Study: NCT01118117

Adverse event: Anaemia
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 5 affected / 261 at risk

Adverse event: Acute coronary syndrome
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 261 at risk

Adverse event: Acute myocardial infarction
Serious: yes
Organ System: Cardiac disorders
Frequency: 6 affected / 261 at risk

Adverse event: Angina pectoris
Serious: yes
Organ System: Cardiac disorders
Frequency: 4 affected / 261 at risk

Adverse event: Angina unstable
Serious: yes
Organ System: Cardiac disorders
Frequency: 2 affected / 261 at risk

Adverse event: Atrial fibrillation
Serious: yes
Organ System: Cardiac disorders
Frequency: 3 affected / 261 at risk

Adverse event: Cardiac arrest
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 261 at risk

Adverse event: Cardiac failure chronic
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 261 at risk

Adverse event: Cardiac failure congestive
Serious: yes
Organ System: Cardiac disorders
Frequency: 5 affected / 261 at risk

Adverse event: Cardiogenic shock
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 261 at risk

Adverse event: Coronary artery disease
Serious: yes
Organ System: Cardiac disorders
Frequency: 7 affected / 261 at risk

Adverse event: Cyanosis
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 261 at risk

Adverse event: Myocardial infarction
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 261 at risk

Adverse event: Pericarditis constrictive
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 261 at risk

Adverse event: Ventricular extrasystoles
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 261 at risk

Adverse event: Ventricular fibrillation
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 261 at risk

Adverse event: Amaurosis fugax
Serious: yes
Organ System: Eye disorders
Frequency: 1 affected / 261 at risk

Adverse event: Cataract
Serious: yes
Organ System: Eye disorders
Frequency: 2 affected / 261 at risk

Adverse event: Abdominal pain
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 261 at risk

Adverse event: Colitis
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 261 at risk

Adverse event: Diverticulum
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 261 at risk

Adverse event: Enteritis
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 261 at risk

Adverse event: Gastric ulcer
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 261 at risk

Adverse event: Gastrointestinal haemorrhage
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 4 affected / 261 at risk

Adverse event: Hiatus hernia
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 261 at risk

Adverse event: Impaired gastric emptying
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 261 at risk

Adverse event: Intestinal ischaemia
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 261 at risk

Adverse event: Mesenteric Artery S'tenosis
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 261 at risk

Adverse event: Pancreatitis acute
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 261 at risk

Adverse event: Periodontitis
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 261 at risk

Adverse event: Retroperitoneal haemorrhage
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 261 at risk

Adverse event: Small intestinal obstruction
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 261 at risk

Adverse event: Asthenia
Serious: yes
Organ System: General disorders
Frequency: 2 affected / 261 at risk

Adverse event: Chest pain
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 261 at risk

Adverse event: Death
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 261 at risk

Adverse event: Device failure
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 261 at risk

Adverse event: Device Occllusion
Serious: yes
Organ System: General disorders
Frequency: 3 affected / 261 at risk

Adverse event: Generalised oedema
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 261 at risk

Adverse event: Malaise
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 261 at risk

Adverse event: Non-cardiac chest pain
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 261 at risk

Adverse event: Cholecystitis
Serious: yes
Organ System: Hepatobiliary disorders
Frequency: 1 affected / 261 at risk

Adverse event: Cholecystitis acute
Serious: yes
Organ System: Hepatobiliary disorders
Frequency: 1 affected / 261 at risk

Adverse event: Hyperbilirubinaemia
Serious: yes
Organ System: Hepatobiliary disorders
Frequency: 1 affected / 261 at risk

Adverse event: Appendicitis
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 261 at risk

Adverse event: Appendicitis perforated
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 261 at risk

Adverse event: Bronchitis
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 261 at risk

Adverse event: Cellulitis
Serious: yes
Organ System: Infections and infestations
Frequency: 4 affected / 261 at risk

Adverse event: Cholecystitis infective
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 261 at risk

Adverse event: Diverticulitis
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 261 at risk

Adverse event: Gangrene
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 261 at risk

Adverse event: Gastroenteritis
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 261 at risk

Adverse event: Graft infection
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 261 at risk

Adverse event: Nasopharyngitis
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 261 at risk

Adverse event: Osteomyelitis
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 261 at risk

Adverse event: Pneumonia
Serious: yes
Organ System: Infections and infestations
Frequency: 6 affected / 261 at risk

Adverse event: Postoperative wound infection
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 261 at risk

Adverse event: Sepsis
Serious: yes
Organ System: Infections and infestations
Frequency: 2 affected / 261 at risk

Adverse event: Septic shock
Serious: yes
Organ System: Infections and infestations
Frequency: 2 affected / 261 at risk

Adverse event: Urinary tract infection
Serious: yes
Organ System: Infections and infestations
Frequency: 2 affected / 261 at risk

Adverse event: Wound infection
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 261 at risk

Adverse event: Arterial restenosis
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 4 affected / 261 at risk

Adverse event: Coronary artery restenosis
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 261 at risk

Adverse event: Femoral neck fracture
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 261 at risk

Adverse event: Hip fracture
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 261 at risk

Adverse event: Peripheral artery restenosis
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 30 affected / 261 at risk

Adverse event: Renal haematoma
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 261 at risk

Adverse event: Toxicity to various agents
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 261 at risk

Adverse event: Vascular pseudoaneurysm
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 2 affected / 261 at risk

Adverse event: Wrist fracture
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 261 at risk

Adverse event: Pulse absent
Serious: yes
Organ System: Investigations
Frequency: 1 affected / 261 at risk

Adverse event: Decreased appetite
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 261 at risk

Adverse event: Dehydration
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 261 at risk

Adverse event: Hyperglycaemia
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 261 at risk

Adverse event: Hypoglycaemia
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 261 at risk

Adverse event: Back pain
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 261 at risk

Adverse event: Osteoarthritis
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 2 affected / 261 at risk

Adverse event: Pain in extremity
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 4 affected / 261 at risk

Adverse event: Spondylolisthesis
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 261 at risk

Adverse event: Benign pancreatic neoplasm
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 1 affected / 261 at risk

Adverse event: Bladder neoplasm
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 1 affected / 261 at risk

Adverse event: Hepatic cancer
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 2 affected / 261 at risk

Adverse event: Lung adenocarcinoma
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 1 affected / 261 at risk

Adverse event: Lung neoplasm malignant
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 1 affected / 261 at risk

Adverse event: Balance disorder
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 261 at risk

Adverse event: Brain stem stroke
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 261 at risk

Adverse event: Carotid artery stenosis
Serious: yes
Organ System: Nervous system disorders
Frequency: 3 affected / 261 at risk

Adverse event: Carotic Artery Disease
Serious: yes
Organ System: Nervous system disorders
Frequency: 2 affected / 261 at risk

Adverse event: Cerbral haemorrhage
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 261 at risk

Adverse event: Cerbral Infarction
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 261 at risk

Adverse event: Seizure
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 261 at risk

Adverse event: Dizziness
Serious: yes
Organ System: Nervous system disorders
Frequency: 2 affected / 261 at risk

Adverse event: Cerebrovascular accident
Serious: yes
Organ System: Nervous system disorders
Frequency: 3 affected / 261 at risk

Adverse event: Essential tremor
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 261 at risk

Adverse event: Lacunar infarction
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 261 at risk

Adverse event: Metabolic encephalopathy
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 261 at risk

Adverse event: Sciatica
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 261 at risk

Adverse event: Spondylitic myelopathy
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 261 at risk

Adverse event: Syncope
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 261 at risk

Adverse event: Transient ischaemic attack
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 261 at risk

Adverse event: Mental status changes
Serious: yes
Organ System: Psychiatric disorders
Frequency: 2 affected / 261 at risk

Adverse event: Haematuria
Serious: yes
Organ System: Renal and urinary disorders
Frequency: 1 affected / 261 at risk

Adverse event: Renal artery stenosis
Serious: yes
Organ System: Renal and urinary disorders
Frequency: 1 affected / 261 at risk

Adverse event: Acute kidney injury
Serious: yes
Organ System: Renal and urinary disorders
Frequency: 7 affected / 261 at risk

Adverse event: Acute respiratory failure
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 261 at risk

Adverse event: Chronic obstructive pulmonary disease
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 3 affected / 261 at risk

Adverse event: Dyspnoea
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 261 at risk

Adverse event: Pneumonia aspiration
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 261 at risk

Adverse event: Pneumonitis
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 261 at risk

Adverse event: Pneumothorax
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 261 at risk

Adverse event: Pulmonary hypertension
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 261 at risk

Adverse event: Pulmonary oedema
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 261 at risk

Adverse event: Respiratory failure
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 2 affected / 261 at risk

Adverse event: Skin ulcer
Serious: yes
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 261 at risk

Adverse event: Arterial thrombosis
Serious: yes
Organ System: Vascular disorders
Frequency: 1 affected / 261 at risk

Adverse event: Arteriosclerosis
Serious: yes
Organ System: Vascular disorders
Frequency: 1 affected / 261 at risk

Adverse event: Extremity necrosis
Serious: yes
Organ System: Vascular disorders
Frequency: 1 affected / 261 at risk

Adverse event: Femoral artery dissection
Serious: yes
Organ System: Vascular disorders
Frequency: 1 affected / 261 at risk

Adverse event: Peripheral artery occlusion
Serious: yes
Organ System: Vascular disorders
Frequency: 4 affected / 261 at risk

Adverse event: Haematoma
Serious: yes
Organ System: Vascular disorders
Frequency: 1 affected / 261 at risk

Adverse event: Hypertension
Serious: yes
Organ System: Vascular disorders
Frequency: 4 affected / 261 at risk

Adverse event: Hypertensive emergency
Serious: yes
Organ System: Vascular disorders
Frequency: 1 affected / 261 at risk

Adverse event: Hypotension
Serious: yes
Organ System: Vascular disorders
Frequency: 4 affected / 261 at risk

Adverse event: Iliac artery occlusion
Serious: yes
Organ System: Vascular disorders
Frequency: 2 affected / 261 at risk

Adverse event: Intermittent claudication
Serious: yes
Organ System: Vascular disorders
Frequency: 15 affected / 261 at risk

Adverse event: Ischaemic limb pain
Serious: yes
Organ System: Vascular disorders
Frequency: 1 affected / 261 at risk

Adverse event: Peripheral Artercy Occlusive Disease
Serious: yes
Organ System: Vascular disorders
Frequency: 2 affected / 261 at risk

Adverse event: Peripheral artery stenosis
Serious: yes
Organ System: Vascular disorders
Frequency: 11 affected / 261 at risk

Adverse event: Peripheral embolism
Serious: yes
Organ System: Vascular disorders
Frequency: 1 affected / 261 at risk

Adverse event: Peripheral ischaemia
Serious: yes
Organ System: Vascular disorders
Frequency: 1 affected / 261 at risk

Adverse event: Peripheral vascular disorder
Serious: yes
Organ System: Vascular disorders
Frequency: 5 affected / 261 at risk

Adverse event: Subclavian artery stenosis
Serious: yes
Organ System: Vascular disorders
Frequency: 1 affected / 261 at risk

Adverse event: Vascular pseudoaneurysm
Serious: yes
Organ System: Vascular disorders
Frequency: 1 affected / 261 at risk

Adverse event: Anaemia
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 13 affected / 261 at risk

Adverse event: Peripheral artery restenosis
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 41 affected / 261 at risk

Adverse event: Back pain
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 21 affected / 261 at risk

Adverse event: Pain in Exteremity
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 14 affected / 261 at risk

Adverse event: Haematoma
Serious: no
Organ System: Vascular disorders
Frequency: 13 affected / 261 at risk

Adverse event: Hypertension
Serious: no
Organ System: Vascular disorders
Frequency: 22 affected / 261 at risk

Adverse event: Intermittent claudication
Serious: no
Organ System: Vascular disorders
Frequency: 27 affected / 261 at risk

Adverse event: Peripheral artery stenosis
Serious: no
Organ System: Vascular disorders
Frequency: 16 affected / 261 at risk

Adverse event: Right Lower Extremity Pain
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 15 at risk

Adverse event: Post Dilatation Dissection
Serious: no
Organ System: Vascular disorders
Frequency: 1 affected / 15 at risk

Adverse event: Non-cardiac chest pain
Serious: no
Organ System: General disorders
Frequency: 1 affected / 15 at risk

Adverse event: Nausea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 15 at risk

Adverse event: Allergy to Vancomycin
Serious: no
Organ System: Immune system disorders
Frequency: 1 affected / 15 at risk

Adverse event: Rash-waist to knees
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 15 at risk

Adverse event: Renal artery stenosis
Serious: no
Organ System: Renal and urinary disorders
Frequency: 1 affected / 15 at risk

Adverse event: Burning Right Leg
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 15 at risk

Adverse event: bilateral leg cramps
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 15 at risk

Adverse event: hypertension post-procedure
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 15 at risk