Trial Outcomes & Findings for The TARGET BP OFF-MED Trial (NCT NCT03503773)
NCT ID: NCT03503773
Last Updated: 2025-05-14
Results Overview
Change from baseline in mean 24-hour ambulatory systolic blood pressure
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
350 participants
Primary outcome timeframe
Baseline to 8 weeks post-treatment
Results posted on
2025-05-14
Participant Flow
Enrolled and consented (n=350)
Participant milestones
| Measure |
Sham Control Arm
Only renal angiography performed
Sham control: endovascular, renal angiography
|
Treatment Arm:
Renal denervation (using the Peregrine Kit) performed with alcohol infused through the Peregrine Catheter
Alcohol: Alcohol is directly infused/delivered to the adventitial and periadventitial space of the renal arteries
|
|---|---|---|
|
Overall Study
STARTED
|
56
|
50
|
|
Overall Study
COMPLETED
|
44
|
43
|
|
Overall Study
NOT COMPLETED
|
12
|
7
|
Reasons for withdrawal
| Measure |
Sham Control Arm
Only renal angiography performed
Sham control: endovascular, renal angiography
|
Treatment Arm:
Renal denervation (using the Peregrine Kit) performed with alcohol infused through the Peregrine Catheter
Alcohol: Alcohol is directly infused/delivered to the adventitial and periadventitial space of the renal arteries
|
|---|---|---|
|
Overall Study
Not receiving bilateral treatment or an unsuccessful procedure
|
0
|
2
|
|
Overall Study
Receiving antihypertensive medications prior to evaluation of the primary ABPM
|
8
|
4
|
|
Overall Study
Not completing the primary ABPM
|
3
|
1
|
|
Overall Study
Not meeting inclusion/exclusion criteria
|
1
|
0
|
Baseline Characteristics
Race and Ethnicity were not collected from any participant.
Baseline characteristics by cohort
| Measure |
Treatment Arm:
n=50 Participants
Renal denervation (using the Peregrine Kit) performed with alcohol infused through the Peregrine Catheter
Alcohol: Alcohol is directly infused/delivered to the adventitial and periadventitial space of the renal arteries
|
Sham Control Arm
n=56 Participants
Only renal angiography performed
Sham control: endovascular, renal angiography
|
Total
n=106 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
53.8 years
STANDARD_DEVIATION 11.0 • n=50 Participants
|
54.4 years
STANDARD_DEVIATION 11.5 • n=56 Participants
|
54.1 years
STANDARD_DEVIATION 11.3 • n=106 Participants
|
|
Sex: Female, Male
Female
|
10 Participants
n=50 Participants
|
18 Participants
n=56 Participants
|
28 Participants
n=106 Participants
|
|
Sex: Female, Male
Male
|
40 Participants
n=50 Participants
|
38 Participants
n=56 Participants
|
78 Participants
n=106 Participants
|
|
Race and Ethnicity Not Collected
|
—
|
—
|
0 Participants
Race and Ethnicity were not collected from any participant.
|
|
Region of Enrollment
Belgium
|
1 participants
n=50 Participants
|
1 participants
n=56 Participants
|
2 participants
n=106 Participants
|
|
Region of Enrollment
United Kingdom
|
7 participants
n=50 Participants
|
9 participants
n=56 Participants
|
16 participants
n=106 Participants
|
|
Region of Enrollment
France
|
7 participants
n=50 Participants
|
6 participants
n=56 Participants
|
13 participants
n=106 Participants
|
|
Region of Enrollment
Germany
|
28 participants
n=50 Participants
|
30 participants
n=56 Participants
|
58 participants
n=106 Participants
|
|
Region of Enrollment
Netherlands
|
4 participants
n=50 Participants
|
4 participants
n=56 Participants
|
8 participants
n=106 Participants
|
|
Region of Enrollment
Ireland
|
2 participants
n=50 Participants
|
2 participants
n=56 Participants
|
4 participants
n=106 Participants
|
|
Region of Enrollment
United States
|
1 participants
n=50 Participants
|
4 participants
n=56 Participants
|
5 participants
n=106 Participants
|
|
eGFR
|
85.8 mL/min per 1.73 m^2
STANDARD_DEVIATION 14.0 • n=50 Participants
|
85.9 mL/min per 1.73 m^2
STANDARD_DEVIATION 13.0 • n=56 Participants
|
85.8 mL/min per 1.73 m^2
STANDARD_DEVIATION 13.4 • n=106 Participants
|
|
Diabetes (type 2)
|
2 Participants
n=50 Participants
|
5 Participants
n=56 Participants
|
7 Participants
n=106 Participants
|
|
Smoking (current)
|
8 Participants
n=50 Participants
|
3 Participants
n=56 Participants
|
11 Participants
n=106 Participants
|
|
Peripheral vascular occlusive disease
|
1 Participants
n=50 Participants
|
1 Participants
n=56 Participants
|
2 Participants
n=106 Participants
|
|
Angiographically determined coronary artery disease
|
2 Participants
n=50 Participants
|
1 Participants
n=56 Participants
|
3 Participants
n=106 Participants
|
PRIMARY outcome
Timeframe: Baseline to 8 weeks post-treatmentChange from baseline in mean 24-hour ambulatory systolic blood pressure
Outcome measures
| Measure |
Sham Control Arm
n=52 Participants
Only renal angiography performed
Sham control: endovascular, renal angiography
|
Treatment Arm:
n=48 Participants
Renal denervation (using the Peregrine Kit) performed with alcohol infused through the Peregrine Catheter
Alcohol: Alcohol is directly infused/delivered to the adventitial and periadventitial space of the renal arteries
|
|---|---|---|
|
Changes in Systolic Ambulatory Blood Pressure
|
-1.4 mmHg
Standard Deviation 8.6
|
-2.9 mmHg
Standard Deviation 7.4
|
SECONDARY outcome
Timeframe: 6 monthsChange from baseline in mean 24-hour ambulatory systolic blood pressure from baseline to 6 months
Outcome measures
| Measure |
Sham Control Arm
n=48 Participants
Only renal angiography performed
Sham control: endovascular, renal angiography
|
Treatment Arm:
n=45 Participants
Renal denervation (using the Peregrine Kit) performed with alcohol infused through the Peregrine Catheter
Alcohol: Alcohol is directly infused/delivered to the adventitial and periadventitial space of the renal arteries
|
|---|---|---|
|
Change in Mean 24-Hour Ambulatory Systolic Blood Pressure at 6 Months
Mean 24-Hour Ambulatory Systolic Blood Pressure
|
135.1 mmHg
Standard Deviation 11.7
|
134.1 mmHg
Standard Deviation 11.6
|
|
Change in Mean 24-Hour Ambulatory Systolic Blood Pressure at 6 Months
Change from baseline in Mean 24-Hour Ambulatory Systolic Blood Pressure
|
-13.4 mmHg
Standard Deviation 12.9
|
-13.9 mmHg
Standard Deviation 11.6
|
SECONDARY outcome
Timeframe: 12 monthsChange from baseline in mean 24-hour systolic blood pressure at 12 months post-procedure
Outcome measures
| Measure |
Sham Control Arm
n=44 Participants
Only renal angiography performed
Sham control: endovascular, renal angiography
|
Treatment Arm:
n=41 Participants
Renal denervation (using the Peregrine Kit) performed with alcohol infused through the Peregrine Catheter
Alcohol: Alcohol is directly infused/delivered to the adventitial and periadventitial space of the renal arteries
|
|---|---|---|
|
Change in Mean 24-Hour Ambulatory Systolic Blood Pressure at 12 Months
Mean 24-hour SBP
|
133.7 mmHg
Standard Deviation 11.3
|
137.6 mmHg
Standard Deviation 11.4
|
|
Change in Mean 24-Hour Ambulatory Systolic Blood Pressure at 12 Months
Change from baseline in mean 24-hour SBP
|
-15.9 mmHg
Standard Deviation 13.1
|
-10.6 mmHg
Standard Deviation 11.5
|
SECONDARY outcome
Timeframe: 8 weeksChange from Baseline in mean office SBP to Week 8
Outcome measures
| Measure |
Sham Control Arm
n=54 Participants
Only renal angiography performed
Sham control: endovascular, renal angiography
|
Treatment Arm:
n=50 Participants
Renal denervation (using the Peregrine Kit) performed with alcohol infused through the Peregrine Catheter
Alcohol: Alcohol is directly infused/delivered to the adventitial and periadventitial space of the renal arteries
|
|---|---|---|
|
Change in Office SBP at 8 Weeks
Change from Baseline in mean office SBP
|
0.63 mmHg
Standard Deviation 13.24
|
-4.0 mmHg
Standard Deviation 12.6
|
|
Change in Office SBP at 8 Weeks
Office SBP
|
160.6 mmHg
Standard Deviation 16.3
|
155.4 mmHg
Standard Deviation 14.3
|
SECONDARY outcome
Timeframe: 8 weeksChange from baseline in mean 24-hour ambulatory diastolic blood pressure and 8 weeks post-procedure
Outcome measures
| Measure |
Sham Control Arm
n=55 Participants
Only renal angiography performed
Sham control: endovascular, renal angiography
|
Treatment Arm:
n=50 Participants
Renal denervation (using the Peregrine Kit) performed with alcohol infused through the Peregrine Catheter
Alcohol: Alcohol is directly infused/delivered to the adventitial and periadventitial space of the renal arteries
|
|---|---|---|
|
Change in Mean 24-Hour Ambulatory Diastolic Blood Pressure at 8 Weeks
Mean 24-hour ambulatory diastolic blood pressure
|
91.0 mmHg
Standard Deviation 6.8
|
92.2 mmHg
Standard Deviation 7.6
|
|
Change in Mean 24-Hour Ambulatory Diastolic Blood Pressure at 8 Weeks
Change from baseline in Mean 24-hour ambulatory diastolic blood pressure
|
-1.1 mmHg
Standard Deviation 6.6
|
-2.0 mmHg
Standard Deviation 5.1
|
SECONDARY outcome
Timeframe: 6 monthsChange from baseline in mean 24-hour ambulatory diastolic blood pressure at 6 months post-procedure
Outcome measures
| Measure |
Sham Control Arm
n=48 Participants
Only renal angiography performed
Sham control: endovascular, renal angiography
|
Treatment Arm:
n=45 Participants
Renal denervation (using the Peregrine Kit) performed with alcohol infused through the Peregrine Catheter
Alcohol: Alcohol is directly infused/delivered to the adventitial and periadventitial space of the renal arteries
|
|---|---|---|
|
Change in Mean 24-Hour Ambulatory Diastolic Blood Pressure at 6 Months
Mean 24-hour ambulatory diastolic blood pressure
|
83.4 mmHg
Standard Deviation 9.0
|
83.0 mmHg
Standard Deviation 8.4
|
|
Change in Mean 24-Hour Ambulatory Diastolic Blood Pressure at 6 Months
Change from baseline in Mean 24-hour ambulatory diastolic blood pressure
|
-8.0 mmHg
Standard Deviation 8.5
|
-9.3 mmHg
Standard Deviation 6.9
|
SECONDARY outcome
Timeframe: 12 monthsChange from baseline in mean 24-hour diastolic blood pressure 12 months post-procedure
Outcome measures
| Measure |
Sham Control Arm
n=44 Participants
Only renal angiography performed
Sham control: endovascular, renal angiography
|
Treatment Arm:
n=41 Participants
Renal denervation (using the Peregrine Kit) performed with alcohol infused through the Peregrine Catheter
Alcohol: Alcohol is directly infused/delivered to the adventitial and periadventitial space of the renal arteries
|
|---|---|---|
|
Change in Mean 24-Hour Ambulatory Diastolic Blood Pressure at 12 Months
Mean 24-hour ambulatory diastolic blood pressure
|
81.0 mmHg
Standard Deviation 7.9
|
85.6 mmHg
Standard Deviation 8.7
|
|
Change in Mean 24-Hour Ambulatory Diastolic Blood Pressure at 12 Months
Change from baseline in Mean 24-hour ambulatory diastolic blood pressure
|
-9.8 mmHg
Standard Deviation 8.3
|
-7.3 mmHg
Standard Deviation 7.5
|
SECONDARY outcome
Timeframe: 30 days post procedureNumber of participants with major adverse events (MAEs) 30 days post-procedure
Outcome measures
| Measure |
Sham Control Arm
n=56 Participants
Only renal angiography performed
Sham control: endovascular, renal angiography
|
Treatment Arm:
n=50 Participants
Renal denervation (using the Peregrine Kit) performed with alcohol infused through the Peregrine Catheter
Alcohol: Alcohol is directly infused/delivered to the adventitial and periadventitial space of the renal arteries
|
|---|---|---|
|
Number of Participants With Major Adverse Events (MAEs)
|
1 Participants
|
1 Participants
|
SECONDARY outcome
Timeframe: 8 weeksUse of antihypertensive medication at 8 weeks
Outcome measures
| Measure |
Sham Control Arm
n=56 Participants
Only renal angiography performed
Sham control: endovascular, renal angiography
|
Treatment Arm:
n=50 Participants
Renal denervation (using the Peregrine Kit) performed with alcohol infused through the Peregrine Catheter
Alcohol: Alcohol is directly infused/delivered to the adventitial and periadventitial space of the renal arteries
|
|---|---|---|
|
Use of Antihypertensive Medication(s)
|
0.089 medications
Standard Deviation 0.288
|
0.060 medications
Standard Deviation 0.240
|
SECONDARY outcome
Timeframe: 8 weeksChange from Baseline in Mean Daytime Ambulatory Systolic Blood Pressure to 8 Weeks
Outcome measures
| Measure |
Sham Control Arm
n=52 Participants
Only renal angiography performed
Sham control: endovascular, renal angiography
|
Treatment Arm:
n=49 Participants
Renal denervation (using the Peregrine Kit) performed with alcohol infused through the Peregrine Catheter
Alcohol: Alcohol is directly infused/delivered to the adventitial and periadventitial space of the renal arteries
|
|---|---|---|
|
Change in Mean Daytime Ambulatory Systolic Blood Pressure at 8 Weeks
Mean Daytime Ambulatory Systolic Blood Pressure
|
153.2 mmHg
Standard Deviation 12.0
|
150.6 mmHg
Standard Deviation 10.5
|
|
Change in Mean Daytime Ambulatory Systolic Blood Pressure at 8 Weeks
Change from Baseline in Mean Daytime Ambulatory Systolic Blood Pressure
|
-1.7 mmHg
Standard Deviation 9.9
|
-3.2 mmHg
Standard Deviation 9.5
|
SECONDARY outcome
Timeframe: 6 monthsChange from Baseline in Mean Daytime Ambulatory Systolic Blood Pressure to 6 Months
Outcome measures
| Measure |
Sham Control Arm
n=46 Participants
Only renal angiography performed
Sham control: endovascular, renal angiography
|
Treatment Arm:
n=44 Participants
Renal denervation (using the Peregrine Kit) performed with alcohol infused through the Peregrine Catheter
Alcohol: Alcohol is directly infused/delivered to the adventitial and periadventitial space of the renal arteries
|
|---|---|---|
|
Change in Mean Daytime Ambulatory Systolic Blood Pressure at 6 Months
Mean Daytime Ambulatory Systolic Blood Pressur
|
140.6 mmHg
Standard Deviation 12.3
|
139.7 mmHg
Standard Deviation 12.8
|
|
Change in Mean Daytime Ambulatory Systolic Blood Pressure at 6 Months
Change from Baseline in Mean Daytime Ambulatory Systolic Blood Pressure to 6 Months
|
-14.5 mmHg
Standard Deviation 13.7
|
-14.0 mmHg
Standard Deviation 13.3
|
SECONDARY outcome
Timeframe: 12 monthsChange from Baseline in Mean Daytime Ambulatory Systolic Blood Pressure to 12 Months
Outcome measures
| Measure |
Sham Control Arm
n=44 Participants
Only renal angiography performed
Sham control: endovascular, renal angiography
|
Treatment Arm:
n=41 Participants
Renal denervation (using the Peregrine Kit) performed with alcohol infused through the Peregrine Catheter
Alcohol: Alcohol is directly infused/delivered to the adventitial and periadventitial space of the renal arteries
|
|---|---|---|
|
Change in Mean Daytime Ambulatory Systolic Blood Pressure at 12 Months
Mean Daytime Ambulatory Systolic Blood Pressure
|
140.1 mmHg
Standard Deviation 12.1
|
143.5 mmHg
Standard Deviation 12.6
|
|
Change in Mean Daytime Ambulatory Systolic Blood Pressure at 12 Months
Change from Baseline in Mean Daytime Ambulatory Systolic Blood Pressure
|
-15.5 mmHg
Standard Deviation 13.6
|
-10.5 mmHg
Standard Deviation 12.8
|
SECONDARY outcome
Timeframe: 8 weeksChange from Baseline in Mean Daytime Ambulatory Diastolic Blood Pressure to 8 Weeks
Outcome measures
| Measure |
Sham Control Arm
n=54 Participants
Only renal angiography performed
Sham control: endovascular, renal angiography
|
Treatment Arm:
n=50 Participants
Renal denervation (using the Peregrine Kit) performed with alcohol infused through the Peregrine Catheter
Alcohol: Alcohol is directly infused/delivered to the adventitial and periadventitial space of the renal arteries
|
|---|---|---|
|
Mean Daytime Ambulatory Diastolic Blood Pressure
Mean Daytime Ambulatory Diastolic Blood Pressure
|
94.7 mmHg
Standard Deviation 9.7
|
95.2 mmHg
Standard Deviation 7.5
|
|
Mean Daytime Ambulatory Diastolic Blood Pressure
hange from Baseline in Mean Daytime Ambulatory Diastolic Blood Pressure
|
-1.4 mmHg
Standard Deviation 6.8
|
-2.3 mmHg
Standard Deviation 6.8
|
SECONDARY outcome
Timeframe: 6 monthsChange from Baseline in Mean Daytime Ambulatory Diastolic Blood Pressure to 6 months
Outcome measures
| Measure |
Sham Control Arm
n=47 Participants
Only renal angiography performed
Sham control: endovascular, renal angiography
|
Treatment Arm:
n=44 Participants
Renal denervation (using the Peregrine Kit) performed with alcohol infused through the Peregrine Catheter
Alcohol: Alcohol is directly infused/delivered to the adventitial and periadventitial space of the renal arteries
|
|---|---|---|
|
Change in Mean Daytime Ambulatory Diastolic Blood Pressure at 6 Months
Mean Daytime Ambulatory Diastolic Blood Pressure
|
87.6 mmHg
Standard Deviation 9.0
|
87.8 mmHg
Standard Deviation 9.2
|
|
Change in Mean Daytime Ambulatory Diastolic Blood Pressure at 6 Months
Change from Baseline in Mean Daytime Ambulatory Diastolic Blood Pressure
|
-8.9 mmHg
Standard Deviation 8.6
|
-9.3 mmHg
Standard Deviation 8.9
|
SECONDARY outcome
Timeframe: 12 monthsChange from Baseline in Mean Daytime Ambulatory Diastolic Blood Pressure to 12 Months
Outcome measures
| Measure |
Sham Control Arm
n=44 Participants
Only renal angiography performed
Sham control: endovascular, renal angiography
|
Treatment Arm:
n=41 Participants
Renal denervation (using the Peregrine Kit) performed with alcohol infused through the Peregrine Catheter
Alcohol: Alcohol is directly infused/delivered to the adventitial and periadventitial space of the renal arteries
|
|---|---|---|
|
Change in Mean Daytime Ambulatory Diastolic Blood Pressure at 12 Months
Mean Daytime Ambulatory Diastolic Blood Pressure
|
86.0 mmHg
Standard Deviation 8.7
|
90.4 mmHg
Standard Deviation 9.6
|
|
Change in Mean Daytime Ambulatory Diastolic Blood Pressure at 12 Months
Change from Baseline in Mean Daytime Ambulatory Diastolic Blood Pressure
|
-9.5 mmHg
Standard Deviation 8.7
|
-7.6 mmHg
Standard Deviation 8.9
|
SECONDARY outcome
Timeframe: 8 weeksChange from Baseline in Mean Nighttime Ambulatory Systolic Blood Pressure to 8 Weeks
Outcome measures
| Measure |
Sham Control Arm
n=52 Participants
Only renal angiography performed
Sham control: endovascular, renal angiography
|
Treatment Arm:
n=48 Participants
Renal denervation (using the Peregrine Kit) performed with alcohol infused through the Peregrine Catheter
Alcohol: Alcohol is directly infused/delivered to the adventitial and periadventitial space of the renal arteries
|
|---|---|---|
|
Change in Mean Nighttime Ambulatory Systolic Blood Pressure at 8 Weeks
Mean Nighttime Ambulatory Systolic Blood Pressure
|
136.9 mmHg
Standard Deviation 14.6
|
134.4 mmHg
Standard Deviation 11.6
|
|
Change in Mean Nighttime Ambulatory Systolic Blood Pressure at 8 Weeks
Change from Baseline in Mean Nighttime Ambulatory Systolic Blood Pressure
|
-0.58 mmHg
Standard Deviation 12.17
|
-3.3 mmHg
Standard Deviation 9.4
|
SECONDARY outcome
Timeframe: 6 monthsChange from Baseline in Mean Nighttime Ambulatory Systolic Blood Pressure to 6 Months
Outcome measures
| Measure |
Sham Control Arm
n=45 Participants
Only renal angiography performed
Sham control: endovascular, renal angiography
|
Treatment Arm:
n=44 Participants
Renal denervation (using the Peregrine Kit) performed with alcohol infused through the Peregrine Catheter
Alcohol: Alcohol is directly infused/delivered to the adventitial and periadventitial space of the renal arteries
|
|---|---|---|
|
Change in Mean Nighttime Ambulatory Systolic Blood Pressure at 6 Months
Mean Nighttime Ambulatory Systolic Blood Pressure
|
125.6 mmHg
Standard Deviation 13.9
|
125.4 mmHg
Standard Deviation 12.1
|
|
Change in Mean Nighttime Ambulatory Systolic Blood Pressure at 6 Months
Change from Baseline in Mean Nighttime Ambulatory Systolic Blood Pressure
|
-12.8 mmHg
Standard Deviation 14.1
|
-13.4 mmHg
Standard Deviation 12.7
|
SECONDARY outcome
Timeframe: 12 monthsChange from Baseline in Mean Nighttime Ambulatory Systolic Blood Pressure to 12 Months
Outcome measures
| Measure |
Sham Control Arm
n=44 Participants
Only renal angiography performed
Sham control: endovascular, renal angiography
|
Treatment Arm:
n=39 Participants
Renal denervation (using the Peregrine Kit) performed with alcohol infused through the Peregrine Catheter
Alcohol: Alcohol is directly infused/delivered to the adventitial and periadventitial space of the renal arteries
|
|---|---|---|
|
Change in Mean Nighttime Ambulatory Systolic Blood Pressure to 12 Months
Mean Nighttime Ambulatory Systolic Blood Pressure
|
123.1 mmHg
Standard Deviation 12.3
|
127.8 mmHg
Standard Deviation 10.7
|
|
Change in Mean Nighttime Ambulatory Systolic Blood Pressure to 12 Months
Change from Baseline in Mean Nighttime Ambulatory Systolic Blood Pressure
|
-17.1 mmHg
Standard Deviation 14.4
|
-11.8 mmHg
Standard Deviation 12.2
|
SECONDARY outcome
Timeframe: 8 weeksChange from Baseline in Mean Nighttime Ambulatory Diastolic Blood Pressure to 8 weeks
Outcome measures
| Measure |
Sham Control Arm
n=52 Participants
Only renal angiography performed
Sham control: endovascular, renal angiography
|
Treatment Arm:
n=48 Participants
Renal denervation (using the Peregrine Kit) performed with alcohol infused through the Peregrine Catheter
Alcohol: Alcohol is directly infused/delivered to the adventitial and periadventitial space of the renal arteries
|
|---|---|---|
|
Change in Mean Nighttime Ambulatory Diastolic Blood Pressure at 8 Weeks
Mean Nighttime Ambulatory Diastolic Blood Pressure
|
82.5 mmHg
Standard Deviation 12.4
|
81.5 mmHg
Standard Deviation 8.4
|
|
Change in Mean Nighttime Ambulatory Diastolic Blood Pressure at 8 Weeks
Change from Baseline in Mean Nighttime Ambulatory Diastolic Blood Pressure
|
-0.44 mmHg
Standard Deviation 10.17
|
-2.5 mmHg
Standard Deviation 7.3
|
SECONDARY outcome
Timeframe: 6 monthsChange from Baseline in Mean Nighttime Ambulatory Diastolic Blood Pressure to 6 Months
Outcome measures
| Measure |
Sham Control Arm
n=46 Participants
Only renal angiography performed
Sham control: endovascular, renal angiography
|
Treatment Arm:
n=45 Participants
Renal denervation (using the Peregrine Kit) performed with alcohol infused through the Peregrine Catheter
Alcohol: Alcohol is directly infused/delivered to the adventitial and periadventitial space of the renal arteries
|
|---|---|---|
|
Change in Mean Nighttime Ambulatory Diastolic Blood Pressure at 6 Months
Mean Nighttime Ambulatory Diastolic Blood Pressure
|
75.8 mmHg
Standard Deviation 10.8
|
75.5 mmHg
Standard Deviation 9.2
|
|
Change in Mean Nighttime Ambulatory Diastolic Blood Pressure at 6 Months
Change from Baseline in Mean Nighttime Ambulatory Diastolic Blood Pressure
|
-7.4 mmHg
Standard Deviation 10.4
|
-9.0 mmHg
Standard Deviation 8.0
|
SECONDARY outcome
Timeframe: 12 monthsChange from Baseline in Mean Nighttime Ambulatory Diastolic Blood Pressure to 12 Months
Outcome measures
| Measure |
Sham Control Arm
n=44 Participants
Only renal angiography performed
Sham control: endovascular, renal angiography
|
Treatment Arm:
n=39 Participants
Renal denervation (using the Peregrine Kit) performed with alcohol infused through the Peregrine Catheter
Alcohol: Alcohol is directly infused/delivered to the adventitial and periadventitial space of the renal arteries
|
|---|---|---|
|
Change in Mean Nighttime Ambulatory Diastolic Blood Pressure at 12 Months
Mean Nighttime Ambulatory Diastolic Blood Pressure
|
72.8 mmHg
Standard Deviation 8.2
|
77.4 mmHg
Standard Deviation 7.8
|
|
Change in Mean Nighttime Ambulatory Diastolic Blood Pressure at 12 Months
Change from Baseline in Mean Nighttime Ambulatory Diastolic Blood Pressure
|
-10.8 mmHg
Standard Deviation 9.7
|
-7.6 mmHg
Standard Deviation 8.1
|
SECONDARY outcome
Timeframe: 6 monthsChange from Baseline in mean office SBP to 6 Months
Outcome measures
| Measure |
Sham Control Arm
n=51 Participants
Only renal angiography performed
Sham control: endovascular, renal angiography
|
Treatment Arm:
n=45 Participants
Renal denervation (using the Peregrine Kit) performed with alcohol infused through the Peregrine Catheter
Alcohol: Alcohol is directly infused/delivered to the adventitial and periadventitial space of the renal arteries
|
|---|---|---|
|
Change in Mean Office SBP at 6 Months
mean office SBP
|
145.7 mmHg
Standard Deviation 14.3
|
146.1 mmHg
Standard Deviation 16.4
|
|
Change in Mean Office SBP at 6 Months
Change from Baseline in mean office SBP to 6 Months
|
-14.7 mmHg
Standard Deviation 15.7
|
-12.9 mmHg
Standard Deviation 15.6
|
SECONDARY outcome
Timeframe: 12 monthsChange from Baseline in mean office SBP to 12 Months
Outcome measures
| Measure |
Sham Control Arm
n=50 Participants
Only renal angiography performed
Sham control: endovascular, renal angiography
|
Treatment Arm:
n=41 Participants
Renal denervation (using the Peregrine Kit) performed with alcohol infused through the Peregrine Catheter
Alcohol: Alcohol is directly infused/delivered to the adventitial and periadventitial space of the renal arteries
|
|---|---|---|
|
Change in Mean Office SBP to 12 Months
mean office SBP
|
147.8 mmHg
Standard Deviation 15.1
|
147.9 mmHg
Standard Deviation 18.5
|
|
Change in Mean Office SBP to 12 Months
Change from Baseline in mean office SBP to 12 Months
|
-13.2 mmHg
Standard Deviation 16.6
|
-11.0 mmHg
Standard Deviation 15.3
|
SECONDARY outcome
Timeframe: 8 weeksChange from Baseline in mean office DBP to 8 Weeks
Outcome measures
| Measure |
Sham Control Arm
n=54 Participants
Only renal angiography performed
Sham control: endovascular, renal angiography
|
Treatment Arm:
n=50 Participants
Renal denervation (using the Peregrine Kit) performed with alcohol infused through the Peregrine Catheter
Alcohol: Alcohol is directly infused/delivered to the adventitial and periadventitial space of the renal arteries
|
|---|---|---|
|
Change in Mean Office DBP to 8 Weeks
mean office DBP
|
97.3 mmHg
Standard Deviation 10.9
|
97.0 mmHg
Standard Deviation 9.4
|
|
Change in Mean Office DBP to 8 Weeks
Change from Baseline in mean office DBP to 8 Weeks
|
-1.1 mmHg
Standard Deviation 8.8
|
-3.5 mmHg
Standard Deviation 7.6
|
SECONDARY outcome
Timeframe: 6 monthsChange from Baseline in mean office DBP to 6 Months
Outcome measures
| Measure |
Sham Control Arm
n=51 Participants
Only renal angiography performed
Sham control: endovascular, renal angiography
|
Treatment Arm:
n=45 Participants
Renal denervation (using the Peregrine Kit) performed with alcohol infused through the Peregrine Catheter
Alcohol: Alcohol is directly infused/delivered to the adventitial and periadventitial space of the renal arteries
|
|---|---|---|
|
Change in Mean Office DBP to 6 Months
mean office DBP
|
89.7 mmHg
Standard Deviation 10.5
|
90.4 mmHg
Standard Deviation 9.4
|
|
Change in Mean Office DBP to 6 Months
Change from Baseline in mean office DBP to 6 Months
|
-8.4 mmHg
Standard Deviation 9.5
|
-10.0 mmHg
Standard Deviation 9.0
|
SECONDARY outcome
Timeframe: 12 monthsChange from Baseline in mean office DBP to 12 Months
Outcome measures
| Measure |
Sham Control Arm
n=50 Participants
Only renal angiography performed
Sham control: endovascular, renal angiography
|
Treatment Arm:
n=41 Participants
Renal denervation (using the Peregrine Kit) performed with alcohol infused through the Peregrine Catheter
Alcohol: Alcohol is directly infused/delivered to the adventitial and periadventitial space of the renal arteries
|
|---|---|---|
|
Change in Mean Office DBP at 12 Months
Change from Baseline in mean office DBP to 12 Months
|
-9.6 mmHg
Standard Deviation 11.0
|
-9.4 mmHg
Standard Deviation 9.4
|
|
Change in Mean Office DBP at 12 Months
mean office DBP
|
88.5 mmHg
Standard Deviation 11.5
|
91.0 mmHg
Standard Deviation 11.0
|
Adverse Events
Sham Control Arm
Serious events: 9 serious events
Other events: 42 other events
Deaths: 0 deaths
Treatment Arm:
Serious events: 7 serious events
Other events: 41 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Sham Control Arm
n=56 participants at risk
Only renal angiography performed
Sham control: endovascular, renal angiography
|
Treatment Arm:
n=50 participants at risk
Renal denervation (using the Peregrine Kit) performed with alcohol infused through the Peregrine Catheter
Alcohol: Alcohol is directly infused/delivered to the adventitial and periadventitial space of the renal arteries
|
|---|---|---|
|
Cardiac disorders
Atrial fibrillation
|
0.00%
0/56 • 12 months
|
4.0%
2/50 • Number of events 2 • 12 months
|
|
Infections and infestations
Abdominal abscess
|
0.00%
0/56 • 12 months
|
2.0%
1/50 • Number of events 1 • 12 months
|
|
Infections and infestations
Appendicitis perforated
|
0.00%
0/56 • 12 months
|
2.0%
1/50 • Number of events 1 • 12 months
|
|
Injury, poisoning and procedural complications
Post procedural haematoma
|
0.00%
0/56 • 12 months
|
2.0%
1/50 • Number of events 1 • 12 months
|
|
Injury, poisoning and procedural complications
Vascular pseudoaneurysm
|
1.8%
1/56 • Number of events 1 • 12 months
|
0.00%
0/50 • 12 months
|
|
Investigations
Haemoglobin decreased
|
1.8%
1/56 • Number of events 1 • 12 months
|
0.00%
0/50 • 12 months
|
|
Metabolism and nutrition disorders
Hyponatraemia
|
1.8%
1/56 • Number of events 1 • 12 months
|
0.00%
0/50 • 12 months
|
|
Musculoskeletal and connective tissue disorders
Lumbar vertebral fracture
|
1.8%
1/56 • Number of events 1 • 12 months
|
0.00%
0/50 • 12 months
|
|
Nervous system disorders
Sciatica
|
1.8%
1/56 • Number of events 1 • 12 months
|
0.00%
0/50 • 12 months
|
|
Renal and urinary disorders
Urethral stenosis
|
0.00%
0/56 • 12 months
|
2.0%
1/50 • Number of events 1 • 12 months
|
|
Respiratory, thoracic and mediastinal disorders
Lung neoplasm malignant
|
1.8%
1/56 • Number of events 1 • 12 months
|
0.00%
0/50 • 12 months
|
|
Respiratory, thoracic and mediastinal disorders
Nasal septum deviation
|
1.8%
1/56 • Number of events 1 • 12 months
|
0.00%
0/50 • 12 months
|
|
Surgical and medical procedures
Mitral valve repair
|
1.8%
1/56 • Number of events 1 • 12 months
|
0.00%
0/50 • 12 months
|
|
Vascular disorders
Aneurysm
|
0.00%
0/56 • 12 months
|
2.0%
1/50 • Number of events 1 • 12 months
|
|
Vascular disorders
Haematoma
|
0.00%
0/56 • 12 months
|
2.0%
1/50 • Number of events 1 • 12 months
|
|
Vascular disorders
Hypertensive crisis
|
0.00%
0/56 • 12 months
|
2.0%
1/50 • Number of events 1 • 12 months
|
|
Vascular disorders
Pulmonary embolism
|
1.8%
1/56 • Number of events 1 • 12 months
|
0.00%
0/50 • 12 months
|
Other adverse events
| Measure |
Sham Control Arm
n=56 participants at risk
Only renal angiography performed
Sham control: endovascular, renal angiography
|
Treatment Arm:
n=50 participants at risk
Renal denervation (using the Peregrine Kit) performed with alcohol infused through the Peregrine Catheter
Alcohol: Alcohol is directly infused/delivered to the adventitial and periadventitial space of the renal arteries
|
|---|---|---|
|
General disorders
Oedema peripheral
|
1.8%
1/56 • Number of events 1 • 12 months
|
6.0%
3/50 • Number of events 3 • 12 months
|
|
Infections and infestations
Nasopharyngitis
|
7.1%
4/56 • Number of events 4 • 12 months
|
4.0%
2/50 • Number of events 2 • 12 months
|
|
Injury, poisoning and procedural complications
Post procedural haematoma
|
7.1%
4/56 • Number of events 4 • 12 months
|
12.0%
6/50 • Number of events 6 • 12 months
|
|
Investigations
Blood pressure increased
|
5.4%
3/56 • Number of events 3 • 12 months
|
4.0%
2/50 • Number of events 2 • 12 months
|
|
Investigations
Glomerular filtration rate decreased
|
8.9%
5/56 • Number of events 5 • 12 months
|
4.0%
2/50 • Number of events 2 • 12 months
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
5.4%
3/56 • Number of events 3 • 12 months
|
4.0%
2/50 • Number of events 2 • 12 months
|
|
Nervous system disorders
Headache
|
12.5%
7/56 • Number of events 7 • 12 months
|
22.0%
11/50 • Number of events 11 • 12 months
|
|
Vascular disorders
Hypertension
|
8.9%
5/56 • Number of events 5 • 12 months
|
6.0%
3/50 • Number of events 3 • 12 months
|
|
Vascular disorders
Hypertensive crisis
|
5.4%
3/56 • Number of events 3 • 12 months
|
2.0%
1/50 • Number of events 1 • 12 months
|
|
Blood and lymphatic system disorders
Anaemia
|
1.8%
1/56 • Number of events 1 • 12 months
|
0.00%
0/50 • 12 months
|
|
Blood and lymphatic system disorders
Lymphadenopathy
|
1.8%
1/56 • Number of events 1 • 12 months
|
0.00%
0/50 • 12 months
|
|
Cardiac disorders
Chest discomfort
|
0.00%
0/56 • 12 months
|
2.0%
1/50 • Number of events 1 • 12 months
|
|
Cardiac disorders
Dyspnoea exertional
|
0.00%
0/56 • 12 months
|
2.0%
1/50 • Number of events 1 • 12 months
|
|
Cardiac disorders
Palpitations
|
0.00%
0/56 • 12 months
|
2.0%
1/50 • Number of events 1 • 12 months
|
|
Cardiac disorders
Sinus tachycardia
|
1.8%
1/56 • Number of events 1 • 12 months
|
0.00%
0/50 • 12 months
|
|
Cardiac disorders
Tachycardia
|
3.6%
2/56 • Number of events 2 • 12 months
|
2.0%
1/50 • Number of events 1 • 12 months
|
|
Eye disorders
Ocular discomfort
|
0.00%
0/56 • 12 months
|
2.0%
1/50 • Number of events 1 • 12 months
|
|
Gastrointestinal disorders
Abdominal discomfort
|
0.00%
0/56 • 12 months
|
4.0%
2/50 • Number of events 2 • 12 months
|
|
Gastrointestinal disorders
Abdominal pain
|
1.8%
1/56 • Number of events 1 • 12 months
|
2.0%
1/50 • Number of events 1 • 12 months
|
|
Gastrointestinal disorders
Coeliac artery compression syndrome
|
1.8%
1/56 • Number of events 1 • 12 months
|
0.00%
0/50 • 12 months
|
|
Gastrointestinal disorders
Dyspepsia
|
1.8%
1/56 • Number of events 1 • 12 months
|
0.00%
0/50 • 12 months
|
|
Gastrointestinal disorders
Gastroenteritis viral
|
1.8%
1/56 • Number of events 1 • 12 months
|
0.00%
0/50 • 12 months
|
|
Gastrointestinal disorders
Haemorrhoids
|
1.8%
1/56 • Number of events 1 • 12 months
|
0.00%
0/50 • 12 months
|
|
Gastrointestinal disorders
Haemorrhoids thrombosed
|
1.8%
1/56 • Number of events 1 • 12 months
|
0.00%
0/50 • 12 months
|
|
General disorders
Adverse drug reaction
|
0.00%
0/56 • 12 months
|
2.0%
1/50 • Number of events 1 • 12 months
|
|
General disorders
Asthenia
|
1.8%
1/56 • Number of events 1 • 12 months
|
0.00%
0/50 • 12 months
|
|
General disorders
Chest pain
|
0.00%
0/56 • 12 months
|
2.0%
1/50 • Number of events 1 • 12 months
|
|
General disorders
Drug intolerance
|
0.00%
0/56 • 12 months
|
2.0%
1/50 • Number of events 1 • 12 months
|
|
General disorders
Non-cardiac chest pain
|
0.00%
0/56 • 12 months
|
2.0%
1/50 • Number of events 1 • 12 months
|
|
General disorders
Oedema
|
1.8%
1/56 • Number of events 1 • 12 months
|
0.00%
0/50 • 12 months
|
|
General disorders
Peripheral swelling
|
0.00%
0/56 • 12 months
|
2.0%
1/50 • Number of events 1 • 12 months
|
|
General disorders
Puncture site haematoma
|
0.00%
0/56 • 12 months
|
2.0%
1/50 • Number of events 1 • 12 months
|
|
General disorders
Puncture site haemorrhage
|
0.00%
0/56 • 12 months
|
2.0%
1/50 • Number of events 1 • 12 months
|
|
Hepatobiliary disorders
Cholelithiasis
|
0.00%
0/56 • 12 months
|
2.0%
1/50 • Number of events 1 • 12 months
|
|
Infections and infestations
Abdominal abscess
|
0.00%
0/56 • 12 months
|
2.0%
1/50 • Number of events 1 • 12 months
|
|
Infections and infestations
Acute sinusitis
|
1.8%
1/56 • Number of events 1 • 12 months
|
0.00%
0/50 • 12 months
|
|
Infections and infestations
Appendicitis perforated
|
0.00%
0/56 • 12 months
|
2.0%
1/50 • Number of events 1 • 12 months
|
|
Infections and infestations
Asymptomatic COVID-19
|
1.8%
1/56 • Number of events 1 • 12 months
|
2.0%
1/50 • Number of events 1 • 12 months
|
|
Infections and infestations
COVID-19
|
3.6%
2/56 • Number of events 2 • 12 months
|
2.0%
1/50 • Number of events 1 • 12 months
|
|
Infections and infestations
Diverticulitis
|
1.8%
1/56 • Number of events 1 • 12 months
|
0.00%
0/50 • 12 months
|
|
Infections and infestations
Pharyngitis
|
0.00%
0/56 • 12 months
|
2.0%
1/50 • Number of events 1 • 12 months
|
|
Injury, poisoning and procedural complications
Sinusitis
|
1.8%
1/56 • Number of events 1 • 12 months
|
0.00%
0/50 • 12 months
|
|
Injury, poisoning and procedural complications
Upper respiratory tract infection
|
1.8%
1/56 • Number of events 1 • 12 months
|
0.00%
0/50 • 12 months
|
|
Infections and infestations
Urinary tract infection
|
0.00%
0/56 • 12 months
|
2.0%
1/50 • Number of events 1 • 12 months
|
|
Injury, poisoning and procedural complications
Arterial intramural haematoma
|
0.00%
0/56 • 12 months
|
2.0%
1/50 • Number of events 1 • 12 months
|
|
Injury, poisoning and procedural complications
Head injury
|
0.00%
0/56 • 12 months
|
2.0%
1/50 • Number of events 1 • 12 months
|
|
Injury, poisoning and procedural complications
Joint injury
|
1.8%
1/56 • Number of events 1 • 12 months
|
0.00%
0/50 • 12 months
|
|
Injury, poisoning and procedural complications
Limb injury
|
0.00%
0/56 • 12 months
|
2.0%
1/50 • Number of events 1 • 12 months
|
|
Injury, poisoning and procedural complications
Post procedural complication
|
0.00%
0/56 • 12 months
|
2.0%
1/50 • Number of events 1 • 12 months
|
|
Injury, poisoning and procedural complications
Post procedural haemorrhage
|
1.8%
1/56 • Number of events 1 • 12 months
|
0.00%
0/50 • 12 months
|
|
Injury, poisoning and procedural complications
Procedural pain
|
0.00%
0/56 • 12 months
|
4.0%
2/50 • Number of events 2 • 12 months
|
|
Injury, poisoning and procedural complications
Scratch
|
0.00%
0/56 • 12 months
|
2.0%
1/50 • Number of events 1 • 12 months
|
|
Injury, poisoning and procedural complications
Vascular pseudoaneurysm
|
1.8%
1/56 • Number of events 1 • 12 months
|
0.00%
0/50 • 12 months
|
|
Investigations
Blood pressure diastolic increased
|
0.00%
0/56 • 12 months
|
2.0%
1/50 • Number of events 1 • 12 months
|
|
Investigations
Blood sodium decreased
|
0.00%
0/56 • 12 months
|
2.0%
1/50 • Number of events 1 • 12 months
|
|
Investigations
Glycosylated haemoglobin increased
|
0.00%
0/56 • 12 months
|
2.0%
1/50 • Number of events 1 • 12 months
|
|
Investigations
Haemoglobin decreased
|
1.8%
1/56 • Number of events 1 • 12 months
|
0.00%
0/50 • 12 months
|
|
Metabolism and nutrition disorders
Gout
|
0.00%
0/56 • 12 months
|
2.0%
1/50 • Number of events 1 • 12 months
|
|
Metabolism and nutrition disorders
Hypercholesterolaemia
|
0.00%
0/56 • 12 months
|
2.0%
1/50 • Number of events 1 • 12 months
|
|
Metabolism and nutrition disorders
Hyperlipidaemia
|
0.00%
0/56 • 12 months
|
2.0%
1/50 • Number of events 1 • 12 months
|
|
Metabolism and nutrition disorders
Hyponatraemia
|
1.8%
1/56 • Number of events 1 • 12 months
|
0.00%
0/50 • 12 months
|
|
Metabolism and nutrition disorders
Protein deficiency
|
1.8%
1/56 • Number of events 1 • 12 months
|
0.00%
0/50 • 12 months
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
3.6%
2/56 • Number of events 2 • 12 months
|
2.0%
1/50 • Number of events 1 • 12 months
|
|
Musculoskeletal and connective tissue disorders
Flank pain
|
1.8%
1/56 • Number of events 1 • 12 months
|
0.00%
0/50 • 12 months
|
|
Musculoskeletal and connective tissue disorders
Groin pain
|
1.8%
1/56 • Number of events 1 • 12 months
|
4.0%
2/50 • Number of events 2 • 12 months
|
|
Musculoskeletal and connective tissue disorders
Joint effusion
|
1.8%
1/56 • Number of events 1 • 12 months
|
0.00%
0/50 • 12 months
|
|
Musculoskeletal and connective tissue disorders
Lumbar vertebral fracture
|
1.8%
1/56 • Number of events 1 • 12 months
|
0.00%
0/50 • 12 months
|
|
Musculoskeletal and connective tissue disorders
Muscle spasms
|
3.6%
2/56 • Number of events 2 • 12 months
|
2.0%
1/50 • Number of events 1 • 12 months
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
1.8%
1/56 • Number of events 1 • 12 months
|
0.00%
0/50 • 12 months
|
|
Musculoskeletal and connective tissue disorders
Osteoarthritis
|
1.8%
1/56 • Number of events 1 • 12 months
|
2.0%
1/50 • Number of events 1 • 12 months
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
1.8%
1/56 • Number of events 1 • 12 months
|
4.0%
2/50 • Number of events 2 • 12 months
|
|
Musculoskeletal and connective tissue disorders
Plantar fasciitis
|
1.8%
1/56 • Number of events 1 • 12 months
|
0.00%
0/50 • 12 months
|
|
Musculoskeletal and connective tissue disorders
Rhabdomyolysis
|
1.8%
1/56 • Number of events 1 • 12 months
|
0.00%
0/50 • 12 months
|
|
Musculoskeletal and connective tissue disorders
Spinal pain
|
1.8%
1/56 • Number of events 1 • 12 months
|
0.00%
0/50 • 12 months
|
|
Nervous system disorders
Ageusia
|
1.8%
1/56 • Number of events 1 • 12 months
|
0.00%
0/50 • 12 months
|
|
Nervous system disorders
Balance disorder
|
1.8%
1/56 • Number of events 1 • 12 months
|
0.00%
0/50 • 12 months
|
|
Nervous system disorders
Disturbance in attention
|
0.00%
0/56 • 12 months
|
2.0%
1/50 • Number of events 1 • 12 months
|
|
Nervous system disorders
Dizziness
|
0.00%
0/56 • 12 months
|
4.0%
2/50 • Number of events 2 • 12 months
|
|
Nervous system disorders
Dizziness postural
|
1.8%
1/56 • Number of events 1 • 12 months
|
0.00%
0/50 • 12 months
|
|
Nervous system disorders
Hypoaesthesia
|
0.00%
0/56 • 12 months
|
2.0%
1/50 • Number of events 1 • 12 months
|
|
Nervous system disorders
Multiple sclerosis
|
1.8%
1/56 • Number of events 1 • 12 months
|
0.00%
0/50 • 12 months
|
|
Nervous system disorders
Restlessness
|
0.00%
0/56 • 12 months
|
2.0%
1/50 • Number of events 1 • 12 months
|
|
Nervous system disorders
Sciatica
|
1.8%
1/56 • Number of events 1 • 12 months
|
0.00%
0/50 • 12 months
|
|
Psychiatric disorders
Sleep disorder
|
1.8%
1/56 • Number of events 1 • 12 months
|
0.00%
0/50 • 12 months
|
|
Renal and urinary disorders
Nocturia
|
0.00%
0/56 • 12 months
|
4.0%
2/50 • Number of events 2 • 12 months
|
|
Psychiatric disorders
Urethral stenosis
|
0.00%
0/56 • 12 months
|
2.0%
1/50 • Number of events 1 • 12 months
|
|
Renal and urinary disorders
Urinary retention
|
0.00%
0/56 • 12 months
|
2.0%
1/50 • Number of events 1 • 12 months
|
|
Reproductive system and breast disorders
Menopausal symptoms
|
1.8%
1/56 • Number of events 1 • 12 months
|
0.00%
0/50 • 12 months
|
|
Reproductive system and breast disorders
Postmenopausal haemorrhage
|
0.00%
0/56 • 12 months
|
2.0%
1/50 • Number of events 1 • 12 months
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
1.8%
1/56 • Number of events 1 • 12 months
|
2.0%
1/50 • Number of events 1 • 12 months
|
|
Respiratory, thoracic and mediastinal disorders
Lung neoplasm malignant
|
1.8%
1/56 • Number of events 1 • 12 months
|
0.00%
0/50 • 12 months
|
|
Respiratory, thoracic and mediastinal disorders
Nasal septum deviation
|
1.8%
1/56 • Number of events 1 • 12 months
|
0.00%
0/50 • 12 months
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal pain
|
0.00%
0/56 • 12 months
|
2.0%
1/50 • Number of events 1 • 12 months
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
1.8%
1/56 • Number of events 1 • 12 months
|
0.00%
0/50 • 12 months
|
|
Skin and subcutaneous tissue disorders
Acarodermatitis
|
0.00%
0/56 • 12 months
|
2.0%
1/50 • Number of events 1 • 12 months
|
|
Skin and subcutaneous tissue disorders
Alopecia
|
0.00%
0/56 • 12 months
|
2.0%
1/50 • Number of events 1 • 12 months
|
|
Skin and subcutaneous tissue disorders
Nail discolouration
|
1.8%
1/56 • Number of events 1 • 12 months
|
0.00%
0/50 • 12 months
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
1.8%
1/56 • Number of events 1 • 12 months
|
0.00%
0/50 • 12 months
|
|
Skin and subcutaneous tissue disorders
Skin hyperpigmentation
|
0.00%
0/56 • 12 months
|
2.0%
1/50 • Number of events 1 • 12 months
|
|
Surgical and medical procedures
Apicectomy
|
0.00%
0/56 • 12 months
|
2.0%
1/50 • Number of events 1 • 12 months
|
|
Surgical and medical procedures
Mitral valve repair
|
1.8%
1/56 • Number of events 1 • 12 months
|
0.00%
0/50 • 12 months
|
|
Skin and subcutaneous tissue disorders
Varicose vein operation
|
1.8%
1/56 • Number of events 1 • 12 months
|
0.00%
0/50 • 12 months
|
|
Vascular disorders
Aneurysm
|
0.00%
0/56 • 12 months
|
2.0%
1/50 • Number of events 1 • 12 months
|
|
Vascular disorders
Arterial disorder
|
0.00%
0/56 • 12 months
|
2.0%
1/50 • Number of events 1 • 12 months
|
|
Vascular disorders
Dizziness
|
3.6%
2/56 • Number of events 2 • 12 months
|
2.0%
1/50 • Number of events 1 • 12 months
|
|
Vascular disorders
Haematoma
|
3.6%
2/56 • Number of events 2 • 12 months
|
10.0%
5/50 • Number of events 5 • 12 months
|
|
Vascular disorders
Hypertensive urgency
|
1.8%
1/56 • Number of events 1 • 12 months
|
0.00%
0/50 • 12 months
|
|
Vascular disorders
Hypotension
|
0.00%
0/56 • 12 months
|
2.0%
1/50 • Number of events 1 • 12 months
|
|
Vascular disorders
Peripheral artery occlusion
|
0.00%
0/56 • 12 months
|
2.0%
1/50 • Number of events 1 • 12 months
|
|
Vascular disorders
Peripheral venous disease
|
0.00%
0/56 • 12 months
|
2.0%
1/50 • Number of events 1 • 12 months
|
|
Vascular disorders
Post procedural haematoma
|
1.8%
1/56 • Number of events 1 • 12 months
|
0.00%
0/50 • 12 months
|
|
Vascular disorders
Pulmonary embolism
|
1.8%
1/56 • Number of events 1 • 12 months
|
0.00%
0/50 • 12 months
|
|
Vascular disorders
Renal artery dissection
|
0.00%
0/56 • 12 months
|
2.0%
1/50 • Number of events 1 • 12 months
|
|
Vascular disorders
Syncope
|
1.8%
1/56 • Number of events 1 • 12 months
|
0.00%
0/50 • 12 months
|
|
Vascular disorders
Thrombophlebitis superficial
|
1.8%
1/56 • Number of events 1 • 12 months
|
0.00%
0/50 • 12 months
|
|
Vascular disorders
Varicose vein
|
0.00%
0/56 • 12 months
|
2.0%
1/50 • Number of events 1 • 12 months
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place