCT02439749