Study: NCT00930813

Adverse event: Target lesion - Restinosis
Serious: yes
Organ System: Vascular disorders
Frequency: 13 affected / 49 at risk

Adverse event: Abscess
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 49 at risk

Adverse event: Access site complication: pseudo aneurysm
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 2 affected / 49 at risk

Adverse event: Acute coronary syndrome
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 49 at risk

Adverse event: Amputation
Serious: yes
Organ System: Surgical and medical procedures
Frequency: 1 affected / 49 at risk

Adverse event: Angina, stable
Serious: yes
Organ System: Cardiac disorders
Frequency: 3 affected / 49 at risk

Adverse event: Arrhythmia - Bradycardia
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 49 at risk

Adverse event: Arrhythmia - Other
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 49 at risk

Adverse event: Arrhytmia - Tachycardia
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 49 at risk

Adverse event: Battery depletion of pacemaker
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 49 at risk

Adverse event: Bleeding out of mouth and nose
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 49 at risk

Adverse event: Neoplasm malignant
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 2 affected / 49 at risk

Adverse event: Death (Cardiovascular)
Serious: yes
Organ System: Vascular disorders
Frequency: 1 affected / 49 at risk

Adverse event: Death (non-cardiac or neurological)
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 49 at risk

Adverse event: Diffuse bleeding on metatarsus
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 49 at risk

Adverse event: Fracture (bone)
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 49 at risk

Adverse event: Gastrointestinal haemorrhage
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 49 at risk

Adverse event: Gastrointestinal: other infectious / inflammatory
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 49 at risk

Adverse event: Inguinal hernia
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 49 at risk

Adverse event: Haematuria
Serious: yes
Organ System: Renal and urinary disorders
Frequency: 1 affected / 49 at risk

Adverse event: Hypertension
Serious: yes
Organ System: Renal and urinary disorders
Frequency: 1 affected / 49 at risk

Adverse event: Malfunction of the defibrillator
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 49 at risk

Adverse event: Myocardial infarction
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 49 at risk

Adverse event: Nausea
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 49 at risk

Adverse event: Not any healing of ulceration on right foot
Serious: yes
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 49 at risk

Adverse event: Patient fell down, pain in the back
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 49 at risk

Adverse event: Patient was injured during fall : bruise left hip
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 49 at risk

Adverse event: Persistent wound healing disorder
Serious: yes
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 49 at risk

Adverse event: Pneumonia
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 49 at risk

Adverse event: Sepsis
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 49 at risk

Adverse event: Stroke - ischemic
Serious: yes
Organ System: Cardiac disorders
Frequency: 2 affected / 49 at risk

Adverse event: Target vessel - Restenosis
Serious: yes
Organ System: Vascular disorders
Frequency: 2 affected / 49 at risk

Adverse event: Transient ischaemic attack
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 49 at risk

Adverse event: Vessel specific complication (not puncture site or target vessel): Arterial occlusion
Serious: yes
Organ System: Vascular disorders
Frequency: 4 affected / 49 at risk

Adverse event: Vessel specific complication (not puncture site or target vessel): Arterial thrombosis
Serious: yes
Organ System: Vascular disorders
Frequency: 1 affected / 49 at risk

Adverse event: Vessel specific complication (not puncture site or target vessel): Atherosclerosis
Serious: yes
Organ System: Vascular disorders
Frequency: 5 affected / 49 at risk

Adverse event: Vessel specific complication (not puncture site or target vessel): Embolism
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 49 at risk

Adverse event: Vessel specific complication (not puncture site or target vessel): Restenosis
Serious: yes
Organ System: Vascular disorders
Frequency: 9 affected / 49 at risk

Adverse event: Worseness of ulceration on amputation wound
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 49 at risk

Adverse event: Wound dehiscence after CABG
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 49 at risk

Adverse event: Wound infection after amputation of second toe
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 49 at risk

Adverse event: Access site complication: pseudo aneurysm
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 49 at risk

Adverse event: Access site complication: Hematoma/bleeding puncture site
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 4 affected / 49 at risk

Adverse event: Intermittent claudication
Serious: no
Organ System: Vascular disorders
Frequency: 4 affected / 49 at risk

Adverse event: Target lesion - Restenosis
Serious: no
Organ System: Vascular disorders
Frequency: 7 affected / 49 at risk

Adverse event: Vessel specific complication (not puncture site or target vessel): Atherosclerosis
Serious: no
Organ System: Vascular disorders
Frequency: 1 affected / 49 at risk

Adverse event: Target lesion - Restinosis
Serious: yes
Organ System: Vascular disorders
Frequency: 17 affected / 52 at risk

Adverse event: Access site complication: pseudo aneurysm
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 3 affected / 52 at risk

Adverse event: Acute coronary syndrome
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 52 at risk

Adverse event: Amputation
Serious: yes
Organ System: Surgical and medical procedures
Frequency: 1 affected / 52 at risk

Adverse event: Angina, stable
Serious: yes
Organ System: Cardiac disorders
Frequency: 2 affected / 52 at risk

Adverse event: Arrhythmia - Other
Serious: yes
Organ System: Cardiac disorders
Frequency: 2 affected / 52 at risk

Adverse event: Arrhytmia - Tachycardia
Serious: yes
Organ System: Cardiac disorders
Frequency: 2 affected / 52 at risk

Adverse event: Death (Cardiovascular)
Serious: yes
Organ System: Vascular disorders
Frequency: 1 affected / 52 at risk

Adverse event: Death (non-cardiac or neurological)
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 52 at risk

Adverse event: Gastrointestinal haemorrhage
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 52 at risk

Adverse event: Hypertension
Serious: yes
Organ System: Renal and urinary disorders
Frequency: 1 affected / 52 at risk

Adverse event: Myocardial infarction
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 52 at risk

Adverse event: Pneumonia
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 2 affected / 52 at risk

Adverse event: Sepsis
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 52 at risk

Adverse event: Target vessel - Restenosis
Serious: yes
Organ System: Vascular disorders
Frequency: 2 affected / 52 at risk

Adverse event: Vessel specific complication (not puncture site or target vessel): Arterial occlusion
Serious: yes
Organ System: Vascular disorders
Frequency: 6 affected / 52 at risk

Adverse event: Vessel specific complication (not puncture site or target vessel): Arterial thrombosis
Serious: yes
Organ System: Vascular disorders
Frequency: 2 affected / 52 at risk

Adverse event: Vessel specific complication (not puncture site or target vessel): Atherosclerosis
Serious: yes
Organ System: Vascular disorders
Frequency: 14 affected / 52 at risk

Adverse event: Vessel specific complication (not puncture site or target vessel): Restenosis
Serious: yes
Organ System: Vascular disorders
Frequency: 7 affected / 52 at risk

Adverse event: Access site complication: Arterial occlusion puncture site
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 2 affected / 52 at risk

Adverse event: Aggregate change of pacemaker
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 52 at risk

Adverse event: Anaemia
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 52 at risk

Adverse event: Arthralgia
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 52 at risk

Adverse event: Cardiogenic shock
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 52 at risk

Adverse event: Intermittent claudication
Serious: yes
Organ System: Vascular disorders
Frequency: 2 affected / 52 at risk

Adverse event: Colon cancer
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 1 affected / 52 at risk

Adverse event: Control coronary angiography
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 52 at risk

Adverse event: Defibrillator control
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 52 at risk

Adverse event: Dementia
Serious: yes
Organ System: Congenital, familial and genetic disorders
Frequency: 1 affected / 52 at risk

Adverse event: Depression
Serious: yes
Organ System: Psychiatric disorders
Frequency: 1 affected / 52 at risk

Adverse event: Dizziness / vertigo
Serious: yes
Organ System: Ear and labyrinth disorders
Frequency: 1 affected / 52 at risk

Adverse event: Dyspnoea
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 2 affected / 52 at risk

Adverse event: Fall from bed - urinary bladder infection
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 52 at risk

Adverse event: Gastritis
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 52 at risk

Adverse event: Hyperthyroidism
Serious: yes
Organ System: Endocrine disorders
Frequency: 1 affected / 52 at risk

Adverse event: Local infection
Serious: yes
Organ System: Infections and infestations
Frequency: 2 affected / 52 at risk

Adverse event: Target lesion - Occlusion / closure
Serious: yes
Organ System: Vascular disorders
Frequency: 3 affected / 52 at risk

Adverse event: Vessel specific complication (not puncture site or target vessel): Hematoma / bleeding
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 52 at risk

Adverse event: Wound lower leg with infection (MRSA) and maggots
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 52 at risk

Adverse event: Target lesion - Thrombus - in-lesion
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 52 at risk

Adverse event: Access site complication: pseudo aneurysm
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 3 affected / 52 at risk

Adverse event: Access site complication: Hematoma/bleeding puncture site
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 3 affected / 52 at risk

Adverse event: Intermittent claudication
Serious: no
Organ System: Vascular disorders
Frequency: 4 affected / 52 at risk

Adverse event: Hypertension
Serious: no
Organ System: Renal and urinary disorders
Frequency: 3 affected / 52 at risk

Adverse event: Target lesion - Dissection
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 4 affected / 52 at risk

Adverse event: Target lesion - Restenosis
Serious: no
Organ System: Vascular disorders
Frequency: 4 affected / 52 at risk

Adverse event: Vessel specific complication (not puncture site or target vessel): Atherosclerosis
Serious: no
Organ System: Vascular disorders
Frequency: 7 affected / 52 at risk