Study: NCT01937351

Adverse event: Clinically Driven Target Lesion Revascularization
Serious: yes
Organ System: Vascular disorders
Frequency: 10 affected / 134 at risk

Adverse event: Myocardial infarction
Serious: yes
Organ System: Cardiac disorders
Frequency: 3 affected / 134 at risk

Adverse event: Clinically Driven Target Vessel Revascularization
Serious: yes
Organ System: Vascular disorders
Frequency: 2 affected / 134 at risk

Adverse event: Access Site Complication
Serious: yes
Organ System: Surgical and medical procedures
Frequency: 3 affected / 134 at risk

Adverse event: Bleeding (other than access site)
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 3 affected / 134 at risk

Adverse event: Hypotension, sustained
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 134 at risk

Adverse event: Infection
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 134 at risk

Adverse event: Loss of distal collateral flow
Serious: yes
Organ System: Vascular disorders
Frequency: 1 affected / 134 at risk

Adverse event: Pain, new onset or worsening from baseline
Serious: yes
Organ System: Vascular disorders
Frequency: 3 affected / 134 at risk

Adverse event: Perforation, NHLBI Type I or II
Serious: yes
Organ System: Surgical and medical procedures
Frequency: 1 affected / 134 at risk

Adverse event: Emboli requiring intervention to resolve acutely
Serious: yes
Organ System: Vascular disorders
Frequency: 3 affected / 134 at risk

Adverse event: Vessel dissection, Grade C or greater
Serious: yes
Organ System: Vascular disorders
Frequency: 3 affected / 134 at risk

Adverse event: Pseudoaneurysm defined as device related disruption of the arterial wall
Serious: yes
Organ System: Vascular disorders
Frequency: 2 affected / 134 at risk

Adverse event: Vessel dissection, Grade A or B
Serious: yes
Organ System: Surgical and medical procedures
Frequency: 4 affected / 134 at risk

Adverse event: Thrombosis
Serious: yes
Organ System: Vascular disorders
Frequency: 1 affected / 134 at risk

Adverse event: Unplanned Limb Amputation (Minor or Non-Target Limb)
Serious: yes
Organ System: Surgical and medical procedures
Frequency: 1 affected / 134 at risk

Adverse event: Other, Abrasion/Cellutitis (R) UE
Serious: yes
Organ System: Vascular disorders
Frequency: 1 affected / 134 at risk

Adverse event: Other, Acute Bronchitis
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 134 at risk

Adverse event: Bronchitis
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 134 at risk

Adverse event: Acute kidney injury
Serious: yes
Organ System: Renal and urinary disorders
Frequency: 2 affected / 134 at risk

Adverse event: Acute on Chronic Anemia
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 134 at risk

Adverse event: Acute on Chronic Kidney Injury
Serious: yes
Organ System: Renal and urinary disorders
Frequency: 1 affected / 134 at risk

Adverse event: Acute on Chronic Systolic Congestive Heart Failure Exacerbation
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 134 at risk

Adverse event: Acute Renal Failure (CR 1.06)
Serious: yes
Organ System: Renal and urinary disorders
Frequency: 1 affected / 134 at risk

Adverse event: Altered Mental Status Due to Hypoglycemia
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 134 at risk

Adverse event: Atrial fibrillation
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 134 at risk

Adverse event: Atypical Chest Pain
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 134 at risk

Adverse event: Bradycardia
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 134 at risk

Adverse event: BTK PAD RLE
Serious: yes
Organ System: Vascular disorders
Frequency: 1 affected / 134 at risk

Adverse event: Burn to Left Heel
Serious: yes
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 134 at risk

Adverse event: Chest pain
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 134 at risk

Adverse event: Chest Pain Syndrome of Unknown Etiology
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 134 at risk

Adverse event: Cardiac failure congestive
Serious: yes
Organ System: Cardiac disorders
Frequency: 2 affected / 134 at risk

Adverse event: Community Acquired RUL Pneumonia
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 134 at risk

Adverse event: Osteoarthritis
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 134 at risk

Adverse event: Left ventricular failure
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 134 at risk

Adverse event: Difficulty Swallowing
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 134 at risk

Adverse event: Dyspnoea
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 134 at risk

Adverse event: Dyspnea on Extertion
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 134 at risk

Adverse event: Episodic Atrial Fibrillation
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 134 at risk

Adverse event: Gangrenous Changes to Bilateral Metatarsals
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 134 at risk

Adverse event: Head Trauma S/P Substantial Fall
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 134 at risk

Adverse event: Hypertensive crisis
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 134 at risk

Adverse event: Hypoglycaemia
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 134 at risk

Adverse event: Hypokalaemia
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 134 at risk

Adverse event: Intermittent Chest Discomfort
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 134 at risk

Adverse event: Intervention Of Contralateral Leg
Serious: yes
Organ System: Vascular disorders
Frequency: 1 affected / 134 at risk

Adverse event: Left Patella Fracture
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 134 at risk

Adverse event: Mild Leukocytosis
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 134 at risk

Adverse event: Multiple organ dysfunction syndrome
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 134 at risk

Adverse event: Nausea
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 134 at risk

Adverse event: Non Target Revascularization
Serious: yes
Organ System: Vascular disorders
Frequency: 1 affected / 134 at risk

Adverse event: Acute myocardial infarction
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 134 at risk

Adverse event: PAD-LSFA
Serious: yes
Organ System: Vascular disorders
Frequency: 1 affected / 134 at risk

Adverse event: Pain - Right Upper Chest
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 134 at risk

Adverse event: Pneumonia
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 134 at risk

Adverse event: Poor Healing Bilateral TMA Wounds Including Infection and Dehiscence
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 134 at risk

Adverse event: Pseudoaneurysm at Non-Index Procedure
Serious: yes
Organ System: Vascular disorders
Frequency: 1 affected / 134 at risk

Adverse event: Reperfusion Edema
Serious: yes
Organ System: Vascular disorders
Frequency: 1 affected / 134 at risk

Adverse event: Respiratory failure
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 134 at risk

Adverse event: Right Anterior Tibia Hematoma
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 134 at risk

Adverse event: Right Leg Ischemia
Serious: yes
Organ System: Vascular disorders
Frequency: 1 affected / 134 at risk

Adverse event: RLE Abscess on Shin
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 134 at risk

Adverse event: Septic Schock
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 134 at risk

Adverse event: Shortness of Breath Due to Influenza A
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 134 at risk

Adverse event: Stenosis Contralateral (Right) Leg
Serious: yes
Organ System: Vascular disorders
Frequency: 1 affected / 134 at risk

Adverse event: Stenosis of Left Common Fem Artery Following Procedure
Serious: yes
Organ System: Vascular disorders
Frequency: 1 affected / 134 at risk

Adverse event: TIA Before Admission
Serious: yes
Organ System: Surgical and medical procedures
Frequency: 1 affected / 134 at risk

Adverse event: Ulcer Right Heel
Serious: yes
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 134 at risk

Adverse event: Unplanned, Nontarget Limb Intervention
Serious: yes
Organ System: Surgical and medical procedures
Frequency: 1 affected / 134 at risk

Adverse event: Urinary Retension
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 134 at risk

Adverse event: Urinary tract infection
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 134 at risk

Adverse event: Vomiting
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 134 at risk

Adverse event: Pain, New Onset or Worsening from Baseline
Serious: no
Organ System: General disorders
Frequency: 14 affected / 22 at risk

Adverse event: Access Site Complication
Serious: no
Organ System: Surgical and medical procedures
Frequency: 8 affected / 22 at risk