Trial Outcomes & Findings for SuperNOVA Clinical Stenting Trial (NCT NCT01292928)
NCT ID: NCT01292928
Last Updated: 2017-03-08
Results Overview
The safety endpoint assesses the occurrence of Major Adverse Events (MAEs) defined as all causes of death through 1 month, target limb major amputation through 12 months and/or target lesion revascularization through 12 months
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
299 participants
Primary outcome timeframe
1 month for death, 12 months for target limb major amputation , and target lesion revascularization
Results posted on
2017-03-08
Participant Flow
A total of 299 subjects were enrolled and treated with the Innova™ Self-Expanding Stent System in this prospective, single-arm, non-randomized clinical study at 49 investigative centers in The Unites States, Canada, Japan and Europe, from 1 April 2011 to 28 June 2013 (with a temporary enrollment suspension from 13 May 2011 to 25 April 2012)
Participant milestones
| Measure |
Innova Stent
Stent implantation into Superficial Femoral Artery (SFA) / Proximal Popliteal Artery (PPA)
|
|---|---|
|
Overall Study
STARTED
|
299
|
|
Overall Study
Completed 12-Month Clinical Follow-up
|
266
|
|
Overall Study
COMPLETED
|
275
|
|
Overall Study
NOT COMPLETED
|
24
|
Reasons for withdrawal
| Measure |
Innova Stent
Stent implantation into Superficial Femoral Artery (SFA) / Proximal Popliteal Artery (PPA)
|
|---|---|
|
Overall Study
Death
|
8
|
|
Overall Study
Withdrawal by Subject
|
8
|
|
Overall Study
Lost to Follow-up
|
6
|
|
Overall Study
Physician Decision
|
2
|
Baseline Characteristics
SuperNOVA Clinical Stenting Trial
Baseline characteristics by cohort
| Measure |
Innova Stent
n=299 Participants
Stent implantation into SFA/PPA
|
|---|---|
|
Age, Continuous
|
67.4 Years
STANDARD_DEVIATION 9.7 • n=5 Participants
|
|
Sex: Female, Male
Female
|
77 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
222 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Hispanic or Latino
|
4 participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Caucasian
|
238 participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Asian (Japanese)
|
42 participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Black, or African heritage
|
13 participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Native Hawaiian or other Pacific Islander
|
1 participants
n=5 Participants
|
|
Race/Ethnicity, Customized
American Indian or Alaska Native
|
1 participants
n=5 Participants
|
|
Region of Enrollment
Canada
|
31 participants
n=5 Participants
|
|
Region of Enrollment
Austria
|
6 participants
n=5 Participants
|
|
Region of Enrollment
Belgium
|
52 participants
n=5 Participants
|
|
Region of Enrollment
United States
|
117 participants
n=5 Participants
|
|
Region of Enrollment
Japan
|
42 participants
n=5 Participants
|
|
Region of Enrollment
United Kingdom
|
7 participants
n=5 Participants
|
|
Region of Enrollment
Germany
|
44 participants
n=5 Participants
|
|
General Medical History
History of Smoking
|
251 participants
n=5 Participants
|
|
General Medical History
Current Diabetes Mellitus
|
121 participants
n=5 Participants
|
|
General Medical History
Medically-Treated Diabetes
|
105 participants
n=5 Participants
|
|
General Medical History
History of Hyperlipidemia requiring medication
|
224 participants
n=5 Participants
|
|
General Medical History
History of Hypertension requiring medication
|
239 participants
n=5 Participants
|
|
General Medical History
History of Chronic Obstructive Pulmonary Disease
|
25 participants
n=5 Participants
|
|
Cardiac History
History of Coronary Artery Disease
|
130 participants
n=5 Participants
|
|
Cardiac History
History of Myocardial Infarction (MI)
|
74 participants
n=5 Participants
|
|
Cardiac History
History of Congestive Heart Failure
|
25 participants
n=5 Participants
|
|
Cardiac History
History of Percutaneous Coronary Intervention
|
85 participants
n=5 Participants
|
|
Cardiac History
History of Coronary Artery Bypass Graft Surgery
|
54 participants
n=5 Participants
|
|
Cardiac History
Stable Angina
|
44 participants
n=5 Participants
|
|
Cardiac History
Unstable Angina
|
1 participants
n=5 Participants
|
|
Cardiac History
No Angina
|
245 participants
n=5 Participants
|
|
Neurological/Renal History
History of Transient Ischemic Attacks
|
21 participants
n=5 Participants
|
|
Neurological/Renal History
History of Cerebrovascular Accident
|
24 participants
n=5 Participants
|
|
Neurological/Renal History
History of Renal Insufficiency
|
31 participants
n=5 Participants
|
|
Neurological/Renal History
History of Renal Percutaneous Intervention
|
4 participants
n=5 Participants
|
|
Peripheral Vascular History
History of Peripheral Vascular Surgery
|
27 participants
n=5 Participants
|
|
Peripheral Vascular History
History of Other Peripheral Interventions
|
125 participants
n=5 Participants
|
|
Peripheral Vascular History
History of Claudication
|
281 participants
n=5 Participants
|
|
Baseline Lesion Characteristics: Treated Limb
Right leg
|
138 lesions
n=5 Participants
|
|
Baseline Lesion Characteristics: Treated Limb
Left leg
|
161 lesions
n=5 Participants
|
|
Baseline Lesion Characteristics: Reference Vessel Diameter
|
5.6 millimeters
STANDARD_DEVIATION 0.7 • n=5 Participants
|
|
Baseline Lesion Characteristics: Diameter Stenosis
|
91.7 percentage occluded
STANDARD_DEVIATION 9.2 • n=5 Participants
|
|
Baseline Lesion Characteristics: Target Lesion Length
|
90.8 millimeters
STANDARD_DEVIATION 44.4 • n=5 Participants
|
|
Baseline Lesion Characteristics: Presence of Calcification
None/Mild
|
88 lesions
n=5 Participants
|
|
Baseline Lesion Characteristics: Presence of Calcification
Moderate
|
103 lesions
n=5 Participants
|
|
Baseline Lesion Characteristics: Presence of Calcification
Severe
|
106 lesions
n=5 Participants
|
|
Baseline Lesion Characteristics: Presence of Calcification
Not Available
|
2 lesions
n=5 Participants
|
PRIMARY outcome
Timeframe: 1 month for death, 12 months for target limb major amputation , and target lesion revascularizationPopulation: From the 275 subjects that were eligible for the 12-Month Follow-Up, data for the Primary Safety Endpoint were available for 268 subjects.
The safety endpoint assesses the occurrence of Major Adverse Events (MAEs) defined as all causes of death through 1 month, target limb major amputation through 12 months and/or target lesion revascularization through 12 months
Outcome measures
| Measure |
Innova Stent
n=268 Participants
Stent implantation into SFA/PPA
|
Innova Stent Entire Matrix (20-200 mm)
Entire Matrix Stent implantation into SFA/PPA
|
|---|---|---|
|
Primary Safety Endpoint and Components
12-Month MAE-Free Rate
|
85.8 percentage of participants
Interval 81.1 to 89.8
|
—
|
|
Primary Safety Endpoint and Components
12-Month MAE (Composite Endpoint)
|
14.2 percentage of participants
Interval 10.2 to 18.9
|
—
|
|
Primary Safety Endpoint and Components
All Causes of Deaths at 1 Month
|
0.0 percentage of participants
Interval 0.0 to 1.4
|
—
|
|
Primary Safety Endpoint and Components
Target Limb Major Amputations
|
0.4 percentage of participants
Interval 0.0 to 2.1
|
—
|
|
Primary Safety Endpoint and Components
Target Lesion Revascularization
|
14.2 percentage of participants
Interval 10.2 to 18.9
|
—
|
PRIMARY outcome
Timeframe: 12 monthsPopulation: From the 275 subjects that were eligible for the 12-Month Follow-Up, data for the Co-Primary Efficacy Endpoints were available for 268 subjects
The co-primary efficacy endpoints assess vessel primary patency at 12 months post-procedure. * The co-primary efficacy analysis (1) will assess vessel primary patency in stented segments intended to be treated with core matrix stents (20 to 150 mm). * The co-primary efficacy analysis (2) will assess vessel primary patency in stented segments intended to be treated with the entire stent matrix (20 to 200 mm).
Outcome measures
| Measure |
Innova Stent
n=231 Participants
Stent implantation into SFA/PPA
|
Innova Stent Entire Matrix (20-200 mm)
n=268 Participants
Entire Matrix Stent implantation into SFA/PPA
|
|---|---|---|
|
Co-Primary Efficacy Endpoints
|
69.7 percentage of participants
Interval 63.3 to 75.6
|
66.8 percentage of participants
Interval 60.8 to 72.4
|
SECONDARY outcome
Timeframe: 1 monthPopulation: From the 299 enrolled subjects, data for the Secondary Safety Endpoint was available for 297 subjects
The secondary safety endpoint assesses the occurrence of Major Adverse Events (MAEs) through 30 days. MAEs will include all causes of death, target limb major amputation and/or target lesion revascularization through 1 month
Outcome measures
| Measure |
Innova Stent
n=297 Participants
Stent implantation into SFA/PPA
|
Innova Stent Entire Matrix (20-200 mm)
Entire Matrix Stent implantation into SFA/PPA
|
|---|---|---|
|
Secondary Safety Endpoint and Components
1-Month MAE (Composite Endpoint)
|
0.3 percentage of participants
Interval 0.0 to 1.9
|
—
|
|
Secondary Safety Endpoint and Components
All Causes of Deaths
|
0.0 percentage of participants
Interval 0.0 to 1.2
|
—
|
|
Secondary Safety Endpoint and Components
Target Limb Major Amputation
|
0.0 percentage of participants
Interval 0.0 to 1.2
|
—
|
|
Secondary Safety Endpoint and Components
Target Lesion Revascularization
|
0.3 percentage of participants
Interval 0.0 to 1.9
|
—
|
|
Secondary Safety Endpoint and Components
1-Month MAE-Free Rate
|
99.7 percentage of participants
Interval 98.1 to 100.0
|
—
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Up to 24 hours after the procedure* Technical success: ability to cross and dilate the lesion to achieve residual angiographic stenosis no greater than 30% * Procedural success: technical success with no MAEs within 24 hours of the procedure
Outcome measures
| Measure |
Innova Stent
n=299 Participants
Stent implantation into SFA/PPA
|
Innova Stent Entire Matrix (20-200 mm)
Entire Matrix Stent implantation into SFA/PPA
|
|---|---|---|
|
Technical and Procedural Success
Technical Success
|
99 percentage of participants
Interval 97.1 to 99.8
|
—
|
|
Technical and Procedural Success
Procedure Success
|
99 percentage of participants
Interval 97.1 to 99.8
|
—
|
OTHER_PRE_SPECIFIED outcome
Timeframe: 12 monthsPopulation: From the 275 subjects that were eligible for the 12-Month Follow-Up, data for the Primary Patency Analysis was available for 268 subjects/lesions
Primary patency is the percentage of lesions (target stented segments) that reach a time point without a hemodynamically significant stenosis assessed by Duplex Ultrasound (DUS) and without Target Lesion Revascularization (TLR) or bypass of the target lesion.
Outcome measures
| Measure |
Innova Stent
n=268 Lesions
Stent implantation into SFA/PPA
|
Innova Stent Entire Matrix (20-200 mm)
Entire Matrix Stent implantation into SFA/PPA
|
|---|---|---|
|
Primary Patency
|
66.8 percentage of lesions
Interval 60.8 to 72.4
|
—
|
OTHER_PRE_SPECIFIED outcome
Timeframe: 12 monthsPopulation: From the 275 subjects that were eligible for the 12-Month Follow-Up, data for the Assisted Primary Patency Analysis was available for 256 subjects
Assisted primary patency is the percentage of lesions without TLR and those with TLR (not due to complete occlusion or bypass) that reach a time point without restenosis.
Outcome measures
| Measure |
Innova Stent
n=256 Participants
Stent implantation into SFA/PPA
|
Innova Stent Entire Matrix (20-200 mm)
Entire Matrix Stent implantation into SFA/PPA
|
|---|---|---|
|
Assisted Primary Patency
|
83.6 percentage of lesions
Interval 78.5 to 87.9
|
—
|
OTHER_PRE_SPECIFIED outcome
Timeframe: 12 monthsPopulation: From the 276 subjects that were eligible for the 12-Month Follow-Up, data for the Stent Fracture Analysis were available for 250 subjects
Vascular InterVentional Advances (VIVA) definitions: Grade 0: No strut fractures Grade I: single strut fracture Grade II: multiple strut fractures Grade III: stent fracture(s) with preserved alignment of the components Grade IV: stent fracture(s) with mal-alignment of the components Grade V: stent fracture(s) in a trans-axial spiral configuration
Outcome measures
| Measure |
Innova Stent
n=264 stents
Stent implantation into SFA/PPA
|
Innova Stent Entire Matrix (20-200 mm)
Entire Matrix Stent implantation into SFA/PPA
|
|---|---|---|
|
Stent Fracture Rate
Grade II
|
0.76 percentage of stents
|
—
|
|
Stent Fracture Rate
Grade III
|
1.14 percentage of stents
|
—
|
|
Stent Fracture Rate
Grade IV
|
0.38 percentage of stents
|
—
|
|
Stent Fracture Rate
Total
|
2.27 percentage of stents
|
—
|
OTHER_PRE_SPECIFIED outcome
Timeframe: 12 monthsPopulation: From the 275 subjects that were eligible for the 12-Month Follow-Up, data for the Rutherford Classification Analysis was available for 263 subjects
Class 0: Asymptomatic Class 1: Mild claudication Class 2: Moderate claudication Class 3: Severe claudication Class 4: Ischemic rest pain Class 5: Minor tissue loss - nonhealing ulcer, focal gangrene with diffuse pedal edema Class 6: Major tissue loss - extending above metatarsal (MT) level Rate of Primary Sustained Clinical Improvement: an improvement in Rutherford classification of one or more categories as compared to pre-procedure without the need for repeat TLR. Rate of Secondary Sustained Clinical Improvement: an improvement in Rutherford classification of one or more categories as compared to pre-procedure including those subjects with repeat TLR. Rate of Clinical Deterioration: downgrade in Rutherford classification of one or more categories as compared to pre-procedure
Outcome measures
| Measure |
Innova Stent
n=263 Participants
Stent implantation into SFA/PPA
|
Innova Stent Entire Matrix (20-200 mm)
Entire Matrix Stent implantation into SFA/PPA
|
|---|---|---|
|
Rutherford Classification
Rutherford Class 0
|
65.8 percentage of participants
|
—
|
|
Rutherford Classification
Rutherford Class 1
|
19.0 percentage of participants
|
—
|
|
Rutherford Classification
Rutherford Class 2
|
8.0 percentage of participants
|
—
|
|
Rutherford Classification
Rutherford Class 3
|
6.8 percentage of participants
|
—
|
|
Rutherford Classification
Rutherford Class 4
|
0.0 percentage of participants
|
—
|
|
Rutherford Classification
Rutherford Class 5
|
0.4 percentage of participants
|
—
|
|
Rutherford Classification
Rutherford Class 6
|
0.0 percentage of participants
|
—
|
|
Rutherford Classification
Primary Sustained Clinical Improvement
|
79.5 percentage of participants
|
—
|
|
Rutherford Classification
Secondary Sustained Clinical Improvement
|
90.1 percentage of participants
|
—
|
|
Rutherford Classification
Clinical Deterioration
|
2.7 percentage of participants
|
—
|
|
Rutherford Classification
No Change from Baseline
|
7.2 percentage of participants
|
—
|
OTHER_PRE_SPECIFIED outcome
Timeframe: 12 monthsPopulation: 278 subjects were included in the Rate of Hemodynamic Improvement Analysis (275 subjects eligible for the 12-Month Follow-Up + 3 subjects with TLR)
The Ankle-Brachial Index (ABI) is the ratio between the systolic pressure measured at the ankle and the systolic pressure measured in the arm. Hemodynamic Improvement: Increases in ABI of ≥ 0.10 or to an ABI ≥ 0.90 as compared to pre-procedure without the need for repeat TLR. Hemodynamic Improvement (Including TLR): Increases in ABI of ≥0.10 or to an ABI ≥0.90 as compared to pre-procedure including TLR.
Outcome measures
| Measure |
Innova Stent
n=278 limbs
Stent implantation into SFA/PPA
|
Innova Stent Entire Matrix (20-200 mm)
Entire Matrix Stent implantation into SFA/PPA
|
|---|---|---|
|
Rate of Hemodynamic Improvement
Hemodynamic Improvement
|
59 percentage of limbs
|
—
|
|
Rate of Hemodynamic Improvement
Hemodynamic Improvement (Including TLR)
|
68.3 percentage of limbs
|
—
|
OTHER_PRE_SPECIFIED outcome
Timeframe: 12 monthsPopulation: From the 275 subjects that were eligible for the 12-Month Follow-Up, data for the Walking Improvement assessed by the Walking Impairment Questionnaire were available for 265 subjects
The Walking Impairment Questionnaire (WIQ) is a validated functional assessment questionnaire that evaluates walking ability with regard to speed, distance and stair climbing ability as well as the reasons that walking ability might be limited. Range of scores is between 0% and 100% with 100% being the best and 0% being the worst score.
Outcome measures
| Measure |
Innova Stent
n=265 Participants
Stent implantation into SFA/PPA
|
Innova Stent Entire Matrix (20-200 mm)
Entire Matrix Stent implantation into SFA/PPA
|
|---|---|---|
|
Walking Improvement Assessed by the Walking Impairment Questionnaire
Walking Impairment
|
73.87 units on a scale
Standard Deviation 30.98
|
—
|
|
Walking Improvement Assessed by the Walking Impairment Questionnaire
Change from Baseline
|
34.03 units on a scale
Standard Deviation 37.22
|
—
|
OTHER_PRE_SPECIFIED outcome
Timeframe: 12 monthsPopulation: From the 275 subjects that were eligible for the 12-Month Follow-Up, data for the Walking Improvement Assessed by 6 minute Hall Walk Analysis were available for 246 subjects
Assessment of walking improvement (time) by the administration of the 6 Minute Walk Test (6MWT). Participants were asked to walk for as long as they could; up to 6 minutes.
Outcome measures
| Measure |
Innova Stent
n=246 Participants
Stent implantation into SFA/PPA
|
Innova Stent Entire Matrix (20-200 mm)
Entire Matrix Stent implantation into SFA/PPA
|
|---|---|---|
|
Walking Improvement (Time) Assessed by 6 Minute Hall Walk
Baseline
|
5.5 minutes
Standard Deviation 1.3
|
—
|
|
Walking Improvement (Time) Assessed by 6 Minute Hall Walk
12-Months
|
5.7 minutes
Standard Deviation 0.9
|
—
|
OTHER_PRE_SPECIFIED outcome
Timeframe: 12 monthsPopulation: From the 275 subjects that were eligible for the 12-Month Follow-Up, data for the Walking Improvement Assessed by 6 minute Hall Walk Analysis were available for 246 subjects
Assessment of walking improvement (distance) by the administration of the 6 Minute Walk Test (6MWT). Participants were asked to walk for as long as they could; up to 6 minutes.
Outcome measures
| Measure |
Innova Stent
n=246 Participants
Stent implantation into SFA/PPA
|
Innova Stent Entire Matrix (20-200 mm)
Entire Matrix Stent implantation into SFA/PPA
|
|---|---|---|
|
Walking Improvement (Distance) Assessed by 6 Minute Hall Walk
Baseline
|
278.6 meters
Standard Deviation 119.1
|
—
|
|
Walking Improvement (Distance) Assessed by 6 Minute Hall Walk
12-Months
|
358.9 meters
Standard Deviation 147.2
|
—
|
OTHER_PRE_SPECIFIED outcome
Timeframe: 12 monthsPopulation: From the 275 subjects that were eligible for the 12-Month Follow-Up, data for the Quality of Life Analysis were available for 265 subjects
Improved Quality of Life assessed by the SF-36 Health Survey. The validated SF-36 Survey, where scores are calibrated so that 50 is the average score or norm, was utilized (scores ranging from 0, worst possible health to 100, best possible health). The SF-36 is a multipurpose, proprietary health survey with 36 questions that yield eight health component scales that can be further summarized into two summary scores: mental and physical health scores. The eight health component scales that can be computed from the questionnaire are physical function, role-physical, bodily pain, general health, vitality, role-emotional, mental health and social functioning.
Outcome measures
| Measure |
Innova Stent
n=265 Participants
Stent implantation into SFA/PPA
|
Innova Stent Entire Matrix (20-200 mm)
Entire Matrix Stent implantation into SFA/PPA
|
|---|---|---|
|
Quality of Life
Vitality
|
50.57 units on a scale
Standard Deviation 10.98
|
—
|
|
Quality of Life
Vitality Change from Baseline
|
3.10 units on a scale
Standard Deviation 10.68
|
—
|
|
Quality of Life
General Health Perceptions
|
44.65 units on a scale
Standard Deviation 9.9
|
—
|
|
Quality of Life
General Health Perceptions Change from Baseline
|
1.32 units on a scale
Standard Deviation 9.51
|
—
|
|
Quality of Life
Mental Component Score
|
51.14 units on a scale
Standard Deviation 10.71
|
—
|
|
Quality of Life
Mental Component Score Change from Baseline
|
0.86 units on a scale
Standard Deviation 11.69
|
—
|
|
Quality of Life
Physical Functioning
|
41.17 units on a scale
Standard Deviation 11.38
|
—
|
|
Quality of Life
Physical Functioning Change from Baseline
|
6.53 units on a scale
Standard Deviation 10.29
|
—
|
|
Quality of Life
Role Physical
|
43.39 units on a scale
Standard Deviation 11.48
|
—
|
|
Quality of Life
Role Physical Change from Baseline
|
5.14 units on a scale
Standard Deviation 11.9
|
—
|
|
Quality of Life
Role Emotional
|
45.45 units on a scale
Standard Deviation 13.22
|
—
|
|
Quality of Life
Role Emotional Change from Baseline
|
3.49 units on a scale
Standard Deviation 14.61
|
—
|
|
Quality of Life
Social Functioning
|
48.12 units on a scale
Standard Deviation 10.55
|
—
|
|
Quality of Life
Social Functioning Change from Baseline
|
2.66 units on a scale
Standard Deviation 13.26
|
—
|
|
Quality of Life
Bodily Pain
|
46.52 units on a scale
Standard Deviation 11.33
|
—
|
|
Quality of Life
Bodily Pain Change from Baseline
|
7.28 units on a scale
Standard Deviation 12.19
|
—
|
|
Quality of Life
Mental Health
|
50.19 units on a scale
Standard Deviation 10.46
|
—
|
|
Quality of Life
Mental Health Change from Baseline
|
2.33 units on a scale
Standard Deviation 11.21
|
—
|
|
Quality of Life
Physical Component Score
|
42.66 units on a scale
Standard Deviation 10.30
|
—
|
|
Quality of Life
Physical Component Score Change from Baseline
|
6.31 units on a scale
Standard Deviation 10.23
|
—
|
Adverse Events
Innova Stent
Serious events: 143 serious events
Other events: 116 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Innova Stent
n=266 participants at risk
Stent implantation into SFA/PPA
|
|---|---|
|
Cardiac disorders
Acute coronary syndrome
|
1.5%
4/266 • Number of events 4 • 12 months
From the 276 subjects that were eligible for the 12-Month Follow-Up, data for the Adverse Events Analysis were available for 266 subjects
|
|
Cardiac disorders
Acute myocardial infarction
|
1.1%
3/266 • Number of events 3 • 12 months
From the 276 subjects that were eligible for the 12-Month Follow-Up, data for the Adverse Events Analysis were available for 266 subjects
|
|
Cardiac disorders
Angina pectoris
|
2.3%
6/266 • Number of events 7 • 12 months
From the 276 subjects that were eligible for the 12-Month Follow-Up, data for the Adverse Events Analysis were available for 266 subjects
|
|
Cardiac disorders
Angina unstable
|
0.38%
1/266 • Number of events 2 • 12 months
From the 276 subjects that were eligible for the 12-Month Follow-Up, data for the Adverse Events Analysis were available for 266 subjects
|
|
Cardiac disorders
Atrial flutter
|
0.38%
1/266 • Number of events 1 • 12 months
From the 276 subjects that were eligible for the 12-Month Follow-Up, data for the Adverse Events Analysis were available for 266 subjects
|
|
Cardiac disorders
Cardiac arrest
|
0.38%
1/266 • Number of events 1 • 12 months
From the 276 subjects that were eligible for the 12-Month Follow-Up, data for the Adverse Events Analysis were available for 266 subjects
|
|
Cardiac disorders
Cardiac failure
|
0.38%
1/266 • Number of events 1 • 12 months
From the 276 subjects that were eligible for the 12-Month Follow-Up, data for the Adverse Events Analysis were available for 266 subjects
|
|
Cardiac disorders
Cardiac failure congestive
|
0.75%
2/266 • Number of events 2 • 12 months
From the 276 subjects that were eligible for the 12-Month Follow-Up, data for the Adverse Events Analysis were available for 266 subjects
|
|
Cardiac disorders
Cardio-respiratory arrest
|
0.38%
1/266 • Number of events 1 • 12 months
From the 276 subjects that were eligible for the 12-Month Follow-Up, data for the Adverse Events Analysis were available for 266 subjects
|
|
Cardiac disorders
Coronary artery disease
|
1.1%
3/266 • Number of events 3 • 12 months
From the 276 subjects that were eligible for the 12-Month Follow-Up, data for the Adverse Events Analysis were available for 266 subjects
|
|
Cardiac disorders
Coronary artery occlusion
|
0.38%
1/266 • Number of events 1 • 12 months
From the 276 subjects that were eligible for the 12-Month Follow-Up, data for the Adverse Events Analysis were available for 266 subjects
|
|
Cardiac disorders
Myocardial ischaemia
|
0.38%
1/266 • Number of events 1 • 12 months
From the 276 subjects that were eligible for the 12-Month Follow-Up, data for the Adverse Events Analysis were available for 266 subjects
|
|
Cardiac disorders
Pericarditis
|
0.38%
1/266 • Number of events 1 • 12 months
From the 276 subjects that were eligible for the 12-Month Follow-Up, data for the Adverse Events Analysis were available for 266 subjects
|
|
Cardiac disorders
Ventricular tachycardia
|
0.38%
1/266 • Number of events 2 • 12 months
From the 276 subjects that were eligible for the 12-Month Follow-Up, data for the Adverse Events Analysis were available for 266 subjects
|
|
Congenital, familial and genetic disorders
Vitello-intestinal duct remnant
|
0.38%
1/266 • Number of events 1 • 12 months
From the 276 subjects that were eligible for the 12-Month Follow-Up, data for the Adverse Events Analysis were available for 266 subjects
|
|
Gastrointestinal disorders
Abdominal pain
|
0.38%
1/266 • Number of events 1 • 12 months
From the 276 subjects that were eligible for the 12-Month Follow-Up, data for the Adverse Events Analysis were available for 266 subjects
|
|
Gastrointestinal disorders
Abdominal pain upper
|
0.75%
2/266 • Number of events 2 • 12 months
From the 276 subjects that were eligible for the 12-Month Follow-Up, data for the Adverse Events Analysis were available for 266 subjects
|
|
Gastrointestinal disorders
Diarrhoea
|
0.38%
1/266 • Number of events 1 • 12 months
From the 276 subjects that were eligible for the 12-Month Follow-Up, data for the Adverse Events Analysis were available for 266 subjects
|
|
Gastrointestinal disorders
Enteritis
|
0.38%
1/266 • Number of events 1 • 12 months
From the 276 subjects that were eligible for the 12-Month Follow-Up, data for the Adverse Events Analysis were available for 266 subjects
|
|
Gastrointestinal disorders
Gastrointestinal disorder
|
0.38%
1/266 • Number of events 1 • 12 months
From the 276 subjects that were eligible for the 12-Month Follow-Up, data for the Adverse Events Analysis were available for 266 subjects
|
|
Gastrointestinal disorders
Gastrointestinal haemorrhage
|
0.75%
2/266 • Number of events 4 • 12 months
From the 276 subjects that were eligible for the 12-Month Follow-Up, data for the Adverse Events Analysis were available for 266 subjects
|
|
Gastrointestinal disorders
Inguinal hernia
|
0.38%
1/266 • Number of events 1 • 12 months
From the 276 subjects that were eligible for the 12-Month Follow-Up, data for the Adverse Events Analysis were available for 266 subjects
|
|
Gastrointestinal disorders
Pancreatitis
|
0.38%
1/266 • Number of events 1 • 12 months
From the 276 subjects that were eligible for the 12-Month Follow-Up, data for the Adverse Events Analysis were available for 266 subjects
|
|
Gastrointestinal disorders
Rectal haemorrhage
|
0.38%
1/266 • Number of events 1 • 12 months
From the 276 subjects that were eligible for the 12-Month Follow-Up, data for the Adverse Events Analysis were available for 266 subjects
|
|
Gastrointestinal disorders
Retroperitoneal haematoma
|
0.75%
2/266 • Number of events 2 • 12 months
From the 276 subjects that were eligible for the 12-Month Follow-Up, data for the Adverse Events Analysis were available for 266 subjects
|
|
Gastrointestinal disorders
Upper gastrointestinal haemorrhage
|
0.38%
1/266 • Number of events 1 • 12 months
From the 276 subjects that were eligible for the 12-Month Follow-Up, data for the Adverse Events Analysis were available for 266 subjects
|
|
Gastrointestinal disorders
Volvulus
|
0.38%
1/266 • Number of events 1 • 12 months
From the 276 subjects that were eligible for the 12-Month Follow-Up, data for the Adverse Events Analysis were available for 266 subjects
|
|
General disorders
Administration site conditions: Catheter site haemorrhage
|
0.75%
2/266 • Number of events 2 • 12 months
From the 276 subjects that were eligible for the 12-Month Follow-Up, data for the Adverse Events Analysis were available for 266 subjects
|
|
General disorders
Death
|
0.38%
1/266 • Number of events 1 • 12 months
From the 276 subjects that were eligible for the 12-Month Follow-Up, data for the Adverse Events Analysis were available for 266 subjects
|
|
General disorders
Drug withdrawal syndrome
|
0.38%
1/266 • Number of events 1 • 12 months
From the 276 subjects that were eligible for the 12-Month Follow-Up, data for the Adverse Events Analysis were available for 266 subjects
|
|
General disorders
General physical health deterioration
|
0.38%
1/266 • Number of events 1 • 12 months
From the 276 subjects that were eligible for the 12-Month Follow-Up, data for the Adverse Events Analysis were available for 266 subjects
|
|
General disorders
Administration site conditions: Impaired healing
|
0.75%
2/266 • Number of events 3 • 12 months
From the 276 subjects that were eligible for the 12-Month Follow-Up, data for the Adverse Events Analysis were available for 266 subjects
|
|
General disorders
Non-cardiac chest pain
|
0.75%
2/266 • Number of events 2 • 12 months
From the 276 subjects that were eligible for the 12-Month Follow-Up, data for the Adverse Events Analysis were available for 266 subjects
|
|
General disorders
Oedema peripheral
|
0.38%
1/266 • Number of events 1 • 12 months
From the 276 subjects that were eligible for the 12-Month Follow-Up, data for the Adverse Events Analysis were available for 266 subjects
|
|
Immune system disorders
Allergic oedema
|
0.38%
1/266 • Number of events 1 • 12 months
From the 276 subjects that were eligible for the 12-Month Follow-Up, data for the Adverse Events Analysis were available for 266 subjects
|
|
Immune system disorders
Contrast media allergy
|
0.38%
1/266 • Number of events 1 • 12 months
From the 276 subjects that were eligible for the 12-Month Follow-Up, data for the Adverse Events Analysis were available for 266 subjects
|
|
Infections and infestations
Bronchitis
|
0.38%
1/266 • Number of events 1 • 12 months
From the 276 subjects that were eligible for the 12-Month Follow-Up, data for the Adverse Events Analysis were available for 266 subjects
|
|
Infections and infestations
Catheter site infection
|
0.38%
1/266 • Number of events 1 • 12 months
From the 276 subjects that were eligible for the 12-Month Follow-Up, data for the Adverse Events Analysis were available for 266 subjects
|
|
Infections and infestations
Cellulitis
|
0.75%
2/266 • Number of events 2 • 12 months
From the 276 subjects that were eligible for the 12-Month Follow-Up, data for the Adverse Events Analysis were available for 266 subjects
|
|
Infections and infestations
Diverticulitis
|
0.75%
2/266 • Number of events 2 • 12 months
From the 276 subjects that were eligible for the 12-Month Follow-Up, data for the Adverse Events Analysis were available for 266 subjects
|
|
Infections and infestations
Enterocolitis bacterial
|
0.38%
1/266 • Number of events 1 • 12 months
From the 276 subjects that were eligible for the 12-Month Follow-Up, data for the Adverse Events Analysis were available for 266 subjects
|
|
Infections and infestations
Osteomyelitis acute
|
0.75%
2/266 • Number of events 2 • 12 months
From the 276 subjects that were eligible for the 12-Month Follow-Up, data for the Adverse Events Analysis were available for 266 subjects
|
|
Infections and infestations
Pneumonia
|
1.5%
4/266 • Number of events 4 • 12 months
From the 276 subjects that were eligible for the 12-Month Follow-Up, data for the Adverse Events Analysis were available for 266 subjects
|
|
Infections and infestations
Postoperative wound infection
|
0.38%
1/266 • Number of events 1 • 12 months
From the 276 subjects that were eligible for the 12-Month Follow-Up, data for the Adverse Events Analysis were available for 266 subjects
|
|
Injury, poisoning and procedural complications
Hip fracture
|
0.75%
2/266 • Number of events 2 • 12 months
From the 276 subjects that were eligible for the 12-Month Follow-Up, data for the Adverse Events Analysis were available for 266 subjects
|
|
Injury, poisoning and procedural complications
Humerus fracture
|
0.38%
1/266 • Number of events 2 • 12 months
From the 276 subjects that were eligible for the 12-Month Follow-Up, data for the Adverse Events Analysis were available for 266 subjects
|
|
Injury, poisoning and procedural complications
Limb injury
|
0.38%
1/266 • Number of events 1 • 12 months
From the 276 subjects that were eligible for the 12-Month Follow-Up, data for the Adverse Events Analysis were available for 266 subjects
|
|
Injury, poisoning and procedural complications
Post procedural haemorrhage
|
0.38%
1/266 • Number of events 1 • 12 months
From the 276 subjects that were eligible for the 12-Month Follow-Up, data for the Adverse Events Analysis were available for 266 subjects
|
|
Injury, poisoning and procedural complications
Rib fracture
|
0.38%
1/266 • Number of events 1 • 12 months
From the 276 subjects that were eligible for the 12-Month Follow-Up, data for the Adverse Events Analysis were available for 266 subjects
|
|
Injury, poisoning and procedural complications
Skull fracture
|
0.38%
1/266 • Number of events 1 • 12 months
From the 276 subjects that were eligible for the 12-Month Follow-Up, data for the Adverse Events Analysis were available for 266 subjects
|
|
Injury, poisoning and procedural complications
Spinal fracture
|
0.38%
1/266 • Number of events 1 • 12 months
From the 276 subjects that were eligible for the 12-Month Follow-Up, data for the Adverse Events Analysis were available for 266 subjects
|
|
Injury, poisoning and procedural complications
Vascular graft occlusion
|
0.75%
2/266 • Number of events 4 • 12 months
From the 276 subjects that were eligible for the 12-Month Follow-Up, data for the Adverse Events Analysis were available for 266 subjects
|
|
Injury, poisoning and procedural complications
Vascular pseudoaneurysm
|
0.75%
2/266 • Number of events 2 • 12 months
From the 276 subjects that were eligible for the 12-Month Follow-Up, data for the Adverse Events Analysis were available for 266 subjects
|
|
Injury, poisoning and procedural complications
Wound
|
0.38%
1/266 • Number of events 2 • 12 months
From the 276 subjects that were eligible for the 12-Month Follow-Up, data for the Adverse Events Analysis were available for 266 subjects
|
|
Metabolism and nutrition disorders
Electrolyte imbalance
|
0.38%
1/266 • Number of events 1 • 12 months
From the 276 subjects that were eligible for the 12-Month Follow-Up, data for the Adverse Events Analysis were available for 266 subjects
|
|
Metabolism and nutrition disorders
Hyponatraemia
|
0.38%
1/266 • Number of events 1 • 12 months
From the 276 subjects that were eligible for the 12-Month Follow-Up, data for the Adverse Events Analysis were available for 266 subjects
|
|
Metabolism and nutrition disorders
Marasmus
|
0.38%
1/266 • Number of events 1 • 12 months
From the 276 subjects that were eligible for the 12-Month Follow-Up, data for the Adverse Events Analysis were available for 266 subjects
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
0.38%
1/266 • Number of events 1 • 12 months
From the 276 subjects that were eligible for the 12-Month Follow-Up, data for the Adverse Events Analysis were available for 266 subjects
|
|
Musculoskeletal and connective tissue disorders
Osteoarthritis
|
0.38%
1/266 • Number of events 1 • 12 months
From the 276 subjects that were eligible for the 12-Month Follow-Up, data for the Adverse Events Analysis were available for 266 subjects
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
1.9%
5/266 • Number of events 5 • 12 months
From the 276 subjects that were eligible for the 12-Month Follow-Up, data for the Adverse Events Analysis were available for 266 subjects
|
|
Musculoskeletal and connective tissue disorders
Rotator cuff syndrome
|
0.38%
1/266 • Number of events 1 • 12 months
From the 276 subjects that were eligible for the 12-Month Follow-Up, data for the Adverse Events Analysis were available for 266 subjects
|
|
Musculoskeletal and connective tissue disorders
Trigger finger
|
0.38%
1/266 • Number of events 1 • 12 months
From the 276 subjects that were eligible for the 12-Month Follow-Up, data for the Adverse Events Analysis were available for 266 subjects
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Benign neoplasm of bladder
|
0.38%
1/266 • Number of events 1 • 12 months
From the 276 subjects that were eligible for the 12-Month Follow-Up, data for the Adverse Events Analysis were available for 266 subjects
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Bladder cancer
|
0.38%
1/266 • Number of events 1 • 12 months
From the 276 subjects that were eligible for the 12-Month Follow-Up, data for the Adverse Events Analysis were available for 266 subjects
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Bladder transitional cell carcinoma recurrent
|
0.38%
1/266 • Number of events 1 • 12 months
From the 276 subjects that were eligible for the 12-Month Follow-Up, data for the Adverse Events Analysis were available for 266 subjects
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Breast cancer
|
0.38%
1/266 • Number of events 1 • 12 months
From the 276 subjects that were eligible for the 12-Month Follow-Up, data for the Adverse Events Analysis were available for 266 subjects
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Colon cancer
|
0.38%
1/266 • Number of events 1 • 12 months
From the 276 subjects that were eligible for the 12-Month Follow-Up, data for the Adverse Events Analysis were available for 266 subjects
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Lung neoplasm malignant
|
0.38%
1/266 • Number of events 1 • 12 months
From the 276 subjects that were eligible for the 12-Month Follow-Up, data for the Adverse Events Analysis were available for 266 subjects
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Non-small cell lung cancer
|
0.38%
1/266 • Number of events 1 • 12 months
From the 276 subjects that were eligible for the 12-Month Follow-Up, data for the Adverse Events Analysis were available for 266 subjects
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Oesophageal carcinoma
|
0.38%
1/266 • Number of events 1 • 12 months
From the 276 subjects that were eligible for the 12-Month Follow-Up, data for the Adverse Events Analysis were available for 266 subjects
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Prostate cancer
|
0.38%
1/266 • Number of events 1 • 12 months
From the 276 subjects that were eligible for the 12-Month Follow-Up, data for the Adverse Events Analysis were available for 266 subjects
|
|
Nervous system disorders
Carotid artery disease
|
0.38%
1/266 • Number of events 1 • 12 months
From the 276 subjects that were eligible for the 12-Month Follow-Up, data for the Adverse Events Analysis were available for 266 subjects
|
|
Nervous system disorders
Carotid artery stenosis
|
0.38%
1/266 • Number of events 1 • 12 months
From the 276 subjects that were eligible for the 12-Month Follow-Up, data for the Adverse Events Analysis were available for 266 subjects
|
|
Nervous system disorders
Cerebral haemorrhage
|
0.38%
1/266 • Number of events 1 • 12 months
From the 276 subjects that were eligible for the 12-Month Follow-Up, data for the Adverse Events Analysis were available for 266 subjects
|
|
Nervous system disorders
Cerebrovascular accident
|
0.75%
2/266 • Number of events 3 • 12 months
From the 276 subjects that were eligible for the 12-Month Follow-Up, data for the Adverse Events Analysis were available for 266 subjects
|
|
Nervous system disorders
Convulsion
|
0.38%
1/266 • Number of events 1 • 12 months
From the 276 subjects that were eligible for the 12-Month Follow-Up, data for the Adverse Events Analysis were available for 266 subjects
|
|
Nervous system disorders
Dementia
|
0.38%
1/266 • Number of events 1 • 12 months
From the 276 subjects that were eligible for the 12-Month Follow-Up, data for the Adverse Events Analysis were available for 266 subjects
|
|
Renal and urinary disorders
Haematuria
|
0.38%
1/266 • Number of events 1 • 12 months
From the 276 subjects that were eligible for the 12-Month Follow-Up, data for the Adverse Events Analysis were available for 266 subjects
|
|
Renal and urinary disorders
Renal artery stenosis
|
0.38%
1/266 • Number of events 1 • 12 months
From the 276 subjects that were eligible for the 12-Month Follow-Up, data for the Adverse Events Analysis were available for 266 subjects
|
|
Renal and urinary disorders
Renal failure
|
0.38%
1/266 • Number of events 1 • 12 months
From the 276 subjects that were eligible for the 12-Month Follow-Up, data for the Adverse Events Analysis were available for 266 subjects
|
|
Renal and urinary disorders
Urinary tract obstruction
|
0.38%
1/266 • Number of events 1 • 12 months
From the 276 subjects that were eligible for the 12-Month Follow-Up, data for the Adverse Events Analysis were available for 266 subjects
|
|
Reproductive system and breast disorders
Benign prostatic hyperplasia
|
0.38%
1/266 • Number of events 1 • 12 months
From the 276 subjects that were eligible for the 12-Month Follow-Up, data for the Adverse Events Analysis were available for 266 subjects
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary embolism
|
0.38%
1/266 • Number of events 1 • 12 months
From the 276 subjects that were eligible for the 12-Month Follow-Up, data for the Adverse Events Analysis were available for 266 subjects
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory disorder
|
0.38%
1/266 • Number of events 1 • 12 months
From the 276 subjects that were eligible for the 12-Month Follow-Up, data for the Adverse Events Analysis were available for 266 subjects
|
|
Skin and subcutaneous tissue disorders
Skin ulcer
|
0.38%
1/266 • Number of events 1 • 12 months
From the 276 subjects that were eligible for the 12-Month Follow-Up, data for the Adverse Events Analysis were available for 266 subjects
|
|
Surgical and medical procedures
Cardiac pacemaker battery replacement
|
0.38%
1/266 • Number of events 1 • 12 months
From the 276 subjects that were eligible for the 12-Month Follow-Up, data for the Adverse Events Analysis were available for 266 subjects
|
|
Vascular disorders
Aortic stenosis
|
0.38%
1/266 • Number of events 1 • 12 months
From the 276 subjects that were eligible for the 12-Month Follow-Up, data for the Adverse Events Analysis were available for 266 subjects
|
|
Vascular disorders
Arterial stenosis limb
|
1.5%
4/266 • Number of events 6 • 12 months
From the 276 subjects that were eligible for the 12-Month Follow-Up, data for the Adverse Events Analysis were available for 266 subjects
|
|
Vascular disorders
Arterial thrombosis limb
|
1.9%
5/266 • Number of events 6 • 12 months
From the 276 subjects that were eligible for the 12-Month Follow-Up, data for the Adverse Events Analysis were available for 266 subjects
|
|
Vascular disorders
Circulatory collapse
|
0.38%
1/266 • Number of events 1 • 12 months
From the 276 subjects that were eligible for the 12-Month Follow-Up, data for the Adverse Events Analysis were available for 266 subjects
|
|
Vascular disorders
Extremity necrosis
|
0.38%
1/266 • Number of events 1 • 12 months
From the 276 subjects that were eligible for the 12-Month Follow-Up, data for the Adverse Events Analysis were available for 266 subjects
|
|
Vascular disorders
Femoral arterial stenosis
|
17.7%
47/266 • Number of events 59 • 12 months
From the 276 subjects that were eligible for the 12-Month Follow-Up, data for the Adverse Events Analysis were available for 266 subjects
|
|
Vascular disorders
Femoral artery occlusion
|
4.1%
11/266 • Number of events 17 • 12 months
From the 276 subjects that were eligible for the 12-Month Follow-Up, data for the Adverse Events Analysis were available for 266 subjects
|
|
Vascular disorders
Haematoma
|
0.38%
1/266 • Number of events 1 • 12 months
From the 276 subjects that were eligible for the 12-Month Follow-Up, data for the Adverse Events Analysis were available for 266 subjects
|
|
Vascular disorders
Haemorrhage
|
0.38%
1/266 • Number of events 1 • 12 months
From the 276 subjects that were eligible for the 12-Month Follow-Up, data for the Adverse Events Analysis were available for 266 subjects
|
|
Vascular disorders
Hypertension
|
0.38%
1/266 • Number of events 1 • 12 months
From the 276 subjects that were eligible for the 12-Month Follow-Up, data for the Adverse Events Analysis were available for 266 subjects
|
|
Vascular disorders
Hypotension
|
0.38%
1/266 • Number of events 1 • 12 months
From the 276 subjects that were eligible for the 12-Month Follow-Up, data for the Adverse Events Analysis were available for 266 subjects
|
|
Vascular disorders
liac artery stenosis
|
2.6%
7/266 • Number of events 8 • 12 months
From the 276 subjects that were eligible for the 12-Month Follow-Up, data for the Adverse Events Analysis were available for 266 subjects
|
|
Vascular disorders
Intermittent claudication
|
6.8%
18/266 • Number of events 24 • 12 months
From the 276 subjects that were eligible for the 12-Month Follow-Up, data for the Adverse Events Analysis were available for 266 subjects
|
|
Vascular disorders
Peripheral arterial occlusive disease
|
0.75%
2/266 • Number of events 4 • 12 months
From the 276 subjects that were eligible for the 12-Month Follow-Up, data for the Adverse Events Analysis were available for 266 subjects
|
|
Vascular disorders
Peripheral embolism
|
0.38%
1/266 • Number of events 1 • 12 months
From the 276 subjects that were eligible for the 12-Month Follow-Up, data for the Adverse Events Analysis were available for 266 subjects
|
|
Vascular disorders
Peripheral ischaemia
|
1.1%
3/266 • Number of events 3 • 12 months
From the 276 subjects that were eligible for the 12-Month Follow-Up, data for the Adverse Events Analysis were available for 266 subjects
|
|
Vascular disorders
Peripheral vascular disorder
|
0.38%
1/266 • Number of events 2 • 12 months
From the 276 subjects that were eligible for the 12-Month Follow-Up, data for the Adverse Events Analysis were available for 266 subjects
|
|
Injury, poisoning and procedural complications
Fall
|
0.38%
1/266 • Number of events 1 • 12 months
From the 276 subjects that were eligible for the 12-Month Follow-Up, data for the Adverse Events Analysis were available for 266 subjects
|
|
Cardiac disorders
Myocardial infarction
|
0.38%
1/266 • Number of events 1 • 12 months
From the 276 subjects that were eligible for the 12-Month Follow-Up, data for the Adverse Events Analysis were available for 266 subjects
|
|
Cardiac disorders
Tachyarrhythmia
|
0.38%
1/266 • Number of events 1 • 12 months
From the 276 subjects that were eligible for the 12-Month Follow-Up, data for the Adverse Events Analysis were available for 266 subjects
|
|
Gastrointestinal disorders
Gastrointestinal hypomotility
|
0.38%
1/266 • Number of events 1 • 12 months
From the 276 subjects that were eligible for the 12-Month Follow-Up, data for the Adverse Events Analysis were available for 266 subjects
|
|
Infections and infestations
Gangrene
|
0.38%
1/266 • Number of events 1 • 12 months
From the 276 subjects that were eligible for the 12-Month Follow-Up, data for the Adverse Events Analysis were available for 266 subjects
|
|
Infections and infestations
Vulval abscess
|
0.38%
1/266 • Number of events 1 • 12 months
From the 276 subjects that were eligible for the 12-Month Follow-Up, data for the Adverse Events Analysis were available for 266 subjects
|
|
Injury, poisoning and procedural complications
Vascular procedure complication
|
1.1%
3/266 • Number of events 3 • 12 months
From the 276 subjects that were eligible for the 12-Month Follow-Up, data for the Adverse Events Analysis were available for 266 subjects
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
0.38%
1/266 • Number of events 1 • 12 months
From the 276 subjects that were eligible for the 12-Month Follow-Up, data for the Adverse Events Analysis were available for 266 subjects
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Benign gastric neoplasm
|
0.38%
1/266 • Number of events 1 • 12 months
From the 276 subjects that were eligible for the 12-Month Follow-Up, data for the Adverse Events Analysis were available for 266 subjects
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Colorectal cancer
|
0.38%
1/266 • Number of events 1 • 12 months
From the 276 subjects that were eligible for the 12-Month Follow-Up, data for the Adverse Events Analysis were available for 266 subjects
|
Other adverse events
| Measure |
Innova Stent
n=266 participants at risk
Stent implantation into SFA/PPA
|
|---|---|
|
Vascular disorders
Intermittent claudication
|
9.0%
24/266 • Number of events 27 • 12 months
From the 276 subjects that were eligible for the 12-Month Follow-Up, data for the Adverse Events Analysis were available for 266 subjects
|
|
General disorders
Catheter site haematoma
|
2.6%
7/266 • Number of events 8 • 12 months
From the 276 subjects that were eligible for the 12-Month Follow-Up, data for the Adverse Events Analysis were available for 266 subjects
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
3.8%
10/266 • Number of events 10 • 12 months
From the 276 subjects that were eligible for the 12-Month Follow-Up, data for the Adverse Events Analysis were available for 266 subjects
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
2.3%
6/266 • Number of events 6 • 12 months
From the 276 subjects that were eligible for the 12-Month Follow-Up, data for the Adverse Events Analysis were available for 266 subjects
|
|
Musculoskeletal and connective tissue disorders
Muscle spasms
|
2.3%
6/266 • Number of events 6 • 12 months
From the 276 subjects that were eligible for the 12-Month Follow-Up, data for the Adverse Events Analysis were available for 266 subjects
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
9.0%
24/266 • Number of events 25 • 12 months
From the 276 subjects that were eligible for the 12-Month Follow-Up, data for the Adverse Events Analysis were available for 266 subjects
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
3.4%
9/266 • Number of events 9 • 12 months
From the 276 subjects that were eligible for the 12-Month Follow-Up, data for the Adverse Events Analysis were available for 266 subjects
|
|
Vascular disorders
Femoral artery stenosis
|
6.8%
18/266 • Number of events 20 • 12 months
From the 276 subjects that were eligible for the 12-Month Follow-Up, data for the Adverse Events Analysis were available for 266 subjects
|
|
Vascular disorders
Haematoma
|
2.3%
6/266 • Number of events 7 • 12 months
From the 276 subjects that were eligible for the 12-Month Follow-Up, data for the Adverse Events Analysis were available for 266 subjects
|
|
Injury, poisoning and procedural complications
Vascular procedure complication
|
2.3%
6/266 • Number of events 6 • 12 months
From the 276 subjects that were eligible for the 12-Month Follow-Up, data for the Adverse Events Analysis were available for 266 subjects
|
Additional Information
Philip Ghizoni, Clinical Trial Manager
Boston Scientific Corporation
Phone: 763-255-0036
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee Institution and Investigator shall have the right to publish the Results, provided that before publishing, Institution and Investigator shall submit copies of any proposed publication or presentation to Sponsor for review at least sixty (60) days in advance of submission for publication or presentation to a publisher or other third party. Sponsor reserves the right to delete any Confidential Information or other proprietary information of Sponsor from the proposed publication or presentation.
- Publication restrictions are in place
Restriction type: OTHER