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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 : May 11, 2022
Sponsor:
Information provided by (Responsible Party):
Medtronic Vascular

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Single (Participant);   Primary Purpose: Treatment
Conditions Hypertension
Vascular Diseases
Cardiovascular Diseases
Interventions Device: Symplicity Spyral™ multi-electrode renal denervation system
Procedure: Sham Procedure
Enrollment 366
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Renal Denervation Sham Procedure
Hide Arm/Group Description

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

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.

Renal angiography

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.

Period Title: Overall Study
Started 182 184
Completed 153 147
Not Completed 29 37
Arm/Group Title Renal Denervation Sham Procedure Total
Hide Arm/Group Description

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

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.

Renal angiography

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.

Total of all reporting groups
Overall Number of Baseline Participants 182 184 366
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 182 participants 184 participants 366 participants
<=18 years
0
   0.0%
0
   0.0%
0
   0.0%
Between 18 and 65 years
158
  86.8%
167
  90.8%
325
  88.8%
>=65 years
24
  13.2%
17
   9.2%
41
  11.2%
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 182 participants 184 participants 366 participants
52.5  (10.8) 52.7  (10.1) 52.6  (10.45)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 182 participants 184 participants 366 participants
Female
65
  35.7%
56
  30.4%
121
  33.1%
Male
117
  64.3%
128
  69.6%
245
  66.9%
Race/Ethnicity, Customized  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 182 participants 184 participants 366 participants
American Indian or Alaska Native
0
   0.0%
0
   0.0%
0
   0.0%
Asian
7
   3.8%
2
   1.1%
9
   2.5%
Native Hawaiian or Other Pacific Islander
0
   0.0%
0
   0.0%
0
   0.0%
Black or African American
37
  20.3%
32
  17.4%
69
  18.9%
White
56
  30.8%
60
  32.6%
116
  31.7%
Japanese from Japan
3
   1.6%
2
   1.1%
5
   1.4%
Other
1
   0.5%
1
   0.5%
2
   0.5%
Unknown or Not Reported
78
  42.9%
87
  47.3%
165
  45.1%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 182 participants 184 participants 366 participants
Greece 28 30 58
Canada 3 2 5
Austria 3 4 7
United States 91 85 176
Japan 3 2 5
Ireland 7 7 14
United Kingdom 6 10 16
Australia 7 6 13
Germany 34 38 72
1.Primary Outcome
Title Number of Participants With Major Adverse Events (MAE) Defined as a Composite of Events.
Hide Description 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)
Time Frame From baseline to 1 month post-procedure
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Renal Denervation Sham Procedure
Hide Arm/Group Description:

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

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.

Renal angiography

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.

Overall Number of Participants Analyzed 182 184
Measure Type: Count of Participants
Unit of Measure: Participants
0
   0.0%
0
   0.0%
2.Primary Outcome
Title Baseline Adjusted Change (Using Analysis of Covariance) in Systolic Blood Pressure as Measured by 24-hour Ambulatory Blood Pressure Monitoring
Hide Description 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.
Time Frame From baseline to 3 months post-procedure
Hide Outcome Measure Data
Hide Analysis Population Description
The number of participants analyzed reflects the number of subjects within each treatment arm who have data available for outcome measure analysis. This number can be variable from the number of subjects in each treatment arm at study start.
Arm/Group Title Renal Denervation Sham Procedure
Hide Arm/Group Description:

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

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.

Renal angiography

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.

Overall Number of Participants Analyzed 153 147
Mean (Standard Deviation)
Unit of Measure: mmHg
-4.5  (10.8) -0.6  (8.7)
3.Secondary Outcome
Title Baseline Adjusted Change (Using Analysis of Covariance) in Office Systolic Blood Pressure
Hide Description 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.
Time Frame From baseline to 3 months post-procedure
Hide Outcome Measure Data
Hide Analysis Population Description
The number of participants analyzed reflects the number of subjects within each treatment arm who have data available for outcome measure analysis. This number can be variable from the number of subjects in each treatment arm at study start.
Arm/Group Title Renal Denervation Sham Procedure
Hide Arm/Group Description:

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

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.

Renal angiography

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.

Overall Number of Participants Analyzed 170 164
Mean (Standard Deviation)
Unit of Measure: mmHg
-9.3  (14.7) -2.3  (12.7)
4.Secondary Outcome
Title Number of Participants With Significant Embolic Event Resulting in End-organ Damage
Hide Description 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)
Time Frame From baseline to 1 month post-procedure
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Renal Denervation Sham Procedure
Hide Arm/Group Description:

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

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.

Renal angiography

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.

Overall Number of Participants Analyzed 182 184
Measure Type: Count of Participants
Unit of Measure: Participants
0
   0.0%
0
   0.0%
5.Secondary Outcome
Title Number of Participants With Renal Artery Perforation Requiring Intervention
Hide Description Renal artery perforation requiring intervention
Time Frame From baseline to 1 month post-procedure
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Renal Denervation Sham Procedure
Hide Arm/Group Description:

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

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.

Renal angiography

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.

Overall Number of Participants Analyzed 182 184
Measure Type: Count of Participants
Unit of Measure: Participants
0
   0.0%
0
   0.0%
6.Secondary Outcome
Title Renal Artery Dissection
Hide Description Number of Participants with Renal artery dissection requiring intervention
Time Frame From baseline to 1 month post-procedure
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Renal Denervation Sham Procedure
Hide Arm/Group Description:

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

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.

Renal angiography

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.

Overall Number of Participants Analyzed 182 184
Measure Type: Count of Participants
Unit of Measure: Participants
0
   0.0%
0
   0.0%
7.Secondary Outcome
Title Number of Participants With Vascular Complications
Hide Description 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).
Time Frame From baseline to 1 month post-procedure
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Renal Denervation Sham Procedure
Hide Arm/Group Description:

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

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.

Renal angiography

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.

Overall Number of Participants Analyzed 182 184
Measure Type: Count of Participants
Unit of Measure: Participants
0
   0.0%
1
   0.5%
8.Secondary Outcome
Title Number of Participants With End-stage Renal Disease
Hide Description

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
Time Frame From baseline to 1 month post-procedure
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Renal Denervation Sham Procedure
Hide Arm/Group Description:

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

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.

Renal angiography

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.

Overall Number of Participants Analyzed 182 184
Measure Type: Count of Participants
Unit of Measure: Participants
0
   0.0%
0
   0.0%
9.Secondary Outcome
Title Number of Participants With Decline in eGFR
Hide Description ≥40% decline in eGFR
Time Frame From baseline to 1 month post-procedure
Hide Outcome Measure Data
Hide Analysis Population Description
The number of participants analyzed reflects the number of subjects within each treatment arm who have data available for outcome measure analysis. This number can be variable from the number of subjects in each treatment arm at study start.
Arm/Group Title Renal Denervation Sham Procedure
Hide Arm/Group Description:

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

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.

Renal angiography

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.

Overall Number of Participants Analyzed 172 170
Measure Type: Count of Participants
Unit of Measure: Participants
0
   0.0%
0
   0.0%
10.Secondary Outcome
Title Myocardial Infarction
Hide Description Number of Participants with New myocardial infarction
Time Frame From baseline to 1 month post-procedure
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Renal Denervation Sham Procedure
Hide Arm/Group Description:

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

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.

Renal angiography

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.

Overall Number of Participants Analyzed 182 184
Measure Type: Count of Participants
Unit of Measure: Participants
0
   0.0%
0
   0.0%
11.Secondary Outcome
Title New Stroke
Hide Description Number of Participants with New stroke
Time Frame From baseline to 1 month post-procedure
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Renal Denervation Sham Procedure
Hide Arm/Group Description:

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

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.

Renal angiography

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.

Overall Number of Participants Analyzed 182 184
Measure Type: Count of Participants
Unit of Measure: Participants
0
   0.0%
0
   0.0%
12.Secondary Outcome
Title Number of Participants With Renal Artery Re-intervention
Hide Description Renal artery re-intervention
Time Frame From baseline to 1 month post-procedure
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Renal Denervation Sham Procedure
Hide Arm/Group Description:

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

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.

Renal angiography

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.

Overall Number of Participants Analyzed 182 184
Measure Type: Count of Participants
Unit of Measure: Participants
0
   0.0%
0
   0.0%
13.Secondary Outcome
Title Number of Participants With Major Bleeding According to TIMI Definition
Hide Description 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).
Time Frame From baseline to 1 month post-procedure
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Renal Denervation Sham Procedure
Hide Arm/Group Description:

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

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.

Renal angiography

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.

Overall Number of Participants Analyzed 182 184
Measure Type: Count of Participants
Unit of Measure: Participants
0
   0.0%
0
   0.0%
14.Secondary Outcome
Title Number of Participants With Increase in Serum Creatinine
Hide Description Increase in serum creatinine > 50% from screening visit 2.
Time Frame From baseline to 1 month post-procedure
Hide Outcome Measure Data
Hide Analysis Population Description
The number of participants analyzed reflects the number of subjects within each treatment arm who have data available for outcome measure analysis. This number can be variable from the number of subjects in each treatment arm at study start.
Arm/Group Title Renal Denervation Sham Procedure
Hide Arm/Group Description:

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

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.

Renal angiography

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.

Overall Number of Participants Analyzed 172 170
Measure Type: Count of Participants
Unit of Measure: Participants
1
   0.6%
0
   0.0%
15.Secondary Outcome
Title Number of Participants With New Renal Artery Stenosis > 70%
Hide Description Confirmed by angiography and as determined by the angiographic core laboratory.
Time Frame From baseline to 6 month post-procedure
Outcome Measure Data Not Reported
16.Secondary Outcome
Title Number of Participants With Hospitalization for Hypertensive Crisis With Medications or the Protocol
Hide Description Hospitalization for hypertensive crisis not related to confirmed non-adherence with medications or the protocol.
Time Frame From baseline to 1 month post-procedure
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Renal Denervation Sham Procedure
Hide Arm/Group Description:

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

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.

Renal angiography

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.

Overall Number of Participants Analyzed 182 184
Measure Type: Count of Participants
Unit of Measure: Participants
0
   0.0%
0
   0.0%
17.Secondary Outcome
Title Number of Participants With All-cause Mortality
Hide Description All-cause mortality
Time Frame From baseline to 3 months post-procedure
Hide Outcome Measure Data
Hide Analysis Population Description
The number of participants analyzed reflects the number of subjects within each treatment arm who have data available for outcome measure analysis. This number can be variable from the number of subjects in each treatment arm at study start.
Arm/Group Title Renal Denervation Sham Procedure
Hide Arm/Group Description:

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

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.

Renal angiography

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.

Overall Number of Participants Analyzed 180 184
Measure Type: Count of Participants
Unit of Measure: Participants
0
   0.0%
0
   0.0%
18.Secondary Outcome
Title Number of Participants With Change in Systolic Blood Pressure as Measured by 24-hour ABPM
Hide Description [Not Specified]
Time Frame From baseline to 36 month post-procedure
Outcome Measure Data Not Reported
19.Secondary Outcome
Title Number of Participants With Incidence of Achieving Target Office Systolic Blood Pressure (SBP <140 mmHg)
Hide Description [Not Specified]
Time Frame From 1 month to 36 months post-procedure
Outcome Measure Data Not Reported
20.Secondary Outcome
Title Number of Participants With Change in Office Diastolic Blood Pressure
Hide Description Change in office diastolic blood pressure
Time Frame From baseline to 36 months post-procedure
Outcome Measure Data Not Reported
21.Secondary Outcome
Title Number of Participants With Change in Diastolic Blood Pressure as Measured by 24-hour ABPM
Hide Description Change in diastolic blood pressure as measured by 24-hour ABPM
Time Frame From baseline to 36 months post-procedure
Outcome Measure Data Not Reported
22.Secondary Outcome
Title Number of Participants With End-Stage Renal Disease (ESRD)
Hide Description

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
Time Frame From baseline to 3 months post randomization
Hide Outcome Measure Data
Hide Analysis Population Description
The number of participants analyzed reflects the number of subjects within each treatment arm who have data available for outcome measure analysis. This number can be variable from the number of subjects in each treatment arm at study start.
Arm/Group Title Renal Denervation Sham Procedure
Hide Arm/Group Description:

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

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.

Renal angiography

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.

Overall Number of Participants Analyzed 180 184
Measure Type: Count of Participants
Unit of Measure: Participants
0
   0.0%
0
   0.0%
23.Secondary Outcome
Title Number of Participants With ≥40% Decline in eGFR
Hide Description ≥40% Decline in eGFR
Time Frame From baseline to 3 months post randomization
Hide Outcome Measure Data
Hide Analysis Population Description
The number of participants analyzed reflects the number of subjects within each treatment arm who have data available for outcome measure analysis. This number can be variable from the number of subjects in each treatment arm at study start.
Arm/Group Title Renal Denervation Sham Procedure
Hide Arm/Group Description:

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

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.

Renal angiography

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.

Overall Number of Participants Analyzed 165 149
Measure Type: Count of Participants
Unit of Measure: Participants
0
   0.0%
0
   0.0%
24.Secondary Outcome
Title Number of Participants With New Myocardial Infarction
Hide Description New Myocardial Infarction
Time Frame From baseline to 3 months post randomization
Hide Outcome Measure Data
Hide Analysis Population Description
The number of participants analyzed reflects the number of subjects within each treatment arm who have data available for outcome measure analysis. This number can be variable from the number of subjects in each treatment arm at study start.
Arm/Group Title Renal Denervation Sham Procedure
Hide Arm/Group Description:

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

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.

Renal angiography

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.

Overall Number of Participants Analyzed 180 184
Measure Type: Count of Participants
Unit of Measure: Participants
0
   0.0%
0
   0.0%
25.Secondary Outcome
Title New Stroke
Hide Description Number of Participants with New Stroke
Time Frame From baseline to 3 months post randomization
Hide Outcome Measure Data
Hide Analysis Population Description
The number of participants analyzed reflects the number of subjects within each treatment arm who have data available for outcome measure analysis. This number can be variable from the number of subjects in each treatment arm at study start.
Arm/Group Title Renal Denervation Sham Procedure
Hide Arm/Group Description:

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

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.

Renal angiography

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.

Overall Number of Participants Analyzed 180 184
Measure Type: Count of Participants
Unit of Measure: Participants
0
   0.0%
0
   0.0%
26.Secondary Outcome
Title Number of Participants With Renal Artery Re-intervention
Hide Description Renal Artery Re-intervention
Time Frame From baseline to 3 months post randomization
Hide Outcome Measure Data
Hide Analysis Population Description
The number of participants analyzed reflects the number of subjects within each treatment arm who have data available for outcome measure analysis. This number can be variable from the number of subjects in each treatment arm at study start.
Arm/Group Title Renal Denervation Sham Procedure
Hide Arm/Group Description:

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

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.

Renal angiography

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.

Overall Number of Participants Analyzed 180 184
Measure Type: Count of Participants
Unit of Measure: Participants
0
   0.0%
0
   0.0%
27.Secondary Outcome
Title Number of Participants With Major Bleeding According to TIMI Definition
Hide Description 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).
Time Frame From baseline to 3 months post randomization
Hide Outcome Measure Data
Hide Analysis Population Description
The number of participants analyzed reflects the number of subjects within each treatment arm who have data available for outcome measure analysis. This number can be variable from the number of subjects in each treatment arm at study start.
Arm/Group Title Renal Denervation Sham Procedure
Hide Arm/Group Description:

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

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.

Renal angiography

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.

Overall Number of Participants Analyzed 180 184
Measure Type: Count of Participants
Unit of Measure: Participants
0
   0.0%
0
   0.0%
28.Secondary Outcome
Title Increase in Serum Creatinine
Hide Description Number of Participants with Increase in Serum Creatinine > 50% from screening visit 2.
Time Frame From baseline to 3 months post randomization
Hide Outcome Measure Data
Hide Analysis Population Description
The number of participants analyzed reflects the number of subjects within each treatment arm who have data available for outcome measure analysis. This number can be variable from the number of subjects in each treatment arm at study start.
Arm/Group Title Renal Denervation Sham Procedure
Hide Arm/Group Description:

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

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.

Renal angiography

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.

Overall Number of Participants Analyzed 165 149
Measure Type: Count of Participants
Unit of Measure: Participants
0
   0.0%
0
   0.0%
29.Secondary Outcome
Title Number of Participants With Hospitalization for Hypertensive Crisis
Hide Description Hospitalization for Hypertensive Crisis Not Related to Confirmed Nonadherence With Medications or the Protocol
Time Frame From baseline to 3 months post randomization
Hide Outcome Measure Data
Hide Analysis Population Description
The number of participants analyzed reflects the number of subjects within each treatment arm who have data available for outcome measure analysis. This number can be variable from the number of subjects in each treatment arm at study start.
Arm/Group Title Renal Denervation Sham Procedure
Hide Arm/Group Description:

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

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.

Renal angiography

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.

Overall Number of Participants Analyzed 180 184
Measure Type: Count of Participants
Unit of Measure: Participants
1
   0.6%
0
   0.0%
30.Secondary Outcome
Title Change in Office Systolic Blood Pressure
Hide Description Change in office systolic blood pressure from baseline (Screening Visit 2) to 1-month
Time Frame From baseline to 1 month post procedure
Hide Outcome Measure Data
Hide Analysis Population Description
The number of participants analyzed reflects the number of subjects within each treatment arm who have data available for outcome measure analysis. This number can be variable from the number of subjects in each treatment arm at study start.
Arm/Group Title Renal Denervation Sham Procedure
Hide Arm/Group Description:

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

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.

Renal angiography

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.

Overall Number of Participants Analyzed 170 169
Mean (Standard Deviation)
Unit of Measure: mmHg
-10.2  (14.0) -5.7  (11.8)
31.Secondary Outcome
Title Number of Participants Achieving Target Office Systolic Blood Pressure
Hide Description Incidence of achieving target office systolic blood pressure (SBP <140 mmHg)
Time Frame From baseline to 1 month post procedure
Hide Outcome Measure Data
Hide Analysis Population Description
The number of participants analyzed reflects the number of subjects within each treatment arm who have data available for outcome measure analysis. This number can be variable from the number of subjects in each treatment arm at study start.
Arm/Group Title Renal Denervation Sham Procedure
Hide Arm/Group Description:

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

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.

Renal angiography

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.

Overall Number of Participants Analyzed 170 169
Measure Type: Count of Participants
Unit of Measure: Participants
32
  18.8%
11
   6.5%
32.Secondary Outcome
Title Number of Participants Achieving Target Office Systolic Blood Pressure
Hide Description Incidence of Achieving Target Office Systolic Blood Pressure (SBP <140 mmHg)
Time Frame From baseline to 3 months post procedure
Hide Outcome Measure Data
Hide Analysis Population Description
The number of participants analyzed reflects the number of subjects within each treatment arm who have data available for outcome measure analysis. This number can be variable from the number of subjects in each treatment arm at study start.
Arm/Group Title Renal Denervation Sham Procedure
Hide Arm/Group Description:

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

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.

Renal angiography

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.

Overall Number of Participants Analyzed 170 164
Measure Type: Count of Participants
Unit of Measure: Participants
26
  15.3%
12
   7.3%
33.Secondary Outcome
Title Change in Office Diastolic Blood Pressure
Hide Description Change in office diastolic blood pressure from baseline (Screening Visit 2)
Time Frame From baseline to 1 month post procedure
Hide Outcome Measure Data
Hide Analysis Population Description
The number of participants analyzed reflects the number of subjects within each treatment arm who have data available for outcome measure analysis. This number can be variable from the number of subjects in each treatment arm at study start.
Arm/Group Title Renal Denervation Sham Procedure
Hide Arm/Group Description:

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

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.

Renal angiography

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.

Overall Number of Participants Analyzed 170 169
Mean (Standard Deviation)
Unit of Measure: mmHg
-5.3  (8.3) -2.8  (7.6)
34.Secondary Outcome
Title Change in Office Diastolic Blood Pressure
Hide Description Change in Office Diastolic Blood Pressure From Baseline (Screening Visit 2) to 3-months
Time Frame From baseline to 3 months post procedure
Hide Outcome Measure Data
Hide Analysis Population Description
The number of participants analyzed reflects the number of subjects within each treatment arm who have data available for outcome measure analysis. This number can be variable from the number of subjects in each treatment arm at study start.
Arm/Group Title Renal Denervation Sham Procedure
Hide Arm/Group Description:

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

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.

Renal angiography

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.

Overall Number of Participants Analyzed 170 164
Mean (Standard Deviation)
Unit of Measure: mmHg
-9.3  (14.7) -2.3  (12.7)
35.Secondary Outcome
Title Change in Diastolic Blood Pressure as Measured by 24-hour Ambulatory Blood Pressure Monitoring (ABPM)
Hide Description Change in diastolic blood pressure from baseline (screening visit 2) to 3-month as measured by 24-hour Ambulatory Blood Pressure Monitoring (ABPM).
Time Frame From baseline to 3 months post procedure
Hide Outcome Measure Data
Hide Analysis Population Description
The number of participants analyzed reflects the number of subjects within each treatment arm who have data available for outcome measure analysis. This number can be variable from the number of subjects in each treatment arm at study start.
Arm/Group Title Renal Denervation Sham Procedure
Hide Arm/Group Description:

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

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.

Renal angiography

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.

Overall Number of Participants Analyzed 153 147
Mean (Standard Deviation)
Unit of Measure: mmHg
-3.5  (6.7) -0.8  (5.7)
Time Frame 3 months.
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Renal Denervation Sham Procedure
Hide Arm/Group Description

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

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.

Renal angiography

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.

All-Cause Mortality
Renal Denervation Sham Procedure
Affected / at Risk (%) Affected / at Risk (%)
Total   0/182 (0.00%)      0/184 (0.00%)    
Hide Serious Adverse Events
Renal Denervation Sham Procedure
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   14/182 (7.69%)      7/184 (3.80%)    
Cardiac disorders     
Angina Pectoris  1  1/182 (0.55%)  1 0/184 (0.00%)  0
Atrial Fibrillation  1  1/182 (0.55%)  1 0/184 (0.00%)  0
Cardiac Arrest  1  1/182 (0.55%)  1 0/184 (0.00%)  0
Cardiac Failure  1  1/182 (0.55%)  1 0/184 (0.00%)  0
Gastrointestinal disorders     
Gastritis  1  1/182 (0.55%)  1 0/184 (0.00%)  0
Infections and infestations     
Abscess  1  1/182 (0.55%)  1 0/184 (0.00%)  0
Infection  1  1/182 (0.55%)  1 0/184 (0.00%)  0
Sepsis  1  1/182 (0.55%)  1 0/184 (0.00%)  0
Injury, poisoning and procedural complications     
Concussion  1  1/182 (0.55%)  1 0/184 (0.00%)  0
Tendon Rupture  1  1/182 (0.55%)  1 0/184 (0.00%)  0
Vascular Access Site Haematoma  1  1/182 (0.55%)  1 2/184 (1.09%)  2
Musculoskeletal and connective tissue disorders     
Arthralgia  1  0/182 (0.00%)  0 1/184 (0.54%)  1
Osteoarthritis  1  1/182 (0.55%)  1 0/184 (0.00%)  0
Vertebral Foraminal Stenosis  1  1/182 (0.55%)  1 0/184 (0.00%)  0
Neoplasms benign, malignant and unspecified (incl cysts and polyps)     
Gastric Neoplasm  1  1/182 (0.55%)  1 0/184 (0.00%)  0
Nervous system disorders     
Aphasia  1  1/182 (0.55%)  1 0/184 (0.00%)  0
Carpal Tunnel Syndrome  1  0/182 (0.00%)  0 1/184 (0.54%)  1
Cerebrovascular Accident  1  0/182 (0.00%)  0 1/184 (0.54%)  1
Dizziness  1  0/182 (0.00%)  0 1/184 (0.54%)  1
Primary Headache Associated With Sexual Activity  1  0/182 (0.00%)  0 1/184 (0.54%)  1
Transient Ischaemic Attack  1  1/182 (0.55%)  1 0/184 (0.00%)  0
Reproductive system and breast disorders     
Benign Prostatic Hyperplasia  1  1/182 (0.55%)  1 0/184 (0.00%)  0
Vascular disorders     
Hypertensive Crisis  1  1/182 (0.55%)  1 0/184 (0.00%)  0
1
Term from vocabulary, MedDRA 14.1
Indicates events were collected by systematic assessment
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Renal Denervation Sham Procedure
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   33/182 (18.13%)      40/184 (21.74%)    
Injury, poisoning and procedural complications     
Vascular Access Site Haematoma  1  15/182 (8.24%)  15 20/184 (10.87%)  20
Nervous system disorders     
Headache  1  22/182 (12.09%)  27 24/184 (13.04%)  26
1
Term from vocabulary, MedDRA 14.1
Indicates events were collected by systematic assessment
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Pamela McKenna, Sr. Principal Clinical Research Specialist
Organization: Medtronic
Phone: (773) 597-5241
EMail: pamela.m.mckenna@medtronic.com
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Layout table for additonal information
Responsible Party: Medtronic Vascular
ClinicalTrials.gov Identifier: NCT02439749    
Other Study ID Numbers: SPYRAL HTN-OFF MED
First Submitted: April 28, 2015
First Posted: May 12, 2015
Results First Submitted: April 30, 2021
Results First Posted: May 27, 2021
Last Update Posted: May 11, 2022