Trial Outcomes & Findings for Tack Optimized Balloon Angioplasty Study of the Tack Endovascular System® in Below the Knee Arteries (NCT NCT02942966)
NCT ID: NCT02942966
Last Updated: 2022-01-31
Results Overview
Freedom from major adverse limb events (MALE) at 6 months defined as above-ankle target limb amputation or major re-intervention to the target lesion(s) (i.e. new bypass graft, jump/interposition graft revision, or thrombectomy / thrombolysis) and perioperative death (POD) at 30 days.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
233 participants
Primary outcome timeframe
6 months
Results posted on
2022-01-31
Participant Flow
Participant milestones
| Measure |
Tack Endovascular System (4F)
Use of the Tack Endovascular System (4F) in the mid/distal popliteal, tibial and peroneal arteries ranging in diameter from 1.5mm to 4.5mm for the repair of post percutaneous transluminal balloon angioplasty (PTA) dissection(s).
|
|---|---|
|
Overall Study
STARTED
|
233
|
|
Overall Study
COMPLETED
|
205
|
|
Overall Study
NOT COMPLETED
|
28
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
BMI is missing for two subjects.
Baseline characteristics by cohort
| Measure |
Tack Endovascular System (4F)
n=233 Participants
Use of the Tack Endovascular System (4F) in the mid/distal popliteal, tibial and peroneal arteries ranging in diameter from 1.5mm to 4.5mm for the repair of post percutaneous transluminal balloon angioplasty (PTA) dissection(s).
|
|---|---|
|
Age, Continuous
|
74.4 years
STANDARD_DEVIATION 10 • n=233 Participants
|
|
Sex: Female, Male
Female
|
76 Participants
n=233 Participants
|
|
Sex: Female, Male
Male
|
157 Participants
n=233 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
1 Participants
n=233 Participants
|
|
Race (NIH/OMB)
Asian
|
3 Participants
n=233 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=233 Participants
|
|
Race (NIH/OMB)
Black or African American
|
39 Participants
n=233 Participants
|
|
Race (NIH/OMB)
White
|
187 Participants
n=233 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=233 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
3 Participants
n=233 Participants
|
|
BMI
|
28.8 Kg/m^2
STANDARD_DEVIATION 5.6 • n=231 Participants • BMI is missing for two subjects.
|
|
BMI >= 30
|
86 Participants
n=231 Participants • BMI is missing for two subjects.
|
|
ABI in treated limb
|
0.74 ratio
STANDARD_DEVIATION 0.27 • n=198 Participants • ABI information is missing for some subjects. Values ≥1.3 are censored as non-compressible.
|
|
TBI in treated limb
|
0.43 ratio
STANDARD_DEVIATION 0.23 • n=117 Participants • TBI information is missing for some subjects
|
|
Rutherford Classification
0
|
0 Participants
n=233 Participants
|
|
Rutherford Classification
1
|
0 Participants
n=233 Participants
|
|
Rutherford Classification
2
|
0 Participants
n=233 Participants
|
|
Rutherford Classification
3
|
38 Participants
n=233 Participants
|
|
Rutherford Classification
4
|
78 Participants
n=233 Participants
|
|
Rutherford Classification
5
|
117 Participants
n=233 Participants
|
|
Rutherford Classification
6
|
0 Participants
n=233 Participants
|
|
Wound Grade
0
|
122 Participants
n=233 Participants
|
|
Wound Grade
1
|
91 Participants
n=233 Participants
|
|
Wound Grade
modified 2
|
20 Participants
n=233 Participants
|
|
Wound Grade
2
|
0 Participants
n=233 Participants
|
|
Wound Grade
3
|
0 Participants
n=233 Participants
|
|
Ischemia Grade
0
|
115 Participants
n=221 Participants • Ischemia grade missing for some subjects
|
|
Ischemia Grade
1
|
55 Participants
n=221 Participants • Ischemia grade missing for some subjects
|
|
Ischemia Grade
2
|
28 Participants
n=221 Participants • Ischemia grade missing for some subjects
|
|
Ischemia Grade
3
|
23 Participants
n=221 Participants • Ischemia grade missing for some subjects
|
|
Foot Infection Grade
0
|
194 Participants
n=233 Participants
|
|
Foot Infection Grade
1
|
39 Participants
n=233 Participants
|
|
Foot Infection Grade
2
|
0 Participants
n=233 Participants
|
|
Foot Infection Grade
3
|
0 Participants
n=233 Participants
|
PRIMARY outcome
Timeframe: 6 monthsPopulation: The number of evaluable subjects for the 6 Month Primacy Efficacy Endpoint was 209.
Freedom from major adverse limb events (MALE) at 6 months defined as above-ankle target limb amputation or major re-intervention to the target lesion(s) (i.e. new bypass graft, jump/interposition graft revision, or thrombectomy / thrombolysis) and perioperative death (POD) at 30 days.
Outcome measures
| Measure |
Tack Endovascular System (4F)
n=209 Participants
Use of the Tack Endovascular System (4F) in the mid/distal popliteal, tibial and peroneal arteries ranging in diameter from 1.5mm to 4.5mm for the repair of post percutaneous transluminal balloon angioplasty (PTA) dissection(s).
|
|---|---|
|
Efficacy - Number of Participants With Freedom From MALE at 6 Months and POD at 30 Days
|
200 Participants
|
PRIMARY outcome
Timeframe: 30 daysPopulation: Four subjects were not evaluable for the 30 Day primary safety endpoint due to missing the 30 day visit and no additional visits occurred beyond day 30. One subject was not evaluable for the 30 Day primary safety endpoint due to an early 30 day visit and no additional visits Day 30. These subjects were therefore not included in the denominator for the primary safety endpoint analysis.
Major adverse limb events (MALE) at 30 days defined as above-ankle target limb amputation or major re-intervention to the target lesion(s) (i.e. new bypass graft, jump/interposition graft revision, or thrombectomy / thrombolysis) and perioperative death at 30 days
Outcome measures
| Measure |
Tack Endovascular System (4F)
n=228 Participants
Use of the Tack Endovascular System (4F) in the mid/distal popliteal, tibial and peroneal arteries ranging in diameter from 1.5mm to 4.5mm for the repair of post percutaneous transluminal balloon angioplasty (PTA) dissection(s).
|
|---|---|
|
Safety - Number of Participants With MALE Plus POD at 30 Days
|
3 Participants
|
SECONDARY outcome
Timeframe: 6 monthsPopulation: Some subjects had Tack implants placed in multiple lesions
Target lesion(s) tacked segment(s) patency at 6 months defined as the presence of blood flow using duplex ultrasound. If angiography is available within the 6 month follow-up visit window, it should be used in place of the duplex ultrasound. Evidence of no blood flow within the Tacked segment indicates restenosis/loss of patency.
Outcome measures
| Measure |
Tack Endovascular System (4F)
n=303 number of lesions
Use of the Tack Endovascular System (4F) in the mid/distal popliteal, tibial and peroneal arteries ranging in diameter from 1.5mm to 4.5mm for the repair of post percutaneous transluminal balloon angioplasty (PTA) dissection(s).
|
|---|---|
|
Patency - Number of Target Lesion(s) Tacked Segment(s) Patent at 6 Months
|
248 number of lesions
|
SECONDARY outcome
Timeframe: 6 monthsPopulation: The number of evaluable subjects for Target Limb Salvage at 6 Months was 209.
Target Limb Salvage defined as freedom from any above-ankle target limb amputation at 6 months.
Outcome measures
| Measure |
Tack Endovascular System (4F)
n=209 Participants
Use of the Tack Endovascular System (4F) in the mid/distal popliteal, tibial and peroneal arteries ranging in diameter from 1.5mm to 4.5mm for the repair of post percutaneous transluminal balloon angioplasty (PTA) dissection(s).
|
|---|---|
|
Target Limb Salvage - Number of Participants With Freedom From Above-Ankle Target Limb Amputation at 6 Months
|
206 Participants
|
Adverse Events
Tack Endovascular System (4F)
Serious events: 179 serious events
Other events: 137 other events
Deaths: 63 deaths
Serious adverse events
| Measure |
Tack Endovascular System (4F)
n=233 participants at risk
Use of the Tack Endovascular System (4F) in the mid/distal popliteal, tibial and peroneal arteries ranging in diameter from 1.5mm to 4.5mm for the repair of post percutaneous transluminal balloon angioplasty (PTA) dissection(s).
|
|---|---|
|
Blood and lymphatic system disorders
Anemia
|
1.7%
4/233 • Number of events 4 • Summary of adverse events that have been reported through 210 days
|
|
Blood and lymphatic system disorders
Microcytic anemia
|
0.43%
1/233 • Number of events 1 • Summary of adverse events that have been reported through 210 days
|
|
Cardiac disorders
Acute on chronic heart failure
|
0.86%
2/233 • Number of events 3 • Summary of adverse events that have been reported through 210 days
|
|
Cardiac disorders
Angina at rest
|
0.43%
1/233 • Number of events 1 • Summary of adverse events that have been reported through 210 days
|
|
Cardiac disorders
Angina pectoris
|
0.43%
1/233 • Number of events 1 • Summary of adverse events that have been reported through 210 days
|
|
Cardiac disorders
Aortic valve stenosis
|
0.86%
2/233 • Number of events 2 • Summary of adverse events that have been reported through 210 days
|
|
Cardiac disorders
Atrial fibrillation
|
0.43%
1/233 • Number of events 1 • Summary of adverse events that have been reported through 210 days
|
|
Cardiac disorders
Bradycardia
|
0.43%
1/233 • Number of events 2 • Summary of adverse events that have been reported through 210 days
|
|
Cardiac disorders
Cardiac failure aggravated
|
0.43%
1/233 • Number of events 1 • Summary of adverse events that have been reported through 210 days
|
|
Cardiac disorders
Cardiomyopathy
|
0.43%
1/233 • Number of events 1 • Summary of adverse events that have been reported through 210 days
|
|
Cardiac disorders
Congestive heart failure
|
0.86%
2/233 • Number of events 2 • Summary of adverse events that have been reported through 210 days
|
|
Cardiac disorders
Coronary artery disease
|
0.43%
1/233 • Number of events 1 • Summary of adverse events that have been reported through 210 days
|
|
Cardiac disorders
Coronary artery stenosis
|
0.43%
1/233 • Number of events 1 • Summary of adverse events that have been reported through 210 days
|
|
Cardiac disorders
Coronary heart disease
|
0.43%
1/233 • Number of events 1 • Summary of adverse events that have been reported through 210 days
|
|
Cardiac disorders
Decompensated heart failure
|
0.43%
1/233 • Number of events 1 • Summary of adverse events that have been reported through 210 days
|
|
Cardiac disorders
Decompensation cardiac
|
1.3%
3/233 • Number of events 3 • Summary of adverse events that have been reported through 210 days
|
|
Cardiac disorders
Heart failure
|
0.86%
2/233 • Number of events 2 • Summary of adverse events that have been reported through 210 days
|
|
Cardiac disorders
Heart failure NYHA class III
|
0.43%
1/233 • Number of events 1 • Summary of adverse events that have been reported through 210 days
|
|
Cardiac disorders
Heart insufficiency
|
0.86%
2/233 • Number of events 2 • Summary of adverse events that have been reported through 210 days
|
|
Cardiac disorders
Myocardial infarction
|
0.86%
2/233 • Number of events 2 • Summary of adverse events that have been reported through 210 days
|
|
Cardiac disorders
New onset angina pectoris
|
0.43%
1/233 • Number of events 1 • Summary of adverse events that have been reported through 210 days
|
|
Cardiac disorders
Non ST segment elevation myocardial infarction
|
1.3%
3/233 • Number of events 3 • Summary of adverse events that have been reported through 210 days
|
|
Cardiac disorders
Paroxysmal atrial fibrillation
|
0.43%
1/233 • Number of events 1 • Summary of adverse events that have been reported through 210 days
|
|
Cardiac disorders
Progressive angina
|
0.43%
1/233 • Number of events 1 • Summary of adverse events that have been reported through 210 days
|
|
Cardiac disorders
Right coronary artery stenosis
|
0.43%
1/233 • Number of events 1 • Summary of adverse events that have been reported through 210 days
|
|
Cardiac disorders
ST segment elevation myocardial infarction
|
0.43%
1/233 • Number of events 1 • Summary of adverse events that have been reported through 210 days
|
|
Cardiac disorders
Supraventricular tachycardia
|
0.43%
1/233 • Number of events 1 • Summary of adverse events that have been reported through 210 days
|
|
Ear and labyrinth disorders
Supraventricular tachycardia
|
0.43%
1/233 • Number of events 1 • Summary of adverse events that have been reported through 210 days
|
|
Gastrointestinal disorders
Abdominal pain
|
0.43%
1/233 • Number of events 2 • Summary of adverse events that have been reported through 210 days
|
|
Gastrointestinal disorders
Coprostasis
|
0.43%
1/233 • Number of events 1 • Summary of adverse events that have been reported through 210 days
|
|
Gastrointestinal disorders
Duodenal ulcer hemorrhage
|
0.43%
1/233 • Number of events 1 • Summary of adverse events that have been reported through 210 days
|
|
Gastrointestinal disorders
Gastrointestinal bleed
|
0.43%
1/233 • Number of events 1 • Summary of adverse events that have been reported through 210 days
|
|
Gastrointestinal disorders
Melena
|
0.43%
1/233 • Number of events 1 • Summary of adverse events that have been reported through 210 days
|
|
Gastrointestinal disorders
Nausea
|
0.43%
1/233 • Number of events 1 • Summary of adverse events that have been reported through 210 days
|
|
Gastrointestinal disorders
Oral hemorrhage
|
0.43%
1/233 • Number of events 1 • Summary of adverse events that have been reported through 210 days
|
|
Gastrointestinal disorders
Retroperitoneal hematoma
|
0.43%
1/233 • Number of events 1 • Summary of adverse events that have been reported through 210 days
|
|
Gastrointestinal disorders
Small bowel obstruction
|
0.43%
1/233 • Number of events 1 • Summary of adverse events that have been reported through 210 days
|
|
Gastrointestinal disorders
Ventral hernia
|
0.43%
1/233 • Number of events 1 • Summary of adverse events that have been reported through 210 days
|
|
General disorders
Acute chest pain
|
0.43%
1/233 • Number of events 1 • Summary of adverse events that have been reported through 210 days
|
|
General disorders
Chest pain
|
0.86%
2/233 • Number of events 2 • Summary of adverse events that have been reported through 210 days
|
|
General disorders
Delayed healing of wound
|
0.86%
2/233 • Number of events 2 • Summary of adverse events that have been reported through 210 days
|
|
General disorders
In-stent peripheral artery restenosis
|
1.3%
3/233 • Number of events 3 • Summary of adverse events that have been reported through 210 days
|
|
General disorders
Opiate withdrawal symptoms
|
0.43%
1/233 • Number of events 1 • Summary of adverse events that have been reported through 210 days
|
|
General disorders
Puncture site bleeding
|
0.43%
1/233 • Number of events 1 • Summary of adverse events that have been reported through 210 days
|
|
General disorders
Sudden cardiac death
|
0.43%
1/233 • Number of events 1 • Summary of adverse events that have been reported through 210 days
|
|
General disorders
Unknown cause of death
|
0.43%
1/233 • Number of events 1 • Summary of adverse events that have been reported through 210 days
|
|
Hepatobiliary disorders
Acute cholecystitis
|
0.43%
1/233 • Number of events 1 • Summary of adverse events that have been reported through 210 days
|
|
Infections and infestations
Bacteremia
|
0.43%
1/233 • Number of events 1 • Summary of adverse events that have been reported through 210 days
|
|
Infections and infestations
Bacteriuria
|
0.43%
1/233 • Number of events 1 • Summary of adverse events that have been reported through 210 days
|
|
Infections and infestations
Cellulitis of toe
|
0.43%
1/233 • Number of events 1 • Summary of adverse events that have been reported through 210 days
|
|
Infections and infestations
Clostridial gastroenteritis
|
0.43%
1/233 • Number of events 1 • Summary of adverse events that have been reported through 210 days
|
|
Infections and infestations
Erysipelas
|
0.43%
1/233 • Number of events 1 • Summary of adverse events that have been reported through 210 days
|
|
Infections and infestations
Gangrene
|
0.43%
1/233 • Number of events 2 • Summary of adverse events that have been reported through 210 days
|
|
Infections and infestations
Gangrene peripheral
|
0.86%
2/233 • Number of events 4 • Summary of adverse events that have been reported through 210 days
|
|
Infections and infestations
Gangrene toe
|
2.1%
5/233 • Number of events 6 • Summary of adverse events that have been reported through 210 days
|
|
Infections and infestations
Infection of amputation stump
|
0.43%
1/233 • Number of events 1 • Summary of adverse events that have been reported through 210 days
|
|
Infections and infestations
Osteomyelitis of the foot
|
1.7%
4/233 • Number of events 5 • Summary of adverse events that have been reported through 210 days
|
|
Infections and infestations
Phlegmon
|
0.43%
1/233 • Number of events 1 • Summary of adverse events that have been reported through 210 days
|
|
Infections and infestations
Pneumonia, organism unspecified
|
1.7%
4/233 • Number of events 5 • Summary of adverse events that have been reported through 210 days
|
|
Infections and infestations
Postoperative infection
|
0.43%
1/233 • Number of events 1 • Summary of adverse events that have been reported through 210 days
|
|
Infections and infestations
Sepsis
|
0.86%
2/233 • Number of events 2 • Summary of adverse events that have been reported through 210 days
|
|
Infections and infestations
Soft tissue infection
|
0.43%
1/233 • Number of events 1 • Summary of adverse events that have been reported through 210 days
|
|
Infections and infestations
Spondylodiscitis
|
0.43%
1/233 • Number of events 2 • Summary of adverse events that have been reported through 210 days
|
|
Infections and infestations
Staphylococcus aureus bacteremia
|
0.43%
1/233 • Number of events 1 • Summary of adverse events that have been reported through 210 days
|
|
Infections and infestations
Urinary tract infection, site not specified
|
0.43%
1/233 • Number of events 1 • Summary of adverse events that have been reported through 210 days
|
|
Infections and infestations
Wet gangrene
|
0.43%
1/233 • Number of events 1 • Summary of adverse events that have been reported through 210 days
|
|
Injury, poisoning and procedural complications
Abdominal wall wound
|
0.43%
1/233 • Number of events 1 • Summary of adverse events that have been reported through 210 days
|
|
Injury, poisoning and procedural complications
Chronic subdural hematoma
|
0.43%
1/233 • Number of events 1 • Summary of adverse events that have been reported through 210 days
|
|
Injury, poisoning and procedural complications
Femoral artery pseudoaneurysm
|
0.43%
1/233 • Number of events 1 • Summary of adverse events that have been reported through 210 days
|
|
Injury, poisoning and procedural complications
Fracture femur
|
0.43%
1/233 • Number of events 1 • Summary of adverse events that have been reported through 210 days
|
|
Injury, poisoning and procedural complications
Fracture of neck of femur
|
0.43%
1/233 • Number of events 1 • Summary of adverse events that have been reported through 210 days
|
|
Injury, poisoning and procedural complications
Overdose NOS
|
0.43%
1/233 • Number of events 1 • Summary of adverse events that have been reported through 210 days
|
|
Injury, poisoning and procedural complications
Peripheral arterial reocclusion
|
1.7%
4/233 • Number of events 6 • Summary of adverse events that have been reported through 210 days
|
|
Injury, poisoning and procedural complications
Peripheral artery restenosis
|
1.7%
4/233 • Number of events 4 • Summary of adverse events that have been reported through 210 days
|
|
Injury, poisoning and procedural complications
Pseudoaneurysm
|
0.86%
2/233 • Number of events 2 • Summary of adverse events that have been reported through 210 days
|
|
Injury, poisoning and procedural complications
Skin tear
|
0.86%
2/233 • Number of events 2 • Summary of adverse events that have been reported through 210 days
|
|
Injury, poisoning and procedural complications
Traumatic brain injury
|
0.43%
1/233 • Number of events 1 • Summary of adverse events that have been reported through 210 days
|
|
Injury, poisoning and procedural complications
Vascular access site bleeding
|
0.43%
1/233 • Number of events 1 • Summary of adverse events that have been reported through 210 days
|
|
Injury, poisoning and procedural complications
Wound
|
0.43%
1/233 • Number of events 2 • Summary of adverse events that have been reported through 210 days
|
|
Injury, poisoning and procedural complications
Wound bleeding
|
0.43%
1/233 • Number of events 1 • Summary of adverse events that have been reported through 210 days
|
|
Metabolism and nutrition disorders
Gout aggravated
|
0.43%
1/233 • Number of events 1 • Summary of adverse events that have been reported through 210 days
|
|
Metabolism and nutrition disorders
Hyperglycemia
|
1.3%
3/233 • Number of events 3 • Summary of adverse events that have been reported through 210 days
|
|
Metabolism and nutrition disorders
Hyperkalemia
|
0.43%
1/233 • Number of events 1 • Summary of adverse events that have been reported through 210 days
|
|
Metabolism and nutrition disorders
Hypokalemia
|
0.43%
1/233 • Number of events 1 • Summary of adverse events that have been reported through 210 days
|
|
Metabolism and nutrition disorders
Hyponatremia
|
0.43%
1/233 • Number of events 4 • Summary of adverse events that have been reported through 210 days
|
|
Metabolism and nutrition disorders
Type II diabetes mellitus inadequate control
|
0.43%
1/233 • Number of events 1 • Summary of adverse events that have been reported through 210 days
|
|
Musculoskeletal and connective tissue disorders
Coxarthrosis
|
0.43%
1/233 • Number of events 1 • Summary of adverse events that have been reported through 210 days
|
|
Musculoskeletal and connective tissue disorders
Hyperuricemic arthritis
|
0.43%
1/233 • Number of events 1 • Summary of adverse events that have been reported through 210 days
|
|
Musculoskeletal and connective tissue disorders
Leg pain
|
0.43%
1/233 • Number of events 1 • Summary of adverse events that have been reported through 210 days
|
|
Musculoskeletal and connective tissue disorders
Polyarthritis
|
0.43%
1/233 • Number of events 1 • Summary of adverse events that have been reported through 210 days
|
|
Musculoskeletal and connective tissue disorders
Prepatellar bursitis
|
0.43%
1/233 • Number of events 1 • Summary of adverse events that have been reported through 210 days
|
|
Musculoskeletal and connective tissue disorders
Soft tissue disorder
|
0.43%
1/233 • Number of events 1 • Summary of adverse events that have been reported through 210 days
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Basalioma
|
0.43%
1/233 • Number of events 1 • Summary of adverse events that have been reported through 210 days
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Diffuse large B-cell lymphoma recurrent
|
0.43%
1/233 • Number of events 1 • Summary of adverse events that have been reported through 210 days
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Leukemia
|
0.43%
1/233 • Number of events 1 • Summary of adverse events that have been reported through 210 days
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Liver carcinoma
|
0.43%
1/233 • Number of events 1 • Summary of adverse events that have been reported through 210 days
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Ovarian granulosa cell tumor
|
0.43%
1/233 • Number of events 1 • Summary of adverse events that have been reported through 210 days
|
|
Nervous system disorders
Ataxia
|
0.43%
1/233 • Number of events 1 • Summary of adverse events that have been reported through 210 days
|
|
Nervous system disorders
Bleeding intracranial
|
0.43%
1/233 • Number of events 1 • Summary of adverse events that have been reported through 210 days
|
|
Nervous system disorders
Carotid artery stenosis
|
0.86%
2/233 • Number of events 2 • Summary of adverse events that have been reported through 210 days
|
|
Nervous system disorders
Dizziness
|
0.43%
1/233 • Number of events 1 • Summary of adverse events that have been reported through 210 days
|
|
Nervous system disorders
Drop attacks
|
0.43%
1/233 • Number of events 1 • Summary of adverse events that have been reported through 210 days
|
|
Nervous system disorders
Focal epilepsy
|
0.43%
1/233 • Number of events 1 • Summary of adverse events that have been reported through 210 days
|
|
Nervous system disorders
Stroke
|
0.86%
2/233 • Number of events 2 • Summary of adverse events that have been reported through 210 days
|
|
Nervous system disorders
Syncopal attack
|
0.43%
1/233 • Number of events 1 • Summary of adverse events that have been reported through 210 days
|
|
Nervous system disorders
TIA
|
0.43%
1/233 • Number of events 1 • Summary of adverse events that have been reported through 210 days
|
|
Nervous system disorders
Transient ischemic attack
|
0.43%
1/233 • Number of events 1 • Summary of adverse events that have been reported through 210 days
|
|
Psychiatric disorders
Confusion
|
0.43%
1/233 • Number of events 1 • Summary of adverse events that have been reported through 210 days
|
|
Psychiatric disorders
Hyperactive delirium
|
0.43%
1/233 • Number of events 1 • Summary of adverse events that have been reported through 210 days
|
|
Psychiatric disorders
Transient psychosis
|
0.43%
1/233 • Number of events 1 • Summary of adverse events that have been reported through 210 days
|
|
Renal and urinary disorders
Acute kidney injury
|
1.3%
3/233 • Number of events 3 • Summary of adverse events that have been reported through 210 days
|
|
Renal and urinary disorders
Acute on chronic renal failure
|
0.86%
2/233 • Number of events 2 • Summary of adverse events that have been reported through 210 days
|
|
Renal and urinary disorders
Acute renal failure
|
1.7%
4/233 • Number of events 4 • Summary of adverse events that have been reported through 210 days
|
|
Renal and urinary disorders
Renal failure
|
0.43%
1/233 • Number of events 1 • Summary of adverse events that have been reported through 210 days
|
|
Reproductive system and breast disorders
Metrorrhagia
|
0.43%
1/233 • Number of events 1 • Summary of adverse events that have been reported through 210 days
|
|
Respiratory, thoracic and mediastinal disorders
Acute respiratory failure
|
0.43%
1/233 • Number of events 1 • Summary of adverse events that have been reported through 210 days
|
|
Respiratory, thoracic and mediastinal disorders
Bilateral pleural effusion
|
0.86%
2/233 • Number of events 2 • Summary of adverse events that have been reported through 210 days
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
0.43%
1/233 • Number of events 1 • Summary of adverse events that have been reported through 210 days
|
|
Respiratory, thoracic and mediastinal disorders
Hypoxia
|
0.43%
1/233 • Number of events 1 • Summary of adverse events that have been reported through 210 days
|
|
Respiratory, thoracic and mediastinal disorders
Lung edema
|
0.43%
1/233 • Number of events 1 • Summary of adverse events that have been reported through 210 days
|
|
Respiratory, thoracic and mediastinal disorders
Shortness of breath
|
0.43%
1/233 • Number of events 1 • Summary of adverse events that have been reported through 210 days
|
|
Skin and subcutaneous tissue disorders
Chronic leg ulcer
|
0.43%
1/233 • Number of events 1 • Summary of adverse events that have been reported through 210 days
|
|
Skin and subcutaneous tissue disorders
Diabetic foot
|
0.43%
1/233 • Number of events 2 • Summary of adverse events that have been reported through 210 days
|
|
Skin and subcutaneous tissue disorders
Digital ulcer
|
0.86%
2/233 • Number of events 2 • Summary of adverse events that have been reported through 210 days
|
|
Skin and subcutaneous tissue disorders
Rash
|
0.43%
1/233 • Number of events 1 • Summary of adverse events that have been reported through 210 days
|
|
Skin and subcutaneous tissue disorders
Ulcer foot
|
0.43%
1/233 • Number of events 1 • Summary of adverse events that have been reported through 210 days
|
|
Skin and subcutaneous tissue disorders
Venous ulceration
|
0.43%
1/233 • Number of events 1 • Summary of adverse events that have been reported through 210 days
|
|
Surgical and medical procedures
Medical device battery replacement
|
0.43%
1/233 • Number of events 1 • Summary of adverse events that have been reported through 210 days
|
|
Vascular disorders
Abdominal aortic aneurysm
|
0.43%
1/233 • Number of events 1 • Summary of adverse events that have been reported through 210 days
|
|
Vascular disorders
Acute limb ischemia
|
0.86%
2/233 • Number of events 2 • Summary of adverse events that have been reported through 210 days
|
|
Vascular disorders
Anterior tibial artery perforation
|
0.43%
1/233 • Number of events 1 • Summary of adverse events that have been reported through 210 days
|
|
Vascular disorders
Arterial occlusion
|
0.43%
1/233 • Number of events 1 • Summary of adverse events that have been reported through 210 days
|
|
Vascular disorders
Arterial stenosis
|
0.43%
1/233 • Number of events 1 • Summary of adverse events that have been reported through 210 days
|
|
Vascular disorders
Atherosclerosis of arteries of the extremities
|
0.43%
1/233 • Number of events 1 • Summary of adverse events that have been reported through 210 days
|
|
Vascular disorders
Claudication
|
3.4%
8/233 • Number of events 10 • Summary of adverse events that have been reported through 210 days
|
|
Vascular disorders
Critical limb ischemia
|
1.3%
3/233 • Number of events 3 • Summary of adverse events that have been reported through 210 days
|
|
Vascular disorders
Digital necrosis
|
0.43%
1/233 • Number of events 1 • Summary of adverse events that have been reported through 210 days
|
|
Vascular disorders
Dry gangrene foot
|
0.43%
1/233 • Number of events 2 • Summary of adverse events that have been reported through 210 days
|
|
Vascular disorders
Dry gangrene toe
|
0.43%
1/233 • Number of events 1 • Summary of adverse events that have been reported through 210 days
|
|
Vascular disorders
Extremity necrosis
|
0.43%
1/233 • Number of events 1 • Summary of adverse events that have been reported through 210 days
|
|
Vascular disorders
Hematoma
|
0.43%
1/233 • Number of events 1 • Summary of adverse events that have been reported through 210 days
|
|
Vascular disorders
Hypertension
|
0.43%
1/233 • Number of events 1 • Summary of adverse events that have been reported through 210 days
|
|
Vascular disorders
Hypotension
|
1.3%
3/233 • Number of events 3 • Summary of adverse events that have been reported through 210 days
|
|
Vascular disorders
Iliac artery stenosis
|
0.43%
1/233 • Number of events 1 • Summary of adverse events that have been reported through 210 days
|
|
Vascular disorders
Internal hemorrhage
|
0.43%
1/233 • Number of events 1 • Summary of adverse events that have been reported through 210 days
|
|
Vascular disorders
Ischemic limb pain
|
0.43%
1/233 • Number of events 1 • Summary of adverse events that have been reported through 210 days
|
|
Vascular disorders
Peripheral arterial occlusive disease
|
0.43%
1/233 • Number of events 1 • Summary of adverse events that have been reported through 210 days
|
|
Vascular disorders
Peripheral arterial occlusive disease Fontaine stage IV
|
0.43%
1/233 • Number of events 1 • Summary of adverse events that have been reported through 210 days
|
|
Vascular disorders
Peripheral arterial occlusive disease aggravated
|
1.7%
4/233 • Number of events 5 • Summary of adverse events that have been reported through 210 days
|
|
Vascular disorders
Peripheral artery occlusion
|
0.43%
1/233 • Number of events 1 • Summary of adverse events that have been reported through 210 days
|
|
Vascular disorders
Peripheral artery thrombosis
|
0.43%
1/233 • Number of events 1 • Summary of adverse events that have been reported through 210 days
|
|
Vascular disorders
Peripheral vascular disease
|
0.43%
1/233 • Number of events 1 • Summary of adverse events that have been reported through 210 days
|
|
Vascular disorders
Superficial femoral arterial stenosis
|
0.43%
1/233 • Number of events 1 • Summary of adverse events that have been reported through 210 days
|
|
Vascular disorders
Superficial femoral artery occlusion
|
0.43%
1/233 • Number of events 1 • Summary of adverse events that have been reported through 210 days
|
|
Vascular disorders
Uncontrolled hypertension
|
0.43%
1/233 • Number of events 1 • Summary of adverse events that have been reported through 210 days
|
|
Vascular disorders
Varicose vein
|
0.43%
1/233 • Number of events 1 • Summary of adverse events that have been reported through 210 days
|
Other adverse events
| Measure |
Tack Endovascular System (4F)
n=233 participants at risk
Use of the Tack Endovascular System (4F) in the mid/distal popliteal, tibial and peroneal arteries ranging in diameter from 1.5mm to 4.5mm for the repair of post percutaneous transluminal balloon angioplasty (PTA) dissection(s).
|
|---|---|
|
Blood and lymphatic system disorders
Anemia
|
1.7%
4/233 • Number of events 4 • Summary of adverse events that have been reported through 210 days
|
|
Blood and lymphatic system disorders
Microcytic anemia
|
0.43%
1/233 • Number of events 1 • Summary of adverse events that have been reported through 210 days
|
|
Cardiac disorders
Acute on chronic heart failure
|
0.86%
2/233 • Number of events 3 • Summary of adverse events that have been reported through 210 days
|
|
Cardiac disorders
Angina at rest
|
0.43%
1/233 • Number of events 1 • Summary of adverse events that have been reported through 210 days
|
|
Cardiac disorders
Angina pectoris
|
0.43%
1/233 • Number of events 1 • Summary of adverse events that have been reported through 210 days
|
|
Cardiac disorders
Aortic valve stenosis
|
0.86%
2/233 • Number of events 2 • Summary of adverse events that have been reported through 210 days
|
|
Cardiac disorders
Atrial fibrillation
|
0.43%
1/233 • Number of events 1 • Summary of adverse events that have been reported through 210 days
|
|
Cardiac disorders
Bradycardia
|
0.43%
1/233 • Number of events 2 • Summary of adverse events that have been reported through 210 days
|
|
Cardiac disorders
Cardiac failure aggravated
|
0.43%
1/233 • Number of events 1 • Summary of adverse events that have been reported through 210 days
|
|
Cardiac disorders
Congestive heart failure
|
0.86%
2/233 • Number of events 2 • Summary of adverse events that have been reported through 210 days
|
|
Cardiac disorders
Coronary artery disease
|
0.43%
1/233 • Number of events 1 • Summary of adverse events that have been reported through 210 days
|
|
Cardiac disorders
Coronary artery stenosis
|
0.43%
1/233 • Number of events 1 • Summary of adverse events that have been reported through 210 days
|
|
Cardiac disorders
Coronary heart disease
|
0.43%
1/233 • Number of events 1 • Summary of adverse events that have been reported through 210 days
|
|
Cardiac disorders
Decompensated heart failure
|
0.43%
1/233 • Number of events 1 • Summary of adverse events that have been reported through 210 days
|
|
Cardiac disorders
Decompensation cardiac
|
1.3%
3/233 • Number of events 3 • Summary of adverse events that have been reported through 210 days
|
|
Cardiac disorders
Heart failure
|
0.86%
2/233 • Number of events 2 • Summary of adverse events that have been reported through 210 days
|
|
Cardiac disorders
Heart failure NYHA class III
|
0.43%
1/233 • Number of events 1 • Summary of adverse events that have been reported through 210 days
|
|
Cardiac disorders
Heart insufficiency
|
0.86%
2/233 • Number of events 2 • Summary of adverse events that have been reported through 210 days
|
|
Cardiac disorders
Ischaemic heart disease
|
0.43%
1/233 • Number of events 1 • Summary of adverse events that have been reported through 210 days
|
|
Cardiac disorders
Myocardial infarction
|
0.86%
2/233 • Number of events 2 • Summary of adverse events that have been reported through 210 days
|
|
Cardiac disorders
New onset angina pectoris
|
0.43%
1/233 • Number of events 1 • Summary of adverse events that have been reported through 210 days
|
|
Cardiac disorders
Non ST segment elevation myocardial infarction
|
1.3%
3/233 • Number of events 3 • Summary of adverse events that have been reported through 210 days
|
|
Cardiac disorders
Paroxysmal atrial fibrillation
|
0.43%
1/233 • Number of events 1 • Summary of adverse events that have been reported through 210 days
|
|
Cardiac disorders
Progressive angina
|
0.43%
1/233 • Number of events 1 • Summary of adverse events that have been reported through 210 days
|
|
Cardiac disorders
Right coronary artery stenosis
|
0.43%
1/233 • Number of events 1 • Summary of adverse events that have been reported through 210 days
|
|
Cardiac disorders
ST segment elevation myocardial infarction
|
0.43%
1/233 • Number of events 1 • Summary of adverse events that have been reported through 210 days
|
|
Cardiac disorders
Supraventricular tachycardia
|
0.43%
1/233 • Number of events 1 • Summary of adverse events that have been reported through 210 days
|
|
Ear and labyrinth disorders
Meniere's disease aggravated
|
0.43%
1/233 • Number of events 1 • Summary of adverse events that have been reported through 210 days
|
|
Gastrointestinal disorders
Abdominal pain
|
0.43%
1/233 • Number of events 2 • Summary of adverse events that have been reported through 210 days
|
|
Gastrointestinal disorders
Coprostasis
|
0.43%
1/233 • Number of events 1 • Summary of adverse events that have been reported through 210 days
|
|
Gastrointestinal disorders
Duodenal ulcer hemorrhage
|
0.43%
1/233 • Number of events 1 • Summary of adverse events that have been reported through 210 days
|
|
Gastrointestinal disorders
Gastrointestinal bleed
|
0.43%
1/233 • Number of events 1 • Summary of adverse events that have been reported through 210 days
|
|
Gastrointestinal disorders
Gastrointestinal bleeding
|
0.86%
2/233 • Number of events 2 • Summary of adverse events that have been reported through 210 days
|
|
Gastrointestinal disorders
Melena
|
0.86%
2/233 • Number of events 2 • Summary of adverse events that have been reported through 210 days
|
|
Gastrointestinal disorders
Nausea
|
0.43%
1/233 • Number of events 1 • Summary of adverse events that have been reported through 210 days
|
|
Gastrointestinal disorders
Oral hemorrhage
|
0.43%
1/233 • Number of events 1 • Summary of adverse events that have been reported through 210 days
|
|
Gastrointestinal disorders
Retroperitoneal hematoma
|
0.43%
1/233 • Number of events 1 • Summary of adverse events that have been reported through 210 days
|
|
Gastrointestinal disorders
Small bowel obstruction
|
0.43%
1/233 • Number of events 1 • Summary of adverse events that have been reported through 210 days
|
|
Gastrointestinal disorders
Ventral hernia
|
0.43%
1/233 • Number of events 1 • Summary of adverse events that have been reported through 210 days
|
|
General disorders
Acute chest pain
|
0.43%
1/233 • Number of events 1 • Summary of adverse events that have been reported through 210 days
|
|
General disorders
Chest pain
|
0.86%
2/233 • Number of events 2 • Summary of adverse events that have been reported through 210 days
|
|
General disorders
Delayed healing of wound
|
1.3%
3/233 • Number of events 3 • Summary of adverse events that have been reported through 210 days
|
|
General disorders
In-stent peripheral artery restenosis
|
1.3%
3/233 • Number of events 3 • Summary of adverse events that have been reported through 210 days
|
|
General disorders
Leg edema
|
0.86%
2/233 • Number of events 2 • Summary of adverse events that have been reported through 210 days
|
|
General disorders
Opiate withdrawal symptoms
|
0.43%
1/233 • Number of events 1 • Summary of adverse events that have been reported through 210 days
|
|
General disorders
Puncture site bleeding
|
0.43%
1/233 • Number of events 1 • Summary of adverse events that have been reported through 210 days
|
|
General disorders
Swelling of limb
|
0.43%
1/233 • Number of events 1 • Summary of adverse events that have been reported through 210 days
|
|
Hepatobiliary disorders
Acute cholecystitis
|
0.43%
1/233 • Number of events 1 • Summary of adverse events that have been reported through 210 days
|
|
Infections and infestations
Bacteremia
|
0.43%
1/233 • Number of events 1 • Summary of adverse events that have been reported through 210 days
|
|
Infections and infestations
Bacteriuria
|
0.43%
1/233 • Number of events 1 • Summary of adverse events that have been reported through 210 days
|
|
Infections and infestations
Cellulitis of toe
|
0.43%
1/233 • Number of events 1 • Summary of adverse events that have been reported through 210 days
|
|
Infections and infestations
Clostridial gastroenteritis
|
0.43%
1/233 • Number of events 1 • Summary of adverse events that have been reported through 210 days
|
|
Infections and infestations
Erysipelas
|
0.43%
1/233 • Number of events 1 • Summary of adverse events that have been reported through 210 days
|
|
Infections and infestations
Gangrene
|
0.43%
1/233 • Number of events 2 • Summary of adverse events that have been reported through 210 days
|
|
Infections and infestations
Gangrene peripheral
|
1.3%
3/233 • Number of events 5 • Summary of adverse events that have been reported through 210 days
|
|
Infections and infestations
Gangrene toe
|
2.1%
5/233 • Number of events 6 • Summary of adverse events that have been reported through 210 days
|
|
Infections and infestations
Infection of amputation stump
|
0.43%
1/233 • Number of events 1 • Summary of adverse events that have been reported through 210 days
|
|
Infections and infestations
Osteomyelitis of the foot
|
1.7%
4/233 • Number of events 5 • Summary of adverse events that have been reported through 210 days
|
|
Infections and infestations
Phlegmon
|
0.43%
1/233 • Number of events 1 • Summary of adverse events that have been reported through 210 days
|
|
Infections and infestations
Pneumonia, organism unspecified
|
1.7%
4/233 • Number of events 5 • Summary of adverse events that have been reported through 210 days
|
|
Infections and infestations
Postoperative infection
|
0.43%
1/233 • Number of events 1 • Summary of adverse events that have been reported through 210 days
|
|
Infections and infestations
Sepsis
|
0.86%
2/233 • Number of events 2 • Summary of adverse events that have been reported through 210 days
|
|
Infections and infestations
Soft tissue infection
|
0.43%
1/233 • Number of events 1 • Summary of adverse events that have been reported through 210 days
|
|
Infections and infestations
Spondylodiscitis
|
0.43%
1/233 • Number of events 2 • Summary of adverse events that have been reported through 210 days
|
|
Infections and infestations
Staphylococcus aureus bacteremia
|
0.43%
1/233 • Number of events 1 • Summary of adverse events that have been reported through 210 days
|
|
Infections and infestations
Urinary tract infection, site not specified
|
0.43%
1/233 • Number of events 1 • Summary of adverse events that have been reported through 210 days
|
|
Infections and infestations
Vascular access site infection
|
0.43%
1/233 • Number of events 1 • Summary of adverse events that have been reported through 210 days
|
|
Infections and infestations
Wet gangrene
|
0.43%
1/233 • Number of events 1 • Summary of adverse events that have been reported through 210 days
|
|
Injury, poisoning and procedural complications
Abdominal wall wound
|
0.43%
1/233 • Number of events 1 • Summary of adverse events that have been reported through 210 days
|
|
Injury, poisoning and procedural complications
Chronic subdural hematoma
|
0.43%
1/233 • Number of events 1 • Summary of adverse events that have been reported through 210 days
|
|
Injury, poisoning and procedural complications
Femoral artery pseudoaneurysm
|
0.43%
1/233 • Number of events 1 • Summary of adverse events that have been reported through 210 days
|
|
Injury, poisoning and procedural complications
Fracture femur
|
0.43%
1/233 • Number of events 1 • Summary of adverse events that have been reported through 210 days
|
|
Injury, poisoning and procedural complications
Fracture of neck of femur
|
0.43%
1/233 • Number of events 1 • Summary of adverse events that have been reported through 210 days
|
|
Injury, poisoning and procedural complications
Overdose NOS
|
0.43%
1/233 • Number of events 1 • Summary of adverse events that have been reported through 210 days
|
|
Injury, poisoning and procedural complications
Peripheral arterial reocclusion
|
3.4%
8/233 • Number of events 10 • Summary of adverse events that have been reported through 210 days
|
|
Injury, poisoning and procedural complications
Peripheral artery restenosis
|
3.9%
9/233 • Number of events 10 • Summary of adverse events that have been reported through 210 days
|
|
Injury, poisoning and procedural complications
Post procedural bleeding
|
0.43%
1/233 • Number of events 1 • Summary of adverse events that have been reported through 210 days
|
|
Injury, poisoning and procedural complications
Post procedural complication
|
1.7%
4/233 • Number of events 4 • Summary of adverse events that have been reported through 210 days
|
|
Injury, poisoning and procedural complications
Post procedural hematoma
|
1.3%
3/233 • Number of events 3 • Summary of adverse events that have been reported through 210 days
|
|
Injury, poisoning and procedural complications
Pseudoaneurysm
|
2.1%
5/233 • Number of events 5 • Summary of adverse events that have been reported through 210 days
|
|
Injury, poisoning and procedural complications
Skin tear
|
0.43%
1/233 • Number of events 1 • Summary of adverse events that have been reported through 210 days
|
|
Injury, poisoning and procedural complications
Traumatic brain injury
|
0.43%
1/233 • Number of events 1 • Summary of adverse events that have been reported through 210 days
|
|
Injury, poisoning and procedural complications
Vascular access site bleeding
|
0.43%
1/233 • Number of events 1 • Summary of adverse events that have been reported through 210 days
|
|
Injury, poisoning and procedural complications
Vascular access site hematoma
|
0.86%
2/233 • Number of events 2 • Summary of adverse events that have been reported through 210 days
|
|
Injury, poisoning and procedural complications
Wound
|
1.3%
3/233 • Number of events 4 • Summary of adverse events that have been reported through 210 days
|
|
Injury, poisoning and procedural complications
Wound bleeding
|
0.43%
1/233 • Number of events 1 • Summary of adverse events that have been reported through 210 days
|
|
Metabolism and nutrition disorders
Gout aggravated
|
0.43%
1/233 • Number of events 1 • Summary of adverse events that have been reported through 210 days
|
|
Metabolism and nutrition disorders
Hyperglycemia
|
1.3%
3/233 • Number of events 3 • Summary of adverse events that have been reported through 210 days
|
|
Metabolism and nutrition disorders
Hyperkalemia
|
0.43%
1/233 • Number of events 1 • Summary of adverse events that have been reported through 210 days
|
|
Metabolism and nutrition disorders
Hypokalemia
|
0.43%
1/233 • Number of events 1 • Summary of adverse events that have been reported through 210 days
|
|
Metabolism and nutrition disorders
Hyponatremia
|
0.43%
1/233 • Number of events 4 • Summary of adverse events that have been reported through 210 days
|
|
Metabolism and nutrition disorders
Type II diabetes mellitus inadequate control
|
0.43%
1/233 • Number of events 1 • Summary of adverse events that have been reported through 210 days
|
|
Musculoskeletal and connective tissue disorders
Coxarthrosis
|
0.43%
1/233 • Number of events 1 • Summary of adverse events that have been reported through 210 days
|
|
Musculoskeletal and connective tissue disorders
Hyperuricemic arthritis
|
0.43%
1/233 • Number of events 1 • Summary of adverse events that have been reported through 210 days
|
|
Musculoskeletal and connective tissue disorders
Leg pain
|
0.86%
2/233 • Number of events 2 • Summary of adverse events that have been reported through 210 days
|
|
Musculoskeletal and connective tissue disorders
Pain of lower extremities
|
0.43%
1/233 • Number of events 1 • Summary of adverse events that have been reported through 210 days
|
|
Musculoskeletal and connective tissue disorders
Polyarthritis
|
0.43%
1/233 • Number of events 1 • Summary of adverse events that have been reported through 210 days
|
|
Musculoskeletal and connective tissue disorders
Prepatellar bursitis
|
0.43%
1/233 • Number of events 1 • Summary of adverse events that have been reported through 210 days
|
|
Musculoskeletal and connective tissue disorders
Soft tissue disorder
|
0.43%
1/233 • Number of events 1 • Summary of adverse events that have been reported through 210 days
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Basalioma
|
0.43%
1/233 • Number of events 1 • Summary of adverse events that have been reported through 210 days
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Diffuse large B-cell lymphoma recurrent
|
0.43%
1/233 • Number of events 1 • Summary of adverse events that have been reported through 210 days
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Leukemia
|
0.43%
1/233 • Number of events 2 • Summary of adverse events that have been reported through 210 days
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Liver carcinoma
|
0.43%
1/233 • Number of events 1 • Summary of adverse events that have been reported through 210 days
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Ovarian granulosa cell tumor
|
0.43%
1/233 • Number of events 1 • Summary of adverse events that have been reported through 210 days
|
|
Nervous system disorders
Ataxia
|
0.43%
1/233 • Number of events 1 • Summary of adverse events that have been reported through 210 days
|
|
Nervous system disorders
Bleeding intracranial
|
0.43%
1/233 • Number of events 1 • Summary of adverse events that have been reported through 210 days
|
|
Nervous system disorders
Carotid artery stenosis
|
0.86%
2/233 • Number of events 2 • Summary of adverse events that have been reported through 210 days
|
|
Nervous system disorders
Dizziness
|
0.43%
1/233 • Number of events 1 • Summary of adverse events that have been reported through 210 days
|
|
Nervous system disorders
Drop attacks
|
0.43%
1/233 • Number of events 1 • Summary of adverse events that have been reported through 210 days
|
|
Nervous system disorders
Focal epilepsy
|
0.43%
1/233 • Number of events 1 • Summary of adverse events that have been reported through 210 days
|
|
Nervous system disorders
Stroke
|
0.86%
2/233 • Number of events 2 • Summary of adverse events that have been reported through 210 days
|
|
Nervous system disorders
Syncopal attack
|
0.43%
1/233 • Number of events 1 • Summary of adverse events that have been reported through 210 days
|
|
Nervous system disorders
TIA
|
0.43%
1/233 • Number of events 1 • Summary of adverse events that have been reported through 210 days
|
|
Nervous system disorders
Transient ischemic attack
|
0.43%
1/233 • Number of events 1 • Summary of adverse events that have been reported through 210 days
|
|
Psychiatric disorders
Confusion
|
0.43%
1/233 • Number of events 1 • Summary of adverse events that have been reported through 210 days
|
|
Psychiatric disorders
Hyperactive delirium
|
0.43%
1/233 • Number of events 1 • Summary of adverse events that have been reported through 210 days
|
|
Psychiatric disorders
Transient psychosis
|
0.43%
1/233 • Number of events 1 • Summary of adverse events that have been reported through 210 days
|
|
Renal and urinary disorders
Acute kidney injury
|
1.3%
3/233 • Number of events 3 • Summary of adverse events that have been reported through 210 days
|
|
Renal and urinary disorders
Acute on chronic renal failure
|
0.86%
2/233 • Number of events 2 • Summary of adverse events that have been reported through 210 days
|
|
Renal and urinary disorders
Acute renal failure
|
1.7%
4/233 • Number of events 4 • Summary of adverse events that have been reported through 210 days
|
|
Renal and urinary disorders
Renal failure
|
0.43%
1/233 • Number of events 1 • Summary of adverse events that have been reported through 210 days
|
|
Renal and urinary disorders
Metrorrhagia
|
0.43%
1/233 • Number of events 1 • Summary of adverse events that have been reported through 210 days
|
|
Respiratory, thoracic and mediastinal disorders
Acute respiratory failure
|
0.43%
1/233 • Number of events 1 • Summary of adverse events that have been reported through 210 days
|
|
Respiratory, thoracic and mediastinal disorders
Bilateral pleural effusion
|
0.86%
2/233 • Number of events 2 • Summary of adverse events that have been reported through 210 days
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
0.43%
1/233 • Number of events 1 • Summary of adverse events that have been reported through 210 days
|
|
Respiratory, thoracic and mediastinal disorders
Hypoxia
|
0.43%
1/233 • Number of events 1 • Summary of adverse events that have been reported through 210 days
|
|
Respiratory, thoracic and mediastinal disorders
Lung edema
|
0.43%
1/233 • Number of events 1 • Summary of adverse events that have been reported through 210 days
|
|
Respiratory, thoracic and mediastinal disorders
Shortness of breath
|
0.43%
1/233 • Number of events 1 • Summary of adverse events that have been reported through 210 days
|
|
Skin and subcutaneous tissue disorders
Chronic leg ulcer
|
0.43%
1/233 • Number of events 1 • Summary of adverse events that have been reported through 210 days
|
|
Skin and subcutaneous tissue disorders
Diabetic foot
|
0.43%
1/233 • Number of events 2 • Summary of adverse events that have been reported through 210 days
|
|
Skin and subcutaneous tissue disorders
Digital ulcer
|
0.86%
2/233 • Number of events 2 • Summary of adverse events that have been reported through 210 days
|
|
Skin and subcutaneous tissue disorders
Rash
|
0.43%
1/233 • Number of events 1 • Summary of adverse events that have been reported through 210 days
|
|
Skin and subcutaneous tissue disorders
Ulcer foot
|
0.43%
1/233 • Number of events 1 • Summary of adverse events that have been reported through 210 days
|
|
Skin and subcutaneous tissue disorders
Venous ulceration
|
0.43%
1/233 • Number of events 1 • Summary of adverse events that have been reported through 210 days
|
|
Surgical and medical procedures
Medical device battery replacement
|
0.43%
1/233 • Number of events 1 • Summary of adverse events that have been reported through 210 days
|
|
Vascular disorders
Abdominal aortic aneurysm
|
0.43%
1/233 • Number of events 1 • Summary of adverse events that have been reported through 210 days
|
|
Vascular disorders
Acute limb ischemia
|
0.86%
2/233 • Number of events 2 • Summary of adverse events that have been reported through 210 days
|
|
Vascular disorders
Anterior tibial artery perforation
|
0.43%
1/233 • Number of events 1 • Summary of adverse events that have been reported through 210 days
|
|
Vascular disorders
Arterial occlusion
|
0.43%
1/233 • Number of events 1 • Summary of adverse events that have been reported through 210 days
|
|
Vascular disorders
Arterial spasm
|
0.43%
1/233 • Number of events 1 • Summary of adverse events that have been reported through 210 days
|
|
Vascular disorders
Arterial stenosis
|
0.86%
2/233 • Number of events 2 • Summary of adverse events that have been reported through 210 days
|
|
Vascular disorders
Arteriovenous fistula
|
0.43%
1/233 • Number of events 1 • Summary of adverse events that have been reported through 210 days
|
|
Vascular disorders
Artery dissection
|
0.43%
1/233 • Number of events 1 • Summary of adverse events that have been reported through 210 days
|
|
Vascular disorders
Atherosclerosis of arteries of the extremities
|
0.43%
1/233 • Number of events 1 • Summary of adverse events that have been reported through 210 days
|
|
Vascular disorders
Claudication
|
3.4%
8/233 • Number of events 10 • Summary of adverse events that have been reported through 210 days
|
|
Vascular disorders
Critical limb ischemia
|
1.3%
3/233 • Number of events 3 • Summary of adverse events that have been reported through 210 days
|
|
Vascular disorders
Deep vein thrombosis leg
|
0.43%
1/233 • Number of events 1 • Summary of adverse events that have been reported through 210 days
|
|
Vascular disorders
Digital necrosis
|
1.3%
3/233 • Number of events 3 • Summary of adverse events that have been reported through 210 days
|
|
Vascular disorders
Dry gangrene foot
|
0.43%
1/233 • Number of events 2 • Summary of adverse events that have been reported through 210 days
|
|
Vascular disorders
Dry gangrene toe
|
0.43%
1/233 • Number of events 1 • Summary of adverse events that have been reported through 210 days
|
|
Vascular disorders
Extremity necrosis
|
0.43%
1/233 • Number of events 1 • Summary of adverse events that have been reported through 210 days
|
|
Vascular disorders
Hematoma
|
0.43%
1/233 • Number of events 1 • Summary of adverse events that have been reported through 210 days
|
|
Vascular disorders
Hypertension
|
0.43%
1/233 • Number of events 1 • Summary of adverse events that have been reported through 210 days
|
|
Vascular disorders
Hypotension
|
1.3%
3/233 • Number of events 3 • Summary of adverse events that have been reported through 210 days
|
|
Vascular disorders
Iliac artery stenosis
|
0.43%
1/233 • Number of events 1 • Summary of adverse events that have been reported through 210 days
|
|
Vascular disorders
Internal hemorrhage
|
0.43%
1/233 • Number of events 1 • Summary of adverse events that have been reported through 210 days
|
|
Vascular disorders
Ischemic limb pain
|
0.43%
1/233 • Number of events 1 • Summary of adverse events that have been reported through 210 days
|
|
Vascular disorders
Peripheral arterial occlusive disease
|
0.43%
1/233 • Number of events 1 • Summary of adverse events that have been reported through 210 days
|
|
Surgical and medical procedures
Peripheral arterial occlusive disease Fontaine stage IV
|
0.43%
1/233 • Number of events 1 • Summary of adverse events that have been reported through 210 days
|
|
Vascular disorders
Peripheral arterial occlusive disease aggravated
|
2.1%
5/233 • Number of events 6 • Summary of adverse events that have been reported through 210 days
|
|
Vascular disorders
Peripheral artery occlusion
|
0.43%
1/233 • Number of events 1 • Summary of adverse events that have been reported through 210 days
|
|
Vascular disorders
Peripheral artery thrombosis
|
0.43%
1/233 • Number of events 1 • Summary of adverse events that have been reported through 210 days
|
|
Vascular disorders
Peripheral embolism
|
0.43%
1/233 • Number of events 1 • Summary of adverse events that have been reported through 210 days
|
|
Vascular disorders
Peripheral vascular disease
|
3.9%
9/233 • Number of events 10 • Summary of adverse events that have been reported through 210 days
|
|
Vascular disorders
Popliteal artery occlusion
|
0.43%
1/233 • Number of events 1 • Summary of adverse events that have been reported through 210 days
|
|
Vascular disorders
Reperfusion injury
|
0.86%
2/233 • Number of events 2 • Summary of adverse events that have been reported through 210 days
|
|
Vascular disorders
Superficial femoral arterial stenosis
|
0.43%
1/233 • Number of events 1 • Summary of adverse events that have been reported through 210 days
|
|
Vascular disorders
Superficial femoral artery occlusion
|
0.43%
1/233 • Number of events 1 • Summary of adverse events that have been reported through 210 days
|
|
Vascular disorders
Thrombosis
|
0.86%
2/233 • Number of events 2 • Summary of adverse events that have been reported through 210 days
|
|
Vascular disorders
Tibial artery occlusion
|
0.43%
1/233 • Number of events 1 • Summary of adverse events that have been reported through 210 days
|
|
Vascular disorders
Tibial artery stenosis
|
0.43%
1/233 • Number of events 1 • Summary of adverse events that have been reported through 210 days
|
|
Vascular disorders
Tibial artery thrombosis
|
0.43%
1/233 • Number of events 1 • Summary of adverse events that have been reported through 210 days
|
|
Vascular disorders
Uncontrolled hypertension
|
0.43%
1/233 • Number of events 1 • Summary of adverse events that have been reported through 210 days
|
|
Vascular disorders
Varicose vein
|
0.43%
1/233 • Number of events 1 • Summary of adverse events that have been reported through 210 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