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IN.PACT Global Clinical Study

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT01609296
Recruitment Status : Active, not recruiting
First Posted : May 31, 2012
Results First Posted : January 28, 2019
Last Update Posted : February 15, 2019
Sponsor:
Information provided by (Responsible Party):
Medtronic Endovascular

Study Type Interventional
Study Design Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition Peripheral Arterial Disease
Intervention Device: IN.PACT Admiral™ Drug Eluting Balloon
Enrollment 1535
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Clinical Cohort 12M
Hide Arm/Group Description [Not Specified]
Period Title: Overall Study
Started 1406
Completed 1286
Not Completed 120
Reason Not Completed
Death             49
Withdrawal by Subject             71
Arm/Group Title Clinical Cohort 12M
Hide Arm/Group Description [Not Specified]
Overall Number of Baseline Participants 1406
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 1406 participants
68.6  (10.1)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 1406 participants
Female
453
  32.2%
Male
953
  67.8%
1.Primary Outcome
Title Primary Endpoint Clinical Cohort
Hide Description Freedom from clinically-driven target lesion revascularization (TLR) within 12 months post-index procedure, which is defined as: • Any re-intervention within the target lesion(s) due to symptoms or drop of ABI ≥ 20% or > 0.15 when compared to post-index procedure baseline ABI.
Time Frame 12 months
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Clinical Cohort 12M
Hide Arm/Group Description:
[Not Specified]
Overall Number of Participants Analyzed 1311
Measure Type: Count of Participants
Unit of Measure: Participants
1213
  92.5%
2.Primary Outcome
Title Primary Safety Endpoint
Hide Description A composite of freedom from device- and procedure-related mortality through 30 days, freedom from major target limb amputation and TLR within 12 months post-index procedure.
Time Frame 12 months
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Clinical Cohort 12M
Hide Arm/Group Description:
[Not Specified]
Overall Number of Participants Analyzed 1311
Measure Type: Count of Participants
Unit of Measure: Participants
1207
  92.1%
3.Secondary Outcome
Title MAEs
Hide Description MAE (Major Adverse Events)is defined as all-cause mortality, clinically-driven TVR (Target Vessel Revascularization), major target limb amputation, thrombosis at the target lesion site.
Time Frame 12 months
Hide Outcome Measure Data
Hide Analysis Population Description
Event rates are based on number of evaluable subjects – subjects with at least one MAE event within 360-day or subjects without any MAE event but had at least 300 days of clinical follow-up.
Arm/Group Title Clinical Cohort 12M
Hide Arm/Group Description:
[Not Specified]
Overall Number of Participants Analyzed 1311
Measure Type: Count of Participants
Unit of Measure: Participants
All MAE
157
  12.0%
All cause death
46
   3.5%
CD-TVR
106
   8.1%
Major Limb amputation
3
   0.2%
Thrombosis
38
   2.9%
4.Secondary Outcome
Title TLR
Hide Description Any Target lesion revascularisation
Time Frame 12 months
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Clinical Cohort 12M
Hide Arm/Group Description:
[Not Specified]
Overall Number of Participants Analyzed 1311
Measure Type: Count of Participants
Unit of Measure: Participants
102
   7.8%
5.Secondary Outcome
Title TVR
Hide Description Any Target vessel revascularisation
Time Frame 12 months.
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Clinical Cohort 12M
Hide Arm/Group Description:
[Not Specified]
Overall Number of Participants Analyzed 1311
Measure Type: Count of Participants
Unit of Measure: Participants
110
   8.4%
6.Secondary Outcome
Title Primary Sustained Clinical Improvement
Hide Description Primary sustained clinical improvement is defined as sustained upward shift of at least 1 category on Rutherford classification as compared to baseline without the need for repeated TLR or surgical revascularization in amputation-free surviving subjects.
Time Frame 12 months.
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Clinical Cohort 12M
Hide Arm/Group Description:
[Not Specified]
Overall Number of Participants Analyzed 1183
Measure Type: Count of Participants
Unit of Measure: Participants
953
  80.6%
7.Secondary Outcome
Title Device Success
Hide Description Device success is defined as successful delivery, balloon inflation and deflation and retrieval of the intact study device without burst below the rated burst pressure (RBP)
Time Frame Index-procedure
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Clinical Cohort 12M
Hide Arm/Group Description:
[Not Specified]
Overall Number of Participants Analyzed 1406
Overall Number of Units Analyzed
Type of Units Analyzed: Admiral™ Drug-Eluting Balloon
3002
Count of Units
Unit of Measure: Admiral™ Drug-Eluting Balloon
2984
8.Secondary Outcome
Title Clinical Success
Hide Description Clinical success is defined as procedural success without procedural complications (mortality, major target limb amputation, thrombosis of the target lesion, or TVR) prior to discharge
Time Frame prior to discharge
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Clinical Cohort 12M
Hide Arm/Group Description:
[Not Specified]
Overall Number of Participants Analyzed 1396
Measure Type: Count of Participants
Unit of Measure: Participants
1379
  98.8%
Time Frame 12 Months
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Clinical Cohort 12M
Hide Arm/Group Description [Not Specified]
All-Cause Mortality
Clinical Cohort 12M
Affected / at Risk (%)
Total   46/1406 (3.27%)    
Show Serious Adverse Events Hide Serious Adverse Events
Clinical Cohort 12M
Affected / at Risk (%) # Events
Total   634/1406 (45.09%)    
Blood and lymphatic system disorders   
Anaemia  7/1406 (0.50%)  7
Haemorrhagic Anaemia  2/1406 (0.14%)  2
Iron Deficiency Anaemia  1/1406 (0.07%)  1
Leukocytosis  1/1406 (0.07%)  1
Cardiac disorders   
Acute Myocardial Infarction  17/1406 (1.21%)  17
Angina Pectoris  7/1406 (0.50%)  7
Angina Unstable  9/1406 (0.64%)  9
Aortic Valve Stenosis  3/1406 (0.21%)  4
Arteriosclerosis Coronary Artery  1/1406 (0.07%)  1
Atrial Fibrillation  11/1406 (0.78%)  11
Atrial Flutter  3/1406 (0.21%)  3
Atrial Thrombosis  1/1406 (0.07%)  1
Atrioventricular Block  1/1406 (0.07%)  1
Atrioventricular Block Complete  1/1406 (0.07%)  1
Bradycardia  3/1406 (0.21%)  3
Cardiac Arrest  4/1406 (0.28%)  4
Cardiac Failure  13/1406 (0.92%)  16
Cardiac Failure Congestive  1/1406 (0.07%)  1
Cardiac Tamponade  1/1406 (0.07%)  1
Cardiac Valve Disease  1/1406 (0.07%)  1
Cardiogenic Shock  1/1406 (0.07%)  1
Cardiopulmonary Failure  1/1406 (0.07%)  1
Congestive Cardiomyopathy  1/1406 (0.07%)  1
Coronary Artery Disease  16/1406 (1.14%)  18
Coronary Artery Occlusion  2/1406 (0.14%)  2
Coronary Artery Stenosis  6/1406 (0.43%)  7
Hypertensive Cardiomyopathy  1/1406 (0.07%)  1
Hypertensive Heart Disease  1/1406 (0.07%)  1
Intracardiac Thrombus  1/1406 (0.07%)  1
Ischaemic Cardiomyopathy  2/1406 (0.14%)  2
Left Ventricular Failure  1/1406 (0.07%)  1
Myocardial Infarction  6/1406 (0.43%)  6
Myocardial Ischaemia  3/1406 (0.21%)  3
Pericardial Effusion  1/1406 (0.07%)  1
Sick Sinus Syndrome  1/1406 (0.07%)  1
Sinus Bradycardia  1/1406 (0.07%)  1
Trifascicular Block  1/1406 (0.07%)  1
Ventricle Rupture  1/1406 (0.07%)  1
Ventricular Tachycardia  1/1406 (0.07%)  1
Congenital, familial and genetic disorders   
Congenital Cystic Kidney Disease  1/1406 (0.07%)  1
Thalassaemia Beta  1/1406 (0.07%)  1
Ear and labyrinth disorders   
Vertigo  4/1406 (0.28%)  4
Endocrine disorders   
Goitre  1/1406 (0.07%)  1
Eye disorders   
Amaurosis Fugax  1/1406 (0.07%)  1
Blindness Unilateral  1/1406 (0.07%)  1
Cataract  7/1406 (0.50%)  11
Retinal Artery Occlusion  1/1406 (0.07%)  1
Visual Impairment  2/1406 (0.14%)  3
Gastrointestinal disorders   
Abdominal Discomfort  1/1406 (0.07%)  1
Abdominal Pain  1/1406 (0.07%)  1
Abdominal Pain Lower  1/1406 (0.07%)  1
Abdominal Pain Upper  1/1406 (0.07%)  1
Abdominal Wall Haematoma  1/1406 (0.07%)  1
Colitis  1/1406 (0.07%)  1
Constipation  1/1406 (0.07%)  1
Dental Caries  1/1406 (0.07%)  1
Duodenal Ulcer  1/1406 (0.07%)  1
Gastric Haemorrhage  1/1406 (0.07%)  1
Gastric Ulcer  1/1406 (0.07%)  1
Gastric Ulcer Haemorrhage  1/1406 (0.07%)  1
Gastritis  2/1406 (0.14%)  2
Gastritis Erosive  1/1406 (0.07%)  1
Gastroduodenal Ulcer  1/1406 (0.07%)  1
Gastrointestinal Haemorrhage  7/1406 (0.50%)  7
Haematochezia  1/1406 (0.07%)  1
Inguinal Hernia  3/1406 (0.21%)  3
Intestinal Ischaemia  1/1406 (0.07%)  1
Intestinal Polyp  2/1406 (0.14%)  2
Mesenteric Artery Stenosis  1/1406 (0.07%)  1
Oesophageal Haemorrhage  1/1406 (0.07%)  1
Pancreatitis Acute  2/1406 (0.14%)  2
Reflux Oesophagitis  1/1406 (0.07%)  1
Retroperitoneal Haemorrhage  2/1406 (0.14%)  2
Subileus  2/1406 (0.14%)  2
Umbilical Hernia  1/1406 (0.07%)  1
General disorders   
Asthenia  2/1406 (0.14%)  2
Cardiac Death  1/1406 (0.07%)  1
Chest Discomfort  1/1406 (0.07%)  1
Chest Pain  7/1406 (0.50%)  7
Death  12/1406 (0.85%)  12
Device Breakage  1/1406 (0.07%)  1
Device Lead Damage  1/1406 (0.07%)  1
Device Occlusion  4/1406 (0.28%)  4
Euthanasia  1/1406 (0.07%)  1
Exercise Tolerance Decreased  1/1406 (0.07%)  1
Impaired Healing  7/1406 (0.50%)  10
Infusion Site Extravasation  1/1406 (0.07%)  1
Ischaemic Ulcer  1/1406 (0.07%)  1
Malaise  1/1406 (0.07%)  1
Oedema Peripheral  2/1406 (0.14%)  2
Pain  1/1406 (0.07%)  1
Sudden Cardiac Death  1/1406 (0.07%)  1
Thrombosis In Device  1/1406 (0.07%)  1
Ulcer  1/1406 (0.07%)  1
Vessel Puncture Site Discharge  1/1406 (0.07%)  1
Vessel Puncture Site Haematoma  13/1406 (0.92%)  13
Vessel Puncture Site Haemorrhage  5/1406 (0.36%)  5
Vessel Puncture Site Reaction  1/1406 (0.07%)  1
Hepatobiliary disorders   
Acute Hepatic Failure  1/1406 (0.07%)  1
Cholangitis  1/1406 (0.07%)  1
Cholecystitis  1/1406 (0.07%)  1
Cholelithiasis  1/1406 (0.07%)  1
Hepatic Cirrhosis  1/1406 (0.07%)  1
Liver Disorder  1/1406 (0.07%)  1
Immune system disorders   
Anaphylactic Reaction  1/1406 (0.07%)  1
Infections and infestations   
Abscess  1/1406 (0.07%)  1
Appendicitis  1/1406 (0.07%)  1
Appendicitis Perforated  1/1406 (0.07%)  1
Bone Abscess  1/1406 (0.07%)  1
Bronchitis  2/1406 (0.14%)  2
Bronchopneumonia  1/1406 (0.07%)  1
Cellulitis  5/1406 (0.36%)  5
Clostridium Difficile Colitis  1/1406 (0.07%)  1
Diverticulitis  2/1406 (0.14%)  2
Endocarditis  1/1406 (0.07%)  1
Erysipelas  5/1406 (0.36%)  5
Gangrene  8/1406 (0.57%)  8
Gastroenteritis Viral  1/1406 (0.07%)  1
Graft Infection  1/1406 (0.07%)  1
Groin Abscess  2/1406 (0.14%)  2
Groin Infection  1/1406 (0.07%)  1
Infected Skin Ulcer  1/1406 (0.07%)  1
Infection  1/1406 (0.07%)  1
Localised Infection  2/1406 (0.14%)  2
Necrotising Fasciitis  2/1406 (0.14%)  2
Osteomyelitis  2/1406 (0.14%)  2
Osteomyelitis Chronic  1/1406 (0.07%)  1
Periorbital Cellulitis  1/1406 (0.07%)  1
Peritoneal Abscess  1/1406 (0.07%)  1
Pilonidal Cyst  1/1406 (0.07%)  1
Pneumonia  20/1406 (1.42%)  21
Postoperative Wound Infection  1/1406 (0.07%)  1
Pseudomembranous Colitis  1/1406 (0.07%)  1
Pulmonary Sepsis  1/1406 (0.07%)  1
Sepsis  1/1406 (0.07%)  1
Urinary Tract Infection  1/1406 (0.07%)  1
Wound Infection  3/1406 (0.21%)  3
Wound Infection Staphylococcal  2/1406 (0.14%)  3
Injury, poisoning and procedural complications   
Ankle Fracture  1/1406 (0.07%)  1
Arterial Injury  4/1406 (0.28%)  4
Arterial Restenosis  27/1406 (1.92%)  29
Arteriovenous Fistula Site Haemorrhage  1/1406 (0.07%)  1
Chemical Peritonitis  1/1406 (0.07%)  1
Concussion  1/1406 (0.07%)  1
Coronary Artery Restenosis  1/1406 (0.07%)  2
Fall  3/1406 (0.21%)  3
Foot Fracture  1/1406 (0.07%)  1
Hip Fracture  1/1406 (0.07%)  1
Humerus Fracture  1/1406 (0.07%)  2
In-Stent Arterial Restenosis  32/1406 (2.28%)  35
In-Stent Coronary Artery Restenosis  1/1406 (0.07%)  1
Incisional Hernia  1/1406 (0.07%)  1
Meniscus Lesion  3/1406 (0.21%)  3
Peripheral Arterial Reocclusion  18/1406 (1.28%)  19
Post Laminectomy Syndrome  1/1406 (0.07%)  1
Post Procedural Swelling  1/1406 (0.07%)  1
Procedural Complication  1/1406 (0.07%)  1
Procedural Pain  1/1406 (0.07%)  1
Procedural Site Reaction  1/1406 (0.07%)  1
Pubis Fracture  1/1406 (0.07%)  1
Radius Fracture  1/1406 (0.07%)  1
Shunt Malfunction  1/1406 (0.07%)  2
Skin Laceration  1/1406 (0.07%)  1
Spinal Fracture  1/1406 (0.07%)  1
Thermal Burn  1/1406 (0.07%)  1
Thoracic Vertebral Fracture  1/1406 (0.07%)  1
Traumatic Haematoma  1/1406 (0.07%)  1
Upper Limb Fracture  1/1406 (0.07%)  1
Vascular Bypass Dysfunction  1/1406 (0.07%)  1
Vascular Graft Occlusion  5/1406 (0.36%)  7
Vascular Pseudoaneurysm  23/1406 (1.64%)  23
Wound  1/1406 (0.07%)  1
Wound Complication  1/1406 (0.07%)  1
Investigations   
Blood Creatinine Increased  1/1406 (0.07%)  1
Blood Glucose Fluctuation  1/1406 (0.07%)  1
C-Reactive Protein Increased  1/1406 (0.07%)  1
Haemoglobin Decreased  1/1406 (0.07%)  1
International Normalised Ratio Increased  2/1406 (0.14%)  2
Metabolism and nutrition disorders   
Decreased Appetite  1/1406 (0.07%)  1
Diabetes Mellitus  2/1406 (0.14%)  2
Diabetic Foot  4/1406 (0.28%)  4
Fluid Overload  1/1406 (0.07%)  1
Gout  2/1406 (0.14%)  2
Hypoglycaemia  2/1406 (0.14%)  2
Hypokalaemia  3/1406 (0.21%)  3
Hyponatraemia  2/1406 (0.14%)  2
Musculoskeletal and connective tissue disorders   
Arthralgia  3/1406 (0.21%)  3
Arthritis  2/1406 (0.14%)  2
Arthropathy  1/1406 (0.07%)  1
Back Pain  8/1406 (0.57%)  8
Bursitis  1/1406 (0.07%)  1
Dupuytren's Contracture  1/1406 (0.07%)  1
Foot Deformity  2/1406 (0.14%)  2
Gouty Arthritis  1/1406 (0.07%)  1
Groin Pain  1/1406 (0.07%)  1
Intervertebral Disc Protrusion  5/1406 (0.36%)  5
Lumbar Spinal Stenosis  3/1406 (0.21%)  3
Musculoskeletal Disorder  1/1406 (0.07%)  1
Musculoskeletal Pain  1/1406 (0.07%)  1
Myofascial Pain Syndrome  1/1406 (0.07%)  1
Neck Pain  1/1406 (0.07%)  1
Osteoarthritis  5/1406 (0.36%)  5
Osteonecrosis  1/1406 (0.07%)  1
Pain In Extremity  11/1406 (0.78%)  12
Polymyositis  1/1406 (0.07%)  1
Rotator Cuff Syndrome  2/1406 (0.14%)  2
Soft Tissue Necrosis  1/1406 (0.07%)  1
Spinal Column Stenosis  2/1406 (0.14%)  2
Spondylolisthesis  1/1406 (0.07%)  1
Systemic Sclerosis  1/1406 (0.07%)  1
Tenosynovitis  1/1406 (0.07%)  1
Neoplasms benign, malignant and unspecified (incl cysts and polyps)   
Basal Cell Carcinoma  3/1406 (0.21%)  3
Bladder Cancer  1/1406 (0.07%)  1
Bladder Papilloma  1/1406 (0.07%)  1
Breast Cancer  2/1406 (0.14%)  2
Carcinoid Tumour Of The Caecum  1/1406 (0.07%)  1
Cervix Neoplasm  1/1406 (0.07%)  1
Colon Adenoma  1/1406 (0.07%)  1
Colon Cancer  1/1406 (0.07%)  1
Gastric Cancer  1/1406 (0.07%)  1
Laryngeal Cancer  2/1406 (0.14%)  2
Lung Adenocarcinoma  1/1406 (0.07%)  1
Lung Cancer Metastatic  1/1406 (0.07%)  1
Lung Carcinoma Cell Type Unspecified Stage 0  1/1406 (0.07%)  1
Lung Neoplasm  2/1406 (0.14%)  2
Lung Neoplasm Malignant  2/1406 (0.14%)  2
Malignant Neoplasm Progression  1/1406 (0.07%)  1
Neoplasm Malignant  1/1406 (0.07%)  1
Neoplasm Skin  1/1406 (0.07%)  1
Non-Hodgkin's Lymphoma Stage Iv  1/1406 (0.07%)  1
Oesophageal Carcinoma  1/1406 (0.07%)  1
Prostate Cancer  1/1406 (0.07%)  1
Prostate Cancer Recurrent  1/1406 (0.07%)  1
Rectal Cancer  1/1406 (0.07%)  1
Respiratory Tract Neoplasm  1/1406 (0.07%)  1
Small Cell Lung Cancer Stage Unspecified  1/1406 (0.07%)  1
Squamous Cell Carcinoma  3/1406 (0.21%)  3
Undifferentiated Sarcoma  1/1406 (0.07%)  1
Nervous system disorders   
Basal Ganglia Infarction  1/1406 (0.07%)  1
Brain Oedema  1/1406 (0.07%)  1
Carotid Artery Stenosis  7/1406 (0.50%)  7
Carpal Tunnel Syndrome  2/1406 (0.14%)  3
Cerebral Artery Occlusion  1/1406 (0.07%)  1
Cerebral Haemorrhage  1/1406 (0.07%)  1
Cerebral Infarction  1/1406 (0.07%)  1
Cerebrovascular Accident  7/1406 (0.50%)  7
Complex Partial Seizures  1/1406 (0.07%)  1
Dementia  1/1406 (0.07%)  1
Dementia Alzheimer's Type  1/1406 (0.07%)  1
Facial Palsy  2/1406 (0.14%)  2
Hemiparesis  2/1406 (0.14%)  2
Intracranial Aneurysm  1/1406 (0.07%)  1
Metabolic Encephalopathy  1/1406 (0.07%)  1
Myoclonus  1/1406 (0.07%)  1
Paraesthesia  1/1406 (0.07%)  1
Sciatica  2/1406 (0.14%)  2
Spinal Claudication  1/1406 (0.07%)  1
Subarachnoid Haemorrhage  1/1406 (0.07%)  1
Syncope  5/1406 (0.36%)  5
Thoracic Outlet Syndrome  1/1406 (0.07%)  1
Transient Ischaemic Attack  1/1406 (0.07%)  1
Vascular Encephalopathy  1/1406 (0.07%)  1
Psychiatric disorders   
Alcohol Withdrawal Syndrome  1/1406 (0.07%)  1
Anxiety  1/1406 (0.07%)  1
Disorientation  2/1406 (0.14%)  3
Mood Disorder Due To A General Medical Condition  1/1406 (0.07%)  1
Panic Attack  1/1406 (0.07%)  1
Renal and urinary disorders   
Azotaemia  1/1406 (0.07%)  1
Bladder Tamponade  1/1406 (0.07%)  1
Haematuria  2/1406 (0.14%)  2
Nephrolithiasis  1/1406 (0.07%)  1
Renal Artery Stenosis  1/1406 (0.07%)  1
Renal Colic  1/1406 (0.07%)  1
Renal Failure  2/1406 (0.14%)  2
Renal Failure Acute  3/1406 (0.21%)  3
Renal Failure Chronic  1/1406 (0.07%)  1
Urinary Retention  1/1406 (0.07%)  1
Reproductive system and breast disorders   
Benign Prostatic Hyperplasia  1/1406 (0.07%)  1
Endometrial Hypertrophy  1/1406 (0.07%)  1
Pelvic Haematoma  1/1406 (0.07%)  1
Postmenopausal Haemorrhage  2/1406 (0.14%)  2
Uterine Polyp  1/1406 (0.07%)  1
Respiratory, thoracic and mediastinal disorders   
Acute Pulmonary Oedema  1/1406 (0.07%)  1
Asthma  1/1406 (0.07%)  1
Chronic Obstructive Pulmonary Disease  2/1406 (0.14%)  3
Dyspnoea  6/1406 (0.43%)  6
Dyspnoea Exertional  1/1406 (0.07%)  1
Epiglottic Oedema  1/1406 (0.07%)  1
Epistaxis  2/1406 (0.14%)  2
Hyperventilation  1/1406 (0.07%)  1
Laryngeal Leukoplakia  2/1406 (0.14%)  2
Pleural Effusion  4/1406 (0.28%)  4
Pneumonia Aspiration  1/1406 (0.07%)  1
Pulmonary Oedema  1/1406 (0.07%)  1
Respiratory Arrest  1/1406 (0.07%)  2
Respiratory Failure  1/1406 (0.07%)  1
Skin and subcutaneous tissue disorders   
Dermatitis Exfoliative  1/1406 (0.07%)  1
Dry Gangrene  1/1406 (0.07%)  1
Eczema  1/1406 (0.07%)  1
Leukoplakia  1/1406 (0.07%)  1
Skin Ulcer  7/1406 (0.50%)  8
Surgical and medical procedures   
Arterial Stent Insertion  1/1406 (0.07%)  1
Arteriovenous Fistula Operation  1/1406 (0.07%)  1
Cardiac Pacemaker Battery Replacement  1/1406 (0.07%)  1
Coronary Artery Bypass  1/1406 (0.07%)  1
Ileostomy Closure  1/1406 (0.07%)  1
Leg Amputation  1/1406 (0.07%)  1
Medical Device Removal  1/1406 (0.07%)  1
Peripheral Artery Angioplasty  1/1406 (0.07%)  1
Surgery  2/1406 (0.14%)  2
Toe Amputation  1/1406 (0.07%)  1
Vitrectomy  1/1406 (0.07%)  1
Vascular disorders   
Aortic Aneurysm  1/1406 (0.07%)  1
Aortic Stenosis  1/1406 (0.07%)  1
Arterial Haemorrhage  3/1406 (0.21%)  3
Arterial Occlusive Disease  2/1406 (0.14%)  2
Arterial Rupture  1/1406 (0.07%)  1
Arterial Spasm  1/1406 (0.07%)  1
Arterial Stenosis  3/1406 (0.21%)  3
Arterial Stenosis Limb  21/1406 (1.49%)  21
Arterial Thrombosis  3/1406 (0.21%)  3
Arterial Thrombosis Limb  19/1406 (1.35%)  22
Arteriosclerosis Obliterans  3/1406 (0.21%)  4
Arteriovenous Fistula  1/1406 (0.07%)  1
Artery Dissection  1/1406 (0.07%)  1
Embolism  1/1406 (0.07%)  1
Extremity Necrosis  2/1406 (0.14%)  2
Femoral Arterial Stenosis  99/1406 (7.04%)  113
Femoral Artery Aneurysm  1/1406 (0.07%)  1
Femoral Artery Dissection  2/1406 (0.14%)  2
Femoral Artery Embolism  1/1406 (0.07%)  1
Femoral Artery Occlusion  44/1406 (3.13%)  49
Haematoma  9/1406 (0.64%)  9
Haemorrhage  1/1406 (0.07%)  1
Hypertension  4/1406 (0.28%)  5
Hypertensive Crisis  2/1406 (0.14%)  2
Iliac Artery Occlusion  3/1406 (0.21%)  3
Iliac Artery Stenosis  18/1406 (1.28%)  20
Intermittent Claudication  37/1406 (2.63%)  40
Ischaemic Limb Pain  3/1406 (0.21%)  3
Lymphocele  1/1406 (0.07%)  1
Necrosis Ischaemic  1/1406 (0.07%)  1
Orthostatic Hypotension  1/1406 (0.07%)  1
Peripheral Arterial Occlusive Disease  53/1406 (3.77%)  57
Peripheral Artery Aneurysm  1/1406 (0.07%)  1
Peripheral Artery Dissection  1/1406 (0.07%)  1
Peripheral Embolism  11/1406 (0.78%)  11
Peripheral Ischaemia  18/1406 (1.28%)  22
Peripheral Vascular Disorder  1/1406 (0.07%)  1
Steal Syndrome  1/1406 (0.07%)  1
Subclavian Artery Occlusion  1/1406 (0.07%)  2
Subclavian Artery Stenosis  2/1406 (0.14%)  2
Thromboangiitis Obliterans  1/1406 (0.07%)  1
Varicose Vein  2/1406 (0.14%)  2
Vascular Stenosis  2/1406 (0.14%)  2
Venous Thrombosis  1/1406 (0.07%)  1
Vessel Perforation  1/1406 (0.07%)  1
1
Term from vocabulary, MedDRA (13.0)
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Clinical Cohort 12M
Affected / at Risk (%) # Events
Total   0/1406 (0.00%)    
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
Name/Title: Kristel Wittebols Clinical Research Director
Organization: Medtronic
Phone: +31433566580
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Medtronic Endovascular
ClinicalTrials.gov Identifier: NCT01609296     History of Changes
Other Study ID Numbers: 10048613
First Submitted: May 24, 2012
First Posted: May 31, 2012
Results First Submitted: May 4, 2017
Results First Posted: January 28, 2019
Last Update Posted: February 15, 2019