Trial Outcomes & Findings for Tack Optimized Balloon Angioplasty Study of the Tack Endovascular System™ in Femoropoliteal Arteries (NCT NCT02522884)
NCT ID: NCT02522884
Last Updated: 2021-04-27
Results Overview
Primary patency defined as freedom from Clinical Events Committee (CEC) adjudicated clinically-driven target lesion revascularization (CD-TLR) and freedom from core lab adjudicated duplex ultrasound derived binary restenosis at 12 months (defined as peak systolic velocity ratio (PSVR) \>2.5)
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
213 participants
Primary outcome timeframe
12 Months
Results posted on
2021-04-27
Participant Flow
Participant milestones
| Measure |
Tack Endovascular System (6F)
Use of the Tack Endovascular System (6F) in the superficial femoral and proximal popliteal arteries ranging in diameter from 2.5mm to 6.0mm for the repair of post percutaneous transluminal balloon angioplasty (PTA) dissection(s).
|
|---|---|
|
Overall Study
STARTED
|
213
|
|
Overall Study
COMPLETED
|
195
|
|
Overall Study
NOT COMPLETED
|
18
|
Reasons for withdrawal
| Measure |
Tack Endovascular System (6F)
Use of the Tack Endovascular System (6F) in the superficial femoral and proximal popliteal arteries ranging in diameter from 2.5mm to 6.0mm for the repair of post percutaneous transluminal balloon angioplasty (PTA) dissection(s).
|
|---|---|
|
Overall Study
Withdrawal by Subject
|
6
|
|
Overall Study
Death
|
3
|
|
Overall Study
Missed 12-month Follow-up
|
9
|
Baseline Characteristics
BMI is missing for one subject.
Baseline characteristics by cohort
| Measure |
Tack Endovascular System (6F)
n=213 Participants
Use of the Tack Endovascular System (6F) in the superficial femoral and proximal popliteal arteries ranging in diameter from 2.5mm to 6.0mm for the repair of post percutaneous transluminal balloon angioplasty (PTA) dissection(s).
|
|---|---|
|
Age, Continuous
|
68.2 years
STANDARD_DEVIATION 9.1 • n=213 Participants
|
|
Sex: Female, Male
Female
|
62 Participants
n=213 Participants
|
|
Sex: Female, Male
Male
|
151 Participants
n=213 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
17 Participants
n=213 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
195 Participants
n=213 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
1 Participants
n=213 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=213 Participants
|
|
Race (NIH/OMB)
Asian
|
3 Participants
n=213 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=213 Participants
|
|
Race (NIH/OMB)
Black or African American
|
29 Participants
n=213 Participants
|
|
Race (NIH/OMB)
White
|
181 Participants
n=213 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=213 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=213 Participants
|
|
Region of Enrollment
Austria
|
40 participants
n=213 Participants
|
|
Region of Enrollment
United States
|
173 participants
n=213 Participants
|
|
BMI
|
29.3 Kg/m^2
STANDARD_DEVIATION 6.1 • n=212 Participants • BMI is missing for one subject.
|
|
BMI less than or equal to 30
|
83 Participants
n=212 Participants • BMI is missing for one subject.
|
|
Ankle-brachial index (ABI) in treated leg
|
0.76 ratio
STANDARD_DEVIATION 0.21 • n=200 Participants • ABI information is missing for some subjects
|
|
ABI in contralateral limb
|
0.90 ratio
STANDARD_DEVIATION 0.18 • n=190 Participants • ABI in contralateral limb is missing for some subjects
|
|
Rutherford Classification
2
|
68 participants
n=213 Participants
|
|
Rutherford Classification
3
|
136 participants
n=213 Participants
|
|
Rutherford Classification
4
|
9 participants
n=213 Participants
|
PRIMARY outcome
Timeframe: 12 MonthsPopulation: ITT population with available data for this assessment.
Primary patency defined as freedom from Clinical Events Committee (CEC) adjudicated clinically-driven target lesion revascularization (CD-TLR) and freedom from core lab adjudicated duplex ultrasound derived binary restenosis at 12 months (defined as peak systolic velocity ratio (PSVR) \>2.5)
Outcome measures
| Measure |
Tack Endovascular System (6F)
n=183 Participants
Use of the study device in the superficial femoral and/or proximal popliteal arteries ranging in diameter from 2.5mm to 6.0mm for the repair of post percutaneous transluminal balloon angioplasty (PTA) dissection(s)
|
|---|---|
|
Efficacy - Number of Subjects That Met Primary Patency Criteria at 12 Months
|
120 Participants
|
PRIMARY outcome
Timeframe: 30 DaysPopulation: ITT population with available data for this assessment.
Freedom from the occurrence of any new-onset major adverse event(s) (MAEs) defined as index limb amputation (above the ankle), CEC adjudicated clinically-driven target lesion revascularization (CD-TLR), or all-cause death at 30 days.
Outcome measures
| Measure |
Tack Endovascular System (6F)
n=212 Participants
Use of the study device in the superficial femoral and/or proximal popliteal arteries ranging in diameter from 2.5mm to 6.0mm for the repair of post percutaneous transluminal balloon angioplasty (PTA) dissection(s)
|
|---|---|
|
Safety - Number of Subjects That Met the Primary Safety Criteria of Freedom From Major Adverse Events at 30 Days
|
212 Participants
|
Adverse Events
Tack Endovascular System (6F)
Serious events: 115 serious events
Other events: 139 other events
Deaths: 4 deaths
Serious adverse events
| Measure |
Tack Endovascular System (6F)
n=213 participants at risk
Use of the Tack Endovascular System (6F) in the superficial femoral and proximal popliteal arteries ranging in diameter from 2.5mm to 6.0mm for the repair of post percutaneous transluminal balloon angioplasty (PTA) dissection(s).
|
|---|---|
|
Cardiac disorders
Coronary artery disease
|
0.94%
2/213 • Number of events 2 • Summary of adverse events that have been reported through 390 days
|
|
Cardiac disorders
Non ST segment elevation acute coronary syndrome
|
1.4%
3/213 • Number of events 4 • Summary of adverse events that have been reported through 390 days
|
|
Cardiac disorders
Non ST segment elevation myocardial infarction
|
0.94%
2/213 • Number of events 2 • Summary of adverse events that have been reported through 390 days
|
|
Cardiac disorders
Non STEMI
|
0.47%
1/213 • Number of events 1 • Summary of adverse events that have been reported through 390 days
|
|
Cardiac disorders
Persistent atrial fibrillation
|
0.47%
1/213 • Number of events 1 • Summary of adverse events that have been reported through 390 days
|
|
Cardiac disorders
Right coronary artery stenosis
|
0.47%
1/213 • Number of events 1 • Summary of adverse events that have been reported through 390 days
|
|
Cardiac disorders
Sick sinus syndrome
|
0.94%
2/213 • Number of events 2 • Summary of adverse events that have been reported through 390 days
|
|
Cardiac disorders
Unstable angina
|
1.9%
4/213 • Number of events 7 • Summary of adverse events that have been reported through 390 days
|
|
Cardiac disorders
Ventricular arrhythmia
|
0.47%
1/213 • Number of events 1 • Summary of adverse events that have been reported through 390 days
|
|
Cardiac disorders
Ventricular tachycardia
|
0.47%
1/213 • Number of events 3 • Summary of adverse events that have been reported through 390 days
|
|
Cardiac disorders
Wenckebach
|
0.47%
1/213 • Number of events 1 • Summary of adverse events that have been reported through 390 days
|
|
Eye disorders
Cataract
|
0.94%
2/213 • Number of events 2 • Summary of adverse events that have been reported through 390 days
|
|
Eye disorders
Double vision
|
0.47%
1/213 • Number of events 1 • Summary of adverse events that have been reported through 390 days
|
|
Eye disorders
Retinal detachment
|
0.47%
1/213 • Number of events 1 • Summary of adverse events that have been reported through 390 days
|
|
Eye disorders
Visual impairment
|
0.47%
1/213 • Number of events 1 • Summary of adverse events that have been reported through 390 days
|
|
Gastrointestinal disorders
Acute pancreatitis
|
0.47%
1/213 • Number of events 1 • Summary of adverse events that have been reported through 390 days
|
|
Gastrointestinal disorders
Diarrhea
|
0.47%
1/213 • Number of events 1 • Summary of adverse events that have been reported through 390 days
|
|
Gastrointestinal disorders
Diarrhea recurrent
|
0.47%
1/213 • Number of events 1 • Summary of adverse events that have been reported through 390 days
|
|
Gastrointestinal disorders
Duodenal ulcer
|
0.47%
1/213 • Number of events 1 • Summary of adverse events that have been reported through 390 days
|
|
Gastrointestinal disorders
Esophageal varices
|
0.47%
1/213 • Number of events 1 • Summary of adverse events that have been reported through 390 days
|
|
Gastrointestinal disorders
Gastric perforation
|
0.47%
1/213 • Number of events 1 • Summary of adverse events that have been reported through 390 days
|
|
Gastrointestinal disorders
Gastroparesis
|
0.47%
1/213 • Number of events 1 • Summary of adverse events that have been reported through 390 days
|
|
Gastrointestinal disorders
Right inguinal hernia
|
0.47%
1/213 • Number of events 1 • Summary of adverse events that have been reported through 390 days
|
|
Gastrointestinal disorders
Upper gastrointestinal bleeding
|
0.94%
2/213 • Number of events 2 • Summary of adverse events that have been reported through 390 days
|
|
General disorders
Chest pain
|
1.9%
4/213 • Number of events 5 • Summary of adverse events that have been reported through 390 days
|
|
General disorders
Chest pressure
|
0.47%
1/213 • Number of events 1 • Summary of adverse events that have been reported through 390 days
|
|
General disorders
Edema
|
0.47%
1/213 • Number of events 1 • Summary of adverse events that have been reported through 390 days
|
|
General disorders
Medical device site thrombosis
|
0.94%
2/213 • Number of events 2 • Summary of adverse events that have been reported through 390 days
|
|
Gastrointestinal disorders
Hernia abdominal wall
|
0.47%
1/213 • Number of events 1 • Summary of adverse events that have been reported through 390 days
|
|
Gastrointestinal disorders
Pain epigastric
|
0.47%
1/213 • Number of events 1 • Summary of adverse events that have been reported through 390 days
|
|
Gastrointestinal disorders
Rectal bleeding
|
0.47%
1/213 • Number of events 1 • Summary of adverse events that have been reported through 390 days
|
|
Blood and lymphatic system disorders
Anemia
|
0.47%
1/213 • Number of events 1 • Summary of adverse events that have been reported through 390 days
|
|
Cardiac disorders
Acute coronary syndrome
|
0.47%
1/213 • Number of events 1 • Summary of adverse events that have been reported through 390 days
|
|
Blood and lymphatic system disorders
Anemia aggravated
|
0.47%
1/213 • Number of events 1 • Summary of adverse events that have been reported through 390 days
|
|
Cardiac disorders
Angina pectoris
|
1.4%
3/213 • Number of events 3 • Summary of adverse events that have been reported through 390 days
|
|
Cardiac disorders
Aortic valve stenosis
|
0.47%
1/213 • Number of events 1 • Summary of adverse events that have been reported through 390 days
|
|
Cardiac disorders
Atrial fibrillation
|
0.94%
2/213 • Number of events 2 • Summary of adverse events that have been reported through 390 days
|
|
Cardiac disorders
Atrial fibrillation with rapid ventricular response
|
0.47%
1/213 • Number of events 1 • Summary of adverse events that have been reported through 390 days
|
|
Cardiac disorders
Atrial flutter
|
0.94%
2/213 • Number of events 2 • Summary of adverse events that have been reported through 390 days
|
|
Cardiac disorders
Cardiopulmonary arrest
|
0.47%
1/213 • Number of events 1 • Summary of adverse events that have been reported through 390 days
|
|
Cardiac disorders
Congestive cardiac failure aggravated
|
0.47%
1/213 • Number of events 1 • Summary of adverse events that have been reported through 390 days
|
|
General disorders
Pain worsened
|
0.47%
1/213 • Number of events 1 • Summary of adverse events that have been reported through 390 days
|
|
General disorders
Peripheral edema
|
0.47%
1/213 • Number of events 1 • Summary of adverse events that have been reported through 390 days
|
|
General disorders
Swelling of feet
|
0.47%
1/213 • Number of events 1 • Summary of adverse events that have been reported through 390 days
|
|
General disorders
Swelling of legs
|
0.47%
1/213 • Number of events 1 • Summary of adverse events that have been reported through 390 days
|
|
General disorders
Weakness
|
0.47%
1/213 • Number of events 1 • Summary of adverse events that have been reported through 390 days
|
|
Hepatobiliary disorders
Acute cholecystitis
|
0.47%
1/213 • Number of events 1 • Summary of adverse events that have been reported through 390 days
|
|
Hepatobiliary disorders
Gallbladder sludge
|
0.47%
1/213 • Number of events 1 • Summary of adverse events that have been reported through 390 days
|
|
Immune system disorders
Allergic reaction
|
0.47%
1/213 • Number of events 1 • Summary of adverse events that have been reported through 390 days
|
|
Immune system disorders
Anaphylaxis
|
0.47%
1/213 • Number of events 1 • Summary of adverse events that have been reported through 390 days
|
|
Infections and infestations
Acute bronchitis
|
0.47%
1/213 • Number of events 1 • Summary of adverse events that have been reported through 390 days
|
|
Infections and infestations
Acute diverticulitis
|
0.47%
1/213 • Number of events 1 • Summary of adverse events that have been reported through 390 days
|
|
Infections and infestations
Acute osteomyelitis
|
0.47%
1/213 • Number of events 1 • Summary of adverse events that have been reported through 390 days
|
|
Infections and infestations
Cellulitis of toe
|
0.47%
1/213 • Number of events 1 • Summary of adverse events that have been reported through 390 days
|
|
Infections and infestations
Diarrhea, Clostridium difficile
|
0.47%
1/213 • Number of events 1 • Summary of adverse events that have been reported through 390 days
|
|
Infections and infestations
Diverticulitis
|
0.47%
1/213 • Number of events 1 • Summary of adverse events that have been reported through 390 days
|
|
Infections and infestations
Influenza B virus infection
|
0.47%
1/213 • Number of events 1 • Summary of adverse events that have been reported through 390 days
|
|
Infections and infestations
Osteomyelitis
|
0.47%
1/213 • Number of events 1 • Summary of adverse events that have been reported through 390 days
|
|
Infections and infestations
Osteomyelitis acute
|
0.47%
1/213 • Number of events 1 • Summary of adverse events that have been reported through 390 days
|
|
Infections and infestations
Pneumonia, organism unspecified
|
2.3%
5/213 • Number of events 5 • Summary of adverse events that have been reported through 390 days
|
|
Infections and infestations
Pyelonephritis
|
0.47%
1/213 • Number of events 1 • Summary of adverse events that have been reported through 390 days
|
|
Infections and infestations
Sepsis
|
0.47%
1/213 • Number of events 1 • Summary of adverse events that have been reported through 390 days
|
|
Infections and infestations
Urinary tract infection, site not specified
|
0.47%
1/213 • Number of events 1 • Summary of adverse events that have been reported through 390 days
|
|
Injury, poisoning and procedural complications
Ankle fracture
|
0.47%
1/213 • Number of events 1 • Summary of adverse events that have been reported through 390 days
|
|
Injury, poisoning and procedural complications
Nausea postoperative
|
0.47%
1/213 • Number of events 1 • Summary of adverse events that have been reported through 390 days
|
|
Injury, poisoning and procedural complications
Peripheral artery restenosis
|
8.0%
17/213 • Number of events 20 • Summary of adverse events that have been reported through 390 days
|
|
Injury, poisoning and procedural complications
Post embolization syndrome
|
1.4%
3/213 • Number of events 3 • Summary of adverse events that have been reported through 390 days
|
|
Injury, poisoning and procedural complications
Post procedural hematoma
|
0.94%
2/213 • Number of events 2 • Summary of adverse events that have been reported through 390 days
|
|
Injury, poisoning and procedural complications
Subdural hematoma
|
0.47%
1/213 • Number of events 1 • Summary of adverse events that have been reported through 390 days
|
|
Injury, poisoning and procedural complications
Vascular pseudoaneurysm ruptured
|
0.47%
1/213 • Number of events 1 • Summary of adverse events that have been reported through 390 days
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
0.47%
1/213 • Number of events 1 • Summary of adverse events that have been reported through 390 days
|
|
Musculoskeletal and connective tissue disorders
Cervical disc herniation
|
0.47%
1/213 • Number of events 1 • Summary of adverse events that have been reported through 390 days
|
|
Musculoskeletal and connective tissue disorders
Cervical pain
|
0.47%
1/213 • Number of events 1 • Summary of adverse events that have been reported through 390 days
|
|
Musculoskeletal and connective tissue disorders
Ganglion cyst
|
0.47%
1/213 • Number of events 1 • Summary of adverse events that have been reported through 390 days
|
|
Musculoskeletal and connective tissue disorders
Groin discomfort
|
0.47%
1/213 • Number of events 1 • Summary of adverse events that have been reported through 390 days
|
|
Musculoskeletal and connective tissue disorders
Knee pain
|
0.47%
1/213 • Number of events 1 • Summary of adverse events that have been reported through 390 days
|
|
Musculoskeletal and connective tissue disorders
Lumbar spinal stenosis
|
0.47%
1/213 • Number of events 1 • Summary of adverse events that have been reported through 390 days
|
|
Musculoskeletal and connective tissue disorders
Osteoarthritis
|
0.47%
1/213 • Number of events 1 • Summary of adverse events that have been reported through 390 days
|
|
Musculoskeletal and connective tissue disorders
Osteoarthritis knee
|
0.47%
1/213 • Number of events 1 • Summary of adverse events that have been reported through 390 days
|
|
Musculoskeletal and connective tissue disorders
Spinal stenosis of lumbar region
|
0.47%
1/213 • Number of events 1 • Summary of adverse events that have been reported through 390 days
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Glomus tympanicum tumor
|
0.47%
1/213 • Number of events 1 • Summary of adverse events that have been reported through 390 days
|
|
Nervous system disorders
Carotid artery disease
|
0.47%
1/213 • Number of events 1 • Summary of adverse events that have been reported through 390 days
|
|
Nervous system disorders
Carotid artery occlusion
|
0.47%
1/213 • Number of events 1 • Summary of adverse events that have been reported through 390 days
|
|
Nervous system disorders
Carotid artery stenosis
|
1.4%
3/213 • Number of events 4 • Summary of adverse events that have been reported through 390 days
|
|
Nervous system disorders
Cerebrovascular accident
|
0.47%
1/213 • Number of events 1 • Summary of adverse events that have been reported through 390 days
|
|
Nervous system disorders
Cervicobrachial syndrome
|
0.47%
1/213 • Number of events 1 • Summary of adverse events that have been reported through 390 days
|
|
Nervous system disorders
Epilepsy
|
0.47%
1/213 • Number of events 1 • Summary of adverse events that have been reported through 390 days
|
|
Nervous system disorders
Ischemia cerebrovascular
|
0.47%
1/213 • Number of events 1 • Summary of adverse events that have been reported through 390 days
|
|
Nervous system disorders
Lumboischialgia
|
0.47%
1/213 • Number of events 1 • Summary of adverse events that have been reported through 390 days
|
|
Nervous system disorders
Syncope
|
0.47%
1/213 • Number of events 1 • Summary of adverse events that have been reported through 390 days
|
|
Renal and urinary disorders
Acute kidney injury
|
0.47%
1/213 • Number of events 1 • Summary of adverse events that have been reported through 390 days
|
|
Renal and urinary disorders
Hematuria
|
0.47%
1/213 • Number of events 1 • Summary of adverse events that have been reported through 390 days
|
|
Renal and urinary disorders
Neurogenic bladder
|
0.47%
1/213 • Number of events 1 • Summary of adverse events that have been reported through 390 days
|
|
Renal and urinary disorders
Stone urinary bladder
|
0.47%
1/213 • Number of events 1 • Summary of adverse events that have been reported through 390 days
|
|
Respiratory, thoracic and mediastinal disorders
COPD
|
0.47%
1/213 • Number of events 1 • Summary of adverse events that have been reported through 390 days
|
|
Respiratory, thoracic and mediastinal disorders
COPD exacerbation
|
0.94%
2/213 • Number of events 2 • Summary of adverse events that have been reported through 390 days
|
|
Respiratory, thoracic and mediastinal disorders
Chronic obstructive lung disease
|
0.47%
1/213 • Number of events 1 • Summary of adverse events that have been reported through 390 days
|
|
Respiratory, thoracic and mediastinal disorders
Hemothorax
|
0.47%
1/213 • Number of events 1 • Summary of adverse events that have been reported through 390 days
|
|
Respiratory, thoracic and mediastinal disorders
Lung edema
|
0.47%
1/213 • Number of events 1 • Summary of adverse events that have been reported through 390 days
|
|
Respiratory, thoracic and mediastinal disorders
Lung mass
|
0.47%
1/213 • Number of events 1 • Summary of adverse events that have been reported through 390 days
|
|
Respiratory, thoracic and mediastinal disorders
Shortness of breath
|
0.47%
1/213 • Number of events 1 • Summary of adverse events that have been reported through 390 days
|
|
Skin and subcutaneous tissue disorders
Skin ulceration
|
0.47%
1/213 • Number of events 1 • Summary of adverse events that have been reported through 390 days
|
|
Vascular disorders
Accelerated hypertension
|
0.47%
1/213 • Number of events 1 • Summary of adverse events that have been reported through 390 days
|
|
Vascular disorders
Arteriovenous fistula, acquired
|
0.47%
1/213 • Number of events 1 • Summary of adverse events that have been reported through 390 days
|
|
Vascular disorders
Claudication
|
10.8%
23/213 • Number of events 31 • Summary of adverse events that have been reported through 390 days
|
|
Vascular disorders
Critical limb ischemia
|
1.9%
4/213 • Number of events 4 • Summary of adverse events that have been reported through 390 days
|
|
Vascular disorders
Femoral artery occlusion
|
1.4%
3/213 • Number of events 3 • Summary of adverse events that have been reported through 390 days
|
|
Vascular disorders
Femoral artery stenosis
|
0.47%
1/213 • Number of events 1 • Summary of adverse events that have been reported through 390 days
|
|
Vascular disorders
Hypertensive crisis
|
0.47%
1/213 • Number of events 1 • Summary of adverse events that have been reported through 390 days
|
|
Vascular disorders
Iliac artery stenosis
|
0.47%
1/213 • Number of events 1 • Summary of adverse events that have been reported through 390 days
|
|
Vascular disorders
Melena
|
0.47%
1/213 • Number of events 1 • Summary of adverse events that have been reported through 390 days
|
|
Vascular disorders
Peripheral arterial disease
|
4.2%
9/213 • Number of events 9 • Summary of adverse events that have been reported through 390 days
|
|
Vascular disorders
Peripheral artery dissection
|
0.94%
2/213 • Number of events 2 • Summary of adverse events that have been reported through 390 days
|
|
Vascular disorders
Peripheral artery occlusion
|
0.47%
1/213 • Number of events 1 • Summary of adverse events that have been reported through 390 days
|
|
Vascular disorders
Peripheral artery stenosis
|
0.47%
1/213 • Number of events 1 • Summary of adverse events that have been reported through 390 days
|
|
Vascular disorders
Peripheral ischaemia
|
0.47%
1/213 • Number of events 1 • Summary of adverse events that have been reported through 390 days
|
|
Vascular disorders
Peripheral vascular disease
|
4.2%
9/213 • Number of events 11 • Summary of adverse events that have been reported through 390 days
|
|
Vascular disorders
Popliteal arterial stenosis
|
0.47%
1/213 • Number of events 1 • Summary of adverse events that have been reported through 390 days
|
|
Vascular disorders
Popliteal stenosis
|
0.47%
1/213 • Number of events 1 • Summary of adverse events that have been reported through 390 days
|
|
Vascular disorders
Superficial femoral arterial stenosis
|
0.47%
1/213 • Number of events 1 • Summary of adverse events that have been reported through 390 days
|
|
Vascular disorders
Thrombosis of leg deep venous
|
0.47%
1/213 • Number of events 1 • Summary of adverse events that have been reported through 390 days
|
|
Vascular disorders
Uncontrolled hypertension
|
0.47%
1/213 • Number of events 1 • Summary of adverse events that have been reported through 390 days
|
|
Cardiac disorders
Coronary artery stenosis
|
1.4%
3/213 • Number of events 3 • Summary of adverse events that have been reported through 390 days
|
Other adverse events
| Measure |
Tack Endovascular System (6F)
n=213 participants at risk
Use of the Tack Endovascular System (6F) in the superficial femoral and proximal popliteal arteries ranging in diameter from 2.5mm to 6.0mm for the repair of post percutaneous transluminal balloon angioplasty (PTA) dissection(s).
|
|---|---|
|
Blood and lymphatic system disorders
Anemia
|
0.47%
1/213 • Number of events 1 • Summary of adverse events that have been reported through 390 days
|
|
Blood and lymphatic system disorders
Anemia aggravated
|
0.47%
1/213 • Number of events 1 • Summary of adverse events that have been reported through 390 days
|
|
Blood and lymphatic system disorders
Anemia iron deficiency
|
0.47%
1/213 • Number of events 1 • Summary of adverse events that have been reported through 390 days
|
|
Blood and lymphatic system disorders
Anemia post chemotherapy
|
0.47%
1/213 • Number of events 1 • Summary of adverse events that have been reported through 390 days
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
0.47%
1/213 • Number of events 1 • Summary of adverse events that have been reported through 390 days
|
|
Cardiac disorders
Acute coronary syndrome
|
0.47%
1/213 • Number of events 1 • Summary of adverse events that have been reported through 390 days
|
|
Cardiac disorders
Angina pectoris
|
1.4%
3/213 • Number of events 3 • Summary of adverse events that have been reported through 390 days
|
|
Cardiac disorders
Angina pectoris aggravated
|
0.47%
1/213 • Number of events 1 • Summary of adverse events that have been reported through 390 days
|
|
Cardiac disorders
Aortic valve stenosis
|
0.47%
1/213 • Number of events 1 • Summary of adverse events that have been reported through 390 days
|
|
Cardiac disorders
Atrial fibrillation
|
0.94%
2/213 • Number of events 2 • Summary of adverse events that have been reported through 390 days
|
|
Cardiac disorders
Atrial fibrillation with rapid ventricular response
|
0.47%
1/213 • Number of events 1 • Summary of adverse events that have been reported through 390 days
|
|
Cardiac disorders
Atrial flutter
|
0.94%
2/213 • Number of events 2 • Summary of adverse events that have been reported through 390 days
|
|
Cardiac disorders
Bradycardia
|
0.47%
1/213 • Number of events 1 • Summary of adverse events that have been reported through 390 days
|
|
Cardiac disorders
Cardiac failure acute
|
0.47%
1/213 • Number of events 1 • Summary of adverse events that have been reported through 390 days
|
|
Cardiac disorders
Cardiopulmonary arrest
|
0.47%
1/213 • Number of events 1 • Summary of adverse events that have been reported through 390 days
|
|
Cardiac disorders
Congestive cardiac failure aggravated
|
0.47%
1/213 • Number of events 1 • Summary of adverse events that have been reported through 390 days
|
|
Cardiac disorders
Coronary artery disease
|
1.4%
3/213 • Number of events 3 • Summary of adverse events that have been reported through 390 days
|
|
Cardiac disorders
Coronary artery disease progression
|
0.47%
1/213 • Number of events 1 • Summary of adverse events that have been reported through 390 days
|
|
Cardiac disorders
Coronary artery stenosis
|
1.4%
3/213 • Number of events 3 • Summary of adverse events that have been reported through 390 days
|
|
Cardiac disorders
Left bundle branch block
|
0.47%
1/213 • Number of events 1 • Summary of adverse events that have been reported through 390 days
|
|
Cardiac disorders
Non ST segment elevation acute coronary syndrome
|
1.4%
3/213 • Number of events 4 • Summary of adverse events that have been reported through 390 days
|
|
Cardiac disorders
Non ST segment elevation myocardial infarction
|
1.4%
3/213 • Number of events 3 • Summary of adverse events that have been reported through 390 days
|
|
Cardiac disorders
Non STEMI
|
0.47%
1/213 • Number of events 1 • Summary of adverse events that have been reported through 390 days
|
|
Cardiac disorders
Palpitations
|
0.47%
1/213 • Number of events 1 • Summary of adverse events that have been reported through 390 days
|
|
Cardiac disorders
Paroxysmal atrial fibrillation
|
0.47%
1/213 • Number of events 1 • Summary of adverse events that have been reported through 390 days
|
|
Cardiac disorders
Pericardial effusion
|
0.47%
1/213 • Number of events 1 • Summary of adverse events that have been reported through 390 days
|
|
Cardiac disorders
Persistent atrial fibrillation
|
0.47%
1/213 • Number of events 1 • Summary of adverse events that have been reported through 390 days
|
|
Cardiac disorders
Recurrent atrial fibrillation
|
0.47%
1/213 • Number of events 1 • Summary of adverse events that have been reported through 390 days
|
|
Cardiac disorders
Right coronary artery stenosis
|
0.47%
1/213 • Number of events 1 • Summary of adverse events that have been reported through 390 days
|
|
Cardiac disorders
Sick sinus syndrome
|
0.94%
2/213 • Number of events 2 • Summary of adverse events that have been reported through 390 days
|
|
Cardiac disorders
Sinus tachycardia
|
0.47%
1/213 • Number of events 1 • Summary of adverse events that have been reported through 390 days
|
|
Cardiac disorders
Unstable angina
|
1.9%
4/213 • Number of events 7 • Summary of adverse events that have been reported through 390 days
|
|
Cardiac disorders
Ventricular arrhythmia
|
0.47%
1/213 • Number of events 1 • Summary of adverse events that have been reported through 390 days
|
|
Cardiac disorders
Ventricular tachycardia
|
0.47%
1/213 • Number of events 3 • Summary of adverse events that have been reported through 390 days
|
|
Cardiac disorders
Wenckebach
|
0.47%
1/213 • Number of events 1 • Summary of adverse events that have been reported through 390 days
|
|
Congenital, familial and genetic disorders
Cystic kidney disease
|
0.47%
1/213 • Number of events 1 • Summary of adverse events that have been reported through 390 days
|
|
Ear and labyrinth disorders
Ear pain
|
0.47%
1/213 • Number of events 1 • Summary of adverse events that have been reported through 390 days
|
|
Ear and labyrinth disorders
Earache
|
0.47%
1/213 • Number of events 1 • Summary of adverse events that have been reported through 390 days
|
|
Ear and labyrinth disorders
Sensation of pressure in ear
|
0.47%
1/213 • Number of events 1 • Summary of adverse events that have been reported through 390 days
|
|
Ear and labyrinth disorders
Vertigo
|
0.47%
1/213 • Number of events 1 • Summary of adverse events that have been reported through 390 days
|
|
Endocrine disorders
Goiter
|
0.47%
1/213 • Number of events 1 • Summary of adverse events that have been reported through 390 days
|
|
Eye disorders
Cataract
|
0.94%
2/213 • Number of events 2 • Summary of adverse events that have been reported through 390 days
|
|
Eye disorders
Cataract (left)
|
0.47%
1/213 • Number of events 1 • Summary of adverse events that have been reported through 390 days
|
|
Eye disorders
Diabetic macular edema
|
0.47%
1/213 • Number of events 1 • Summary of adverse events that have been reported through 390 days
|
|
Eye disorders
Double vision
|
0.47%
1/213 • Number of events 1 • Summary of adverse events that have been reported through 390 days
|
|
Eye disorders
Retinal detachment
|
0.47%
1/213 • Number of events 1 • Summary of adverse events that have been reported through 390 days
|
|
Eye disorders
Visual impairment
|
0.47%
1/213 • Number of events 1 • Summary of adverse events that have been reported through 390 days
|
|
Gastrointestinal disorders
Abdominal pain
|
0.47%
1/213 • Number of events 1 • Summary of adverse events that have been reported through 390 days
|
|
Gastrointestinal disorders
Acute pancreatitis
|
0.47%
1/213 • Number of events 1 • Summary of adverse events that have been reported through 390 days
|
|
Gastrointestinal disorders
Appendix disorder
|
0.47%
1/213 • Number of events 1 • Summary of adverse events that have been reported through 390 days
|
|
Gastrointestinal disorders
Bilateral inguinal hernia
|
0.47%
1/213 • Number of events 1 • Summary of adverse events that have been reported through 390 days
|
|
Gastrointestinal disorders
Constipation
|
0.47%
1/213 • Number of events 1 • Summary of adverse events that have been reported through 390 days
|
|
Gastrointestinal disorders
Dental disorder NOS
|
0.47%
1/213 • Number of events 1 • Summary of adverse events that have been reported through 390 days
|
|
Gastrointestinal disorders
Diarrhea
|
0.94%
2/213 • Number of events 2 • Summary of adverse events that have been reported through 390 days
|
|
Gastrointestinal disorders
Diarrhea recurrent
|
0.47%
1/213 • Number of events 1 • Summary of adverse events that have been reported through 390 days
|
|
Gastrointestinal disorders
Duodenal ulcer
|
0.47%
1/213 • Number of events 1 • Summary of adverse events that have been reported through 390 days
|
|
Gastrointestinal disorders
Esophageal spasm
|
0.47%
1/213 • Number of events 1 • Summary of adverse events that have been reported through 390 days
|
|
Gastrointestinal disorders
Esophageal varices
|
0.47%
1/213 • Number of events 1 • Summary of adverse events that have been reported through 390 days
|
|
Gastrointestinal disorders
Esophagitis
|
0.47%
1/213 • Number of events 1 • Summary of adverse events that have been reported through 390 days
|
|
Gastrointestinal disorders
Gastric perforation
|
0.47%
1/213 • Number of events 1 • Summary of adverse events that have been reported through 390 days
|
|
Gastrointestinal disorders
Gastroparesis
|
0.47%
1/213 • Number of events 1 • Summary of adverse events that have been reported through 390 days
|
|
Gastrointestinal disorders
Hernia abdominal wall
|
0.47%
1/213 • Number of events 1 • Summary of adverse events that have been reported through 390 days
|
|
Gastrointestinal disorders
Pain epigastric
|
0.47%
1/213 • Number of events 1 • Summary of adverse events that have been reported through 390 days
|
|
Gastrointestinal disorders
Rectal bleeding
|
0.47%
1/213 • Number of events 1 • Summary of adverse events that have been reported through 390 days
|
|
Gastrointestinal disorders
Retroperitoneal bleeding
|
0.47%
1/213 • Number of events 1 • Summary of adverse events that have been reported through 390 days
|
|
Gastrointestinal disorders
Right inguinal hernia
|
0.47%
1/213 • Number of events 1 • Summary of adverse events that have been reported through 390 days
|
|
Gastrointestinal disorders
Upper gastrointestinal bleeding
|
0.94%
2/213 • Number of events 2 • Summary of adverse events that have been reported through 390 days
|
|
General disorders
Adverse drug reaction
|
0.47%
1/213 • Number of events 1 • Summary of adverse events that have been reported through 390 days
|
|
General disorders
Chest pain
|
3.8%
8/213 • Number of events 9 • Summary of adverse events that have been reported through 390 days
|
|
General disorders
Chest pressure
|
0.47%
1/213 • Number of events 1 • Summary of adverse events that have been reported through 390 days
|
|
General disorders
Chronic edema of legs
|
0.47%
1/213 • Number of events 1 • Summary of adverse events that have been reported through 390 days
|
|
General disorders
Complication of device insertion
|
0.47%
1/213 • Number of events 1 • Summary of adverse events that have been reported through 390 days
|
|
General disorders
Device failure
|
0.47%
1/213 • Number of events 1 • Summary of adverse events that have been reported through 390 days
|
|
General disorders
Drug side effect
|
0.47%
1/213 • Number of events 1 • Summary of adverse events that have been reported through 390 days
|
|
General disorders
Edema
|
0.47%
1/213 • Number of events 1 • Summary of adverse events that have been reported through 390 days
|
|
General disorders
Leg edema
|
0.94%
2/213 • Number of events 2 • Summary of adverse events that have been reported through 390 days
|
|
General disorders
Medical device site thrombosis
|
0.94%
2/213 • Number of events 2 • Summary of adverse events that have been reported through 390 days
|
|
General disorders
Pain
|
0.47%
1/213 • Number of events 1 • Summary of adverse events that have been reported through 390 days
|
|
General disorders
Pain chest
|
0.47%
1/213 • Number of events 1 • Summary of adverse events that have been reported through 390 days
|
|
General disorders
Pain worsened
|
0.47%
1/213 • Number of events 1 • Summary of adverse events that have been reported through 390 days
|
|
General disorders
Peripheral edema
|
0.47%
1/213 • Number of events 1 • Summary of adverse events that have been reported through 390 days
|
|
General disorders
Swelling of feet
|
0.47%
1/213 • Number of events 1 • Summary of adverse events that have been reported through 390 days
|
|
General disorders
Swelling of legs
|
0.47%
1/213 • Number of events 1 • Summary of adverse events that have been reported through 390 days
|
|
General disorders
Unevaluable event
|
0.47%
1/213 • Number of events 1 • Summary of adverse events that have been reported through 390 days
|
|
General disorders
Weakness
|
0.47%
1/213 • Number of events 1 • Summary of adverse events that have been reported through 390 days
|
|
Hepatobiliary disorders
Acute cholecystitis
|
0.47%
1/213 • Number of events 1 • Summary of adverse events that have been reported through 390 days
|
|
Hepatobiliary disorders
Gallbladder sludge
|
0.47%
1/213 • Number of events 1 • Summary of adverse events that have been reported through 390 days
|
|
Hepatobiliary disorders
Hepatic cyst
|
0.47%
1/213 • Number of events 1 • Summary of adverse events that have been reported through 390 days
|
|
Hepatobiliary disorders
Hepatic steatosis
|
0.47%
1/213 • Number of events 1 • Summary of adverse events that have been reported through 390 days
|
|
Hepatobiliary disorders
Liver cirrhosis
|
0.47%
1/213 • Number of events 1 • Summary of adverse events that have been reported through 390 days
|
|
Hepatobiliary disorders
Steatosis hepatic
|
0.47%
1/213 • Number of events 1 • Summary of adverse events that have been reported through 390 days
|
|
Immune system disorders
Allergic reaction
|
0.94%
2/213 • Number of events 2 • Summary of adverse events that have been reported through 390 days
|
|
Immune system disorders
Anaphylaxis
|
0.47%
1/213 • Number of events 1 • Summary of adverse events that have been reported through 390 days
|
|
Infections and infestations
Acute bronchitis
|
1.4%
3/213 • Number of events 3 • Summary of adverse events that have been reported through 390 days
|
|
Infections and infestations
Acute diverticulitis
|
0.47%
1/213 • Number of events 1 • Summary of adverse events that have been reported through 390 days
|
|
Infections and infestations
Acute osteomyelitis
|
0.47%
1/213 • Number of events 1 • Summary of adverse events that have been reported through 390 days
|
|
Infections and infestations
Cellulitis of foot
|
0.47%
1/213 • Number of events 1 • Summary of adverse events that have been reported through 390 days
|
|
Infections and infestations
Cellulitis of leg
|
0.94%
2/213 • Number of events 2 • Summary of adverse events that have been reported through 390 days
|
|
Infections and infestations
Cellulitis of toe
|
0.47%
1/213 • Number of events 1 • Summary of adverse events that have been reported through 390 days
|
|
Infections and infestations
Cold
|
0.47%
1/213 • Number of events 1 • Summary of adverse events that have been reported through 390 days
|
|
Infections and infestations
Common cold
|
1.4%
3/213 • Number of events 3 • Summary of adverse events that have been reported through 390 days
|
|
Infections and infestations
Diarrhea, Clostridium difficile
|
0.47%
1/213 • Number of events 1 • Summary of adverse events that have been reported through 390 days
|
|
Infections and infestations
Diverticulitis
|
0.47%
1/213 • Number of events 1 • Summary of adverse events that have been reported through 390 days
|
|
Infections and infestations
Erysipelas
|
0.47%
1/213 • Number of events 1 • Summary of adverse events that have been reported through 390 days
|
|
Infections and infestations
Foot infection
|
0.47%
1/213 • Number of events 1 • Summary of adverse events that have been reported through 390 days
|
|
Infections and infestations
Hepatitis C
|
0.47%
1/213 • Number of events 1 • Summary of adverse events that have been reported through 390 days
|
|
Infections and infestations
Influenza B virus infection
|
0.47%
1/213 • Number of events 1 • Summary of adverse events that have been reported through 390 days
|
|
Infections and infestations
Laryngitis
|
0.47%
1/213 • Number of events 1 • Summary of adverse events that have been reported through 390 days
|
|
Infections and infestations
Lyme disease
|
0.47%
1/213 • Number of events 1 • Summary of adverse events that have been reported through 390 days
|
|
Infections and infestations
Nasal abscess
|
0.47%
1/213 • Number of events 1 • Summary of adverse events that have been reported through 390 days
|
|
Infections and infestations
Onychomycosis
|
0.47%
1/213 • Number of events 2 • Summary of adverse events that have been reported through 390 days
|
|
Infections and infestations
Osteomyelitis
|
0.47%
1/213 • Number of events 1 • Summary of adverse events that have been reported through 390 days
|
|
Infections and infestations
Osteomyelitis acute
|
0.47%
1/213 • Number of events 1 • Summary of adverse events that have been reported through 390 days
|
|
Infections and infestations
Pneumonia, organism unspecified
|
2.8%
6/213 • Number of events 6 • Summary of adverse events that have been reported through 390 days
|
|
Infections and infestations
Pyelonephritis
|
0.47%
1/213 • Number of events 1 • Summary of adverse events that have been reported through 390 days
|
|
Infections and infestations
Respiratory infection
|
0.47%
1/213 • Number of events 1 • Summary of adverse events that have been reported through 390 days
|
|
Infections and infestations
Sepsis
|
0.47%
1/213 • Number of events 1 • Summary of adverse events that have been reported through 390 days
|
|
Infections and infestations
Shingles
|
0.47%
1/213 • Number of events 1 • Summary of adverse events that have been reported through 390 days
|
|
Infections and infestations
Sinusitis
|
0.47%
1/213 • Number of events 1 • Summary of adverse events that have been reported through 390 days
|
|
Infections and infestations
Skin infection aggravated
|
0.47%
1/213 • Number of events 1 • Summary of adverse events that have been reported through 390 days
|
|
Infections and infestations
Tinea pedis
|
0.47%
1/213 • Number of events 1 • Summary of adverse events that have been reported through 390 days
|
|
Infections and infestations
Urinary tract infection, site not specified
|
1.4%
3/213 • Number of events 3 • Summary of adverse events that have been reported through 390 days
|
|
Injury, poisoning and procedural complications
Ankle fracture
|
0.47%
1/213 • Number of events 1 • Summary of adverse events that have been reported through 390 days
|
|
Injury, poisoning and procedural complications
Bruising
|
1.4%
3/213 • Number of events 3 • Summary of adverse events that have been reported through 390 days
|
|
Injury, poisoning and procedural complications
Cartilage injury
|
0.47%
1/213 • Number of events 1 • Summary of adverse events that have been reported through 390 days
|
|
Injury, poisoning and procedural complications
Contusion
|
0.47%
1/213 • Number of events 1 • Summary of adverse events that have been reported through 390 days
|
|
Injury, poisoning and procedural complications
Fall
|
0.94%
2/213 • Number of events 3 • Summary of adverse events that have been reported through 390 days
|
|
Injury, poisoning and procedural complications
Laceration of hand
|
0.47%
1/213 • Number of events 1 • Summary of adverse events that have been reported through 390 days
|
|
Injury, poisoning and procedural complications
Meniscus lesion
|
0.47%
1/213 • Number of events 1 • Summary of adverse events that have been reported through 390 days
|
|
Injury, poisoning and procedural complications
Nausea postoperative
|
0.47%
1/213 • Number of events 1 • Summary of adverse events that have been reported through 390 days
|
|
Injury, poisoning and procedural complications
Open wound of fingers, without mention of complication
|
0.47%
1/213 • Number of events 1 • Summary of adverse events that have been reported through 390 days
|
|
Injury, poisoning and procedural complications
Peripheral artery restenosis
|
8.5%
18/213 • Number of events 22 • Summary of adverse events that have been reported through 390 days
|
|
Injury, poisoning and procedural complications
Post embolization syndrome
|
1.4%
3/213 • Number of events 3 • Summary of adverse events that have been reported through 390 days
|
|
Injury, poisoning and procedural complications
Post procedural hematoma
|
4.2%
9/213 • Number of events 9 • Summary of adverse events that have been reported through 390 days
|
|
Injury, poisoning and procedural complications
Spider bite
|
0.47%
1/213 • Number of events 1 • Summary of adverse events that have been reported through 390 days
|
|
Injury, poisoning and procedural complications
Stress fracture
|
0.47%
1/213 • Number of events 1 • Summary of adverse events that have been reported through 390 days
|
|
Injury, poisoning and procedural complications
Subdural hematoma
|
0.47%
1/213 • Number of events 1 • Summary of adverse events that have been reported through 390 days
|
|
Injury, poisoning and procedural complications
Vascular pseudoaneurysm ruptured
|
0.47%
1/213 • Number of events 1 • Summary of adverse events that have been reported through 390 days
|
|
Injury, poisoning and procedural complications
Wound
|
0.94%
2/213 • Number of events 2 • Summary of adverse events that have been reported through 390 days
|
|
Investigations
Blood sugar increased
|
0.47%
1/213 • Number of events 1 • Summary of adverse events that have been reported through 390 days
|
|
Metabolism and nutrition disorders
Folic acid deficiency
|
0.47%
1/213 • Number of events 1 • Summary of adverse events that have been reported through 390 days
|
|
Metabolism and nutrition disorders
Hyperkalemia
|
0.94%
2/213 • Number of events 2 • Summary of adverse events that have been reported through 390 days
|
|
Metabolism and nutrition disorders
Hypoglycemia, unspecified
|
0.47%
1/213 • Number of events 1 • Summary of adverse events that have been reported through 390 days
|
|
Metabolism and nutrition disorders
Osteoporosis
|
0.47%
1/213 • Number of events 1 • Summary of adverse events that have been reported through 390 days
|
|
Metabolism and nutrition disorders
Vitamin D deficiency
|
0.47%
1/213 • Number of events 1 • Summary of adverse events that have been reported through 390 days
|
|
Musculoskeletal and connective tissue disorders
Arthrosis
|
0.47%
1/213 • Number of events 1 • Summary of adverse events that have been reported through 390 days
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
1.9%
4/213 • Number of events 4 • Summary of adverse events that have been reported through 390 days
|
|
Musculoskeletal and connective tissue disorders
Back pain aggravated
|
0.94%
2/213 • Number of events 2 • Summary of adverse events that have been reported through 390 days
|
|
Musculoskeletal and connective tissue disorders
Calf pain
|
0.47%
1/213 • Number of events 1 • Summary of adverse events that have been reported through 390 days
|
|
Musculoskeletal and connective tissue disorders
Cervical disc herniation
|
0.47%
1/213 • Number of events 1 • Summary of adverse events that have been reported through 390 days
|
|
Musculoskeletal and connective tissue disorders
Cervical pain
|
0.47%
1/213 • Number of events 1 • Summary of adverse events that have been reported through 390 days
|
|
Musculoskeletal and connective tissue disorders
Degeneration of lumbar or lumbosacral intervertebral disc
|
0.47%
1/213 • Number of events 1 • Summary of adverse events that have been reported through 390 days
|
|
Musculoskeletal and connective tissue disorders
Foot pain
|
0.47%
1/213 • Number of events 1 • Summary of adverse events that have been reported through 390 days
|
|
Musculoskeletal and connective tissue disorders
Ganglion cyst
|
0.47%
1/213 • Number of events 1 • Summary of adverse events that have been reported through 390 days
|
|
Musculoskeletal and connective tissue disorders
Gonarthrosis
|
1.4%
3/213 • Number of events 3 • Summary of adverse events that have been reported through 390 days
|
|
Musculoskeletal and connective tissue disorders
Groin discomfort
|
0.47%
1/213 • Number of events 1 • Summary of adverse events that have been reported through 390 days
|
|
Musculoskeletal and connective tissue disorders
Herniated disc
|
0.47%
1/213 • Number of events 1 • Summary of adverse events that have been reported through 390 days
|
|
Musculoskeletal and connective tissue disorders
Intervertebral disc bulging
|
0.47%
1/213 • Number of events 1 • Summary of adverse events that have been reported through 390 days
|
|
Musculoskeletal and connective tissue disorders
Intervertebral disc protrusion
|
0.47%
1/213 • Number of events 1 • Summary of adverse events that have been reported through 390 days
|
|
Musculoskeletal and connective tissue disorders
Knee pain
|
1.4%
3/213 • Number of events 3 • Summary of adverse events that have been reported through 390 days
|
|
Musculoskeletal and connective tissue disorders
Leg pain
|
0.47%
1/213 • Number of events 1 • Summary of adverse events that have been reported through 390 days
|
|
Musculoskeletal and connective tissue disorders
Low back pain
|
0.47%
1/213 • Number of events 3 • Summary of adverse events that have been reported through 390 days
|
|
Musculoskeletal and connective tissue disorders
Lower extremities weakness of
|
0.47%
1/213 • Number of events 1 • Summary of adverse events that have been reported through 390 days
|
|
Musculoskeletal and connective tissue disorders
Lumbar spinal stenosis
|
0.47%
1/213 • Number of events 1 • Summary of adverse events that have been reported through 390 days
|
|
Musculoskeletal and connective tissue disorders
Neck pain
|
0.94%
2/213 • Number of events 2 • Summary of adverse events that have been reported through 390 days
|
|
Musculoskeletal and connective tissue disorders
Osteoarthritis
|
0.47%
1/213 • Number of events 1 • Summary of adverse events that have been reported through 390 days
|
|
Musculoskeletal and connective tissue disorders
Osteoarthritis knee
|
0.47%
1/213 • Number of events 1 • Summary of adverse events that have been reported through 390 days
|
|
Musculoskeletal and connective tissue disorders
Pain in hip
|
0.94%
2/213 • Number of events 3 • Summary of adverse events that have been reported through 390 days
|
|
Musculoskeletal and connective tissue disorders
Pain knee
|
0.47%
1/213 • Number of events 1 • Summary of adverse events that have been reported through 390 days
|
|
Musculoskeletal and connective tissue disorders
Prolapsed lumbar disc
|
0.47%
1/213 • Number of events 1 • Summary of adverse events that have been reported through 390 days
|
|
Musculoskeletal and connective tissue disorders
Shoulder pain
|
0.47%
1/213 • Number of events 1 • Summary of adverse events that have been reported through 390 days
|
|
Musculoskeletal and connective tissue disorders
Spinal stenosis of lumbar region
|
0.47%
1/213 • Number of events 1 • Summary of adverse events that have been reported through 390 days
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Basal cell carcinoma
|
0.47%
1/213 • Number of events 1 • Summary of adverse events that have been reported through 390 days
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Glomus tympanicum tumor
|
0.47%
1/213 • Number of events 1 • Summary of adverse events that have been reported through 390 days
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Mucinous carcinoma
|
0.47%
1/213 • Number of events 1 • Summary of adverse events that have been reported through 390 days
|
|
Nervous system disorders
Burning sensation
|
0.47%
1/213 • Number of events 3 • Summary of adverse events that have been reported through 390 days
|
|
Nervous system disorders
Carotid artery disease
|
0.47%
1/213 • Number of events 1 • Summary of adverse events that have been reported through 390 days
|
|
Nervous system disorders
Carotid artery occlusion
|
0.47%
1/213 • Number of events 1 • Summary of adverse events that have been reported through 390 days
|
|
Nervous system disorders
Carotid artery stenosis
|
1.4%
3/213 • Number of events 4 • Summary of adverse events that have been reported through 390 days
|
|
Nervous system disorders
Carpal tunnel syndrome
|
0.47%
1/213 • Number of events 2 • Summary of adverse events that have been reported through 390 days
|
|
Nervous system disorders
Cerebrovascular accident
|
0.47%
1/213 • Number of events 1 • Summary of adverse events that have been reported through 390 days
|
|
Nervous system disorders
Cervicobrachial syndrome
|
0.47%
1/213 • Number of events 1 • Summary of adverse events that have been reported through 390 days
|
|
Nervous system disorders
Epilepsy
|
0.47%
1/213 • Number of events 1 • Summary of adverse events that have been reported through 390 days
|
|
Nervous system disorders
Headache
|
0.47%
1/213 • Number of events 1 • Summary of adverse events that have been reported through 390 days
|
|
Nervous system disorders
Headache aggravated
|
0.47%
1/213 • Number of events 1 • Summary of adverse events that have been reported through 390 days
|
|
Nervous system disorders
Ischemia cerebrovascular
|
0.47%
1/213 • Number of events 1 • Summary of adverse events that have been reported through 390 days
|
|
Nervous system disorders
Lumboischialgia
|
0.47%
1/213 • Number of events 1 • Summary of adverse events that have been reported through 390 days
|
|
Nervous system disorders
Migraine
|
0.47%
1/213 • Number of events 1 • Summary of adverse events that have been reported through 390 days
|
|
Nervous system disorders
Neuropathy
|
0.47%
1/213 • Number of events 1 • Summary of adverse events that have been reported through 390 days
|
|
Nervous system disorders
Neuropathy peripheral
|
0.47%
1/213 • Number of events 1 • Summary of adverse events that have been reported through 390 days
|
|
Nervous system disorders
Numbness in feet
|
0.94%
2/213 • Number of events 3 • Summary of adverse events that have been reported through 390 days
|
|
Nervous system disorders
Numbness of extremities
|
0.47%
1/213 • Number of events 1 • Summary of adverse events that have been reported through 390 days
|
|
Nervous system disorders
Restless legs
|
0.47%
1/213 • Number of events 1 • Summary of adverse events that have been reported through 390 days
|
|
Nervous system disorders
Seizure
|
0.47%
1/213 • Number of events 1 • Summary of adverse events that have been reported through 390 days
|
|
Nervous system disorders
Syncope
|
0.47%
1/213 • Number of events 1 • Summary of adverse events that have been reported through 390 days
|
|
Nervous system disorders
TIA
|
0.47%
1/213 • Number of events 1 • Summary of adverse events that have been reported through 390 days
|
|
Nervous system disorders
Tension headache
|
0.47%
1/213 • Number of events 1 • Summary of adverse events that have been reported through 390 days
|
|
Renal and urinary disorders
Acute kidney injury
|
0.94%
2/213 • Number of events 3 • Summary of adverse events that have been reported through 390 days
|
|
Renal and urinary disorders
Hematuria
|
0.47%
1/213 • Number of events 1 • Summary of adverse events that have been reported through 390 days
|
|
Renal and urinary disorders
Neurogenic bladder
|
0.47%
1/213 • Number of events 1 • Summary of adverse events that have been reported through 390 days
|
|
Renal and urinary disorders
Renal cyst
|
0.47%
1/213 • Number of events 1 • Summary of adverse events that have been reported through 390 days
|
|
Renal and urinary disorders
Stone urinary bladder
|
0.47%
1/213 • Number of events 1 • Summary of adverse events that have been reported through 390 days
|
|
Renal and urinary disorders
Urinary frequency
|
0.47%
1/213 • Number of events 1 • Summary of adverse events that have been reported through 390 days
|
|
Reproductive system and breast disorders
Epididymal cyst
|
0.47%
1/213 • Number of events 1 • Summary of adverse events that have been reported through 390 days
|
|
Reproductive system and breast disorders
Erectile dysfunction
|
0.47%
1/213 • Number of events 1 • Summary of adverse events that have been reported through 390 days
|
|
Reproductive system and breast disorders
Prostatic hypertrophy
|
0.94%
2/213 • Number of events 2 • Summary of adverse events that have been reported through 390 days
|
|
Reproductive system and breast disorders
Vaginal bleeding
|
0.47%
1/213 • Number of events 1 • Summary of adverse events that have been reported through 390 days
|
|
Respiratory, thoracic and mediastinal disorders
Bleeding nose
|
0.47%
1/213 • Number of events 1 • Summary of adverse events that have been reported through 390 days
|
|
Respiratory, thoracic and mediastinal disorders
Bronchiectasis
|
0.47%
1/213 • Number of events 1 • Summary of adverse events that have been reported through 390 days
|
|
Respiratory, thoracic and mediastinal disorders
COPD
|
0.94%
2/213 • Number of events 2 • Summary of adverse events that have been reported through 390 days
|
|
Respiratory, thoracic and mediastinal disorders
COPD exacerbation
|
1.4%
3/213 • Number of events 4 • Summary of adverse events that have been reported through 390 days
|
|
Respiratory, thoracic and mediastinal disorders
Chronic obstructive lung disease
|
0.47%
1/213 • Number of events 1 • Summary of adverse events that have been reported through 390 days
|
|
Respiratory, thoracic and mediastinal disorders
Emphysema
|
0.47%
1/213 • Number of events 1 • Summary of adverse events that have been reported through 390 days
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
0.94%
2/213 • Number of events 2 • Summary of adverse events that have been reported through 390 days
|
|
Respiratory, thoracic and mediastinal disorders
Exertional dyspnea
|
0.47%
1/213 • Number of events 1 • Summary of adverse events that have been reported through 390 days
|
|
Respiratory, thoracic and mediastinal disorders
Hemothorax
|
0.47%
1/213 • Number of events 1 • Summary of adverse events that have been reported through 390 days
|
|
Respiratory, thoracic and mediastinal disorders
Lung edema
|
0.47%
1/213 • Number of events 1 • Summary of adverse events that have been reported through 390 days
|
|
Respiratory, thoracic and mediastinal disorders
Lung mass
|
0.47%
1/213 • Number of events 1 • Summary of adverse events that have been reported through 390 days
|
|
Respiratory, thoracic and mediastinal disorders
Lung nodule
|
0.47%
1/213 • Number of events 1 • Summary of adverse events that have been reported through 390 days
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
0.94%
2/213 • Number of events 3 • Summary of adverse events that have been reported through 390 days
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary arterial hypertension
|
0.47%
1/213 • Number of events 1 • Summary of adverse events that have been reported through 390 days
|
|
Respiratory, thoracic and mediastinal disorders
Shortness of breath
|
1.4%
3/213 • Number of events 3 • Summary of adverse events that have been reported through 390 days
|
|
Respiratory, thoracic and mediastinal disorders
Sleep apnea
|
0.47%
1/213 • Number of events 1 • Summary of adverse events that have been reported through 390 days
|
|
Skin and subcutaneous tissue disorders
Angioedema
|
0.47%
1/213 • Number of events 1 • Summary of adverse events that have been reported through 390 days
|
|
Skin and subcutaneous tissue disorders
Facial swelling
|
0.47%
1/213 • Number of events 1 • Summary of adverse events that have been reported through 390 days
|
|
Skin and subcutaneous tissue disorders
Foot callus
|
0.47%
1/213 • Number of events 1 • Summary of adverse events that have been reported through 390 days
|
|
Skin and subcutaneous tissue disorders
Heel ulcer
|
0.94%
2/213 • Number of events 2 • Summary of adverse events that have been reported through 390 days
|
|
Skin and subcutaneous tissue disorders
Rash
|
0.94%
2/213 • Number of events 2 • Summary of adverse events that have been reported through 390 days
|
|
Skin and subcutaneous tissue disorders
Skin ulceration
|
0.47%
1/213 • Number of events 1 • Summary of adverse events that have been reported through 390 days
|
|
Vascular disorders
Accelerated hypertension
|
0.47%
1/213 • Number of events 1 • Summary of adverse events that have been reported through 390 days
|
|
Vascular disorders
Arterial perforation
|
0.47%
1/213 • Number of events 1 • Summary of adverse events that have been reported through 390 days
|
|
Vascular disorders
Arterial thrombosis limb
|
0.94%
2/213 • Number of events 2 • Summary of adverse events that have been reported through 390 days
|
|
Vascular disorders
Arteriovenous fistula, acquired
|
0.47%
1/213 • Number of events 1 • Summary of adverse events that have been reported through 390 days
|
|
Vascular disorders
Bleeding
|
0.47%
1/213 • Number of events 1 • Summary of adverse events that have been reported through 390 days
|
|
Vascular disorders
Chronic venous insufficiency
|
0.47%
1/213 • Number of events 1 • Summary of adverse events that have been reported through 390 days
|
|
Vascular disorders
Claudication
|
13.1%
28/213 • Number of events 37 • Summary of adverse events that have been reported through 390 days
|
|
Vascular disorders
Critical limb ischemia
|
1.9%
4/213 • Number of events 4 • Summary of adverse events that have been reported through 390 days
|
|
Vascular disorders
Dry gangrene
|
0.47%
1/213 • Number of events 1 • Summary of adverse events that have been reported through 390 days
|
|
Vascular disorders
Femoral artery dissection
|
0.47%
1/213 • Number of events 1 • Summary of adverse events that have been reported through 390 days
|
|
Vascular disorders
Femoral artery occlusion
|
1.9%
4/213 • Number of events 4 • Summary of adverse events that have been reported through 390 days
|
|
Vascular disorders
Femoral artery stenosis
|
0.47%
1/213 • Number of events 1 • Summary of adverse events that have been reported through 390 days
|
|
Vascular disorders
Hematoma
|
0.47%
1/213 • Number of events 1 • Summary of adverse events that have been reported through 390 days
|
|
Vascular disorders
Hypertension aggravated
|
0.47%
1/213 • Number of events 1 • Summary of adverse events that have been reported through 390 days
|
|
Vascular disorders
Hypertension worsened
|
1.9%
4/213 • Number of events 4 • Summary of adverse events that have been reported through 390 days
|
|
Vascular disorders
Hypertensive crisis
|
0.47%
1/213 • Number of events 1 • Summary of adverse events that have been reported through 390 days
|
|
Vascular disorders
Hypotension
|
0.47%
1/213 • Number of events 1 • Summary of adverse events that have been reported through 390 days
|
|
Vascular disorders
Iliac artery dissection
|
0.47%
1/213 • Number of events 1 • Summary of adverse events that have been reported through 390 days
|
|
Vascular disorders
Iliac artery stenosis
|
0.47%
1/213 • Number of events 1 • Summary of adverse events that have been reported through 390 days
|
|
Vascular disorders
Intermittent claudication
|
0.47%
1/213 • Number of events 1 • Summary of adverse events that have been reported through 390 days
|
|
Vascular disorders
Lymphedema
|
0.47%
1/213 • Number of events 1 • Summary of adverse events that have been reported through 390 days
|
|
Vascular disorders
Melena
|
0.47%
1/213 • Number of events 1 • Summary of adverse events that have been reported through 390 days
|
|
Vascular disorders
Orthostatic hypotension
|
0.47%
1/213 • Number of events 1 • Summary of adverse events that have been reported through 390 days
|
|
Vascular disorders
Peripheral arterial disease
|
5.2%
11/213 • Number of events 11 • Summary of adverse events that have been reported through 390 days
|
|
Vascular disorders
Peripheral artery dissection
|
1.9%
4/213 • Number of events 4 • Summary of adverse events that have been reported through 390 days
|
|
Vascular disorders
Peripheral artery occlusion
|
0.47%
1/213 • Number of events 1 • Summary of adverse events that have been reported through 390 days
|
|
Vascular disorders
Peripheral artery stenosis
|
0.47%
1/213 • Number of events 1 • Summary of adverse events that have been reported through 390 days
|
|
Vascular disorders
Peripheral ischaemia
|
0.47%
1/213 • Number of events 1 • Summary of adverse events that have been reported through 390 days
|
|
Vascular disorders
Peripheral vascular disease
|
5.2%
11/213 • Number of events 13 • Summary of adverse events that have been reported through 390 days
|
|
Vascular disorders
Popliteal arterial stenosis
|
0.47%
1/213 • Number of events 1 • Summary of adverse events that have been reported through 390 days
|
|
Vascular disorders
Popliteal stenosis
|
0.47%
1/213 • Number of events 1 • Summary of adverse events that have been reported through 390 days
|
|
Vascular disorders
Posterior tibial artery perforation
|
0.47%
1/213 • Number of events 1 • Summary of adverse events that have been reported through 390 days
|
|
Vascular disorders
Superficial femoral arterial stenosis
|
0.47%
1/213 • Number of events 1 • Summary of adverse events that have been reported through 390 days
|
|
Vascular disorders
Thrombosis of leg deep venous
|
0.47%
1/213 • Number of events 1 • Summary of adverse events that have been reported through 390 days
|
|
Vascular disorders
Uncontrolled hypertension
|
0.47%
1/213 • Number of events 1 • Summary of adverse events that have been reported through 390 days
|
|
Vascular disorders
Varicose veins
|
0.47%
1/213 • Number of events 1 • Summary of adverse events that have been reported through 390 days
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee PI acknowledges that Clinical Trial is part of multi-center clinical study. Publication of multi-center data requires prior review and consent of both Sponsor and all participating sites. PI agrees that the first publication of the results of the Clinical Trial shall be made in conjunction with results from other participating sites. Provided, however, that if no multi-center publication is made within one year from database lock, then PI may publish individually.
- Publication restrictions are in place
Restriction type: OTHER