Study: NCT01855412

Adverse event: Arrhythmias
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 501 at risk

Adverse event: Neoplasm malignant
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 501 at risk

Adverse event: Death-unknown cause
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 501 at risk

Adverse event: Other peripheral procedural complication
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 2 affected / 501 at risk

Adverse event: Peripheral arteriovenous fistula
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 501 at risk

Adverse event: Peripheral artery abrupt closure
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 2 affected / 501 at risk

Adverse event: Peripheral artery dissection
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 43 affected / 501 at risk

Adverse event: Peripheral artery distal embolization
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 3 affected / 501 at risk

Adverse event: Peripheral artery perforation
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 7 affected / 501 at risk

Adverse event: Peripheral artery pseudoaneurysm
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 501 at risk

Adverse event: Peripheral artery slow flow
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 501 at risk

Adverse event: Peripheral artery thrombus/thrombosis
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 6 affected / 501 at risk

Adverse event: Peripheral artery vasospasm
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 2 affected / 501 at risk

Adverse event: Cerebrovascular accident
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 501 at risk

Adverse event: Bleeding/hemorrhage, access site
Serious: yes
Organ System: Vascular disorders
Frequency: 2 affected / 501 at risk

Adverse event: Bruising/hematoma access site
Serious: yes
Organ System: Vascular disorders
Frequency: 2 affected / 501 at risk

Adverse event: Peripheral artery restenosis
Serious: yes
Organ System: Vascular disorders
Frequency: 1 affected / 501 at risk

Adverse event: Peripheral artery stenosis
Serious: yes
Organ System: Vascular disorders
Frequency: 6 affected / 501 at risk

Adverse event: Peripheral artery dissection
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 28 affected / 501 at risk

Adverse event: Myocardial infarction
Serious: yes
Organ System: Cardiac disorders
Frequency: 6 affected / 603 at risk

Adverse event: Hypersensitivity
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 603 at risk

Adverse event: Blood and lymphatic system disorder-anemia
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 603 at risk

Adverse event: Other peripheral procedural complication
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 4 affected / 603 at risk

Adverse event: Peripheral arteriovenous fistula
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 603 at risk

Adverse event: Peripheral artery dissection
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 28 affected / 603 at risk

Adverse event: Peripheral artery distal embolization
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 5 affected / 603 at risk

Adverse event: Peripheral artery perforation
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 7 affected / 603 at risk

Adverse event: Peripheral artery thrombus/thrombosis
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 11 affected / 603 at risk

Adverse event: Peripheral artery vasospasm
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 3 affected / 603 at risk

Adverse event: Cerebrovascular accident
Serious: yes
Organ System: Nervous system disorders
Frequency: 2 affected / 603 at risk

Adverse event: Transient ischemic attack (TIA)
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 603 at risk

Adverse event: Bleeding/hemorrhage non-access site
Serious: yes
Organ System: Vascular disorders
Frequency: 1 affected / 603 at risk

Adverse event: Bleeding/hemorrhage, access site
Serious: yes
Organ System: Vascular disorders
Frequency: 4 affected / 603 at risk

Adverse event: Hypotension
Serious: yes
Organ System: Vascular disorders
Frequency: 2 affected / 603 at risk

Adverse event: New/worsening infection
Serious: yes
Organ System: Vascular disorders
Frequency: 8 affected / 603 at risk

Adverse event: New/worsening pain
Serious: yes
Organ System: Vascular disorders
Frequency: 1 affected / 603 at risk

Adverse event: New/worsening wound
Serious: yes
Organ System: Vascular disorders
Frequency: 11 affected / 603 at risk

Adverse event: Other peripheral vascular disorder
Serious: yes
Organ System: Vascular disorders
Frequency: 1 affected / 603 at risk

Adverse event: Other vascular disorder
Serious: yes
Organ System: Vascular disorders
Frequency: 1 affected / 603 at risk

Adverse event: Peripheral artery restenosis
Serious: yes
Organ System: Vascular disorders
Frequency: 15 affected / 603 at risk

Adverse event: Peripheral artery stenosis
Serious: yes
Organ System: Vascular disorders
Frequency: 18 affected / 603 at risk

Adverse event: Peripheral artery dissection
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 31 affected / 603 at risk

Adverse event: Arrhythmias
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 100 at risk

Adverse event: Cardiac dysfunction - Chronic heart failure or aggravated
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 100 at risk

Adverse event: Cardiac/cardiopulmonary arrest
Serious: yes
Organ System: Cardiac disorders
Frequency: 3 affected / 100 at risk

Adverse event: Myocardial infarction
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 100 at risk

Adverse event: Peripheral artery dissection
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 2 affected / 100 at risk

Adverse event: Peripheral artery distal embolization
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 2 affected / 100 at risk

Adverse event: Peripheral artery no reflow
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 100 at risk

Adverse event: Peripheral artery thrombus/thrombosis
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 100 at risk

Adverse event: Peripheral artery vasospasm
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 100 at risk

Adverse event: Other neuro/pshychiatric disorders
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 100 at risk

Adverse event: Bruising/hematoma access site
Serious: yes
Organ System: Vascular disorders
Frequency: 1 affected / 100 at risk

Adverse event: New/worsening infection
Serious: yes
Organ System: Vascular disorders
Frequency: 6 affected / 100 at risk

Adverse event: New/worsening wound
Serious: yes
Organ System: Vascular disorders
Frequency: 10 affected / 100 at risk

Adverse event: Peripheral artery restenosis
Serious: yes
Organ System: Vascular disorders
Frequency: 2 affected / 100 at risk

Adverse event: Peripheral artery stenosis
Serious: yes
Organ System: Vascular disorders
Frequency: 2 affected / 100 at risk

Adverse event: Peripheral artery dissection
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 2 affected / 100 at risk

Adverse event: Cardiac/cardiopulmonary arrest
Serious: yes
Organ System: Cardiac disorders
Frequency: 2 affected / 501 at risk

Adverse event: Coronary artery thrombus/thrombosis
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 501 at risk

Adverse event: Myocardial infarction
Serious: yes
Organ System: Cardiac disorders
Frequency: 3 affected / 501 at risk

Adverse event: Gastrointestional infection/inflammation
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 501 at risk

Adverse event: Neoplasm malignant
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 501 at risk

Adverse event: Death-unknown cause
Serious: yes
Organ System: General disorders
Frequency: 4 affected / 501 at risk

Adverse event: Multiple organ dysfunction syndrome
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 501 at risk

Adverse event: Other adverse event
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 501 at risk

Adverse event: Cerebrovascular accident
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 501 at risk

Adverse event: Respiratory failure
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 2 affected / 501 at risk

Adverse event: New/worsening infection
Serious: yes
Organ System: Vascular disorders
Frequency: 1 affected / 501 at risk

Adverse event: New/worsening wound
Serious: yes
Organ System: Vascular disorders
Frequency: 5 affected / 501 at risk

Adverse event: Peripheral artery aneurysm
Serious: yes
Organ System: Vascular disorders
Frequency: 1 affected / 501 at risk

Adverse event: Peripheral artery restenosis
Serious: yes
Organ System: Vascular disorders
Frequency: 80 affected / 501 at risk

Adverse event: Peripheral artery stenosis
Serious: yes
Organ System: Vascular disorders
Frequency: 71 affected / 501 at risk

Adverse event: Arrhythmias
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 603 at risk

Adverse event: Cardiac dysfunction - Chronic heart failure or aggravated
Serious: yes
Organ System: Cardiac disorders
Frequency: 3 affected / 603 at risk

Adverse event: Cardiac/cardiopulmonary arrest
Serious: yes
Organ System: Cardiac disorders
Frequency: 4 affected / 603 at risk

Adverse event: Cardiomyopathy
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 603 at risk

Adverse event: Coronary artery disease
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 603 at risk

Adverse event: Myocardial infarction
Serious: yes
Organ System: Cardiac disorders
Frequency: 2 affected / 603 at risk

Adverse event: Neoplasm malignant
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 603 at risk

Adverse event: Death-unknown cause
Serious: yes
Organ System: General disorders
Frequency: 10 affected / 603 at risk

Adverse event: Infection-Systemic
Serious: yes
Organ System: General disorders
Frequency: 6 affected / 603 at risk

Adverse event: Multiple organ dysfunction syndrome
Serious: yes
Organ System: General disorders
Frequency: 2 affected / 603 at risk

Adverse event: Other adverse event
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 603 at risk

Adverse event: Cerebrovascular accident
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 603 at risk

Adverse event: Chronic renal failure or worsened
Serious: yes
Organ System: Renal and urinary disorders
Frequency: 4 affected / 603 at risk

Adverse event: Respiratory failure
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 2 affected / 603 at risk

Adverse event: Embolism, pulmonary
Serious: yes
Organ System: Vascular disorders
Frequency: 1 affected / 603 at risk

Adverse event: New/worsening infection
Serious: yes
Organ System: Vascular disorders
Frequency: 27 affected / 603 at risk

Adverse event: New/worsening pain
Serious: yes
Organ System: Vascular disorders
Frequency: 3 affected / 603 at risk

Adverse event: New/worsening wound
Serious: yes
Organ System: Vascular disorders
Frequency: 21 affected / 603 at risk

Adverse event: Other peripheral vascular disorder
Serious: yes
Organ System: Vascular disorders
Frequency: 1 affected / 603 at risk

Adverse event: Peripheral artery restenosis
Serious: yes
Organ System: Vascular disorders
Frequency: 131 affected / 603 at risk

Adverse event: Peripheral artery stenosis
Serious: yes
Organ System: Vascular disorders
Frequency: 129 affected / 603 at risk

Adverse event: Peripheral artery/vascular disease
Serious: yes
Organ System: Vascular disorders
Frequency: 2 affected / 603 at risk

Adverse event: Peripheral thrombus/thrombosis
Serious: yes
Organ System: Vascular disorders
Frequency: 2 affected / 603 at risk

Adverse event: Cardiac/cardiopulmonary arrest
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 100 at risk

Adverse event: Coronary artery disease
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 100 at risk

Adverse event: Myocardial infarction
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 100 at risk

Adverse event: Other cardiac
Serious: yes
Organ System: Cardiac disorders
Frequency: 2 affected / 100 at risk

Adverse event: Death-unknown cause
Serious: yes
Organ System: General disorders
Frequency: 7 affected / 100 at risk

Adverse event: Infection-Systemic
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 100 at risk

Adverse event: Multiple organ dysfunction syndrome
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 100 at risk

Adverse event: Bleeding/hemorrhage non-access site
Serious: yes
Organ System: Vascular disorders
Frequency: 1 affected / 100 at risk

Adverse event: New/worsening infection
Serious: yes
Organ System: Vascular disorders
Frequency: 9 affected / 100 at risk

Adverse event: New/worsening wound
Serious: yes
Organ System: Vascular disorders
Frequency: 11 affected / 100 at risk

Adverse event: Peripheral artery restenosis
Serious: yes
Organ System: Vascular disorders
Frequency: 18 affected / 100 at risk

Adverse event: Peripheral artery stenosis
Serious: yes
Organ System: Vascular disorders
Frequency: 11 affected / 100 at risk

Adverse event: Arrhythmias
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 501 at risk

Adverse event: Cardiac dysfunction - Chronic heart failure or aggravated
Serious: yes
Organ System: Cardiac disorders
Frequency: 3 affected / 501 at risk

Adverse event: Cardiac/cardiopulmonary arrest
Serious: yes
Organ System: Cardiac disorders
Frequency: 4 affected / 501 at risk

Adverse event: Coronary artery disease
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 501 at risk

Adverse event: Myocardial infarction
Serious: yes
Organ System: Cardiac disorders
Frequency: 2 affected / 501 at risk

Adverse event: Other cardiac
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 501 at risk

Adverse event: Other digestive disorders
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 501 at risk

Adverse event: Neoplasm malignant
Serious: yes
Organ System: General disorders
Frequency: 3 affected / 501 at risk

Adverse event: Death-unknown cause
Serious: yes
Organ System: General disorders
Frequency: 19 affected / 501 at risk

Adverse event: Infection-Systemic
Serious: yes
Organ System: General disorders
Frequency: 2 affected / 501 at risk

Adverse event: Injury/trauma
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 501 at risk

Adverse event: Multiple organ dysfunction syndrome
Serious: yes
Organ System: General disorders
Frequency: 4 affected / 501 at risk

Adverse event: Shock
Serious: yes
Organ System: General disorders
Frequency: 2 affected / 501 at risk

Adverse event: Encephalopathy
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 501 at risk

Adverse event: Cerebrovascular accident
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 501 at risk

Adverse event: Chronic renal failure or worsened
Serious: yes
Organ System: Renal and urinary disorders
Frequency: 2 affected / 501 at risk

Adverse event: Chronic obstructive pulmonary disease (COPD)
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 501 at risk

Adverse event: Pneumonia
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 501 at risk

Adverse event: Respiratory failure
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 501 at risk

Adverse event: Aortic aneurysm
Serious: yes
Organ System: Vascular disorders
Frequency: 1 affected / 501 at risk

Adverse event: Bleeding/hemorrhage non-access site
Serious: yes
Organ System: Vascular disorders
Frequency: 1 affected / 501 at risk

Adverse event: New/worsening infection
Serious: yes
Organ System: Vascular disorders
Frequency: 4 affected / 501 at risk

Adverse event: New/worsening pain
Serious: yes
Organ System: Vascular disorders
Frequency: 1 affected / 501 at risk

Adverse event: New/worsening wound
Serious: yes
Organ System: Vascular disorders
Frequency: 9 affected / 501 at risk

Adverse event: Peripheral artery aneurysm
Serious: yes
Organ System: Vascular disorders
Frequency: 1 affected / 501 at risk

Adverse event: Peripheral artery restenosis
Serious: yes
Organ System: Vascular disorders
Frequency: 85 affected / 501 at risk

Adverse event: Peripheral artery stenosis
Serious: yes
Organ System: Vascular disorders
Frequency: 76 affected / 501 at risk

Adverse event: Arrhythmias
Serious: yes
Organ System: Cardiac disorders
Frequency: 2 affected / 603 at risk

Adverse event: Cardiac dysfunction - Chronic heart failure or aggravated
Serious: yes
Organ System: Cardiac disorders
Frequency: 2 affected / 603 at risk

Adverse event: Cardiac/cardiopulmonary arrest
Serious: yes
Organ System: Cardiac disorders
Frequency: 9 affected / 603 at risk

Adverse event: Coronary artery disease
Serious: yes
Organ System: Cardiac disorders
Frequency: 2 affected / 603 at risk

Adverse event: Myocardial infarction
Serious: yes
Organ System: Cardiac disorders
Frequency: 4 affected / 603 at risk

Adverse event: Other cardiac
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 603 at risk

Adverse event: Neoplasm malignant
Serious: yes
Organ System: General disorders
Frequency: 6 affected / 603 at risk

Adverse event: Death-unknown cause
Serious: yes
Organ System: General disorders
Frequency: 23 affected / 603 at risk

Adverse event: Infection-Systemic
Serious: yes
Organ System: General disorders
Frequency: 4 affected / 603 at risk

Adverse event: Injury/trauma
Serious: yes
Organ System: General disorders
Frequency: 2 affected / 603 at risk

Adverse event: Multiple organ dysfunction syndrome
Serious: yes
Organ System: General disorders
Frequency: 5 affected / 603 at risk

Adverse event: Other adverse event
Serious: yes
Organ System: General disorders
Frequency: 3 affected / 603 at risk

Adverse event: Shock
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 603 at risk

Adverse event: Hepatic-biliary system disorders (e.g. liver, bile duct)
Serious: yes
Organ System: Hepatobiliary disorders
Frequency: 1 affected / 603 at risk

Adverse event: Cerebrovascular accident (CVA)
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 603 at risk

Adverse event: Haemorrhage intracranial
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 603 at risk

Adverse event: Cerebrovascular accident
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 603 at risk

Adverse event: Chronic renal failure or worsened
Serious: yes
Organ System: Renal and urinary disorders
Frequency: 6 affected / 603 at risk

Adverse event: Chronic obstructive pulmonary disease (COPD)
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 603 at risk

Adverse event: Respiratory failure
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 2 affected / 603 at risk

Adverse event: New/worsening infection
Serious: yes
Organ System: Vascular disorders
Frequency: 17 affected / 603 at risk

Adverse event: New/worsening pain
Serious: yes
Organ System: Vascular disorders
Frequency: 3 affected / 603 at risk

Adverse event: New/worsening wound
Serious: yes
Organ System: Vascular disorders
Frequency: 15 affected / 603 at risk

Adverse event: Peripheral artery restenosis
Serious: yes
Organ System: Vascular disorders
Frequency: 130 affected / 603 at risk

Adverse event: Peripheral artery stenosis
Serious: yes
Organ System: Vascular disorders
Frequency: 95 affected / 603 at risk

Adverse event: Peripheral artery/vascular disease
Serious: yes
Organ System: Vascular disorders
Frequency: 2 affected / 603 at risk

Adverse event: Peripheral thrombus/thrombosis
Serious: yes
Organ System: Vascular disorders
Frequency: 2 affected / 603 at risk

Adverse event: Cardiac dysfunction - Chronic heart failure or aggravated
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 100 at risk

Adverse event: Other cardiac
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 100 at risk

Adverse event: Compartment syndrome
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 100 at risk

Adverse event: Death-unknown cause
Serious: yes
Organ System: General disorders
Frequency: 4 affected / 100 at risk

Adverse event: Multiple organ dysfunction syndrome
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 100 at risk

Adverse event: Shock
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 100 at risk

Adverse event: New/worsening infection
Serious: yes
Organ System: Vascular disorders
Frequency: 4 affected / 100 at risk

Adverse event: New/worsening wound
Serious: yes
Organ System: Vascular disorders
Frequency: 2 affected / 100 at risk

Adverse event: Peripheral artery restenosis
Serious: yes
Organ System: Vascular disorders
Frequency: 10 affected / 100 at risk

Adverse event: Peripheral artery stenosis
Serious: yes
Organ System: Vascular disorders
Frequency: 4 affected / 100 at risk

Adverse event: Peripheral artery/vascular disease
Serious: yes
Organ System: Vascular disorders
Frequency: 1 affected / 100 at risk