Study: NCT02400905

Adverse event: Restenosis of treated segment
Serious: yes
Organ System: Vascular disorders
Frequency: 47 affected / 271 at risk

Adverse event: Arterial stenosis (non-target)
Serious: yes
Organ System: Vascular disorders
Frequency: 38 affected / 271 at risk

Adverse event: Restenosis
Serious: yes
Organ System: Vascular disorders
Frequency: 14 affected / 271 at risk

Adverse event: Restenosis of treated vessel
Serious: yes
Organ System: Vascular disorders
Frequency: 12 affected / 271 at risk

Adverse event: Thrombosis
Serious: yes
Organ System: Vascular disorders
Frequency: 4 affected / 271 at risk

Adverse event: Peripheral ischaemia
Serious: yes
Organ System: Vascular disorders
Frequency: 4 affected / 271 at risk

Adverse event: Dissection
Serious: yes
Organ System: Vascular disorders
Frequency: 2 affected / 271 at risk

Adverse event: Hypotension
Serious: yes
Organ System: Vascular disorders
Frequency: 2 affected / 271 at risk

Adverse event: Vascular pseudoaneurysm
Serious: yes
Organ System: Vascular disorders
Frequency: 2 affected / 271 at risk

Adverse event: Abrupt occlusion
Serious: yes
Organ System: Vascular disorders
Frequency: 1 affected / 271 at risk

Adverse event: Amputation (unplanned, spontaneous)
Serious: yes
Organ System: Vascular disorders
Frequency: 1 affected / 271 at risk

Adverse event: Aneurysm
Serious: yes
Organ System: Vascular disorders
Frequency: 2 affected / 271 at risk

Adverse event: Dissection (≥ Grade C) in target vessel requiring intervention
Serious: yes
Organ System: Vascular disorders
Frequency: 1 affected / 271 at risk

Adverse event: Embolization, distal
Serious: yes
Organ System: Vascular disorders
Frequency: 1 affected / 271 at risk

Adverse event: Hypertension
Serious: yes
Organ System: Vascular disorders
Frequency: 1 affected / 271 at risk

Adverse event: Total occlusion of the peripheral artery
Serious: yes
Organ System: Vascular disorders
Frequency: 4 affected / 271 at risk

Adverse event: Angina pectoris
Serious: yes
Organ System: Cardiac disorders
Frequency: 10 affected / 271 at risk

Adverse event: Congestive heart failure (CHF)
Serious: yes
Organ System: Cardiac disorders
Frequency: 10 affected / 271 at risk

Adverse event: Atrial fibrillation
Serious: yes
Organ System: Cardiac disorders
Frequency: 10 affected / 271 at risk

Adverse event: Myocardial infarction
Serious: yes
Organ System: Cardiac disorders
Frequency: 13 affected / 271 at risk

Adverse event: Myocardial ischaemia
Serious: yes
Organ System: Cardiac disorders
Frequency: 5 affected / 271 at risk

Adverse event: Arrhythmia
Serious: yes
Organ System: Cardiac disorders
Frequency: 4 affected / 271 at risk

Adverse event: Ventricular tachycardia
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 271 at risk

Adverse event: Anaemia
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 2 affected / 271 at risk

Adverse event: Gastro-intestinal bleeding
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 3 affected / 271 at risk

Adverse event: Sepsis
Serious: yes
Organ System: Infections and infestations
Frequency: 6 affected / 271 at risk

Adverse event: Infected peripheral wound
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 271 at risk

Adverse event: Urinary tract infection (UTI)
Serious: yes
Organ System: Infections and infestations
Frequency: 3 affected / 271 at risk

Adverse event: Arterial occlusion/thrombus at puncture site
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 2 affected / 271 at risk

Adverse event: Vascular access complications
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 2 affected / 271 at risk

Adverse event: Groin hematoma ≥ 5 cm, with or without surgical repair
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 271 at risk

Adverse event: Seizure
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 271 at risk

Adverse event: Stroke or other neurological complications
Serious: yes
Organ System: Nervous system disorders
Frequency: 5 affected / 271 at risk

Adverse event: Renal failure/renal insufficiency
Serious: yes
Organ System: Renal and urinary disorders
Frequency: 7 affected / 271 at risk

Adverse event: Respiratory distress
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 3 affected / 271 at risk

Adverse event: Pneumonia
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 6 affected / 271 at risk

Adverse event: Allergic reaction (medication, contrast media, device, etc.)
Serious: yes
Organ System: Immune system disorders
Frequency: 1 affected / 271 at risk

Adverse event: Amputation (planned)
Serious: yes
Organ System: Vascular disorders
Frequency: 1 affected / 271 at risk

Adverse event: Bleeding from anticoagulant or antiplatelet medications s
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 271 at risk

Adverse event: Haemorrhage, with or without transfusion
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 271 at risk

Adverse event: Death (MAE if cardiovascular-related)
Serious: yes
Organ System: Cardiac disorders
Frequency: 5 affected / 271 at risk

Adverse event: Pulmonary embolism
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 271 at risk

Adverse event: Transient ischemic attack (TIA)
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 271 at risk

Adverse event: Other
Serious: yes
Organ System: Investigations
Frequency: 95 affected / 271 at risk

Adverse event: Angina pectoris
Serious: no
Organ System: Cardiac disorders
Frequency: 18 affected / 271 at risk

Adverse event: Arterial stenosis (non-target)
Serious: no
Organ System: Vascular disorders
Frequency: 50 affected / 271 at risk

Adverse event: Restenosis
Serious: no
Organ System: Vascular disorders
Frequency: 18 affected / 271 at risk

Adverse event: Restenosis of treated segment
Serious: no
Organ System: Vascular disorders
Frequency: 63 affected / 271 at risk

Adverse event: Restenosis of treated vessel
Serious: no
Organ System: Vascular disorders
Frequency: 14 affected / 271 at risk

Adverse event: Vascular access complications
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 14 affected / 271 at risk