Trial Outcomes & Findings for SPYRAL DYSTAL Renal Denervation Global Clinical Study (NCT NCT04311086)
NCT ID: NCT04311086
Last Updated: 2024-04-17
Results Overview
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
128 participants
Primary outcome timeframe
From Baseline (SV2) to 12 months post-procedure
Results posted on
2024-04-17
Participant Flow
Comparison of this study and the SPYRAL HTN-OFF MED study (NCT02439749) who, after a renal angiography according to standard procedures, are treated with the renal denervation procedure have been made for several end points and noted in the descriptions.
Participant milestones
| Measure |
Renal Denervation
Renal angiography and Renal Denervation (Symplicity Spyral™ multi-electrode renal denervation system)
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.
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|---|---|
|
Overall Study
STARTED
|
128
|
|
Overall Study
COMPLETED
|
56
|
|
Overall Study
NOT COMPLETED
|
72
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
SPYRAL DYSTAL Renal Denervation Global Clinical Study
Baseline characteristics by cohort
| Measure |
Renal Denervation
n=56 Participants
Renal angiography and Renal Denervation (Symplicity Spyral™ multi-electrode renal denervation system)
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.
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|---|---|
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Age, Continuous
|
56.3 Years
STANDARD_DEVIATION 9.1 • n=93 Participants
|
|
Sex: Female, Male
Female
|
17 Participants
n=93 Participants
|
|
Sex: Female, Male
Male
|
39 Participants
n=93 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
1 Participants
n=93 Participants
|
|
Race (NIH/OMB)
Asian
|
1 Participants
n=93 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=93 Participants
|
|
Race (NIH/OMB)
Black or African American
|
3 Participants
n=93 Participants
|
|
Race (NIH/OMB)
White
|
23 Participants
n=93 Participants
|
|
Race (NIH/OMB)
More than one race
|
1 Participants
n=93 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
27 Participants
n=93 Participants
|
|
Region of Enrollment
Greece
|
7 participants
n=93 Participants
|
|
Region of Enrollment
United States
|
24 participants
n=93 Participants
|
|
Region of Enrollment
United Kingdom
|
5 participants
n=93 Participants
|
|
Region of Enrollment
Italy
|
6 participants
n=93 Participants
|
|
Region of Enrollment
Germany
|
14 participants
n=93 Participants
|
PRIMARY outcome
Timeframe: From Baseline (SV2) to 12 months post-procedurePopulation: Subjects with evaluable data
Outcome measures
| Measure |
Renal Denervation
n=46 Participants
Renal angiography and Renal Denervation (Symplicity Spyral™ multi-electrode renal denervation system)
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.
|
|---|---|
|
Change in Systolic Blood Pressure (SBP) as Measured by 24-hour Ambulatory Blood Pressure Monitoring (ABPM)
|
-16.6 mmHg
Standard Deviation 10.6
|
SECONDARY outcome
Timeframe: From Baseline (SV2) to 3 months post-procedurePopulation: Subjects with evaluable data
Outcome measures
| Measure |
Renal Denervation
n=53 Participants
Renal angiography and Renal Denervation (Symplicity Spyral™ multi-electrode renal denervation system)
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.
|
|---|---|
|
Change in Systolic Blood Pressure (SBP) as Measured by 24-hour Ambulatory Blood Pressure Monitoring (ABPM)
|
-1.4 mmHg
Standard Deviation 10.0
|
SECONDARY outcome
Timeframe: From Baseline (SV2) to 3 months post-procedurePopulation: Subjects with evaluable data
Outcome measures
| Measure |
Renal Denervation
n=55 Participants
Renal angiography and Renal Denervation (Symplicity Spyral™ multi-electrode renal denervation system)
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.
|
|---|---|
|
Change in Office Systolic Blood Pressure (SBP)
|
-9.0 mmHg
Standard Deviation 13.9
|
SECONDARY outcome
Timeframe: From Baseline (SV2) to 12 months post-procedureOutcome measures
| Measure |
Renal Denervation
n=56 Participants
Renal angiography and Renal Denervation (Symplicity Spyral™ multi-electrode renal denervation system)
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.
|
|---|---|
|
Change in Office Systolic Blood Pressure (SBP)
|
-20.3 mmHg
Standard Deviation 16.3
|
SECONDARY outcome
Timeframe: From Baseline (SV2) to 3 months post-procedurePopulation: Subjects with evaluable data
Outcome measures
| Measure |
Renal Denervation
n=53 Participants
Renal angiography and Renal Denervation (Symplicity Spyral™ multi-electrode renal denervation system)
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.
|
|---|---|
|
Change in Diastolic Blood Pressure (DBP) as Measured by 24-hour Ambulatory Blood Pressure Monitoring (ABPM)
|
-1.1 mmHg
Standard Deviation 7.5
|
SECONDARY outcome
Timeframe: From Baseline (SV2) to 12 months post-procedurePopulation: Subjects with evaluable data
Outcome measures
| Measure |
Renal Denervation
n=46 Participants
Renal angiography and Renal Denervation (Symplicity Spyral™ multi-electrode renal denervation system)
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.
|
|---|---|
|
Change in Diastolic Blood Pressure (DBP) as Measured by 24-hour Ambulatory Blood Pressure Monitoring (ABPM)
|
-11.2 mmHg
Standard Deviation 8.2
|
SECONDARY outcome
Timeframe: From Baseline (SV2) to 3 month post-procedurePopulation: Subjects with evaluable data
Outcome measures
| Measure |
Renal Denervation
n=55 Participants
Renal angiography and Renal Denervation (Symplicity Spyral™ multi-electrode renal denervation system)
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.
|
|---|---|
|
Change in Office Diastolic Blood Pressure (DBP)
|
-4.1 mmHg
Standard Deviation 8.5
|
SECONDARY outcome
Timeframe: From Baseline (SV2) to 12 months post-procedureOutcome measures
| Measure |
Renal Denervation
n=56 Participants
Renal angiography and Renal Denervation (Symplicity Spyral™ multi-electrode renal denervation system)
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.
|
|---|---|
|
Change in Office Diastolic Blood Pressure (DBP)
|
-9.8 mmHg
Standard Deviation 10.8
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SECONDARY outcome
Timeframe: 3 months post-procedurePopulation: Subjects with evaluable data
Target blood pressure defined as \<140 mmHg office Systolic Blood Pressure (SBP)
Outcome measures
| Measure |
Renal Denervation
n=55 Participants
Renal angiography and Renal Denervation (Symplicity Spyral™ multi-electrode renal denervation system)
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.
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|---|---|
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Incidence of Achieving Target Office Systolic Blood Pressure (SBP)
|
8 Participants
|
SECONDARY outcome
Timeframe: 12 months post-procedureTarget blood pressure defined as \<140 mmHg office Systolic Blood Pressure (SBP)
Outcome measures
| Measure |
Renal Denervation
n=56 Participants
Renal angiography and Renal Denervation (Symplicity Spyral™ multi-electrode renal denervation system)
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.
|
|---|---|
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Incidence of Achieving Target Office Systolic Blood Pressure (SBP)
|
27 Participants
|
SECONDARY outcome
Timeframe: From Baseline (SV2) to 12 months post-procedureIncidence of the following events: * 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%, confirmed by angiography and as determined by the angiographic core lab at 6 months follow up
Outcome measures
| Measure |
Renal Denervation
n=56 Participants
Renal angiography and Renal Denervation (Symplicity Spyral™ multi-electrode renal denervation system)
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.
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|---|---|
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Acute and Chronic Safety by Evaluating Incidence of Major Adverse Events
All Cause Mortality
|
0 Participants
|
|
Acute and Chronic Safety by Evaluating Incidence of Major Adverse Events
End-stage renal disease (ESRD)
|
0 Participants
|
|
Acute and Chronic Safety by Evaluating Incidence of Major Adverse Events
Significant embolic event resulting in end-organ damage
|
2 Participants
|
|
Acute and Chronic Safety by Evaluating Incidence of Major Adverse Events
Significant Embolic Event, Kidney
|
2 Participants
|
|
Acute and Chronic Safety by Evaluating Incidence of Major Adverse Events
Renal artery perforation requiring intervention
|
0 Participants
|
|
Acute and Chronic Safety by Evaluating Incidence of Major Adverse Events
Renal artery dissection requiring intervention
|
0 Participants
|
|
Acute and Chronic Safety by Evaluating Incidence of Major Adverse Events
Vascular complications
|
0 Participants
|
|
Acute and Chronic Safety by Evaluating Incidence of Major Adverse Events
Hospitalization for hypertensive crisis
|
0 Participants
|
|
Acute and Chronic Safety by Evaluating Incidence of Major Adverse Events
New renal artery stenosis >70%
|
0 Participants
|
SECONDARY outcome
Timeframe: From baseline (SV2) to 12 months post-procedureDefined as the concurrent documentation of two of the three elements listed below in the appropriate clinical circumstance: 1. Chest pain or ischemic equivalent 2. New pathologic q waves in at least 2 contiguous ECG leads 3. Cardiac biomarker elevation by any of the definitions below: Appropriate cardiac enzyme data (respecting top-down hierarchy): 1. CK greater than or equal to 2\* URL confirmed by: * CKMB \> l\*URL or * in the absence of CKMB: Troponin \> l\*URL or 2. in the absence of CK: * CKMB \> 3\*URL * In the absence of CK and CKMB: Troponin \> 3\*URL * In the absence of CK, CKMB and Troponin, clinical decision based upon clinical scenario
Outcome measures
| Measure |
Renal Denervation
n=56 Participants
Renal angiography and Renal Denervation (Symplicity Spyral™ multi-electrode renal denervation system)
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.
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|---|---|
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Incidence of Myocardial Infarction
|
0 Participants
|
SECONDARY outcome
Timeframe: From baseline (SV2) to 12 months post-procedureOutcome measures
| Measure |
Renal Denervation
n=56 Participants
Renal angiography and Renal Denervation (Symplicity Spyral™ multi-electrode renal denervation system)
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.
|
|---|---|
|
Incidence of Stroke
|
0 Participants
|
SECONDARY outcome
Timeframe: From baseline (SV2) to 12 months post-procedureInterventional procedure performed on the renal artery following completion of the renal denervation procedure and removal of the guide catheter.
Outcome measures
| Measure |
Renal Denervation
n=56 Participants
Renal angiography and Renal Denervation (Symplicity Spyral™ multi-electrode renal denervation system)
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.
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|---|---|
|
Incidence of Renal Artery Re-intervention
|
0 Participants
|
SECONDARY outcome
Timeframe: From baseline (SV2) to 12 months post-procedureIntracranial hemorrhage; ≥5g/dl decrease in hemoglobin concentration, a ≥15% absolute decrease in hematocrit, or death due to bleeding within seven days of the procedure)
Outcome measures
| Measure |
Renal Denervation
n=56 Participants
Renal angiography and Renal Denervation (Symplicity Spyral™ multi-electrode renal denervation system)
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.
|
|---|---|
|
Incidence of Major Bleeding According to TIMI Definition
|
0 Participants
|
SECONDARY outcome
Timeframe: From baseline (SV2) to 12 months post-procedurePopulation: Subjects with evaluable data
Outcome measures
| Measure |
Renal Denervation
n=53 Participants
Renal angiography and Renal Denervation (Symplicity Spyral™ multi-electrode renal denervation system)
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.
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|---|---|
|
Incidence of Increase in Serum Creatinine >50%
|
0 Participants
|
OTHER_PRE_SPECIFIED outcome
Timeframe: 3 months post-procedurePopulation: 53 Subjects from the SPYRAL DYSTAL study and 153 Intent-to-Treat Subjects from the SPYRAL HTN-OFF MED study (NCT02439749). Within each of the 5 strata ANCOVA model with 24-hr SBP change as dependent variable. Treatment and baseline 24-hr SBP as independent variables. In subjects with evaluable data.
Comparison of systolic blood pressure reduction over 24 hours of ABPM between the SPYRAL DYSTAL study and the SPYRAL HTN-OFF MED study (NCT02439749) who, after a renal angiography according to standard procedures, are treated with the renal denervation procedure.
Outcome measures
| Measure |
Renal Denervation
n=206 Participants
Renal angiography and Renal Denervation (Symplicity Spyral™ multi-electrode renal denervation system)
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.
|
|---|---|
|
Reduction in Systolic Blood Pressure (SBP) Over 24 Hours of ABPM as Measured With 24- Ambulatory Blood Pressure Monitor (ABPM) at 3 Months Post-procedure From Baseline
SPYRAL DYSTAL
|
-1.4 mmHg
Standard Deviation 10.0
|
|
Reduction in Systolic Blood Pressure (SBP) Over 24 Hours of ABPM as Measured With 24- Ambulatory Blood Pressure Monitor (ABPM) at 3 Months Post-procedure From Baseline
SPYRAL HTN-OFF MED
|
-4.5 mmHg
Standard Deviation 10.8
|
OTHER_PRE_SPECIFIED outcome
Timeframe: 3 Months post-procedurePopulation: 53 Subjects from the SPYRAL DYSTAL study and 153 Intent-to-Treat Subjects from the SPYRAL HTN-OFF MED study (NCT02439749). Within each of the 5 strata ANCOVA model with 24-hr DBP change as dependent variable. Treatment and baseline 24-hr DBP as independent variables. In subjects with evaluable data.
Comparison of diastolic blood pressure reduction over 24 hours of ABPM between the SPYRAL DYSTAL study and the SPYRAL HTN-OFF MED study (NCT02439749) who, after a renal angiography according to standard procedures, are treated with the renal denervation procedure.
Outcome measures
| Measure |
Renal Denervation
n=206 Participants
Renal angiography and Renal Denervation (Symplicity Spyral™ multi-electrode renal denervation system)
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.
|
|---|---|
|
Reduction in Diastolic Blood Pressure (DBP) Over 24 Hours as Measured With 24-Ambulatory Blood Pressure Monitor (ABPM) at 3 Months Post-procedure From Baseline
SPYRAL DYSTAL
|
-1.1 mmHg
Standard Deviation 7.5
|
|
Reduction in Diastolic Blood Pressure (DBP) Over 24 Hours as Measured With 24-Ambulatory Blood Pressure Monitor (ABPM) at 3 Months Post-procedure From Baseline
SPYRAL HTN-OFF MED
|
-3.5 mmHg
Standard Deviation 6.7
|
OTHER_PRE_SPECIFIED outcome
Timeframe: From Baseline (SV2) to 3 months post-procedurePopulation: 55 Subjects from the SPYRAL DYSTAL study and 170 Intent-to-Treat Subjects from the SPYRAL HTN-OFF MED study (NCT02439749). Within each of the 5 strata ANCOVA model with Office SBP change as dependent variable. Treatment and baseline Office SBP as independent variables. In subjects with evaluable data.
Comparison of Office Systolic Blood Pressure (SBP) reduction between the SPYRAL DYSTAL study and the SPYRAL HTN-OFF MED study (NCT02439749) who, after a renal angiography according to standard procedures, are treated with the renal denervation procedure.
Outcome measures
| Measure |
Renal Denervation
n=225 Participants
Renal angiography and Renal Denervation (Symplicity Spyral™ multi-electrode renal denervation system)
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.
|
|---|---|
|
Office Systolic Blood Pressure (SBP) Reduction
SPYRAL HTN-OFF MED
|
-9.4 mmHg
Standard Deviation 14.8
|
|
Office Systolic Blood Pressure (SBP) Reduction
SPYRAL DYSTAL
|
-9.0 mmHg
Standard Deviation 13.9
|
OTHER_PRE_SPECIFIED outcome
Timeframe: From Baseline (SV2) to 3 months post-procedurePopulation: 55 Subjects from the SPYRAL DYSTAL study and 170 Intent-to-Treat Subjects from the SPYRAL HTN-OFF MED study (NCT02439749). Within each of the 5 strata ANCOVA model with Office DBP change as dependent variable. Treatment and baseline Office DBP as independent variables. In subjects with evaluable data.
Comparison of Office Diastolic Blood Pressure (DBP) reduction between the SPYRAL DYSTAL study and the SPYRAL HTN-OFF MED study (NCT02439749) who, after a renal angiography according to standard procedures, are treated with the renal denervation procedure.
Outcome measures
| Measure |
Renal Denervation
n=225 Participants
Renal angiography and Renal Denervation (Symplicity Spyral™ multi-electrode renal denervation system)
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.
|
|---|---|
|
Office Diastolic Blood Pressure (DBP) Reduction
SPYRAL DYSTAL
|
-4.1 mmHg
Standard Deviation 8.5
|
|
Office Diastolic Blood Pressure (DBP) Reduction
SPYRAL HTN-OFF MED
|
-5.0 mmHg
Standard Deviation 8.3
|
OTHER_PRE_SPECIFIED outcome
Timeframe: ProcedurePopulation: 56 Subjects from the SPYRAL DYSTAL study and 182 Subjects from the SPYRAL HTN-OFF MED study (NCT02439749).
Comparison of procedural characteristics: total procedure duration (minutes) between the SPYRAL DYSTAL study and the SPYRAL HTN-OFF MED study (NCT02439749) who, after a renal angiography according to standard procedures, are treated with the renal denervation procedure.
Outcome measures
| Measure |
Renal Denervation
n=238 Participants
Renal angiography and Renal Denervation (Symplicity Spyral™ multi-electrode renal denervation system)
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.
|
|---|---|
|
Procedural Characteristics: Procedure Time (Minutes)
SPYRAL DYSTAL
|
67.3 Minutes
Standard Deviation 20.6
|
|
Procedural Characteristics: Procedure Time (Minutes)
SPYRAL HTN-OFF MED
|
99.3 Minutes
Standard Deviation 36.2
|
OTHER_PRE_SPECIFIED outcome
Timeframe: ProcedurePopulation: 56 Subjects from the SPYRAL DYSTAL study and 182 Subjects from the SPYRAL HTN-OFF MED study (NCT02439749).
Comparison of the procedural characteristics: total denervation time between the SPYRAL DYSTAL study and the SPYRAL HTN-OFF MED study (NCT02439749) who, after a renal angiography according to standard procedures, are treated with the renal denervation procedure.
Outcome measures
| Measure |
Renal Denervation
n=238 Participants
Renal angiography and Renal Denervation (Symplicity Spyral™ multi-electrode renal denervation system)
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.
|
|---|---|
|
Procedural Characteristics: Denervation Time (Minutes)
SPYRAL DYSTAL
|
35.9 Minutes
Standard Deviation 13.8
|
|
Procedural Characteristics: Denervation Time (Minutes)
SPYRAL HTN-OFF MED
|
59.7 Minutes
Standard Deviation 24.3
|
OTHER_PRE_SPECIFIED outcome
Timeframe: ProcedurePopulation: 56 Subjects from the SPYRAL DYSTAL study and 178 Subjects from the SPYRAL HTN-OFF MED study (NCT02439749) with evaluable data.
Comparison of the procedural characteristics: amount of contrast used (cubic centimeter(cc)) between the SPYRAL DYSTAL study and the SPYRAL HTN-OFF MED study (NCT02439749) who, after a renal angiography according to standard procedures, are treated with the renal denervation procedure.
Outcome measures
| Measure |
Renal Denervation
n=235 Participants
Renal angiography and Renal Denervation (Symplicity Spyral™ multi-electrode renal denervation system)
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.
|
|---|---|
|
Procedural Characteristics: Amount of Contrast Used (cc)
SPYRAL DYSTAL
|
172.8 (cubic centimeter(cc))
Standard Deviation 76.6
|
|
Procedural Characteristics: Amount of Contrast Used (cc)
SPYRAL HTN-OFF MED
|
207.8 (cubic centimeter(cc))
Standard Deviation 96.1
|
POST_HOC outcome
Timeframe: 12 months post-procedurePopulation: 46 Subjects from the SPYRAL DYSTAL study and 146 Intent-to-Treat Subjects from the SPYRAL HTN-OFF MED study (NCT02439749). Within each of the 5 strata ANCOVA model with 24-hr SBP change as dependent variable. Treatment and baseline 24-hr SBP as independent variables. In subjects with evaluable data.
Comparison of systolic blood pressure reduction over 24 hours of ABPM between the SPYRAL DYSTAL study and the SPYRAL HTN-OFF MED study (NCT02439749) who, after a renal angiography according to standard procedures, are treated with the renal denervation procedure.
Outcome measures
| Measure |
Renal Denervation
n=192 Participants
Renal angiography and Renal Denervation (Symplicity Spyral™ multi-electrode renal denervation system)
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.
|
|---|---|
|
Reduction in Systolic Blood Pressure (SBP) Over 24 Hours of ABPM as Measured With 24-Ambulatory Blood Pressure Monitor (ABPM) at 12 Months Post-procedure From Baseline
SPYRAL DYSTAL
|
-16.6 mmHg
Standard Deviation 10.6
|
|
Reduction in Systolic Blood Pressure (SBP) Over 24 Hours of ABPM as Measured With 24-Ambulatory Blood Pressure Monitor (ABPM) at 12 Months Post-procedure From Baseline
SPYRAL HTN-OFF MED
|
-14.3 mmHg
Standard Deviation 11.9
|
POST_HOC outcome
Timeframe: 12 months post-procedurePopulation: 46 Subjects from the SPYRAL DYSTAL study and 146 Intent-to-Treat Subjects from the SPYRAL HTN-OFF MED study (NCT02439749). Within each of the 5 strata ANCOVA model with 24-hr DBP change as dependent variable. Treatment and baseline 24-hr DBP as independent variables. In subjects with evaluable data.
Comparison of diastolic blood pressure reduction over 24 hours of ABPM between the SPYRAL DYSTAL study and the SPYRAL HTN-OFF MED study (NCT02439749) who, after a renal angiography according to standard procedures, are treated with the renal denervation procedure.
Outcome measures
| Measure |
Renal Denervation
n=192 Participants
Renal angiography and Renal Denervation (Symplicity Spyral™ multi-electrode renal denervation system)
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.
|
|---|---|
|
Reduction in Diastolic Blood Pressure (DBP) Over 24 Hours as Measured With 24-Ambulatory Blood Pressure Monitor (ABPM) at 12 Months Post-procedure From Baseline
SPYRAL DYSTAL
|
-11.2 mmHg
Standard Deviation 8.2
|
|
Reduction in Diastolic Blood Pressure (DBP) Over 24 Hours as Measured With 24-Ambulatory Blood Pressure Monitor (ABPM) at 12 Months Post-procedure From Baseline
SPYRAL HTN-OFF MED
|
-10.2 mmHg
Standard Deviation 8.2
|
POST_HOC outcome
Timeframe: From Baseline (SV2) to 12 months post-procedurePopulation: 56 Subjects from the SPYRAL DYSTAL study and 171 Intent-to-Treat Subjects from the SPYRAL HTN-OFF MED study (NCT02439749). Within each of the 5 strata ANCOVA model with Office SBP change as dependent variable. Treatment and baseline Office SBP as independent variables. In subjects with evaluable data.
Comparison of Office Systolic Blood Pressure (SBP) reduction between the SPYRAL DYSTAL study and the SPYRAL HTN-OFF MED study (NCT02439749) who, after a renal angiography according to standard procedures, are treated with the renal denervation procedure.
Outcome measures
| Measure |
Renal Denervation
n=227 Participants
Renal angiography and Renal Denervation (Symplicity Spyral™ multi-electrode renal denervation system)
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.
|
|---|---|
|
Office Systolic Blood Pressure (SBP) Reduction
SPYRAL DYSTAL
|
-20.3 mmHg
Standard Deviation 16.3
|
|
Office Systolic Blood Pressure (SBP) Reduction
SPYRAL HTN-OFF MED
|
-21.3 mmHg
Standard Deviation 14.2
|
POST_HOC outcome
Timeframe: From Baseline (SV2) to 12 months post-procedurePopulation: 56 Subjects from the SPYRAL DYSTAL study and 171 Intent-to-Treat Subjects from the SPYRAL HTN-OFF MED study (NCT02439749). Within each of the 5 strata ANCOVA model with Office DBP change as dependent variable. Treatment and baseline Office DBP as independent variables. In subjects with evaluable data.
Comparison of Office Diastolic Blood Pressure (DBP) reduction between the SPYRAL DYSTAL study and the SPYRAL HTN-OFF MED study (NCT02439749) who, after a renal angiography according to standard procedures, are treated with the renal denervation procedure.
Outcome measures
| Measure |
Renal Denervation
n=227 Participants
Renal angiography and Renal Denervation (Symplicity Spyral™ multi-electrode renal denervation system)
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.
|
|---|---|
|
Office Diastolic Blood Pressure (DBP) Reduction
SPYRAL DYSTAL
|
-9.8 mmHg
Standard Deviation 10.8
|
|
Office Diastolic Blood Pressure (DBP) Reduction
SPYRAL HTN-OFF MED
|
-10.7 mmHg
Standard Deviation 8.8
|
Adverse Events
Renal Denervation
Serious events: 7 serious events
Other events: 38 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Renal Denervation
n=56 participants at risk
Renal angiography and Renal Denervation (Symplicity Spyral™ multi-electrode renal denervation system)
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.
|
|---|---|
|
Cardiac disorders
Cardiac arrest
|
1.8%
1/56 • Number of events 1 • Serious Adverse Events were monitored/assessed from subject enrollment (consent) through study exit (up to 12 Months Post Procedure) while Adverse Events were monitored/assessed from subject enrollment (consent) through 6-month visits.
|
|
Infections and infestations
Appendicitis
|
1.8%
1/56 • Number of events 1 • Serious Adverse Events were monitored/assessed from subject enrollment (consent) through study exit (up to 12 Months Post Procedure) while Adverse Events were monitored/assessed from subject enrollment (consent) through 6-month visits.
|
|
Infections and infestations
Arthritis infective
|
1.8%
1/56 • Number of events 1 • Serious Adverse Events were monitored/assessed from subject enrollment (consent) through study exit (up to 12 Months Post Procedure) while Adverse Events were monitored/assessed from subject enrollment (consent) through 6-month visits.
|
|
Infections and infestations
COVID-19 pneumonia
|
1.8%
1/56 • Number of events 1 • Serious Adverse Events were monitored/assessed from subject enrollment (consent) through study exit (up to 12 Months Post Procedure) while Adverse Events were monitored/assessed from subject enrollment (consent) through 6-month visits.
|
|
Infections and infestations
Urinary tract infection
|
1.8%
1/56 • Number of events 1 • Serious Adverse Events were monitored/assessed from subject enrollment (consent) through study exit (up to 12 Months Post Procedure) while Adverse Events were monitored/assessed from subject enrollment (consent) through 6-month visits.
|
|
Injury, poisoning and procedural complications
Humerus fracture
|
1.8%
1/56 • Number of events 1 • Serious Adverse Events were monitored/assessed from subject enrollment (consent) through study exit (up to 12 Months Post Procedure) while Adverse Events were monitored/assessed from subject enrollment (consent) through 6-month visits.
|
|
Injury, poisoning and procedural complications
Wrist fracture
|
1.8%
1/56 • Number of events 1 • Serious Adverse Events were monitored/assessed from subject enrollment (consent) through study exit (up to 12 Months Post Procedure) while Adverse Events were monitored/assessed from subject enrollment (consent) through 6-month visits.
|
|
Musculoskeletal and connective tissue disorders
Intervertebral disc protrusion
|
1.8%
1/56 • Number of events 1 • Serious Adverse Events were monitored/assessed from subject enrollment (consent) through study exit (up to 12 Months Post Procedure) while Adverse Events were monitored/assessed from subject enrollment (consent) through 6-month visits.
|
|
Nervous system disorders
Presyncope
|
1.8%
1/56 • Number of events 1 • Serious Adverse Events were monitored/assessed from subject enrollment (consent) through study exit (up to 12 Months Post Procedure) while Adverse Events were monitored/assessed from subject enrollment (consent) through 6-month visits.
|
|
Renal and urinary disorders
Renal artery dissection
|
1.8%
1/56 • Number of events 1 • Serious Adverse Events were monitored/assessed from subject enrollment (consent) through study exit (up to 12 Months Post Procedure) while Adverse Events were monitored/assessed from subject enrollment (consent) through 6-month visits.
|
|
Renal and urinary disorders
Renal infarct
|
1.8%
1/56 • Number of events 1 • Serious Adverse Events were monitored/assessed from subject enrollment (consent) through study exit (up to 12 Months Post Procedure) while Adverse Events were monitored/assessed from subject enrollment (consent) through 6-month visits.
|
|
Vascular disorders
Hypertension
|
1.8%
1/56 • Number of events 1 • Serious Adverse Events were monitored/assessed from subject enrollment (consent) through study exit (up to 12 Months Post Procedure) while Adverse Events were monitored/assessed from subject enrollment (consent) through 6-month visits.
|
Other adverse events
| Measure |
Renal Denervation
n=56 participants at risk
Renal angiography and Renal Denervation (Symplicity Spyral™ multi-electrode renal denervation system)
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.
|
|---|---|
|
Blood and lymphatic system disorders
Blood loss anaemia
|
1.8%
1/56 • Number of events 1 • Serious Adverse Events were monitored/assessed from subject enrollment (consent) through study exit (up to 12 Months Post Procedure) while Adverse Events were monitored/assessed from subject enrollment (consent) through 6-month visits.
|
|
Blood and lymphatic system disorders
Increased tendency to bruise
|
1.8%
1/56 • Number of events 1 • Serious Adverse Events were monitored/assessed from subject enrollment (consent) through study exit (up to 12 Months Post Procedure) while Adverse Events were monitored/assessed from subject enrollment (consent) through 6-month visits.
|
|
Cardiac disorders
Bradycardia
|
1.8%
1/56 • Number of events 1 • Serious Adverse Events were monitored/assessed from subject enrollment (consent) through study exit (up to 12 Months Post Procedure) while Adverse Events were monitored/assessed from subject enrollment (consent) through 6-month visits.
|
|
Cardiac disorders
Palpitations
|
1.8%
1/56 • Number of events 1 • Serious Adverse Events were monitored/assessed from subject enrollment (consent) through study exit (up to 12 Months Post Procedure) while Adverse Events were monitored/assessed from subject enrollment (consent) through 6-month visits.
|
|
Cardiac disorders
Sinus arrest
|
1.8%
1/56 • Number of events 1 • Serious Adverse Events were monitored/assessed from subject enrollment (consent) through study exit (up to 12 Months Post Procedure) while Adverse Events were monitored/assessed from subject enrollment (consent) through 6-month visits.
|
|
Eye disorders
Dry eye
|
1.8%
1/56 • Number of events 1 • Serious Adverse Events were monitored/assessed from subject enrollment (consent) through study exit (up to 12 Months Post Procedure) while Adverse Events were monitored/assessed from subject enrollment (consent) through 6-month visits.
|
|
Eye disorders
Ocular hyperaemia
|
1.8%
1/56 • Number of events 1 • Serious Adverse Events were monitored/assessed from subject enrollment (consent) through study exit (up to 12 Months Post Procedure) while Adverse Events were monitored/assessed from subject enrollment (consent) through 6-month visits.
|
|
Gastrointestinal disorders
Anal fissure
|
1.8%
1/56 • Number of events 1 • Serious Adverse Events were monitored/assessed from subject enrollment (consent) through study exit (up to 12 Months Post Procedure) while Adverse Events were monitored/assessed from subject enrollment (consent) through 6-month visits.
|
|
Gastrointestinal disorders
Constipation
|
1.8%
1/56 • Number of events 1 • Serious Adverse Events were monitored/assessed from subject enrollment (consent) through study exit (up to 12 Months Post Procedure) while Adverse Events were monitored/assessed from subject enrollment (consent) through 6-month visits.
|
|
Gastrointestinal disorders
Diarrhoea
|
1.8%
1/56 • Number of events 1 • Serious Adverse Events were monitored/assessed from subject enrollment (consent) through study exit (up to 12 Months Post Procedure) while Adverse Events were monitored/assessed from subject enrollment (consent) through 6-month visits.
|
|
Gastrointestinal disorders
Epigastric discomfort
|
1.8%
1/56 • Number of events 1 • Serious Adverse Events were monitored/assessed from subject enrollment (consent) through study exit (up to 12 Months Post Procedure) while Adverse Events were monitored/assessed from subject enrollment (consent) through 6-month visits.
|
|
General disorders
Adverse drug reaction
|
1.8%
1/56 • Number of events 1 • Serious Adverse Events were monitored/assessed from subject enrollment (consent) through study exit (up to 12 Months Post Procedure) while Adverse Events were monitored/assessed from subject enrollment (consent) through 6-month visits.
|
|
General disorders
Chest discomfort
|
3.6%
2/56 • Number of events 2 • Serious Adverse Events were monitored/assessed from subject enrollment (consent) through study exit (up to 12 Months Post Procedure) while Adverse Events were monitored/assessed from subject enrollment (consent) through 6-month visits.
|
|
General disorders
Fatigue
|
1.8%
1/56 • Number of events 1 • Serious Adverse Events were monitored/assessed from subject enrollment (consent) through study exit (up to 12 Months Post Procedure) while Adverse Events were monitored/assessed from subject enrollment (consent) through 6-month visits.
|
|
General disorders
Influenza like illness
|
1.8%
1/56 • Number of events 1 • Serious Adverse Events were monitored/assessed from subject enrollment (consent) through study exit (up to 12 Months Post Procedure) while Adverse Events were monitored/assessed from subject enrollment (consent) through 6-month visits.
|
|
General disorders
Peripheral swelling
|
1.8%
1/56 • Number of events 1 • Serious Adverse Events were monitored/assessed from subject enrollment (consent) through study exit (up to 12 Months Post Procedure) while Adverse Events were monitored/assessed from subject enrollment (consent) through 6-month visits.
|
|
General disorders
Swelling face
|
1.8%
1/56 • Number of events 1 • Serious Adverse Events were monitored/assessed from subject enrollment (consent) through study exit (up to 12 Months Post Procedure) while Adverse Events were monitored/assessed from subject enrollment (consent) through 6-month visits.
|
|
Immune system disorders
Immunisation reaction
|
1.8%
1/56 • Number of events 1 • Serious Adverse Events were monitored/assessed from subject enrollment (consent) through study exit (up to 12 Months Post Procedure) while Adverse Events were monitored/assessed from subject enrollment (consent) through 6-month visits.
|
|
Infections and infestations
COVID-19
|
14.3%
8/56 • Number of events 8 • Serious Adverse Events were monitored/assessed from subject enrollment (consent) through study exit (up to 12 Months Post Procedure) while Adverse Events were monitored/assessed from subject enrollment (consent) through 6-month visits.
|
|
Infections and infestations
Diverticulitis
|
1.8%
1/56 • Number of events 1 • Serious Adverse Events were monitored/assessed from subject enrollment (consent) through study exit (up to 12 Months Post Procedure) while Adverse Events were monitored/assessed from subject enrollment (consent) through 6-month visits.
|
|
Infections and infestations
Influenza
|
1.8%
1/56 • Number of events 1 • Serious Adverse Events were monitored/assessed from subject enrollment (consent) through study exit (up to 12 Months Post Procedure) while Adverse Events were monitored/assessed from subject enrollment (consent) through 6-month visits.
|
|
Infections and infestations
Nasopharyngitis
|
1.8%
1/56 • Number of events 1 • Serious Adverse Events were monitored/assessed from subject enrollment (consent) through study exit (up to 12 Months Post Procedure) while Adverse Events were monitored/assessed from subject enrollment (consent) through 6-month visits.
|
|
Infections and infestations
Otitis media
|
1.8%
1/56 • Number of events 1 • Serious Adverse Events were monitored/assessed from subject enrollment (consent) through study exit (up to 12 Months Post Procedure) while Adverse Events were monitored/assessed from subject enrollment (consent) through 6-month visits.
|
|
Infections and infestations
Sinusitis
|
3.6%
2/56 • Number of events 2 • Serious Adverse Events were monitored/assessed from subject enrollment (consent) through study exit (up to 12 Months Post Procedure) while Adverse Events were monitored/assessed from subject enrollment (consent) through 6-month visits.
|
|
Injury, poisoning and procedural complications
Contusion
|
3.6%
2/56 • Number of events 2 • Serious Adverse Events were monitored/assessed from subject enrollment (consent) through study exit (up to 12 Months Post Procedure) while Adverse Events were monitored/assessed from subject enrollment (consent) through 6-month visits.
|
|
Injury, poisoning and procedural complications
Meniscus injury
|
1.8%
1/56 • Number of events 1 • Serious Adverse Events were monitored/assessed from subject enrollment (consent) through study exit (up to 12 Months Post Procedure) while Adverse Events were monitored/assessed from subject enrollment (consent) through 6-month visits.
|
|
Injury, poisoning and procedural complications
Muscle contusion
|
1.8%
1/56 • Number of events 1 • Serious Adverse Events were monitored/assessed from subject enrollment (consent) through study exit (up to 12 Months Post Procedure) while Adverse Events were monitored/assessed from subject enrollment (consent) through 6-month visits.
|
|
Injury, poisoning and procedural complications
Spinal column injury
|
1.8%
1/56 • Number of events 1 • Serious Adverse Events were monitored/assessed from subject enrollment (consent) through study exit (up to 12 Months Post Procedure) while Adverse Events were monitored/assessed from subject enrollment (consent) through 6-month visits.
|
|
Injury, poisoning and procedural complications
Vascular access site haematoma
|
14.3%
8/56 • Number of events 8 • Serious Adverse Events were monitored/assessed from subject enrollment (consent) through study exit (up to 12 Months Post Procedure) while Adverse Events were monitored/assessed from subject enrollment (consent) through 6-month visits.
|
|
Injury, poisoning and procedural complications
Vascular access site haemorrhage
|
1.8%
1/56 • Number of events 1 • Serious Adverse Events were monitored/assessed from subject enrollment (consent) through study exit (up to 12 Months Post Procedure) while Adverse Events were monitored/assessed from subject enrollment (consent) through 6-month visits.
|
|
Injury, poisoning and procedural complications
Vascular access site pain
|
1.8%
1/56 • Number of events 1 • Serious Adverse Events were monitored/assessed from subject enrollment (consent) through study exit (up to 12 Months Post Procedure) while Adverse Events were monitored/assessed from subject enrollment (consent) through 6-month visits.
|
|
Investigations
Blood aldosterone increased
|
1.8%
1/56 • Number of events 1 • Serious Adverse Events were monitored/assessed from subject enrollment (consent) through study exit (up to 12 Months Post Procedure) while Adverse Events were monitored/assessed from subject enrollment (consent) through 6-month visits.
|
|
Investigations
Blood cholesterol increased
|
1.8%
1/56 • Number of events 1 • Serious Adverse Events were monitored/assessed from subject enrollment (consent) through study exit (up to 12 Months Post Procedure) while Adverse Events were monitored/assessed from subject enrollment (consent) through 6-month visits.
|
|
Investigations
Blood pressure increased
|
7.1%
4/56 • Number of events 4 • Serious Adverse Events were monitored/assessed from subject enrollment (consent) through study exit (up to 12 Months Post Procedure) while Adverse Events were monitored/assessed from subject enrollment (consent) through 6-month visits.
|
|
Investigations
Blood pressure systolic increased
|
1.8%
1/56 • Number of events 1 • Serious Adverse Events were monitored/assessed from subject enrollment (consent) through study exit (up to 12 Months Post Procedure) while Adverse Events were monitored/assessed from subject enrollment (consent) through 6-month visits.
|
|
Investigations
Blood testosterone decreased
|
1.8%
1/56 • Number of events 1 • Serious Adverse Events were monitored/assessed from subject enrollment (consent) through study exit (up to 12 Months Post Procedure) while Adverse Events were monitored/assessed from subject enrollment (consent) through 6-month visits.
|
|
Investigations
Carotid pulse abnormal
|
1.8%
1/56 • Number of events 1 • Serious Adverse Events were monitored/assessed from subject enrollment (consent) through study exit (up to 12 Months Post Procedure) while Adverse Events were monitored/assessed from subject enrollment (consent) through 6-month visits.
|
|
Investigations
Computerised tomogram kidney abnormal
|
1.8%
1/56 • Number of events 1 • Serious Adverse Events were monitored/assessed from subject enrollment (consent) through study exit (up to 12 Months Post Procedure) while Adverse Events were monitored/assessed from subject enrollment (consent) through 6-month visits.
|
|
Metabolism and nutrition disorders
Glucose tolerance impaired
|
1.8%
1/56 • Number of events 1 • Serious Adverse Events were monitored/assessed from subject enrollment (consent) through study exit (up to 12 Months Post Procedure) while Adverse Events were monitored/assessed from subject enrollment (consent) through 6-month visits.
|
|
Metabolism and nutrition disorders
Hyperlipidaemia
|
3.6%
2/56 • Number of events 2 • Serious Adverse Events were monitored/assessed from subject enrollment (consent) through study exit (up to 12 Months Post Procedure) while Adverse Events were monitored/assessed from subject enrollment (consent) through 6-month visits.
|
|
Metabolism and nutrition disorders
Type 2 diabetes mellitus
|
1.8%
1/56 • Number of events 1 • Serious Adverse Events were monitored/assessed from subject enrollment (consent) through study exit (up to 12 Months Post Procedure) while Adverse Events were monitored/assessed from subject enrollment (consent) through 6-month visits.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
5.4%
3/56 • Number of events 3 • Serious Adverse Events were monitored/assessed from subject enrollment (consent) through study exit (up to 12 Months Post Procedure) while Adverse Events were monitored/assessed from subject enrollment (consent) through 6-month visits.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
3.6%
2/56 • Number of events 2 • Serious Adverse Events were monitored/assessed from subject enrollment (consent) through study exit (up to 12 Months Post Procedure) while Adverse Events were monitored/assessed from subject enrollment (consent) through 6-month visits.
|
|
Musculoskeletal and connective tissue disorders
Flank pain
|
1.8%
1/56 • Number of events 1 • Serious Adverse Events were monitored/assessed from subject enrollment (consent) through study exit (up to 12 Months Post Procedure) while Adverse Events were monitored/assessed from subject enrollment (consent) through 6-month visits.
|
|
Musculoskeletal and connective tissue disorders
Joint swelling
|
3.6%
2/56 • Number of events 2 • Serious Adverse Events were monitored/assessed from subject enrollment (consent) through study exit (up to 12 Months Post Procedure) while Adverse Events were monitored/assessed from subject enrollment (consent) through 6-month visits.
|
|
Musculoskeletal and connective tissue disorders
Muscle spasms
|
1.8%
1/56 • Number of events 1 • Serious Adverse Events were monitored/assessed from subject enrollment (consent) through study exit (up to 12 Months Post Procedure) while Adverse Events were monitored/assessed from subject enrollment (consent) through 6-month visits.
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal pain
|
1.8%
1/56 • Number of events 1 • Serious Adverse Events were monitored/assessed from subject enrollment (consent) through study exit (up to 12 Months Post Procedure) while Adverse Events were monitored/assessed from subject enrollment (consent) through 6-month visits.
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
1.8%
1/56 • Number of events 1 • Serious Adverse Events were monitored/assessed from subject enrollment (consent) through study exit (up to 12 Months Post Procedure) while Adverse Events were monitored/assessed from subject enrollment (consent) through 6-month visits.
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
3.6%
2/56 • Number of events 2 • Serious Adverse Events were monitored/assessed from subject enrollment (consent) through study exit (up to 12 Months Post Procedure) while Adverse Events were monitored/assessed from subject enrollment (consent) through 6-month visits.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Melanocytic naevus
|
1.8%
1/56 • Number of events 1 • Serious Adverse Events were monitored/assessed from subject enrollment (consent) through study exit (up to 12 Months Post Procedure) while Adverse Events were monitored/assessed from subject enrollment (consent) through 6-month visits.
|
|
Nervous system disorders
Dizziness
|
1.8%
1/56 • Number of events 1 • Serious Adverse Events were monitored/assessed from subject enrollment (consent) through study exit (up to 12 Months Post Procedure) while Adverse Events were monitored/assessed from subject enrollment (consent) through 6-month visits.
|
|
Nervous system disorders
Dizziness postural
|
1.8%
1/56 • Number of events 1 • Serious Adverse Events were monitored/assessed from subject enrollment (consent) through study exit (up to 12 Months Post Procedure) while Adverse Events were monitored/assessed from subject enrollment (consent) through 6-month visits.
|
|
Nervous system disorders
Head discomfort
|
1.8%
1/56 • Number of events 1 • Serious Adverse Events were monitored/assessed from subject enrollment (consent) through study exit (up to 12 Months Post Procedure) while Adverse Events were monitored/assessed from subject enrollment (consent) through 6-month visits.
|
|
Nervous system disorders
Headache
|
17.9%
10/56 • Number of events 10 • Serious Adverse Events were monitored/assessed from subject enrollment (consent) through study exit (up to 12 Months Post Procedure) while Adverse Events were monitored/assessed from subject enrollment (consent) through 6-month visits.
|
|
Nervous system disorders
Migraine
|
3.6%
2/56 • Number of events 2 • Serious Adverse Events were monitored/assessed from subject enrollment (consent) through study exit (up to 12 Months Post Procedure) while Adverse Events were monitored/assessed from subject enrollment (consent) through 6-month visits.
|
|
Nervous system disorders
Sciatica
|
1.8%
1/56 • Number of events 1 • Serious Adverse Events were monitored/assessed from subject enrollment (consent) through study exit (up to 12 Months Post Procedure) while Adverse Events were monitored/assessed from subject enrollment (consent) through 6-month visits.
|
|
Nervous system disorders
Sinus headache
|
1.8%
1/56 • Number of events 1 • Serious Adverse Events were monitored/assessed from subject enrollment (consent) through study exit (up to 12 Months Post Procedure) while Adverse Events were monitored/assessed from subject enrollment (consent) through 6-month visits.
|
|
Psychiatric disorders
Anxiety
|
1.8%
1/56 • Number of events 1 • Serious Adverse Events were monitored/assessed from subject enrollment (consent) through study exit (up to 12 Months Post Procedure) while Adverse Events were monitored/assessed from subject enrollment (consent) through 6-month visits.
|
|
Psychiatric disorders
Depression
|
1.8%
1/56 • Number of events 1 • Serious Adverse Events were monitored/assessed from subject enrollment (consent) through study exit (up to 12 Months Post Procedure) while Adverse Events were monitored/assessed from subject enrollment (consent) through 6-month visits.
|
|
Psychiatric disorders
Stress
|
3.6%
2/56 • Number of events 2 • Serious Adverse Events were monitored/assessed from subject enrollment (consent) through study exit (up to 12 Months Post Procedure) while Adverse Events were monitored/assessed from subject enrollment (consent) through 6-month visits.
|
|
Renal and urinary disorders
Nephrolithiasis
|
3.6%
2/56 • Number of events 2 • Serious Adverse Events were monitored/assessed from subject enrollment (consent) through study exit (up to 12 Months Post Procedure) while Adverse Events were monitored/assessed from subject enrollment (consent) through 6-month visits.
|
|
Renal and urinary disorders
Nocturia
|
1.8%
1/56 • Number of events 1 • Serious Adverse Events were monitored/assessed from subject enrollment (consent) through study exit (up to 12 Months Post Procedure) while Adverse Events were monitored/assessed from subject enrollment (consent) through 6-month visits.
|
|
Renal and urinary disorders
Pollakiuria
|
3.6%
2/56 • Number of events 2 • Serious Adverse Events were monitored/assessed from subject enrollment (consent) through study exit (up to 12 Months Post Procedure) while Adverse Events were monitored/assessed from subject enrollment (consent) through 6-month visits.
|
|
Renal and urinary disorders
Renal artery dissection
|
1.8%
1/56 • Number of events 1 • Serious Adverse Events were monitored/assessed from subject enrollment (consent) through study exit (up to 12 Months Post Procedure) while Adverse Events were monitored/assessed from subject enrollment (consent) through 6-month visits.
|
|
Renal and urinary disorders
Renal infarct
|
1.8%
1/56 • Number of events 1 • Serious Adverse Events were monitored/assessed from subject enrollment (consent) through study exit (up to 12 Months Post Procedure) while Adverse Events were monitored/assessed from subject enrollment (consent) through 6-month visits.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
1.8%
1/56 • Number of events 1 • Serious Adverse Events were monitored/assessed from subject enrollment (consent) through study exit (up to 12 Months Post Procedure) while Adverse Events were monitored/assessed from subject enrollment (consent) through 6-month visits.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
1.8%
1/56 • Number of events 1 • Serious Adverse Events were monitored/assessed from subject enrollment (consent) through study exit (up to 12 Months Post Procedure) while Adverse Events were monitored/assessed from subject enrollment (consent) through 6-month visits.
|
|
Skin and subcutaneous tissue disorders
Blister
|
5.4%
3/56 • Number of events 3 • Serious Adverse Events were monitored/assessed from subject enrollment (consent) through study exit (up to 12 Months Post Procedure) while Adverse Events were monitored/assessed from subject enrollment (consent) through 6-month visits.
|
|
Skin and subcutaneous tissue disorders
Dermal cyst
|
1.8%
1/56 • Number of events 1 • Serious Adverse Events were monitored/assessed from subject enrollment (consent) through study exit (up to 12 Months Post Procedure) while Adverse Events were monitored/assessed from subject enrollment (consent) through 6-month visits.
|
|
Skin and subcutaneous tissue disorders
Dermatitis allergic
|
1.8%
1/56 • Number of events 1 • Serious Adverse Events were monitored/assessed from subject enrollment (consent) through study exit (up to 12 Months Post Procedure) while Adverse Events were monitored/assessed from subject enrollment (consent) through 6-month visits.
|
|
Vascular disorders
Essential hypertension
|
1.8%
1/56 • Number of events 1 • Serious Adverse Events were monitored/assessed from subject enrollment (consent) through study exit (up to 12 Months Post Procedure) while Adverse Events were monitored/assessed from subject enrollment (consent) through 6-month visits.
|
|
Vascular disorders
Hypertension
|
5.4%
3/56 • Number of events 3 • Serious Adverse Events were monitored/assessed from subject enrollment (consent) through study exit (up to 12 Months Post Procedure) while Adverse Events were monitored/assessed from subject enrollment (consent) through 6-month visits.
|
|
Vascular disorders
Hypertensive crisis
|
1.8%
1/56 • Number of events 1 • Serious Adverse Events were monitored/assessed from subject enrollment (consent) through study exit (up to 12 Months Post Procedure) while Adverse Events were monitored/assessed from subject enrollment (consent) through 6-month visits.
|
Additional Information
Sara Dinkins SPYRAL DYSTAL Global Study Manager
Medtronic
Phone: 303-840-4034
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place