Trial Outcomes & Findings for A Study of the ReCor Medical Paradise System in Clinical Hypertension (NCT NCT02649426)
NCT ID: NCT02649426
Last Updated: 2024-06-28
Results Overview
Mean difference in average daytime ambulatory systolic BP of the Solo cohort
Recruitment status
ACTIVE_NOT_RECRUITING
Study phase
NA
Target enrollment
282 participants
Primary outcome timeframe
from baseline to 2 months post procedure
Results posted on
2024-06-28
Participant Flow
Participant milestones
| Measure |
Solo Cohort - Renal Denervation
Subjects with essential hypertension controlled on 1 or 2 antihypertensive medications or uncontrolled on 0-2 antihypertensive medications will be included in the RADIANCE Solo cohort.
After the post-randomisation qualifying renal angiogram, patients assigned to the renal denervation group underwent immediate endovascular ultrasound nerve ablation with the Paradise endovascular ultrasound renal denervation system.
|
Solo Cohort - Sham
Subjects with essential hypertension controlled on 1 or 2 antihypertensive medications or uncontrolled on 0-2 antihypertensive medications will be included in the RADIANCE Solo cohort.
After the post-randomisation qualifying renal angiogram, patients randomised to the sham group had no further endovascular procedure.
|
Trio Cohort - Renal Denervation
Subjects with treatment resistant hypertension on a minimum of 3 antihypertensive medications will be included in the RADIANCE Trio cohort.
After the post-randomisation qualifying renal angiogram, patients assigned to the renal denervation group underwent immediate endovascular ultrasound nerve ablation with the Paradise endovascular ultrasound renal denervation system.
|
Trio Cohort - Sham
Subjects with treatment resistant hypertension on a minimum of 3 antihypertensive medications will be included in the RADIANCE Trio cohort.
After the post-randomisation qualifying renal angiogram, patients randomised to the sham group had no further endovascular procedure.
|
|---|---|---|---|---|
|
Overall Study
STARTED
|
74
|
72
|
69
|
67
|
|
Overall Study
Patient Crossed-over From Sham to Renal Denervation
|
0
|
37
|
0
|
22
|
|
Overall Study
COMPLETED
|
73
|
46
|
41
|
36
|
|
Overall Study
NOT COMPLETED
|
1
|
26
|
28
|
31
|
Reasons for withdrawal
| Measure |
Solo Cohort - Renal Denervation
Subjects with essential hypertension controlled on 1 or 2 antihypertensive medications or uncontrolled on 0-2 antihypertensive medications will be included in the RADIANCE Solo cohort.
After the post-randomisation qualifying renal angiogram, patients assigned to the renal denervation group underwent immediate endovascular ultrasound nerve ablation with the Paradise endovascular ultrasound renal denervation system.
|
Solo Cohort - Sham
Subjects with essential hypertension controlled on 1 or 2 antihypertensive medications or uncontrolled on 0-2 antihypertensive medications will be included in the RADIANCE Solo cohort.
After the post-randomisation qualifying renal angiogram, patients randomised to the sham group had no further endovascular procedure.
|
Trio Cohort - Renal Denervation
Subjects with treatment resistant hypertension on a minimum of 3 antihypertensive medications will be included in the RADIANCE Trio cohort.
After the post-randomisation qualifying renal angiogram, patients assigned to the renal denervation group underwent immediate endovascular ultrasound nerve ablation with the Paradise endovascular ultrasound renal denervation system.
|
Trio Cohort - Sham
Subjects with treatment resistant hypertension on a minimum of 3 antihypertensive medications will be included in the RADIANCE Trio cohort.
After the post-randomisation qualifying renal angiogram, patients randomised to the sham group had no further endovascular procedure.
|
|---|---|---|---|---|
|
Overall Study
Follow-up on going
|
1
|
26
|
28
|
31
|
Baseline Characteristics
A Study of the ReCor Medical Paradise System in Clinical Hypertension
Baseline characteristics by cohort
| Measure |
Solo Cohort - Renal Denervation
n=74 Participants
Subjects with essential hypertension controlled on 1 or 2 antihypertensive medications or uncontrolled on 0-2 antihypertensive medications will be included in the RADIANCE Solo cohort
|
Solo Cohort - Sham
n=72 Participants
Subjects with essential hypertension controlled on 1 or 2 antihypertensive medications or uncontrolled on 0-2 antihypertensive medications will be included in the RADIANCE Solo cohort
|
Trio Cohort - Renal Denervation
n=69 Participants
Subjects with treatment resistant hypertension on a minimum of 3 antihypertensive medications will be included in the RADIANCE Trio cohort.
|
Trio Cohort - Sham
n=67 Participants
Subjects with treatment resistant hypertension on a minimum of 3 antihypertensive medications will be included in the RADIANCE Trio cohort.
|
Total
n=282 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
74 Participants
n=5 Participants
|
72 Participants
n=7 Participants
|
69 Participants
n=5 Participants
|
67 Participants
n=4 Participants
|
282 Participants
n=21 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
|
Age, Continuous
|
54.4 years
STANDARD_DEVIATION 10.2 • n=5 Participants
|
53.8 years
STANDARD_DEVIATION 10.0 • n=7 Participants
|
52.3 years
STANDARD_DEVIATION 7.5 • n=5 Participants
|
52.8 years
STANDARD_DEVIATION 9.1 • n=4 Participants
|
53.32 years
STANDARD_DEVIATION 9.2 • n=21 Participants
|
|
Sex: Female, Male
Female
|
28 Participants
n=5 Participants
|
33 Participants
n=7 Participants
|
13 Participants
n=5 Participants
|
14 Participants
n=4 Participants
|
88 Participants
n=21 Participants
|
|
Sex: Female, Male
Male
|
46 Participants
n=5 Participants
|
39 Participants
n=7 Participants
|
56 Participants
n=5 Participants
|
53 Participants
n=4 Participants
|
194 Participants
n=21 Participants
|
|
Race/Ethnicity, Customized
White
|
60 Participants
n=5 Participants
|
52 Participants
n=7 Participants
|
44 Participants
n=5 Participants
|
50 Participants
n=4 Participants
|
206 Participants
n=21 Participants
|
|
Race/Ethnicity, Customized
Black
|
12 Participants
n=5 Participants
|
13 Participants
n=7 Participants
|
14 Participants
n=5 Participants
|
13 Participants
n=4 Participants
|
52 Participants
n=21 Participants
|
|
Race/Ethnicity, Customized
Other or unknown
|
2 Participants
n=5 Participants
|
7 Participants
n=7 Participants
|
11 Participants
n=5 Participants
|
4 Participants
n=4 Participants
|
24 Participants
n=21 Participants
|
PRIMARY outcome
Timeframe: from baseline to 2 months post procedurePopulation: Intention-to-treat population
Mean difference in average daytime ambulatory systolic BP of the Solo cohort
Outcome measures
| Measure |
Solo Cohort - Renal Denervation
n=74 Participants
Subjects with essential hypertension controlled on 1 or 2 antihypertensive medications or uncontrolled on 0-2 antihypertensive medications will be included in the RADIANCE Solo cohort
|
Solo Cohort - Sham
n=72 Participants
Subjects with essential hypertension controlled on 1 or 2 antihypertensive medications or uncontrolled on 0-2 antihypertensive medications will be included in the RADIANCE Solo cohort
|
|---|---|---|
|
Solo Cohort - Mean Difference in Average Daytime Ambulatory Systolic BP
|
-8.5 mm Hg
Standard Deviation 9.3
|
-2.2 mm Hg
Standard Deviation 10.0
|
PRIMARY outcome
Timeframe: from baseline to 2 months post procedurePopulation: Intention-to-treat population
Median change in daytime ambulatory systolic BP of the Trio cohort
Outcome measures
| Measure |
Solo Cohort - Renal Denervation
n=69 Participants
Subjects with essential hypertension controlled on 1 or 2 antihypertensive medications or uncontrolled on 0-2 antihypertensive medications will be included in the RADIANCE Solo cohort
|
Solo Cohort - Sham
n=67 Participants
Subjects with essential hypertension controlled on 1 or 2 antihypertensive medications or uncontrolled on 0-2 antihypertensive medications will be included in the RADIANCE Solo cohort
|
|---|---|---|
|
Trio Cohort - Median Change in Daytime Ambulatory Systolic BP
|
-8 mm Hg
Interval -16.4 to 0.0
|
-3 mm Hg
Interval -10.3 to 1.8
|
SECONDARY outcome
Timeframe: from baseline to 2 months post procedureOutcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: from baseline to 2 months post procedureOutcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: from baseline to 36 months post-procedureOutcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: up to 36 monthsOutcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: from baseline to 36 months post-procedureOutcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: from baseline to 36 months post-procedureOutcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: from baseline to 36 months post-procedureOutcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: from baseline to 36 months post-procedureOutcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: from baseline to 36 months post-procedureOutcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: from baseline to 1 month and 36 months post-procedureOutcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: from baseline to 1 month and 36 months post-procedureOutcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: from baseline to 1 month and 36 months post-procedureOutcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: from baseline to 6, 12, 24 and 36 months post-procedureas diagnosed by duplex ultrasound and confirmed by renal CTA/MRA or as diagnosed/confirmed by study defined renal CTA/MRA at 12 months
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: from baseline to 1 month and 36 months post-procedureOutcome measures
Outcome data not reported
Adverse Events
Solo Cohort - Treatment Group
Serious events: 7 serious events
Other events: 60 other events
Deaths: 0 deaths
Solo Cohort - Sham Group
Serious events: 0 serious events
Other events: 40 other events
Deaths: 0 deaths
Trio Cohort - Treatment Group
Serious events: 12 serious events
Other events: 56 other events
Deaths: 1 deaths
Trio Cohort - Sham Group
Serious events: 4 serious events
Other events: 34 other events
Deaths: 0 deaths
Cross-over Group
Serious events: 1 serious events
Other events: 19 other events
Deaths: 1 deaths
Serious adverse events
| Measure |
Solo Cohort - Treatment Group
n=74 participants at risk
Subjects with essential hypertension controlled on 1 or 2 antihypertensive medications or uncontrolled on 0-2 antihypertensive medications were included in the RADIANCE Solo cohort and were treated by renal denervation
|
Solo Cohort - Sham Group
n=72 participants at risk
Subjects with essential hypertension controlled on 1 or 2 antihypertensive medications or uncontrolled on 0-2 antihypertensive medications were included in the RADIANCE Solo cohort with the option for cross-over treatment after 6-months
|
Trio Cohort - Treatment Group
n=69 participants at risk
Subjects with treatment resistant hypertension on a minimum of 3 antihypertensive medications were included in the RADIANCE Trio cohort, were treated by renal denervation with maintenance of anti-hypertensive medications
|
Trio Cohort - Sham Group
n=67 participants at risk
Subjects with treatment resistant hypertension on a minimum of 3 antihypertensive medications were included in the RADIANCE Trio cohort were maintained with anti-hypertensive medications with option for cross-over treatment after 6-months
|
Cross-over Group
n=59 participants at risk
Subjects from Solo and Trio cohorts who crossed over to the treatment arm after 6-months post-randomization.
|
|---|---|---|---|---|---|
|
Blood and lymphatic system disorders
Blood sodium abnormal
|
0.00%
0/74 • List of AE and SAE by term and by arm at 2 months post-procedure (0-67 days post-procedure)
For the cross-over group, AEs were collected and we reported here the list of AE and SAE over the period of 0 to 67 days post-cross-over procedure.
|
0.00%
0/72 • List of AE and SAE by term and by arm at 2 months post-procedure (0-67 days post-procedure)
For the cross-over group, AEs were collected and we reported here the list of AE and SAE over the period of 0 to 67 days post-cross-over procedure.
|
1.4%
1/69 • Number of events 1 • List of AE and SAE by term and by arm at 2 months post-procedure (0-67 days post-procedure)
For the cross-over group, AEs were collected and we reported here the list of AE and SAE over the period of 0 to 67 days post-cross-over procedure.
|
0.00%
0/67 • List of AE and SAE by term and by arm at 2 months post-procedure (0-67 days post-procedure)
For the cross-over group, AEs were collected and we reported here the list of AE and SAE over the period of 0 to 67 days post-cross-over procedure.
|
0.00%
0/59 • List of AE and SAE by term and by arm at 2 months post-procedure (0-67 days post-procedure)
For the cross-over group, AEs were collected and we reported here the list of AE and SAE over the period of 0 to 67 days post-cross-over procedure.
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonia
|
0.00%
0/74 • List of AE and SAE by term and by arm at 2 months post-procedure (0-67 days post-procedure)
For the cross-over group, AEs were collected and we reported here the list of AE and SAE over the period of 0 to 67 days post-cross-over procedure.
|
0.00%
0/72 • List of AE and SAE by term and by arm at 2 months post-procedure (0-67 days post-procedure)
For the cross-over group, AEs were collected and we reported here the list of AE and SAE over the period of 0 to 67 days post-cross-over procedure.
|
0.00%
0/69 • List of AE and SAE by term and by arm at 2 months post-procedure (0-67 days post-procedure)
For the cross-over group, AEs were collected and we reported here the list of AE and SAE over the period of 0 to 67 days post-cross-over procedure.
|
1.5%
1/67 • Number of events 1 • List of AE and SAE by term and by arm at 2 months post-procedure (0-67 days post-procedure)
For the cross-over group, AEs were collected and we reported here the list of AE and SAE over the period of 0 to 67 days post-cross-over procedure.
|
0.00%
0/59 • List of AE and SAE by term and by arm at 2 months post-procedure (0-67 days post-procedure)
For the cross-over group, AEs were collected and we reported here the list of AE and SAE over the period of 0 to 67 days post-cross-over procedure.
|
|
Surgical and medical procedures
Sedation complication - Drug therapy
|
0.00%
0/74 • List of AE and SAE by term and by arm at 2 months post-procedure (0-67 days post-procedure)
For the cross-over group, AEs were collected and we reported here the list of AE and SAE over the period of 0 to 67 days post-cross-over procedure.
|
0.00%
0/72 • List of AE and SAE by term and by arm at 2 months post-procedure (0-67 days post-procedure)
For the cross-over group, AEs were collected and we reported here the list of AE and SAE over the period of 0 to 67 days post-cross-over procedure.
|
1.4%
1/69 • Number of events 1 • List of AE and SAE by term and by arm at 2 months post-procedure (0-67 days post-procedure)
For the cross-over group, AEs were collected and we reported here the list of AE and SAE over the period of 0 to 67 days post-cross-over procedure.
|
0.00%
0/67 • List of AE and SAE by term and by arm at 2 months post-procedure (0-67 days post-procedure)
For the cross-over group, AEs were collected and we reported here the list of AE and SAE over the period of 0 to 67 days post-cross-over procedure.
|
0.00%
0/59 • List of AE and SAE by term and by arm at 2 months post-procedure (0-67 days post-procedure)
For the cross-over group, AEs were collected and we reported here the list of AE and SAE over the period of 0 to 67 days post-cross-over procedure.
|
|
Surgical and medical procedures
Vascular access site haematoma
|
0.00%
0/74 • List of AE and SAE by term and by arm at 2 months post-procedure (0-67 days post-procedure)
For the cross-over group, AEs were collected and we reported here the list of AE and SAE over the period of 0 to 67 days post-cross-over procedure.
|
0.00%
0/72 • List of AE and SAE by term and by arm at 2 months post-procedure (0-67 days post-procedure)
For the cross-over group, AEs were collected and we reported here the list of AE and SAE over the period of 0 to 67 days post-cross-over procedure.
|
1.4%
1/69 • Number of events 1 • List of AE and SAE by term and by arm at 2 months post-procedure (0-67 days post-procedure)
For the cross-over group, AEs were collected and we reported here the list of AE and SAE over the period of 0 to 67 days post-cross-over procedure.
|
0.00%
0/67 • List of AE and SAE by term and by arm at 2 months post-procedure (0-67 days post-procedure)
For the cross-over group, AEs were collected and we reported here the list of AE and SAE over the period of 0 to 67 days post-cross-over procedure.
|
0.00%
0/59 • List of AE and SAE by term and by arm at 2 months post-procedure (0-67 days post-procedure)
For the cross-over group, AEs were collected and we reported here the list of AE and SAE over the period of 0 to 67 days post-cross-over procedure.
|
|
Surgical and medical procedures
Vascular pseudoaneurysm
|
0.00%
0/74 • List of AE and SAE by term and by arm at 2 months post-procedure (0-67 days post-procedure)
For the cross-over group, AEs were collected and we reported here the list of AE and SAE over the period of 0 to 67 days post-cross-over procedure.
|
0.00%
0/72 • List of AE and SAE by term and by arm at 2 months post-procedure (0-67 days post-procedure)
For the cross-over group, AEs were collected and we reported here the list of AE and SAE over the period of 0 to 67 days post-cross-over procedure.
|
1.4%
1/69 • Number of events 1 • List of AE and SAE by term and by arm at 2 months post-procedure (0-67 days post-procedure)
For the cross-over group, AEs were collected and we reported here the list of AE and SAE over the period of 0 to 67 days post-cross-over procedure.
|
0.00%
0/67 • List of AE and SAE by term and by arm at 2 months post-procedure (0-67 days post-procedure)
For the cross-over group, AEs were collected and we reported here the list of AE and SAE over the period of 0 to 67 days post-cross-over procedure.
|
0.00%
0/59 • List of AE and SAE by term and by arm at 2 months post-procedure (0-67 days post-procedure)
For the cross-over group, AEs were collected and we reported here the list of AE and SAE over the period of 0 to 67 days post-cross-over procedure.
|
|
Cardiac disorders
Adverse drug reaction - Sevikar HCT (Amlodipine, Olmesartan and Hydrochlorothiazide)
|
0.00%
0/74 • List of AE and SAE by term and by arm at 2 months post-procedure (0-67 days post-procedure)
For the cross-over group, AEs were collected and we reported here the list of AE and SAE over the period of 0 to 67 days post-cross-over procedure.
|
0.00%
0/72 • List of AE and SAE by term and by arm at 2 months post-procedure (0-67 days post-procedure)
For the cross-over group, AEs were collected and we reported here the list of AE and SAE over the period of 0 to 67 days post-cross-over procedure.
|
1.4%
1/69 • Number of events 1 • List of AE and SAE by term and by arm at 2 months post-procedure (0-67 days post-procedure)
For the cross-over group, AEs were collected and we reported here the list of AE and SAE over the period of 0 to 67 days post-cross-over procedure.
|
0.00%
0/67 • List of AE and SAE by term and by arm at 2 months post-procedure (0-67 days post-procedure)
For the cross-over group, AEs were collected and we reported here the list of AE and SAE over the period of 0 to 67 days post-cross-over procedure.
|
0.00%
0/59 • List of AE and SAE by term and by arm at 2 months post-procedure (0-67 days post-procedure)
For the cross-over group, AEs were collected and we reported here the list of AE and SAE over the period of 0 to 67 days post-cross-over procedure.
|
|
Surgical and medical procedures
Cholecystectomy
|
0.00%
0/74 • List of AE and SAE by term and by arm at 2 months post-procedure (0-67 days post-procedure)
For the cross-over group, AEs were collected and we reported here the list of AE and SAE over the period of 0 to 67 days post-cross-over procedure.
|
0.00%
0/72 • List of AE and SAE by term and by arm at 2 months post-procedure (0-67 days post-procedure)
For the cross-over group, AEs were collected and we reported here the list of AE and SAE over the period of 0 to 67 days post-cross-over procedure.
|
0.00%
0/69 • List of AE and SAE by term and by arm at 2 months post-procedure (0-67 days post-procedure)
For the cross-over group, AEs were collected and we reported here the list of AE and SAE over the period of 0 to 67 days post-cross-over procedure.
|
1.5%
1/67 • Number of events 1 • List of AE and SAE by term and by arm at 2 months post-procedure (0-67 days post-procedure)
For the cross-over group, AEs were collected and we reported here the list of AE and SAE over the period of 0 to 67 days post-cross-over procedure.
|
0.00%
0/59 • List of AE and SAE by term and by arm at 2 months post-procedure (0-67 days post-procedure)
For the cross-over group, AEs were collected and we reported here the list of AE and SAE over the period of 0 to 67 days post-cross-over procedure.
|
|
Gastrointestinal disorders
Cholelithiasis
|
1.4%
1/74 • Number of events 1 • List of AE and SAE by term and by arm at 2 months post-procedure (0-67 days post-procedure)
For the cross-over group, AEs were collected and we reported here the list of AE and SAE over the period of 0 to 67 days post-cross-over procedure.
|
0.00%
0/72 • List of AE and SAE by term and by arm at 2 months post-procedure (0-67 days post-procedure)
For the cross-over group, AEs were collected and we reported here the list of AE and SAE over the period of 0 to 67 days post-cross-over procedure.
|
0.00%
0/69 • List of AE and SAE by term and by arm at 2 months post-procedure (0-67 days post-procedure)
For the cross-over group, AEs were collected and we reported here the list of AE and SAE over the period of 0 to 67 days post-cross-over procedure.
|
0.00%
0/67 • List of AE and SAE by term and by arm at 2 months post-procedure (0-67 days post-procedure)
For the cross-over group, AEs were collected and we reported here the list of AE and SAE over the period of 0 to 67 days post-cross-over procedure.
|
0.00%
0/59 • List of AE and SAE by term and by arm at 2 months post-procedure (0-67 days post-procedure)
For the cross-over group, AEs were collected and we reported here the list of AE and SAE over the period of 0 to 67 days post-cross-over procedure.
|
|
Cardiac disorders
Atrioventricular block - Drug therapy
|
1.4%
1/74 • Number of events 1 • List of AE and SAE by term and by arm at 2 months post-procedure (0-67 days post-procedure)
For the cross-over group, AEs were collected and we reported here the list of AE and SAE over the period of 0 to 67 days post-cross-over procedure.
|
0.00%
0/72 • List of AE and SAE by term and by arm at 2 months post-procedure (0-67 days post-procedure)
For the cross-over group, AEs were collected and we reported here the list of AE and SAE over the period of 0 to 67 days post-cross-over procedure.
|
0.00%
0/69 • List of AE and SAE by term and by arm at 2 months post-procedure (0-67 days post-procedure)
For the cross-over group, AEs were collected and we reported here the list of AE and SAE over the period of 0 to 67 days post-cross-over procedure.
|
0.00%
0/67 • List of AE and SAE by term and by arm at 2 months post-procedure (0-67 days post-procedure)
For the cross-over group, AEs were collected and we reported here the list of AE and SAE over the period of 0 to 67 days post-cross-over procedure.
|
0.00%
0/59 • List of AE and SAE by term and by arm at 2 months post-procedure (0-67 days post-procedure)
For the cross-over group, AEs were collected and we reported here the list of AE and SAE over the period of 0 to 67 days post-cross-over procedure.
|
|
Cardiac disorders
Atrial fibrillation
|
1.4%
1/74 • Number of events 1 • List of AE and SAE by term and by arm at 2 months post-procedure (0-67 days post-procedure)
For the cross-over group, AEs were collected and we reported here the list of AE and SAE over the period of 0 to 67 days post-cross-over procedure.
|
0.00%
0/72 • List of AE and SAE by term and by arm at 2 months post-procedure (0-67 days post-procedure)
For the cross-over group, AEs were collected and we reported here the list of AE and SAE over the period of 0 to 67 days post-cross-over procedure.
|
0.00%
0/69 • List of AE and SAE by term and by arm at 2 months post-procedure (0-67 days post-procedure)
For the cross-over group, AEs were collected and we reported here the list of AE and SAE over the period of 0 to 67 days post-cross-over procedure.
|
0.00%
0/67 • List of AE and SAE by term and by arm at 2 months post-procedure (0-67 days post-procedure)
For the cross-over group, AEs were collected and we reported here the list of AE and SAE over the period of 0 to 67 days post-cross-over procedure.
|
0.00%
0/59 • List of AE and SAE by term and by arm at 2 months post-procedure (0-67 days post-procedure)
For the cross-over group, AEs were collected and we reported here the list of AE and SAE over the period of 0 to 67 days post-cross-over procedure.
|
|
Cardiac disorders
Bradycardia - Drug therapy
|
2.7%
2/74 • Number of events 2 • List of AE and SAE by term and by arm at 2 months post-procedure (0-67 days post-procedure)
For the cross-over group, AEs were collected and we reported here the list of AE and SAE over the period of 0 to 67 days post-cross-over procedure.
|
0.00%
0/72 • List of AE and SAE by term and by arm at 2 months post-procedure (0-67 days post-procedure)
For the cross-over group, AEs were collected and we reported here the list of AE and SAE over the period of 0 to 67 days post-cross-over procedure.
|
0.00%
0/69 • List of AE and SAE by term and by arm at 2 months post-procedure (0-67 days post-procedure)
For the cross-over group, AEs were collected and we reported here the list of AE and SAE over the period of 0 to 67 days post-cross-over procedure.
|
0.00%
0/67 • List of AE and SAE by term and by arm at 2 months post-procedure (0-67 days post-procedure)
For the cross-over group, AEs were collected and we reported here the list of AE and SAE over the period of 0 to 67 days post-cross-over procedure.
|
0.00%
0/59 • List of AE and SAE by term and by arm at 2 months post-procedure (0-67 days post-procedure)
For the cross-over group, AEs were collected and we reported here the list of AE and SAE over the period of 0 to 67 days post-cross-over procedure.
|
|
Infections and infestations
Hematoma Infection
|
0.00%
0/74 • List of AE and SAE by term and by arm at 2 months post-procedure (0-67 days post-procedure)
For the cross-over group, AEs were collected and we reported here the list of AE and SAE over the period of 0 to 67 days post-cross-over procedure.
|
0.00%
0/72 • List of AE and SAE by term and by arm at 2 months post-procedure (0-67 days post-procedure)
For the cross-over group, AEs were collected and we reported here the list of AE and SAE over the period of 0 to 67 days post-cross-over procedure.
|
0.00%
0/69 • List of AE and SAE by term and by arm at 2 months post-procedure (0-67 days post-procedure)
For the cross-over group, AEs were collected and we reported here the list of AE and SAE over the period of 0 to 67 days post-cross-over procedure.
|
1.5%
1/67 • Number of events 1 • List of AE and SAE by term and by arm at 2 months post-procedure (0-67 days post-procedure)
For the cross-over group, AEs were collected and we reported here the list of AE and SAE over the period of 0 to 67 days post-cross-over procedure.
|
0.00%
0/59 • List of AE and SAE by term and by arm at 2 months post-procedure (0-67 days post-procedure)
For the cross-over group, AEs were collected and we reported here the list of AE and SAE over the period of 0 to 67 days post-cross-over procedure.
|
|
Cardiac disorders
Hypotension
|
0.00%
0/74 • List of AE and SAE by term and by arm at 2 months post-procedure (0-67 days post-procedure)
For the cross-over group, AEs were collected and we reported here the list of AE and SAE over the period of 0 to 67 days post-cross-over procedure.
|
0.00%
0/72 • List of AE and SAE by term and by arm at 2 months post-procedure (0-67 days post-procedure)
For the cross-over group, AEs were collected and we reported here the list of AE and SAE over the period of 0 to 67 days post-cross-over procedure.
|
1.4%
1/69 • Number of events 1 • List of AE and SAE by term and by arm at 2 months post-procedure (0-67 days post-procedure)
For the cross-over group, AEs were collected and we reported here the list of AE and SAE over the period of 0 to 67 days post-cross-over procedure.
|
0.00%
0/67 • List of AE and SAE by term and by arm at 2 months post-procedure (0-67 days post-procedure)
For the cross-over group, AEs were collected and we reported here the list of AE and SAE over the period of 0 to 67 days post-cross-over procedure.
|
0.00%
0/59 • List of AE and SAE by term and by arm at 2 months post-procedure (0-67 days post-procedure)
For the cross-over group, AEs were collected and we reported here the list of AE and SAE over the period of 0 to 67 days post-cross-over procedure.
|
|
Infections and infestations
Infection
|
0.00%
0/74 • List of AE and SAE by term and by arm at 2 months post-procedure (0-67 days post-procedure)
For the cross-over group, AEs were collected and we reported here the list of AE and SAE over the period of 0 to 67 days post-cross-over procedure.
|
0.00%
0/72 • List of AE and SAE by term and by arm at 2 months post-procedure (0-67 days post-procedure)
For the cross-over group, AEs were collected and we reported here the list of AE and SAE over the period of 0 to 67 days post-cross-over procedure.
|
2.9%
2/69 • Number of events 3 • List of AE and SAE by term and by arm at 2 months post-procedure (0-67 days post-procedure)
For the cross-over group, AEs were collected and we reported here the list of AE and SAE over the period of 0 to 67 days post-cross-over procedure.
|
0.00%
0/67 • List of AE and SAE by term and by arm at 2 months post-procedure (0-67 days post-procedure)
For the cross-over group, AEs were collected and we reported here the list of AE and SAE over the period of 0 to 67 days post-cross-over procedure.
|
0.00%
0/59 • List of AE and SAE by term and by arm at 2 months post-procedure (0-67 days post-procedure)
For the cross-over group, AEs were collected and we reported here the list of AE and SAE over the period of 0 to 67 days post-cross-over procedure.
|
|
Cardiac disorders
Presyncope - Drug therapy
|
1.4%
1/74 • Number of events 1 • List of AE and SAE by term and by arm at 2 months post-procedure (0-67 days post-procedure)
For the cross-over group, AEs were collected and we reported here the list of AE and SAE over the period of 0 to 67 days post-cross-over procedure.
|
0.00%
0/72 • List of AE and SAE by term and by arm at 2 months post-procedure (0-67 days post-procedure)
For the cross-over group, AEs were collected and we reported here the list of AE and SAE over the period of 0 to 67 days post-cross-over procedure.
|
0.00%
0/69 • List of AE and SAE by term and by arm at 2 months post-procedure (0-67 days post-procedure)
For the cross-over group, AEs were collected and we reported here the list of AE and SAE over the period of 0 to 67 days post-cross-over procedure.
|
0.00%
0/67 • List of AE and SAE by term and by arm at 2 months post-procedure (0-67 days post-procedure)
For the cross-over group, AEs were collected and we reported here the list of AE and SAE over the period of 0 to 67 days post-cross-over procedure.
|
0.00%
0/59 • List of AE and SAE by term and by arm at 2 months post-procedure (0-67 days post-procedure)
For the cross-over group, AEs were collected and we reported here the list of AE and SAE over the period of 0 to 67 days post-cross-over procedure.
|
|
Surgical and medical procedures
Coronary arterial stent insertion
|
0.00%
0/74 • List of AE and SAE by term and by arm at 2 months post-procedure (0-67 days post-procedure)
For the cross-over group, AEs were collected and we reported here the list of AE and SAE over the period of 0 to 67 days post-cross-over procedure.
|
0.00%
0/72 • List of AE and SAE by term and by arm at 2 months post-procedure (0-67 days post-procedure)
For the cross-over group, AEs were collected and we reported here the list of AE and SAE over the period of 0 to 67 days post-cross-over procedure.
|
0.00%
0/69 • List of AE and SAE by term and by arm at 2 months post-procedure (0-67 days post-procedure)
For the cross-over group, AEs were collected and we reported here the list of AE and SAE over the period of 0 to 67 days post-cross-over procedure.
|
1.5%
1/67 • Number of events 1 • List of AE and SAE by term and by arm at 2 months post-procedure (0-67 days post-procedure)
For the cross-over group, AEs were collected and we reported here the list of AE and SAE over the period of 0 to 67 days post-cross-over procedure.
|
0.00%
0/59 • List of AE and SAE by term and by arm at 2 months post-procedure (0-67 days post-procedure)
For the cross-over group, AEs were collected and we reported here the list of AE and SAE over the period of 0 to 67 days post-cross-over procedure.
|
|
General disorders
Death
|
0.00%
0/74 • List of AE and SAE by term and by arm at 2 months post-procedure (0-67 days post-procedure)
For the cross-over group, AEs were collected and we reported here the list of AE and SAE over the period of 0 to 67 days post-cross-over procedure.
|
0.00%
0/72 • List of AE and SAE by term and by arm at 2 months post-procedure (0-67 days post-procedure)
For the cross-over group, AEs were collected and we reported here the list of AE and SAE over the period of 0 to 67 days post-cross-over procedure.
|
1.4%
1/69 • Number of events 1 • List of AE and SAE by term and by arm at 2 months post-procedure (0-67 days post-procedure)
For the cross-over group, AEs were collected and we reported here the list of AE and SAE over the period of 0 to 67 days post-cross-over procedure.
|
0.00%
0/67 • List of AE and SAE by term and by arm at 2 months post-procedure (0-67 days post-procedure)
For the cross-over group, AEs were collected and we reported here the list of AE and SAE over the period of 0 to 67 days post-cross-over procedure.
|
1.7%
1/59 • Number of events 1 • List of AE and SAE by term and by arm at 2 months post-procedure (0-67 days post-procedure)
For the cross-over group, AEs were collected and we reported here the list of AE and SAE over the period of 0 to 67 days post-cross-over procedure.
|
|
Vascular disorders
Deep vein thrombosis
|
0.00%
0/74 • List of AE and SAE by term and by arm at 2 months post-procedure (0-67 days post-procedure)
For the cross-over group, AEs were collected and we reported here the list of AE and SAE over the period of 0 to 67 days post-cross-over procedure.
|
0.00%
0/72 • List of AE and SAE by term and by arm at 2 months post-procedure (0-67 days post-procedure)
For the cross-over group, AEs were collected and we reported here the list of AE and SAE over the period of 0 to 67 days post-cross-over procedure.
|
2.9%
2/69 • Number of events 2 • List of AE and SAE by term and by arm at 2 months post-procedure (0-67 days post-procedure)
For the cross-over group, AEs were collected and we reported here the list of AE and SAE over the period of 0 to 67 days post-cross-over procedure.
|
0.00%
0/67 • List of AE and SAE by term and by arm at 2 months post-procedure (0-67 days post-procedure)
For the cross-over group, AEs were collected and we reported here the list of AE and SAE over the period of 0 to 67 days post-cross-over procedure.
|
0.00%
0/59 • List of AE and SAE by term and by arm at 2 months post-procedure (0-67 days post-procedure)
For the cross-over group, AEs were collected and we reported here the list of AE and SAE over the period of 0 to 67 days post-cross-over procedure.
|
|
Cardiac disorders
Myocardial infarction
|
0.00%
0/74 • List of AE and SAE by term and by arm at 2 months post-procedure (0-67 days post-procedure)
For the cross-over group, AEs were collected and we reported here the list of AE and SAE over the period of 0 to 67 days post-cross-over procedure.
|
0.00%
0/72 • List of AE and SAE by term and by arm at 2 months post-procedure (0-67 days post-procedure)
For the cross-over group, AEs were collected and we reported here the list of AE and SAE over the period of 0 to 67 days post-cross-over procedure.
|
1.4%
1/69 • Number of events 1 • List of AE and SAE by term and by arm at 2 months post-procedure (0-67 days post-procedure)
For the cross-over group, AEs were collected and we reported here the list of AE and SAE over the period of 0 to 67 days post-cross-over procedure.
|
0.00%
0/67 • List of AE and SAE by term and by arm at 2 months post-procedure (0-67 days post-procedure)
For the cross-over group, AEs were collected and we reported here the list of AE and SAE over the period of 0 to 67 days post-cross-over procedure.
|
0.00%
0/59 • List of AE and SAE by term and by arm at 2 months post-procedure (0-67 days post-procedure)
For the cross-over group, AEs were collected and we reported here the list of AE and SAE over the period of 0 to 67 days post-cross-over procedure.
|
|
Renal and urinary disorders
Renal artery stenosis
|
1.4%
1/74 • List of AE and SAE by term and by arm at 2 months post-procedure (0-67 days post-procedure)
For the cross-over group, AEs were collected and we reported here the list of AE and SAE over the period of 0 to 67 days post-cross-over procedure.
|
0.00%
0/72 • List of AE and SAE by term and by arm at 2 months post-procedure (0-67 days post-procedure)
For the cross-over group, AEs were collected and we reported here the list of AE and SAE over the period of 0 to 67 days post-cross-over procedure.
|
0.00%
0/69 • List of AE and SAE by term and by arm at 2 months post-procedure (0-67 days post-procedure)
For the cross-over group, AEs were collected and we reported here the list of AE and SAE over the period of 0 to 67 days post-cross-over procedure.
|
0.00%
0/67 • List of AE and SAE by term and by arm at 2 months post-procedure (0-67 days post-procedure)
For the cross-over group, AEs were collected and we reported here the list of AE and SAE over the period of 0 to 67 days post-cross-over procedure.
|
0.00%
0/59 • List of AE and SAE by term and by arm at 2 months post-procedure (0-67 days post-procedure)
For the cross-over group, AEs were collected and we reported here the list of AE and SAE over the period of 0 to 67 days post-cross-over procedure.
|
Other adverse events
| Measure |
Solo Cohort - Treatment Group
n=74 participants at risk
Subjects with essential hypertension controlled on 1 or 2 antihypertensive medications or uncontrolled on 0-2 antihypertensive medications were included in the RADIANCE Solo cohort and were treated by renal denervation
|
Solo Cohort - Sham Group
n=72 participants at risk
Subjects with essential hypertension controlled on 1 or 2 antihypertensive medications or uncontrolled on 0-2 antihypertensive medications were included in the RADIANCE Solo cohort with the option for cross-over treatment after 6-months
|
Trio Cohort - Treatment Group
n=69 participants at risk
Subjects with treatment resistant hypertension on a minimum of 3 antihypertensive medications were included in the RADIANCE Trio cohort, were treated by renal denervation with maintenance of anti-hypertensive medications
|
Trio Cohort - Sham Group
n=67 participants at risk
Subjects with treatment resistant hypertension on a minimum of 3 antihypertensive medications were included in the RADIANCE Trio cohort were maintained with anti-hypertensive medications with option for cross-over treatment after 6-months
|
Cross-over Group
n=59 participants at risk
Subjects from Solo and Trio cohorts who crossed over to the treatment arm after 6-months post-randomization.
|
|---|---|---|---|---|---|
|
Musculoskeletal and connective tissue disorders
Back Pain
|
6.8%
5/74 • Number of events 5 • List of AE and SAE by term and by arm at 2 months post-procedure (0-67 days post-procedure)
For the cross-over group, AEs were collected and we reported here the list of AE and SAE over the period of 0 to 67 days post-cross-over procedure.
|
2.8%
2/72 • Number of events 2 • List of AE and SAE by term and by arm at 2 months post-procedure (0-67 days post-procedure)
For the cross-over group, AEs were collected and we reported here the list of AE and SAE over the period of 0 to 67 days post-cross-over procedure.
|
7.2%
5/69 • Number of events 5 • List of AE and SAE by term and by arm at 2 months post-procedure (0-67 days post-procedure)
For the cross-over group, AEs were collected and we reported here the list of AE and SAE over the period of 0 to 67 days post-cross-over procedure.
|
9.0%
6/67 • Number of events 6 • List of AE and SAE by term and by arm at 2 months post-procedure (0-67 days post-procedure)
For the cross-over group, AEs were collected and we reported here the list of AE and SAE over the period of 0 to 67 days post-cross-over procedure.
|
10.2%
6/59 • Number of events 6 • List of AE and SAE by term and by arm at 2 months post-procedure (0-67 days post-procedure)
For the cross-over group, AEs were collected and we reported here the list of AE and SAE over the period of 0 to 67 days post-cross-over procedure.
|
|
Surgical and medical procedures
Vascular access site haematoma
|
14.9%
11/74 • Number of events 11 • List of AE and SAE by term and by arm at 2 months post-procedure (0-67 days post-procedure)
For the cross-over group, AEs were collected and we reported here the list of AE and SAE over the period of 0 to 67 days post-cross-over procedure.
|
18.1%
13/72 • Number of events 13 • List of AE and SAE by term and by arm at 2 months post-procedure (0-67 days post-procedure)
For the cross-over group, AEs were collected and we reported here the list of AE and SAE over the period of 0 to 67 days post-cross-over procedure.
|
14.5%
10/69 • Number of events 10 • List of AE and SAE by term and by arm at 2 months post-procedure (0-67 days post-procedure)
For the cross-over group, AEs were collected and we reported here the list of AE and SAE over the period of 0 to 67 days post-cross-over procedure.
|
7.5%
5/67 • Number of events 5 • List of AE and SAE by term and by arm at 2 months post-procedure (0-67 days post-procedure)
For the cross-over group, AEs were collected and we reported here the list of AE and SAE over the period of 0 to 67 days post-cross-over procedure.
|
0.00%
0/59 • List of AE and SAE by term and by arm at 2 months post-procedure (0-67 days post-procedure)
For the cross-over group, AEs were collected and we reported here the list of AE and SAE over the period of 0 to 67 days post-cross-over procedure.
|
|
Cardiac disorders
Bradycardia
|
2.7%
2/74 • Number of events 2 • List of AE and SAE by term and by arm at 2 months post-procedure (0-67 days post-procedure)
For the cross-over group, AEs were collected and we reported here the list of AE and SAE over the period of 0 to 67 days post-cross-over procedure.
|
0.00%
0/72 • List of AE and SAE by term and by arm at 2 months post-procedure (0-67 days post-procedure)
For the cross-over group, AEs were collected and we reported here the list of AE and SAE over the period of 0 to 67 days post-cross-over procedure.
|
10.1%
7/69 • Number of events 7 • List of AE and SAE by term and by arm at 2 months post-procedure (0-67 days post-procedure)
For the cross-over group, AEs were collected and we reported here the list of AE and SAE over the period of 0 to 67 days post-cross-over procedure.
|
0.00%
0/67 • List of AE and SAE by term and by arm at 2 months post-procedure (0-67 days post-procedure)
For the cross-over group, AEs were collected and we reported here the list of AE and SAE over the period of 0 to 67 days post-cross-over procedure.
|
8.5%
5/59 • Number of events 6 • List of AE and SAE by term and by arm at 2 months post-procedure (0-67 days post-procedure)
For the cross-over group, AEs were collected and we reported here the list of AE and SAE over the period of 0 to 67 days post-cross-over procedure.
|
|
Surgical and medical procedures
Vascular access site pain
|
17.6%
13/74 • Number of events 13 • List of AE and SAE by term and by arm at 2 months post-procedure (0-67 days post-procedure)
For the cross-over group, AEs were collected and we reported here the list of AE and SAE over the period of 0 to 67 days post-cross-over procedure.
|
13.9%
10/72 • Number of events 10 • List of AE and SAE by term and by arm at 2 months post-procedure (0-67 days post-procedure)
For the cross-over group, AEs were collected and we reported here the list of AE and SAE over the period of 0 to 67 days post-cross-over procedure.
|
13.0%
9/69 • Number of events 9 • List of AE and SAE by term and by arm at 2 months post-procedure (0-67 days post-procedure)
For the cross-over group, AEs were collected and we reported here the list of AE and SAE over the period of 0 to 67 days post-cross-over procedure.
|
13.4%
9/67 • Number of events 9 • List of AE and SAE by term and by arm at 2 months post-procedure (0-67 days post-procedure)
For the cross-over group, AEs were collected and we reported here the list of AE and SAE over the period of 0 to 67 days post-cross-over procedure.
|
8.5%
5/59 • Number of events 5 • List of AE and SAE by term and by arm at 2 months post-procedure (0-67 days post-procedure)
For the cross-over group, AEs were collected and we reported here the list of AE and SAE over the period of 0 to 67 days post-cross-over procedure.
|
|
Vascular disorders
Vasospasm
|
20.3%
15/74 • Number of events 15 • List of AE and SAE by term and by arm at 2 months post-procedure (0-67 days post-procedure)
For the cross-over group, AEs were collected and we reported here the list of AE and SAE over the period of 0 to 67 days post-cross-over procedure.
|
0.00%
0/72 • List of AE and SAE by term and by arm at 2 months post-procedure (0-67 days post-procedure)
For the cross-over group, AEs were collected and we reported here the list of AE and SAE over the period of 0 to 67 days post-cross-over procedure.
|
18.8%
13/69 • Number of events 13 • List of AE and SAE by term and by arm at 2 months post-procedure (0-67 days post-procedure)
For the cross-over group, AEs were collected and we reported here the list of AE and SAE over the period of 0 to 67 days post-cross-over procedure.
|
1.5%
1/67 • Number of events 1 • List of AE and SAE by term and by arm at 2 months post-procedure (0-67 days post-procedure)
For the cross-over group, AEs were collected and we reported here the list of AE and SAE over the period of 0 to 67 days post-cross-over procedure.
|
5.1%
3/59 • Number of events 3 • List of AE and SAE by term and by arm at 2 months post-procedure (0-67 days post-procedure)
For the cross-over group, AEs were collected and we reported here the list of AE and SAE over the period of 0 to 67 days post-cross-over procedure.
|
|
General disorders
Headache
|
6.8%
5/74 • Number of events 5 • List of AE and SAE by term and by arm at 2 months post-procedure (0-67 days post-procedure)
For the cross-over group, AEs were collected and we reported here the list of AE and SAE over the period of 0 to 67 days post-cross-over procedure.
|
8.3%
6/72 • Number of events 7 • List of AE and SAE by term and by arm at 2 months post-procedure (0-67 days post-procedure)
For the cross-over group, AEs were collected and we reported here the list of AE and SAE over the period of 0 to 67 days post-cross-over procedure.
|
4.3%
3/69 • Number of events 5 • List of AE and SAE by term and by arm at 2 months post-procedure (0-67 days post-procedure)
For the cross-over group, AEs were collected and we reported here the list of AE and SAE over the period of 0 to 67 days post-cross-over procedure.
|
7.5%
5/67 • Number of events 5 • List of AE and SAE by term and by arm at 2 months post-procedure (0-67 days post-procedure)
For the cross-over group, AEs were collected and we reported here the list of AE and SAE over the period of 0 to 67 days post-cross-over procedure.
|
0.00%
0/59 • List of AE and SAE by term and by arm at 2 months post-procedure (0-67 days post-procedure)
For the cross-over group, AEs were collected and we reported here the list of AE and SAE over the period of 0 to 67 days post-cross-over procedure.
|
|
Cardiac disorders
Hypertension - Condition aggravated
|
4.1%
3/74 • Number of events 3 • List of AE and SAE by term and by arm at 2 months post-procedure (0-67 days post-procedure)
For the cross-over group, AEs were collected and we reported here the list of AE and SAE over the period of 0 to 67 days post-cross-over procedure.
|
12.5%
9/72 • Number of events 9 • List of AE and SAE by term and by arm at 2 months post-procedure (0-67 days post-procedure)
For the cross-over group, AEs were collected and we reported here the list of AE and SAE over the period of 0 to 67 days post-cross-over procedure.
|
2.9%
2/69 • Number of events 2 • List of AE and SAE by term and by arm at 2 months post-procedure (0-67 days post-procedure)
For the cross-over group, AEs were collected and we reported here the list of AE and SAE over the period of 0 to 67 days post-cross-over procedure.
|
10.4%
7/67 • Number of events 8 • List of AE and SAE by term and by arm at 2 months post-procedure (0-67 days post-procedure)
For the cross-over group, AEs were collected and we reported here the list of AE and SAE over the period of 0 to 67 days post-cross-over procedure.
|
0.00%
0/59 • List of AE and SAE by term and by arm at 2 months post-procedure (0-67 days post-procedure)
For the cross-over group, AEs were collected and we reported here the list of AE and SAE over the period of 0 to 67 days post-cross-over procedure.
|
|
Cardiac disorders
Hypotension
|
1.4%
1/74 • Number of events 1 • List of AE and SAE by term and by arm at 2 months post-procedure (0-67 days post-procedure)
For the cross-over group, AEs were collected and we reported here the list of AE and SAE over the period of 0 to 67 days post-cross-over procedure.
|
0.00%
0/72 • List of AE and SAE by term and by arm at 2 months post-procedure (0-67 days post-procedure)
For the cross-over group, AEs were collected and we reported here the list of AE and SAE over the period of 0 to 67 days post-cross-over procedure.
|
5.8%
4/69 • Number of events 4 • List of AE and SAE by term and by arm at 2 months post-procedure (0-67 days post-procedure)
For the cross-over group, AEs were collected and we reported here the list of AE and SAE over the period of 0 to 67 days post-cross-over procedure.
|
1.5%
1/67 • Number of events 1 • List of AE and SAE by term and by arm at 2 months post-procedure (0-67 days post-procedure)
For the cross-over group, AEs were collected and we reported here the list of AE and SAE over the period of 0 to 67 days post-cross-over procedure.
|
0.00%
0/59 • List of AE and SAE by term and by arm at 2 months post-procedure (0-67 days post-procedure)
For the cross-over group, AEs were collected and we reported here the list of AE and SAE over the period of 0 to 67 days post-cross-over procedure.
|
|
Vascular disorders
Vasospasm - Drug therapy
|
6.8%
5/74 • Number of events 5 • List of AE and SAE by term and by arm at 2 months post-procedure (0-67 days post-procedure)
For the cross-over group, AEs were collected and we reported here the list of AE and SAE over the period of 0 to 67 days post-cross-over procedure.
|
0.00%
0/72 • List of AE and SAE by term and by arm at 2 months post-procedure (0-67 days post-procedure)
For the cross-over group, AEs were collected and we reported here the list of AE and SAE over the period of 0 to 67 days post-cross-over procedure.
|
4.3%
3/69 • Number of events 3 • List of AE and SAE by term and by arm at 2 months post-procedure (0-67 days post-procedure)
For the cross-over group, AEs were collected and we reported here the list of AE and SAE over the period of 0 to 67 days post-cross-over procedure.
|
0.00%
0/67 • List of AE and SAE by term and by arm at 2 months post-procedure (0-67 days post-procedure)
For the cross-over group, AEs were collected and we reported here the list of AE and SAE over the period of 0 to 67 days post-cross-over procedure.
|
0.00%
0/59 • List of AE and SAE by term and by arm at 2 months post-procedure (0-67 days post-procedure)
For the cross-over group, AEs were collected and we reported here the list of AE and SAE over the period of 0 to 67 days post-cross-over procedure.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place