Trial Outcomes & Findings for Evaluation of the Valiant Mona LSA Thoracic Stent Graft System in Descending TAA and Chronic Dissections (NCT NCT02365467)
NCT ID: NCT02365467
Last Updated: 2025-08-17
Results Overview
Within 1 month (Day 0 - Day 30) from the index procedure, composite endpoint consisting of: * Aorta Related Mortality * Stroke * Paraplegia * Left Arm/Hand Ischemia
Recruitment status
COMPLETED
Target enrollment
32 participants
Primary outcome timeframe
1 month
Results posted on
2025-08-17
Participant Flow
A total of 32 subjects were enrolled in the study. 30 enrolled subjects were implanted with the study device. The 30-day primary endpoint was evaluated when 29 subjects completed the 30-day follow-up.
Participant milestones
| Measure |
Endovascular Repair
Subjects who were appropriate candidates for endovascular repair of the Descending Thoracic Aorta (DTA) who require coverage of the left subclavian artery (LSA) and who met the inclusion and exclusion criteria.
|
|---|---|
|
Overall Study
STARTED
|
32
|
|
Overall Study
Implanted
|
30
|
|
Overall Study
COMPLETED
|
29
|
|
Overall Study
NOT COMPLETED
|
3
|
Reasons for withdrawal
| Measure |
Endovascular Repair
Subjects who were appropriate candidates for endovascular repair of the Descending Thoracic Aorta (DTA) who require coverage of the left subclavian artery (LSA) and who met the inclusion and exclusion criteria.
|
|---|---|
|
Overall Study
Death
|
3
|
Baseline Characteristics
Evaluation of the Valiant Mona LSA Thoracic Stent Graft System in Descending TAA and Chronic Dissections
Baseline characteristics by cohort
| Measure |
Endovascular Repair
n=32 Participants
Subjects who were appropriate candidates for endovascular repair of the Descending Thoracic Aorta (DTA) who require coverage of the left subclavian artery (LSA) and who met the inclusion and exclusion criteria.
|
|---|---|
|
Age, Continuous
|
69.44 years
STANDARD_DEVIATION 10.45 • n=5 Participants
|
|
Sex: Female, Male
Female
|
18 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
14 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Black or African-American
|
5 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Caucasian
|
26 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Asian
|
1 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
32 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 1 monthPopulation: The analysis was performed on all enrolled subjects who were considered evaluable. The subjects were considered enrolled after arterial access is achieved and the Valiant Mona LSA Thoracic Stent Graft System was introduced into the vasculature. Subjects were evaluable if they had the event, or did not have the event and completed a follow-up 15 days or more after the index procedure.
Within 1 month (Day 0 - Day 30) from the index procedure, composite endpoint consisting of: * Aorta Related Mortality * Stroke * Paraplegia * Left Arm/Hand Ischemia
Outcome measures
| Measure |
Endovascular Repair
n=30 Participants
Subjects who were appropriate candidates for endovascular repair of the Descending Thoracic Aorta (DTA) who require coverage of the left subclavian artery (LSA) and who met the inclusion and exclusion criteria.
|
|---|---|
|
30 Day Composite Safety Endpoint
|
10.0 percentage of participants
Interval 2.1 to 26.5
|
PRIMARY outcome
Timeframe: 1 monthPopulation: The analysis was performed on all enrolled subjects who were considered evaluable. There were 3 patients who were not evaluable because they did not have the event and were missing at least one of the three components (technical success, successful exclusion at 30 days, or maintaining patency at the 30 day visit).
Treatment success which is defined as technical success (the successful delivery and deployment of the Valiant Mona LSA Thoracic Stent Graft System in the planned location with no unintentional coverage of other vessels, assessed intra-operatively, and the removal of the delivery system) and successful exclusion of the aneurysm or false lumen while maintaining patency of the Main Stent Graft and Branch Stent Graft at 30 day visit. This endpoint is site reported.
Outcome measures
| Measure |
Endovascular Repair
n=29 Participants
Subjects who were appropriate candidates for endovascular repair of the Descending Thoracic Aorta (DTA) who require coverage of the left subclavian artery (LSA) and who met the inclusion and exclusion criteria.
|
|---|---|
|
30 Day Treatment Success
|
62.1 percentage of participants
Interval 42.3 to 79.3
|
Adverse Events
Endovascular Repair
Serious events: 30 serious events
Other events: 27 other events
Deaths: 9 deaths
Serious adverse events
| Measure |
Endovascular Repair
n=32 participants at risk
Subjects who were appropriate candidates for endovascular repair of the Descending Thoracic Aorta (DTA) who require coverage of the left subclavian artery (LSA) and who met the inclusion and exclusion criteria.
|
|---|---|
|
Blood and lymphatic system disorders
Anaemia
|
6.2%
2/32 • Adverse Events and All-Cause Mortality through 5 years (05DEC2024)
|
|
Blood and lymphatic system disorders
Blood Loss Anaemia
|
6.2%
2/32 • Adverse Events and All-Cause Mortality through 5 years (05DEC2024)
|
|
Blood and lymphatic system disorders
Iron Deficiency Anaemia
|
3.1%
1/32 • Adverse Events and All-Cause Mortality through 5 years (05DEC2024)
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
3.1%
1/32 • Adverse Events and All-Cause Mortality through 5 years (05DEC2024)
|
|
Cardiac disorders
Acute Myocardial Infarction
|
6.2%
2/32 • Adverse Events and All-Cause Mortality through 5 years (05DEC2024)
|
|
Cardiac disorders
Atrial Fibrillation
|
15.6%
5/32 • Adverse Events and All-Cause Mortality through 5 years (05DEC2024)
|
|
Cardiac disorders
Cardiac Arrest
|
3.1%
1/32 • Adverse Events and All-Cause Mortality through 5 years (05DEC2024)
|
|
Cardiac disorders
Cardiac Failure Congestive
|
6.2%
2/32 • Adverse Events and All-Cause Mortality through 5 years (05DEC2024)
|
|
Cardiac disorders
Coronary Artery Disease
|
3.1%
1/32 • Adverse Events and All-Cause Mortality through 5 years (05DEC2024)
|
|
Cardiac disorders
Coronary Artery Stenosis
|
3.1%
1/32 • Adverse Events and All-Cause Mortality through 5 years (05DEC2024)
|
|
Cardiac disorders
Ventricular Fibrillation
|
6.2%
2/32 • Adverse Events and All-Cause Mortality through 5 years (05DEC2024)
|
|
Congenital, familial and genetic disorders
Gastrointestinal Arteriovenous Malformation
|
3.1%
1/32 • Adverse Events and All-Cause Mortality through 5 years (05DEC2024)
|
|
Congenital, familial and genetic disorders
Haemorrhagic Arteriovenous Malformation
|
3.1%
1/32 • Adverse Events and All-Cause Mortality through 5 years (05DEC2024)
|
|
Ear and labyrinth disorders
Vertigo
|
3.1%
1/32 • Adverse Events and All-Cause Mortality through 5 years (05DEC2024)
|
|
Gastrointestinal disorders
Abdominal Pain
|
3.1%
1/32 • Adverse Events and All-Cause Mortality through 5 years (05DEC2024)
|
|
Gastrointestinal disorders
Abdominal Pain Upper
|
3.1%
1/32 • Adverse Events and All-Cause Mortality through 5 years (05DEC2024)
|
|
Gastrointestinal disorders
Gastrointestinal Haemorrhage
|
3.1%
1/32 • Adverse Events and All-Cause Mortality through 5 years (05DEC2024)
|
|
Gastrointestinal disorders
Ileus
|
6.2%
2/32 • Adverse Events and All-Cause Mortality through 5 years (05DEC2024)
|
|
Gastrointestinal disorders
Upper Gastrointestinal Haemorrhage
|
6.2%
2/32 • Adverse Events and All-Cause Mortality through 5 years (05DEC2024)
|
|
General disorders
Chest Pain
|
6.2%
2/32 • Adverse Events and All-Cause Mortality through 5 years (05DEC2024)
|
|
General disorders
Death
|
3.1%
1/32 • Adverse Events and All-Cause Mortality through 5 years (05DEC2024)
|
|
General disorders
Non-Cardiac Chest Pain
|
3.1%
1/32 • Adverse Events and All-Cause Mortality through 5 years (05DEC2024)
|
|
General disorders
Stent-Graft Endoleak
|
9.4%
3/32 • Adverse Events and All-Cause Mortality through 5 years (05DEC2024)
|
|
General disorders
Sudden Cardiac Death
|
3.1%
1/32 • Adverse Events and All-Cause Mortality through 5 years (05DEC2024)
|
|
General disorders
Systemic Inflammatory Response Syndrome
|
3.1%
1/32 • Adverse Events and All-Cause Mortality through 5 years (05DEC2024)
|
|
Immune system disorders
Transplant Rejection
|
3.1%
1/32 • Adverse Events and All-Cause Mortality through 5 years (05DEC2024)
|
|
Infections and infestations
Appendicitis Perforated
|
3.1%
1/32 • Adverse Events and All-Cause Mortality through 5 years (05DEC2024)
|
|
Infections and infestations
Breast Abscess
|
3.1%
1/32 • Adverse Events and All-Cause Mortality through 5 years (05DEC2024)
|
|
Infections and infestations
Clostridium Difficile Infection
|
3.1%
1/32 • Adverse Events and All-Cause Mortality through 5 years (05DEC2024)
|
|
Infections and infestations
Enterococcal Bacteraemia
|
3.1%
1/32 • Adverse Events and All-Cause Mortality through 5 years (05DEC2024)
|
|
Infections and infestations
Folliculitis
|
3.1%
1/32 • Adverse Events and All-Cause Mortality through 5 years (05DEC2024)
|
|
Infections and infestations
Furuncle
|
3.1%
1/32 • Adverse Events and All-Cause Mortality through 5 years (05DEC2024)
|
|
Infections and infestations
Influenza
|
3.1%
1/32 • Adverse Events and All-Cause Mortality through 5 years (05DEC2024)
|
|
Infections and infestations
Meningitis Bacterial
|
3.1%
1/32 • Adverse Events and All-Cause Mortality through 5 years (05DEC2024)
|
|
Infections and infestations
Pneumonia
|
12.5%
4/32 • Adverse Events and All-Cause Mortality through 5 years (05DEC2024)
|
|
Infections and infestations
Postoperative Wound Infection
|
6.2%
2/32 • Adverse Events and All-Cause Mortality through 5 years (05DEC2024)
|
|
Infections and infestations
Urinary Tract Infection
|
6.2%
2/32 • Adverse Events and All-Cause Mortality through 5 years (05DEC2024)
|
|
Infections and infestations
Vascular Access Site Infection
|
3.1%
1/32 • Adverse Events and All-Cause Mortality through 5 years (05DEC2024)
|
|
Injury, poisoning and procedural complications
Anaemia Postoperative
|
6.2%
2/32 • Adverse Events and All-Cause Mortality through 5 years (05DEC2024)
|
|
Injury, poisoning and procedural complications
Arterial Injury
|
3.1%
1/32 • Adverse Events and All-Cause Mortality through 5 years (05DEC2024)
|
|
Injury, poisoning and procedural complications
Femoral Neck Fracture
|
3.1%
1/32 • Adverse Events and All-Cause Mortality through 5 years (05DEC2024)
|
|
Injury, poisoning and procedural complications
Hip Fracture
|
3.1%
1/32 • Adverse Events and All-Cause Mortality through 5 years (05DEC2024)
|
|
Injury, poisoning and procedural complications
Post Procedural Haemorrhage
|
3.1%
1/32 • Adverse Events and All-Cause Mortality through 5 years (05DEC2024)
|
|
Injury, poisoning and procedural complications
Procedural Haemorrhage
|
3.1%
1/32 • Adverse Events and All-Cause Mortality through 5 years (05DEC2024)
|
|
Injury, poisoning and procedural complications
Vascular Access Site Complication
|
3.1%
1/32 • Adverse Events and All-Cause Mortality through 5 years (05DEC2024)
|
|
Injury, poisoning and procedural complications
Vascular Access Site Haematoma
|
3.1%
1/32 • Adverse Events and All-Cause Mortality through 5 years (05DEC2024)
|
|
Injury, poisoning and procedural complications
Vascular Access Site Haemorrhage
|
3.1%
1/32 • Adverse Events and All-Cause Mortality through 5 years (05DEC2024)
|
|
Injury, poisoning and procedural complications
Vascular Access Site Pseudoaneurysm
|
3.1%
1/32 • Adverse Events and All-Cause Mortality through 5 years (05DEC2024)
|
|
Injury, poisoning and procedural complications
Wound Secretion
|
3.1%
1/32 • Adverse Events and All-Cause Mortality through 5 years (05DEC2024)
|
|
Investigations
Troponin Increased
|
3.1%
1/32 • Adverse Events and All-Cause Mortality through 5 years (05DEC2024)
|
|
Metabolism and nutrition disorders
Dehydration
|
3.1%
1/32 • Adverse Events and All-Cause Mortality through 5 years (05DEC2024)
|
|
Metabolism and nutrition disorders
Hypervolaemia
|
3.1%
1/32 • Adverse Events and All-Cause Mortality through 5 years (05DEC2024)
|
|
Metabolism and nutrition disorders
Hypokalaemia
|
3.1%
1/32 • Adverse Events and All-Cause Mortality through 5 years (05DEC2024)
|
|
Musculoskeletal and connective tissue disorders
Osteoarthritis
|
3.1%
1/32 • Adverse Events and All-Cause Mortality through 5 years (05DEC2024)
|
|
Nervous system disorders
Cerebral Haematoma
|
3.1%
1/32 • Adverse Events and All-Cause Mortality through 5 years (05DEC2024)
|
|
Nervous system disorders
Cerebrovascular Accident
|
3.1%
1/32 • Adverse Events and All-Cause Mortality through 5 years (05DEC2024)
|
|
Nervous system disorders
Headache
|
3.1%
1/32 • Adverse Events and All-Cause Mortality through 5 years (05DEC2024)
|
|
Nervous system disorders
Hydrocephalus
|
3.1%
1/32 • Adverse Events and All-Cause Mortality through 5 years (05DEC2024)
|
|
Nervous system disorders
Ischaemic Stroke
|
3.1%
1/32 • Adverse Events and All-Cause Mortality through 5 years (05DEC2024)
|
|
Nervous system disorders
Normal Pressure Hydrocephalus
|
3.1%
1/32 • Adverse Events and All-Cause Mortality through 5 years (05DEC2024)
|
|
Nervous system disorders
Seizure
|
3.1%
1/32 • Adverse Events and All-Cause Mortality through 5 years (05DEC2024)
|
|
Nervous system disorders
Syncope
|
3.1%
1/32 • Adverse Events and All-Cause Mortality through 5 years (05DEC2024)
|
|
Nervous system disorders
Transient Ischaemic Attack
|
3.1%
1/32 • Adverse Events and All-Cause Mortality through 5 years (05DEC2024)
|
|
Psychiatric disorders
Anxiety
|
3.1%
1/32 • Adverse Events and All-Cause Mortality through 5 years (05DEC2024)
|
|
Psychiatric disorders
Confusional State
|
3.1%
1/32 • Adverse Events and All-Cause Mortality through 5 years (05DEC2024)
|
|
Psychiatric disorders
Delirium
|
3.1%
1/32 • Adverse Events and All-Cause Mortality through 5 years (05DEC2024)
|
|
Renal and urinary disorders
Acute Kidney Injury
|
9.4%
3/32 • Adverse Events and All-Cause Mortality through 5 years (05DEC2024)
|
|
Reproductive system and breast disorders
Breast Haematoma
|
3.1%
1/32 • Adverse Events and All-Cause Mortality through 5 years (05DEC2024)
|
|
Respiratory, thoracic and mediastinal disorders
Asthma
|
3.1%
1/32 • Adverse Events and All-Cause Mortality through 5 years (05DEC2024)
|
|
Respiratory, thoracic and mediastinal disorders
Bronchiectasis
|
3.1%
1/32 • Adverse Events and All-Cause Mortality through 5 years (05DEC2024)
|
|
Respiratory, thoracic and mediastinal disorders
Chronic Obstructive Pulmonary Disease
|
9.4%
3/32 • Adverse Events and All-Cause Mortality through 5 years (05DEC2024)
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory Failure
|
3.1%
1/32 • Adverse Events and All-Cause Mortality through 5 years (05DEC2024)
|
|
Skin and subcutaneous tissue disorders
Skin Ulcer
|
3.1%
1/32 • Adverse Events and All-Cause Mortality through 5 years (05DEC2024)
|
|
Surgical and medical procedures
Lymphadenectomy
|
3.1%
1/32 • Adverse Events and All-Cause Mortality through 5 years (05DEC2024)
|
|
Surgical and medical procedures
Peripheral Endarterectomy
|
3.1%
1/32 • Adverse Events and All-Cause Mortality through 5 years (05DEC2024)
|
|
Vascular disorders
Aneurysm
|
3.1%
1/32 • Adverse Events and All-Cause Mortality through 5 years (05DEC2024)
|
|
Vascular disorders
Aortic Aneurysm
|
12.5%
4/32 • Adverse Events and All-Cause Mortality through 5 years (05DEC2024)
|
|
Vascular disorders
Aortic Aneurysm Rupture
|
3.1%
1/32 • Adverse Events and All-Cause Mortality through 5 years (05DEC2024)
|
|
Vascular disorders
Aortic Dissection
|
3.1%
1/32 • Adverse Events and All-Cause Mortality through 5 years (05DEC2024)
|
|
Vascular disorders
Aortic Dissection Rupture
|
3.1%
1/32 • Adverse Events and All-Cause Mortality through 5 years (05DEC2024)
|
|
Vascular disorders
Haematoma
|
3.1%
1/32 • Adverse Events and All-Cause Mortality through 5 years (05DEC2024)
|
|
Vascular disorders
Haemorrhage
|
3.1%
1/32 • Adverse Events and All-Cause Mortality through 5 years (05DEC2024)
|
|
Vascular disorders
Hypertension
|
3.1%
1/32 • Adverse Events and All-Cause Mortality through 5 years (05DEC2024)
|
|
Vascular disorders
Hypertensive Emergency
|
3.1%
1/32 • Adverse Events and All-Cause Mortality through 5 years (05DEC2024)
|
|
Vascular disorders
Iliac Artery Dissection
|
6.2%
2/32 • Adverse Events and All-Cause Mortality through 5 years (05DEC2024)
|
|
Vascular disorders
Jugular Vein Thrombosis
|
3.1%
1/32 • Adverse Events and All-Cause Mortality through 5 years (05DEC2024)
|
|
Vascular disorders
Peripheral Arterial Occlusive Disease
|
3.1%
1/32 • Adverse Events and All-Cause Mortality through 5 years (05DEC2024)
|
|
Vascular disorders
Peripheral Artery Thrombosis
|
9.4%
3/32 • Adverse Events and All-Cause Mortality through 5 years (05DEC2024)
|
|
Vascular disorders
Peripheral Ischaemia
|
3.1%
1/32 • Adverse Events and All-Cause Mortality through 5 years (05DEC2024)
|
|
Vascular disorders
Thrombosis
|
3.1%
1/32 • Adverse Events and All-Cause Mortality through 5 years (05DEC2024)
|
|
Vascular disorders
Peripheral Artery Dissection
|
3.1%
1/32 • Adverse Events and All-Cause Mortality through 5 years (05DEC2024)
|
|
General disorders
Asthenia
|
3.1%
1/32 • Adverse Events and All-Cause Mortality through 5 years (05DEC2024)
|
|
Respiratory, thoracic and mediastinal disorders
Acute Respiratory Failure
|
6.2%
2/32 • Adverse Events and All-Cause Mortality through 5 years (05DEC2024)
|
|
Cardiac disorders
Dilated Cardiomyopathy
|
3.1%
1/32 • Adverse Events and All-Cause Mortality through 5 years (05DEC2024)
|
|
Infections and infestations
Tooth Abscess
|
3.1%
1/32 • Adverse Events and All-Cause Mortality through 5 years (05DEC2024)
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Renal Cancer
|
3.1%
1/32 • Adverse Events and All-Cause Mortality through 5 years (05DEC2024)
|
|
Injury, poisoning and procedural complications
Ankle Fracture
|
3.1%
1/32 • Adverse Events and All-Cause Mortality through 5 years (05DEC2024)
|
Other adverse events
| Measure |
Endovascular Repair
n=32 participants at risk
Subjects who were appropriate candidates for endovascular repair of the Descending Thoracic Aorta (DTA) who require coverage of the left subclavian artery (LSA) and who met the inclusion and exclusion criteria.
|
|---|---|
|
Blood and lymphatic system disorders
Anaemia
|
15.6%
5/32 • Adverse Events and All-Cause Mortality through 5 years (05DEC2024)
|
|
Blood and lymphatic system disorders
Blood Loss Anaemia
|
3.1%
1/32 • Adverse Events and All-Cause Mortality through 5 years (05DEC2024)
|
|
Blood and lymphatic system disorders
Heparin-Induced Thrombocytopenia
|
3.1%
1/32 • Adverse Events and All-Cause Mortality through 5 years (05DEC2024)
|
|
Blood and lymphatic system disorders
Iron Deficiency Anaemia
|
3.1%
1/32 • Adverse Events and All-Cause Mortality through 5 years (05DEC2024)
|
|
Blood and lymphatic system disorders
Leukocytosis
|
6.2%
2/32 • Adverse Events and All-Cause Mortality through 5 years (05DEC2024)
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
3.1%
1/32 • Adverse Events and All-Cause Mortality through 5 years (05DEC2024)
|
|
Cardiac disorders
Angina Pectoris
|
3.1%
1/32 • Adverse Events and All-Cause Mortality through 5 years (05DEC2024)
|
|
Cardiac disorders
Angina Unstable
|
3.1%
1/32 • Adverse Events and All-Cause Mortality through 5 years (05DEC2024)
|
|
Cardiac disorders
Atrial Fibrillation
|
3.1%
1/32 • Adverse Events and All-Cause Mortality through 5 years (05DEC2024)
|
|
Cardiac disorders
Atrial Tachycardia
|
3.1%
1/32 • Adverse Events and All-Cause Mortality through 5 years (05DEC2024)
|
|
Cardiac disorders
Bradycardia
|
6.2%
2/32 • Adverse Events and All-Cause Mortality through 5 years (05DEC2024)
|
|
Cardiac disorders
Cardiac Failure Chronic
|
3.1%
1/32 • Adverse Events and All-Cause Mortality through 5 years (05DEC2024)
|
|
Cardiac disorders
Cardiomegaly
|
3.1%
1/32 • Adverse Events and All-Cause Mortality through 5 years (05DEC2024)
|
|
Cardiac disorders
Pericardial Effusion
|
9.4%
3/32 • Adverse Events and All-Cause Mortality through 5 years (05DEC2024)
|
|
Cardiac disorders
Sinus Bradycardia
|
3.1%
1/32 • Adverse Events and All-Cause Mortality through 5 years (05DEC2024)
|
|
Gastrointestinal disorders
Abdominal Pain
|
3.1%
1/32 • Adverse Events and All-Cause Mortality through 5 years (05DEC2024)
|
|
Gastrointestinal disorders
Constipation
|
3.1%
1/32 • Adverse Events and All-Cause Mortality through 5 years (05DEC2024)
|
|
Gastrointestinal disorders
Gastrointestinal Haemorrhage
|
3.1%
1/32 • Adverse Events and All-Cause Mortality through 5 years (05DEC2024)
|
|
Gastrointestinal disorders
Gastrooesophageal Reflux Disease
|
3.1%
1/32 • Adverse Events and All-Cause Mortality through 5 years (05DEC2024)
|
|
Gastrointestinal disorders
Haemorrhoids
|
3.1%
1/32 • Adverse Events and All-Cause Mortality through 5 years (05DEC2024)
|
|
Gastrointestinal disorders
Haemorrhoids Thrombosed
|
3.1%
1/32 • Adverse Events and All-Cause Mortality through 5 years (05DEC2024)
|
|
General disorders
Asthenia
|
6.2%
2/32 • Adverse Events and All-Cause Mortality through 5 years (05DEC2024)
|
|
General disorders
Chest Pain
|
9.4%
3/32 • Adverse Events and All-Cause Mortality through 5 years (05DEC2024)
|
|
General disorders
Non-Cardiac Chest Pain
|
3.1%
1/32 • Adverse Events and All-Cause Mortality through 5 years (05DEC2024)
|
|
General disorders
Oedema Peripheral
|
3.1%
1/32 • Adverse Events and All-Cause Mortality through 5 years (05DEC2024)
|
|
General disorders
Physical Deconditioning
|
3.1%
1/32 • Adverse Events and All-Cause Mortality through 5 years (05DEC2024)
|
|
Infections and infestations
Bronchitis
|
9.4%
3/32 • Adverse Events and All-Cause Mortality through 5 years (05DEC2024)
|
|
Infections and infestations
Clostridium Difficile Colitis
|
3.1%
1/32 • Adverse Events and All-Cause Mortality through 5 years (05DEC2024)
|
|
Infections and infestations
Influenza
|
3.1%
1/32 • Adverse Events and All-Cause Mortality through 5 years (05DEC2024)
|
|
Infections and infestations
Nasopharyngitis
|
3.1%
1/32 • Adverse Events and All-Cause Mortality through 5 years (05DEC2024)
|
|
Infections and infestations
Postoperative Wound Infection
|
3.1%
1/32 • Adverse Events and All-Cause Mortality through 5 years (05DEC2024)
|
|
Infections and infestations
Tooth Abscess
|
3.1%
1/32 • Adverse Events and All-Cause Mortality through 5 years (05DEC2024)
|
|
Infections and infestations
Urinary Tract Infection
|
15.6%
5/32 • Adverse Events and All-Cause Mortality through 5 years (05DEC2024)
|
|
Injury, poisoning and procedural complications
Aortic Pseudoaneurysm
|
3.1%
1/32 • Adverse Events and All-Cause Mortality through 5 years (05DEC2024)
|
|
Injury, poisoning and procedural complications
Contusion
|
3.1%
1/32 • Adverse Events and All-Cause Mortality through 5 years (05DEC2024)
|
|
Injury, poisoning and procedural complications
Incision Site Haemorrhage
|
3.1%
1/32 • Adverse Events and All-Cause Mortality through 5 years (05DEC2024)
|
|
Injury, poisoning and procedural complications
Incision Site Oedema
|
3.1%
1/32 • Adverse Events and All-Cause Mortality through 5 years (05DEC2024)
|
|
Injury, poisoning and procedural complications
Post Lumbar Puncture Syndrome
|
3.1%
1/32 • Adverse Events and All-Cause Mortality through 5 years (05DEC2024)
|
|
Injury, poisoning and procedural complications
Post Procedural Fever
|
3.1%
1/32 • Adverse Events and All-Cause Mortality through 5 years (05DEC2024)
|
|
Injury, poisoning and procedural complications
Post Procedural Haematoma
|
3.1%
1/32 • Adverse Events and All-Cause Mortality through 5 years (05DEC2024)
|
|
Injury, poisoning and procedural complications
Postimplantation Syndrome
|
3.1%
1/32 • Adverse Events and All-Cause Mortality through 5 years (05DEC2024)
|
|
Injury, poisoning and procedural complications
Shoulder Fracture
|
3.1%
1/32 • Adverse Events and All-Cause Mortality through 5 years (05DEC2024)
|
|
Injury, poisoning and procedural complications
Vascular Access Site Haematoma
|
6.2%
2/32 • Adverse Events and All-Cause Mortality through 5 years (05DEC2024)
|
|
Injury, poisoning and procedural complications
Vascular Access Site Pseudoaneurysm
|
3.1%
1/32 • Adverse Events and All-Cause Mortality through 5 years (05DEC2024)
|
|
Investigations
Blood Creatinine Increased
|
6.2%
2/32 • Adverse Events and All-Cause Mortality through 5 years (05DEC2024)
|
|
Investigations
Body Temperature Increased
|
3.1%
1/32 • Adverse Events and All-Cause Mortality through 5 years (05DEC2024)
|
|
Investigations
Peripheral Pulse Decreased
|
3.1%
1/32 • Adverse Events and All-Cause Mortality through 5 years (05DEC2024)
|
|
Investigations
Prostatic Specific Antigen Increased
|
3.1%
1/32 • Adverse Events and All-Cause Mortality through 5 years (05DEC2024)
|
|
Investigations
Transaminases Increased
|
3.1%
1/32 • Adverse Events and All-Cause Mortality through 5 years (05DEC2024)
|
|
Investigations
Urine Output Decreased
|
3.1%
1/32 • Adverse Events and All-Cause Mortality through 5 years (05DEC2024)
|
|
Metabolism and nutrition disorders
Electrolyte Imbalance
|
3.1%
1/32 • Adverse Events and All-Cause Mortality through 5 years (05DEC2024)
|
|
Metabolism and nutrition disorders
Hypokalaemia
|
9.4%
3/32 • Adverse Events and All-Cause Mortality through 5 years (05DEC2024)
|
|
Metabolism and nutrition disorders
Hypomagnesaemia
|
3.1%
1/32 • Adverse Events and All-Cause Mortality through 5 years (05DEC2024)
|
|
Metabolism and nutrition disorders
Hyponatraemia
|
3.1%
1/32 • Adverse Events and All-Cause Mortality through 5 years (05DEC2024)
|
|
Metabolism and nutrition disorders
Malnutrition
|
3.1%
1/32 • Adverse Events and All-Cause Mortality through 5 years (05DEC2024)
|
|
Musculoskeletal and connective tissue disorders
Back Pain
|
12.5%
4/32 • Adverse Events and All-Cause Mortality through 5 years (05DEC2024)
|
|
Musculoskeletal and connective tissue disorders
Neck Pain
|
3.1%
1/32 • Adverse Events and All-Cause Mortality through 5 years (05DEC2024)
|
|
Musculoskeletal and connective tissue disorders
Pain In Extremity
|
3.1%
1/32 • Adverse Events and All-Cause Mortality through 5 years (05DEC2024)
|
|
Musculoskeletal and connective tissue disorders
Rotator Cuff Syndrome
|
3.1%
1/32 • Adverse Events and All-Cause Mortality through 5 years (05DEC2024)
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Basal Cell Carcinoma
|
3.1%
1/32 • Adverse Events and All-Cause Mortality through 5 years (05DEC2024)
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Breast Cancer
|
3.1%
1/32 • Adverse Events and All-Cause Mortality through 5 years (05DEC2024)
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Carcinoid Tumour Pulmonary
|
3.1%
1/32 • Adverse Events and All-Cause Mortality through 5 years (05DEC2024)
|
|
Nervous system disorders
Balance Disorder
|
3.1%
1/32 • Adverse Events and All-Cause Mortality through 5 years (05DEC2024)
|
|
Nervous system disorders
Bell's Palsy
|
3.1%
1/32 • Adverse Events and All-Cause Mortality through 5 years (05DEC2024)
|
|
Nervous system disorders
Carotid Artery Dissection
|
3.1%
1/32 • Adverse Events and All-Cause Mortality through 5 years (05DEC2024)
|
|
Nervous system disorders
Carpal Tunnel Syndrome
|
3.1%
1/32 • Adverse Events and All-Cause Mortality through 5 years (05DEC2024)
|
|
Nervous system disorders
Cerebrovascular Accident
|
3.1%
1/32 • Adverse Events and All-Cause Mortality through 5 years (05DEC2024)
|
|
Nervous system disorders
Dementia
|
3.1%
1/32 • Adverse Events and All-Cause Mortality through 5 years (05DEC2024)
|
|
Nervous system disorders
Dizziness
|
6.2%
2/32 • Adverse Events and All-Cause Mortality through 5 years (05DEC2024)
|
|
Nervous system disorders
Encephalopathy
|
3.1%
1/32 • Adverse Events and All-Cause Mortality through 5 years (05DEC2024)
|
|
Nervous system disorders
Headache
|
9.4%
3/32 • Adverse Events and All-Cause Mortality through 5 years (05DEC2024)
|
|
Nervous system disorders
Paraesthesia
|
3.1%
1/32 • Adverse Events and All-Cause Mortality through 5 years (05DEC2024)
|
|
Nervous system disorders
Taste Disorder
|
3.1%
1/32 • Adverse Events and All-Cause Mortality through 5 years (05DEC2024)
|
|
Product Issues
Thrombosis In Device
|
3.1%
1/32 • Adverse Events and All-Cause Mortality through 5 years (05DEC2024)
|
|
Psychiatric disorders
Agitation
|
3.1%
1/32 • Adverse Events and All-Cause Mortality through 5 years (05DEC2024)
|
|
Psychiatric disorders
Anxiety
|
3.1%
1/32 • Adverse Events and All-Cause Mortality through 5 years (05DEC2024)
|
|
Psychiatric disorders
Depression
|
3.1%
1/32 • Adverse Events and All-Cause Mortality through 5 years (05DEC2024)
|
|
Renal and urinary disorders
Chronic Kidney Disease
|
6.2%
2/32 • Adverse Events and All-Cause Mortality through 5 years (05DEC2024)
|
|
Renal and urinary disorders
Haematuria
|
3.1%
1/32 • Adverse Events and All-Cause Mortality through 5 years (05DEC2024)
|
|
Renal and urinary disorders
Urinary Retention
|
9.4%
3/32 • Adverse Events and All-Cause Mortality through 5 years (05DEC2024)
|
|
Respiratory, thoracic and mediastinal disorders
Acute Respiratory Failure
|
3.1%
1/32 • Adverse Events and All-Cause Mortality through 5 years (05DEC2024)
|
|
Respiratory, thoracic and mediastinal disorders
Atelectasis
|
12.5%
4/32 • Adverse Events and All-Cause Mortality through 5 years (05DEC2024)
|
|
Respiratory, thoracic and mediastinal disorders
Chronic Obstructive Pulmonary Disease
|
6.2%
2/32 • Adverse Events and All-Cause Mortality through 5 years (05DEC2024)
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
3.1%
1/32 • Adverse Events and All-Cause Mortality through 5 years (05DEC2024)
|
|
Respiratory, thoracic and mediastinal disorders
Diaphragmatic Disorder
|
3.1%
1/32 • Adverse Events and All-Cause Mortality through 5 years (05DEC2024)
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
6.2%
2/32 • Adverse Events and All-Cause Mortality through 5 years (05DEC2024)
|
|
Respiratory, thoracic and mediastinal disorders
Emphysema
|
3.1%
1/32 • Adverse Events and All-Cause Mortality through 5 years (05DEC2024)
|
|
Respiratory, thoracic and mediastinal disorders
Pleural Effusion
|
9.4%
3/32 • Adverse Events and All-Cause Mortality through 5 years (05DEC2024)
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary Mass
|
3.1%
1/32 • Adverse Events and All-Cause Mortality through 5 years (05DEC2024)
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary Oedema
|
3.1%
1/32 • Adverse Events and All-Cause Mortality through 5 years (05DEC2024)
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
3.1%
1/32 • Adverse Events and All-Cause Mortality through 5 years (05DEC2024)
|
|
Skin and subcutaneous tissue disorders
Rash Maculo-Papular
|
3.1%
1/32 • Adverse Events and All-Cause Mortality through 5 years (05DEC2024)
|
|
Vascular disorders
Aneurysm
|
6.2%
2/32 • Adverse Events and All-Cause Mortality through 5 years (05DEC2024)
|
|
Vascular disorders
Aortic Aneurysm
|
6.2%
2/32 • Adverse Events and All-Cause Mortality through 5 years (05DEC2024)
|
|
Vascular disorders
Hypertension
|
15.6%
5/32 • Adverse Events and All-Cause Mortality through 5 years (05DEC2024)
|
|
Vascular disorders
Hypertensive Urgency
|
3.1%
1/32 • Adverse Events and All-Cause Mortality through 5 years (05DEC2024)
|
|
Vascular disorders
Hypotension
|
3.1%
1/32 • Adverse Events and All-Cause Mortality through 5 years (05DEC2024)
|
|
Vascular disorders
Iliac Artery Dissection
|
3.1%
1/32 • Adverse Events and All-Cause Mortality through 5 years (05DEC2024)
|
|
Vascular disorders
Peripheral Artery Dissection
|
3.1%
1/32 • Adverse Events and All-Cause Mortality through 5 years (05DEC2024)
|
|
Vascular disorders
Subclavian Artery Aneurysm
|
3.1%
1/32 • Adverse Events and All-Cause Mortality through 5 years (05DEC2024)
|
|
Vascular disorders
Subclavian Artery Stenosis
|
3.1%
1/32 • Adverse Events and All-Cause Mortality through 5 years (05DEC2024)
|
|
Vascular disorders
Venous Stenosis
|
3.1%
1/32 • Adverse Events and All-Cause Mortality through 5 years (05DEC2024)
|
|
Infections and infestations
Pneumonia
|
3.1%
1/32 • Adverse Events and All-Cause Mortality through 5 years (05DEC2024)
|
|
Nervous system disorders
Syncope
|
3.1%
1/32 • Adverse Events and All-Cause Mortality through 5 years (05DEC2024)
|
|
Injury, poisoning and procedural complications
Vascular Pseudoaneurysm
|
3.1%
1/32 • Adverse Events and All-Cause Mortality through 5 years (05DEC2024)
|
|
Injury, poisoning and procedural complications
Hand Fracture
|
3.1%
1/32 • Adverse Events and All-Cause Mortality through 5 years (05DEC2024)
|
Additional Information
Alexa Glandon, Medtronic Clinical Study Manager
Medtronic
Phone: 12624087021
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee Medtronic owns the data of this clinical study, a single investigation site may access and use the data provided by itself for scientific publications following prior approval by Medtronic.
- Publication restrictions are in place
Restriction type: OTHER