Trial Outcomes & Findings for Stenting of the Superficial Femoral and/or Proximal Popliteal Artery Project (NCT NCT01820637)
NCT ID: NCT01820637
Last Updated: 2019-03-22
Results Overview
Primary patency of target lesion at 9-months assessed by duplex ultrasound (DUS) as adjudicated by an independent core laboratory. Primary Patency: percentage (%) of lesions (target stented segments) that reach endpoint without a hemodynamically significant stenosis on DUS and without target lesion revascularization (TLR) or, bypass of the target lesion.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
57 participants
Primary outcome timeframe
9-months
Results posted on
2019-03-22
Participant Flow
There were 57 subjects enrolled at 14 investigative centers in Europe, Australia and New Zealand. The first subject was enrolled on 23 August 2013. Enrollment was completed on 03 March 2014, when the last subject was enrolled.
Participant milestones
| Measure |
Test Device Arm (DES SFA, ELUVIA™)
All patients in this arm were treated with the study device.
The Boston Scientific DES SFA Paclitaxel-Eluting Self-Expanding Stent System (DES SFA, ELUVIA™)
|
|---|---|
|
Overall Study
STARTED
|
57
|
|
Overall Study
COMPLETED
|
54
|
|
Overall Study
NOT COMPLETED
|
3
|
Reasons for withdrawal
| Measure |
Test Device Arm (DES SFA, ELUVIA™)
All patients in this arm were treated with the study device.
The Boston Scientific DES SFA Paclitaxel-Eluting Self-Expanding Stent System (DES SFA, ELUVIA™)
|
|---|---|
|
Overall Study
Death
|
2
|
|
Overall Study
Withdrawal by Subject
|
1
|
Baseline Characteristics
Stenting of the Superficial Femoral and/or Proximal Popliteal Artery Project
Baseline characteristics by cohort
| Measure |
Test Device Arm (DES SFA, ELUVIA™)
n=57 Participants
All patients in this arm were treated with the study device.
The Boston Scientific DES SFA Paclitaxel-Eluting Self-Expanding Stent System (DES SFA, ELUVIA™)
|
|---|---|
|
Age, Continuous
|
69.3 years
STANDARD_DEVIATION 9.3 • n=5 Participants
|
|
Sex: Female, Male
Female
|
10 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
47 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Caucasian
|
54 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Asian
|
1 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Other
|
2 Participants
n=5 Participants
|
|
Region of Enrollment
New Zealand
|
10 participants
n=5 Participants
|
|
Region of Enrollment
Austria
|
3 participants
n=5 Participants
|
|
Region of Enrollment
Belgium
|
19 participants
n=5 Participants
|
|
Region of Enrollment
Australia
|
4 participants
n=5 Participants
|
|
Region of Enrollment
Germany
|
21 participants
n=5 Participants
|
|
General Medical History
History of Smoking
|
50 Participants
n=5 Participants
|
|
General Medical History
Current Diabetes Mellitus
|
20 Participants
n=5 Participants
|
|
General Medical History
History of Hyperlipidemia requiring medication
|
36 Participants
n=5 Participants
|
|
General Medical History
History of Hypertension requiring medication
|
42 Participants
n=5 Participants
|
|
General Medical History
History of Chronic Obstructive Pulmonary Disease
|
6 Participants
n=5 Participants
|
|
General Medical History
History of Coronary Artery Disease (CAD)
|
22 Participants
n=5 Participants
|
|
General Medical History
History of Myocardial Infarction (MI)
|
9 Participants
n=5 Participants
|
|
General Medical History
History of Congestive Heart Failure (CHF)
|
3 Participants
n=5 Participants
|
|
General Medical History
History of Percutaneous Coronary Intervention(PCI)
|
11 Participants
n=5 Participants
|
|
General Medical History
History of Coronary Artery Bypass Graft (CABG)
|
8 Participants
n=5 Participants
|
|
General Medical History
Stable Angina
|
6 Participants
n=5 Participants
|
|
General Medical History
History of Transient Ischemic Attacks (TIA)
|
3 Participants
n=5 Participants
|
|
General Medical History
History of Cerebrovascular Accident (CVA)
|
5 Participants
n=5 Participants
|
|
General Medical History
History of Renal Insufficiency
|
5 Participants
n=5 Participants
|
|
General Medical History
History of Renal Percutaneous Intervention
|
1 Participants
n=5 Participants
|
|
General Medical History
History of Peripheral Vascular Surgery
|
3 Participants
n=5 Participants
|
|
General Medical History
History of Peripheral Endovascular Intervention
|
14 Participants
n=5 Participants
|
|
General Medical History
History of Claudication
|
51 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 9-monthsPopulation: 54 subjects were included in this analysis - one 9 month visit was completed too early, outside the protocol defined visit window, one subject withdrew consent at the 1 month follow-up visit and one subject did not complete the 9 month follow up visit due to site relocation.
Primary patency of target lesion at 9-months assessed by duplex ultrasound (DUS) as adjudicated by an independent core laboratory. Primary Patency: percentage (%) of lesions (target stented segments) that reach endpoint without a hemodynamically significant stenosis on DUS and without target lesion revascularization (TLR) or, bypass of the target lesion.
Outcome measures
| Measure |
Test Device Arm (DES SFA, ELUVIA™)
n=54 Lesions
All patients in this arm were treated with the study device. The Boston Scientific DES SFA Paclitaxel-Eluting Self-Expanding Stent System (DES SFA, ELUVIA™)
|
|---|---|
|
Primary Patency
|
94.4 percentage of lesions
Interval 86.3 to 98.5
|
OTHER_PRE_SPECIFIED outcome
Timeframe: 9 monthsPopulation: 55 subjects were included in this analysis - one subject withdrew consent at the 1 month follow-up visit and one subject did not complete the 9 month follow up visit due to site relocation.
The composite rate of Major Adverse Events (MAEs) is defined as all causes of death through 1 month, target limb major amputation through 9 months and/or target lesion revascularization through 9 months.
Outcome measures
| Measure |
Test Device Arm (DES SFA, ELUVIA™)
n=55 Participants
All patients in this arm were treated with the study device. The Boston Scientific DES SFA Paclitaxel-Eluting Self-Expanding Stent System (DES SFA, ELUVIA™)
|
|---|---|
|
Percentage of Participants With Composite of Major Adverse Events
Target Lesion Revascularization (TLR)
|
3.6 percentage of participants
Interval 0.4 to 12.5
|
|
Percentage of Participants With Composite of Major Adverse Events
9-Month MAE (Composite Endpoint)
|
3.6 percentage of participants
Interval 0.4 to 12.5
|
|
Percentage of Participants With Composite of Major Adverse Events
All Causes of Death at 1 month
|
0.0 percentage of participants
Interval 0.0 to 6.5
|
|
Percentage of Participants With Composite of Major Adverse Events
Target Limb Major Amputation
|
0.0 percentage of participants
Interval 0.0 to 6.5
|
Adverse Events
Test Device Arm (DES SFA, ELUVIA™)
Serious events: 34 serious events
Other events: 36 other events
Deaths: 2 deaths
Serious adverse events
| Measure |
Test Device Arm (DES SFA, ELUVIA™)
n=57 participants at risk
All patients in this arm were treated with the study device. The Boston Scientific DES SFA Paclitaxel-Eluting Self-Expanding Stent System (DES SFA, ELUVIA™)
|
|---|---|
|
Vascular disorders
Femoral artery stenosis
|
24.6%
14/57 • Number of events 21 • 3 years +/- 30 days visit window from the date of the index procedure.
|
|
Vascular disorders
Peripheral arterial occlusive disease
|
7.0%
4/57 • Number of events 6 • 3 years +/- 30 days visit window from the date of the index procedure.
|
|
Vascular disorders
Arterial thrombosis limb
|
5.3%
3/57 • Number of events 5 • 3 years +/- 30 days visit window from the date of the index procedure.
|
|
Vascular disorders
Arterial stenosis limb
|
5.3%
3/57 • Number of events 3 • 3 years +/- 30 days visit window from the date of the index procedure.
|
|
Vascular disorders
Peripheral ischaemia
|
1.8%
1/57 • Number of events 3 • 3 years +/- 30 days visit window from the date of the index procedure.
|
|
Vascular disorders
Femoral artery occlusion
|
3.5%
2/57 • Number of events 2 • 3 years +/- 30 days visit window from the date of the index procedure.
|
|
Vascular disorders
Intermittent claudication
|
3.5%
2/57 • Number of events 2 • 3 years +/- 30 days visit window from the date of the index procedure.
|
|
Vascular disorders
Arterial occlusive disease
|
1.8%
1/57 • Number of events 1 • 3 years +/- 30 days visit window from the date of the index procedure.
|
|
Vascular disorders
Arterial spasm
|
1.8%
1/57 • Number of events 1 • 3 years +/- 30 days visit window from the date of the index procedure.
|
|
Vascular disorders
Arteriosclerosis
|
1.8%
1/57 • Number of events 1 • 3 years +/- 30 days visit window from the date of the index procedure.
|
|
Vascular disorders
Arteriovenous fistula
|
1.8%
1/57 • Number of events 1 • 3 years +/- 30 days visit window from the date of the index procedure.
|
|
Vascular disorders
Iliac artery occlusion
|
1.8%
1/57 • Number of events 1 • 3 years +/- 30 days visit window from the date of the index procedure.
|
|
Vascular disorders
Iliac artery stenosis
|
1.8%
1/57 • Number of events 1 • 3 years +/- 30 days visit window from the date of the index procedure.
|
|
Vascular disorders
Peripheral artery aneurysm
|
1.8%
1/57 • Number of events 1 • 3 years +/- 30 days visit window from the date of the index procedure.
|
|
Vascular disorders
Venous stenosis
|
1.8%
1/57 • Number of events 1 • 3 years +/- 30 days visit window from the date of the index procedure.
|
|
Injury, poisoning and procedural complications
Pelvic fracture
|
1.8%
1/57 • Number of events 2 • 3 years +/- 30 days visit window from the date of the index procedure.
|
|
Injury, poisoning and procedural complications
Arterial injury
|
1.8%
1/57 • Number of events 1 • 3 years +/- 30 days visit window from the date of the index procedure.
|
|
Injury, poisoning and procedural complications
Contusion
|
1.8%
1/57 • Number of events 1 • 3 years +/- 30 days visit window from the date of the index procedure.
|
|
Injury, poisoning and procedural complications
Femoral neck fracture
|
1.8%
1/57 • Number of events 1 • 3 years +/- 30 days visit window from the date of the index procedure.
|
|
Injury, poisoning and procedural complications
Graft thrombosis
|
1.8%
1/57 • Number of events 1 • 3 years +/- 30 days visit window from the date of the index procedure.
|
|
Injury, poisoning and procedural complications
Humerus fracture
|
1.8%
1/57 • Number of events 1 • 3 years +/- 30 days visit window from the date of the index procedure.
|
|
Injury, poisoning and procedural complications
Joint injury
|
1.8%
1/57 • Number of events 1 • 3 years +/- 30 days visit window from the date of the index procedure.
|
|
Injury, poisoning and procedural complications
Vascular graft complication
|
1.8%
1/57 • Number of events 1 • 3 years +/- 30 days visit window from the date of the index procedure.
|
|
Cardiac disorders
Atrial fibrillation
|
3.5%
2/57 • Number of events 2 • 3 years +/- 30 days visit window from the date of the index procedure.
|
|
Cardiac disorders
Acute myocardial infarction
|
1.8%
1/57 • Number of events 1 • 3 years +/- 30 days visit window from the date of the index procedure.
|
|
Cardiac disorders
Bundle branch block left
|
1.8%
1/57 • Number of events 1 • 3 years +/- 30 days visit window from the date of the index procedure.
|
|
Cardiac disorders
Cardiogenic shock
|
1.8%
1/57 • Number of events 1 • 3 years +/- 30 days visit window from the date of the index procedure.
|
|
Cardiac disorders
Coronary artery stenosis
|
1.8%
1/57 • Number of events 1 • 3 years +/- 30 days visit window from the date of the index procedure.
|
|
Cardiac disorders
Extrasystoles
|
1.8%
1/57 • Number of events 1 • 3 years +/- 30 days visit window from the date of the index procedure.
|
|
Cardiac disorders
Myocardial infarction
|
1.8%
1/57 • Number of events 1 • 3 years +/- 30 days visit window from the date of the index procedure.
|
|
Infections and infestations
Bronchitis viral
|
1.8%
1/57 • Number of events 1 • 3 years +/- 30 days visit window from the date of the index procedure.
|
|
Infections and infestations
Empyema
|
1.8%
1/57 • Number of events 1 • 3 years +/- 30 days visit window from the date of the index procedure.
|
|
Infections and infestations
Gastroenteritis
|
1.8%
1/57 • Number of events 1 • 3 years +/- 30 days visit window from the date of the index procedure.
|
|
Infections and infestations
Infection
|
1.8%
1/57 • Number of events 1 • 3 years +/- 30 days visit window from the date of the index procedure.
|
|
Infections and infestations
Lung infection
|
1.8%
1/57 • Number of events 1 • 3 years +/- 30 days visit window from the date of the index procedure.
|
|
Infections and infestations
Pneumonia
|
1.8%
1/57 • Number of events 1 • 3 years +/- 30 days visit window from the date of the index procedure.
|
|
Infections and infestations
Sepsis
|
1.8%
1/57 • Number of events 1 • 3 years +/- 30 days visit window from the date of the index procedure.
|
|
Musculoskeletal and connective tissue disorders
Dupuytren's contracture
|
1.8%
1/57 • Number of events 1 • 3 years +/- 30 days visit window from the date of the index procedure.
|
|
Musculoskeletal and connective tissue disorders
Osteoarthritis
|
1.8%
1/57 • Number of events 1 • 3 years +/- 30 days visit window from the date of the index procedure.
|
|
Musculoskeletal and connective tissue disorders
Rheumatoid arthritis
|
1.8%
1/57 • Number of events 1 • 3 years +/- 30 days visit window from the date of the index procedure.
|
|
Musculoskeletal and connective tissue disorders
Rotator cuff syndrome
|
1.8%
1/57 • Number of events 1 • 3 years +/- 30 days visit window from the date of the index procedure.
|
|
Musculoskeletal and connective tissue disorders
Spinal column stenosis
|
1.8%
1/57 • Number of events 1 • 3 years +/- 30 days visit window from the date of the index procedure.
|
|
Musculoskeletal and connective tissue disorders
Tendon disorder
|
1.8%
1/57 • Number of events 1 • 3 years +/- 30 days visit window from the date of the index procedure.
|
|
Gastrointestinal disorders
Abdominal pain upper
|
1.8%
1/57 • Number of events 1 • 3 years +/- 30 days visit window from the date of the index procedure.
|
|
Gastrointestinal disorders
Abdominal wall haemorrhage
|
1.8%
1/57 • Number of events 1 • 3 years +/- 30 days visit window from the date of the index procedure.
|
|
Gastrointestinal disorders
Haemorrhoids
|
1.8%
1/57 • Number of events 1 • 3 years +/- 30 days visit window from the date of the index procedure.
|
|
Gastrointestinal disorders
Retroperitoneal haematoma
|
1.8%
1/57 • Number of events 1 • 3 years +/- 30 days visit window from the date of the index procedure.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Lung neoplasm malignant
|
1.8%
1/57 • Number of events 1 • 3 years +/- 30 days visit window from the date of the index procedure.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Metastatic squamous cell carcinoma
|
1.8%
1/57 • Number of events 1 • 3 years +/- 30 days visit window from the date of the index procedure.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Squamous cell carcinoma of skin
|
1.8%
1/57 • Number of events 1 • 3 years +/- 30 days visit window from the date of the index procedure.
|
|
Renal and urinary disorders
Renal artery occlusion
|
1.8%
1/57 • Number of events 1 • 3 years +/- 30 days visit window from the date of the index procedure.
|
|
Renal and urinary disorders
Renal failure
|
1.8%
1/57 • Number of events 1 • 3 years +/- 30 days visit window from the date of the index procedure.
|
|
Renal and urinary disorders
Renal failure acute
|
1.8%
1/57 • Number of events 1 • 3 years +/- 30 days visit window from the date of the index procedure.
|
|
General disorders
Cardiac death
|
1.8%
1/57 • Number of events 1 • 3 years +/- 30 days visit window from the date of the index procedure.
|
|
General disorders
Catheter site haematoma
|
1.8%
1/57 • Number of events 1 • 3 years +/- 30 days visit window from the date of the index procedure.
|
|
Hepatobiliary disorders
Biliary colic
|
1.8%
1/57 • Number of events 1 • 3 years +/- 30 days visit window from the date of the index procedure.
|
|
Hepatobiliary disorders
Cholangitis
|
1.8%
1/57 • Number of events 1 • 3 years +/- 30 days visit window from the date of the index procedure.
|
|
Nervous system disorders
Carotid artery stenosis
|
3.5%
2/57 • Number of events 2 • 3 years +/- 30 days visit window from the date of the index procedure.
|
|
Respiratory, thoracic and mediastinal disorders
Acute respiratory failure
|
1.8%
1/57 • Number of events 1 • 3 years +/- 30 days visit window from the date of the index procedure.
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory failure
|
1.8%
1/57 • Number of events 1 • 3 years +/- 30 days visit window from the date of the index procedure.
|
Other adverse events
| Measure |
Test Device Arm (DES SFA, ELUVIA™)
n=57 participants at risk
All patients in this arm were treated with the study device. The Boston Scientific DES SFA Paclitaxel-Eluting Self-Expanding Stent System (DES SFA, ELUVIA™)
|
|---|---|
|
Vascular disorders
Femoral arterial stenosis
|
15.8%
9/57 • Number of events 13 • 3 years +/- 30 days visit window from the date of the index procedure.
|
|
Vascular disorders
Femoral artery occlusion
|
5.3%
3/57 • Number of events 3 • 3 years +/- 30 days visit window from the date of the index procedure.
|
|
Vascular disorders
Iliac artery stenosis
|
3.5%
2/57 • Number of events 2 • 3 years +/- 30 days visit window from the date of the index procedure.
|
|
Vascular disorders
Arterial stenosis limb
|
1.8%
1/57 • Number of events 1 • 3 years +/- 30 days visit window from the date of the index procedure.
|
|
Vascular disorders
Arterial thrombosis limb
|
1.8%
1/57 • Number of events 1 • 3 years +/- 30 days visit window from the date of the index procedure.
|
|
Vascular disorders
Hypertension
|
1.8%
1/57 • Number of events 1 • 3 years +/- 30 days visit window from the date of the index procedure.
|
|
Vascular disorders
Intermittent claudication
|
1.8%
1/57 • Number of events 1 • 3 years +/- 30 days visit window from the date of the index procedure.
|
|
Vascular disorders
Lymphoedema
|
1.8%
1/57 • Number of events 1 • 3 years +/- 30 days visit window from the date of the index procedure.
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
8.8%
5/57 • Number of events 5 • 3 years +/- 30 days visit window from the date of the index procedure.
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal pain
|
5.3%
3/57 • Number of events 3 • 3 years +/- 30 days visit window from the date of the index procedure.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
1.8%
1/57 • Number of events 1 • 3 years +/- 30 days visit window from the date of the index procedure.
|
|
Musculoskeletal and connective tissue disorders
Bone pain
|
1.8%
1/57 • Number of events 1 • 3 years +/- 30 days visit window from the date of the index procedure.
|
|
Musculoskeletal and connective tissue disorders
Bursitis
|
1.8%
1/57 • Number of events 1 • 3 years +/- 30 days visit window from the date of the index procedure.
|
|
Musculoskeletal and connective tissue disorders
Gouty arthritis
|
1.8%
1/57 • Number of events 1 • 3 years +/- 30 days visit window from the date of the index procedure.
|
|
Musculoskeletal and connective tissue disorders
Groin pain
|
1.8%
1/57 • Number of events 1 • 3 years +/- 30 days visit window from the date of the index procedure.
|
|
Musculoskeletal and connective tissue disorders
Joint swelling
|
1.8%
1/57 • Number of events 1 • 3 years +/- 30 days visit window from the date of the index procedure.
|
|
Musculoskeletal and connective tissue disorders
Muscle haemorrhage
|
1.8%
1/57 • Number of events 1 • 3 years +/- 30 days visit window from the date of the index procedure.
|
|
Musculoskeletal and connective tissue disorders
Muscle spasms
|
1.8%
1/57 • Number of events 1 • 3 years +/- 30 days visit window from the date of the index procedure.
|
|
Musculoskeletal and connective tissue disorders
Osteoarthritis
|
1.8%
1/57 • Number of events 1 • 3 years +/- 30 days visit window from the date of the index procedure.
|
|
Musculoskeletal and connective tissue disorders
Rotator cuff syndrome
|
1.8%
1/57 • Number of events 1 • 3 years +/- 30 days visit window from the date of the index procedure.
|
|
General disorders
Adverse drug reaction
|
5.3%
3/57 • Number of events 3 • 3 years +/- 30 days visit window from the date of the index procedure.
|
|
General disorders
Catheter site haematoma
|
3.5%
2/57 • Number of events 3 • 3 years +/- 30 days visit window from the date of the index procedure.
|
|
General disorders
Catheter site haemorrhage
|
5.3%
3/57 • Number of events 3 • 3 years +/- 30 days visit window from the date of the index procedure.
|
|
General disorders
Oedema peripheral
|
5.3%
3/57 • Number of events 3 • 3 years +/- 30 days visit window from the date of the index procedure.
|
|
General disorders
Feeling cold
|
1.8%
1/57 • Number of events 1 • 3 years +/- 30 days visit window from the date of the index procedure.
|
|
General disorders
General symptom
|
1.8%
1/57 • Number of events 1 • 3 years +/- 30 days visit window from the date of the index procedure.
|
|
General disorders
Oedema
|
1.8%
1/57 • Number of events 1 • 3 years +/- 30 days visit window from the date of the index procedure.
|
|
Eye disorders
Cataract
|
1.8%
1/57 • Number of events 2 • 3 years +/- 30 days visit window from the date of the index procedure.
|
|
Eye disorders
Dry eye
|
3.5%
2/57 • Number of events 2 • 3 years +/- 30 days visit window from the date of the index procedure.
|
|
Eye disorders
Abnormal sensation in eye
|
1.8%
1/57 • Number of events 1 • 3 years +/- 30 days visit window from the date of the index procedure.
|
|
Eye disorders
Eye pain
|
1.8%
1/57 • Number of events 1 • 3 years +/- 30 days visit window from the date of the index procedure.
|
|
Eye disorders
Hyphaema
|
1.8%
1/57 • Number of events 1 • 3 years +/- 30 days visit window from the date of the index procedure.
|
|
Eye disorders
Retinal detachment
|
1.8%
1/57 • Number of events 1 • 3 years +/- 30 days visit window from the date of the index procedure.
|
|
Gastrointestinal disorders
Tooth disorder
|
1.8%
1/57 • Number of events 2 • 3 years +/- 30 days visit window from the date of the index procedure.
|
|
Gastrointestinal disorders
Abdominal wall haematoma
|
1.8%
1/57 • Number of events 1 • 3 years +/- 30 days visit window from the date of the index procedure.
|
|
Gastrointestinal disorders
Constipation
|
1.8%
1/57 • Number of events 1 • 3 years +/- 30 days visit window from the date of the index procedure.
|
|
Gastrointestinal disorders
Diarrhoea
|
1.8%
1/57 • Number of events 1 • 3 years +/- 30 days visit window from the date of the index procedure.
|
|
Gastrointestinal disorders
Hiatus hernia
|
1.8%
1/57 • Number of events 1 • 3 years +/- 30 days visit window from the date of the index procedure.
|
|
Gastrointestinal disorders
Vomiting
|
1.8%
1/57 • Number of events 1 • 3 years +/- 30 days visit window from the date of the index procedure.
|
|
Infections and infestations
Cellulitis
|
1.8%
1/57 • Number of events 1 • 3 years +/- 30 days visit window from the date of the index procedure.
|
|
Infections and infestations
Fungal infection
|
1.8%
1/57 • Number of events 1 • 3 years +/- 30 days visit window from the date of the index procedure.
|
|
Infections and infestations
Lower respiratory tract infection
|
1.8%
1/57 • Number of events 1 • 3 years +/- 30 days visit window from the date of the index procedure.
|
|
Infections and infestations
Pneumonia
|
1.8%
1/57 • Number of events 1 • 3 years +/- 30 days visit window from the date of the index procedure.
|
|
Infections and infestations
Urinary tract infection
|
1.8%
1/57 • Number of events 1 • 3 years +/- 30 days visit window from the date of the index procedure.
|
|
Injury, poisoning and procedural complications
Fibula fracture
|
1.8%
1/57 • Number of events 1 • 3 years +/- 30 days visit window from the date of the index procedure.
|
|
Injury, poisoning and procedural complications
Joint sprain
|
1.8%
1/57 • Number of events 1 • 3 years +/- 30 days visit window from the date of the index procedure.
|
|
Injury, poisoning and procedural complications
Nail injury
|
1.8%
1/57 • Number of events 1 • 3 years +/- 30 days visit window from the date of the index procedure.
|
|
Injury, poisoning and procedural complications
Post procedural oedema
|
1.8%
1/57 • Number of events 1 • 3 years +/- 30 days visit window from the date of the index procedure.
|
|
Injury, poisoning and procedural complications
Tendon injury
|
1.8%
1/57 • Number of events 1 • 3 years +/- 30 days visit window from the date of the index procedure.
|
|
Nervous system disorders
Hypoaesthesia
|
3.5%
2/57 • Number of events 2 • 3 years +/- 30 days visit window from the date of the index procedure.
|
|
Nervous system disorders
Paraesthesia
|
3.5%
2/57 • Number of events 2 • 3 years +/- 30 days visit window from the date of the index procedure.
|
|
Nervous system disorders
Dementia
|
1.8%
1/57 • Number of events 1 • 3 years +/- 30 days visit window from the date of the index procedure.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
3.5%
2/57 • Number of events 2 • 3 years +/- 30 days visit window from the date of the index procedure.
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
1.8%
1/57 • Number of events 1 • 3 years +/- 30 days visit window from the date of the index procedure.
|
|
Cardiac disorders
Atrioventricular block first degree
|
1.8%
1/57 • Number of events 1 • 3 years +/- 30 days visit window from the date of the index procedure.
|
|
Cardiac disorders
Mitral valve incompetence
|
1.8%
1/57 • Number of events 1 • 3 years +/- 30 days visit window from the date of the index procedure.
|
|
Investigations
Intraocular pressure increased
|
1.8%
1/57 • Number of events 1 • 3 years +/- 30 days visit window from the date of the index procedure.
|
|
Investigations
Weight decreased
|
1.8%
1/57 • Number of events 1 • 3 years +/- 30 days visit window from the date of the index procedure.
|
|
Skin and subcutaneous tissue disorders
Dermal cyst
|
1.8%
1/57 • Number of events 1 • 3 years +/- 30 days visit window from the date of the index procedure.
|
|
Skin and subcutaneous tissue disorders
Hyperkeratosis
|
1.8%
1/57 • Number of events 1 • 3 years +/- 30 days visit window from the date of the index procedure.
|
|
Ear and labyrinth disorders
Deafness bilateral
|
1.8%
1/57 • Number of events 1 • 3 years +/- 30 days visit window from the date of the index procedure.
|
|
Hepatobiliary disorders
Biliary colic
|
1.8%
1/57 • Number of events 1 • 3 years +/- 30 days visit window from the date of the index procedure.
|
|
Renal and urinary disorders
Haematuria
|
1.8%
1/57 • Number of events 1 • 3 years +/- 30 days visit window from the date of the index procedure.
|
|
Reproductive system and breast disorders
Prostatism
|
1.8%
1/57 • Number of events 1 • 3 years +/- 30 days visit window from the date of the index procedure.
|
|
Gastrointestinal disorders
Gastritis
|
1.8%
1/57 • Number of events 1 • 3 years +/- 30 days visit window from the date of the index procedure.
|
Additional Information
Lieve Cornelis, Clinical Trial Manager
Boston Scientific
Phone: + 32 476-840-183
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