Trial Outcomes & Findings for The Angel® Catheter Pivotal Clinical Trial (NCT NCT02186223)
NCT ID: NCT02186223
Last Updated: 2017-04-04
Results Overview
1. Clinically Significant PE: Subjects will be assessed daily for signs and symptoms of PE. If present and no alternative diagnosis is suspected, at least one of four defined diagnostic examinations will performed to confirm or rule out PE. 2. Fatal PE: Defined as unexpected death within 24 hours of onset of the acute event with a verified initial symptomatic DVT or PE where there is no other reasonable cause of death.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
172 participants
Primary outcome timeframe
Assessed daily from Baseline through Study Exit which occurs 3 days post-Angel Catheter Removal OR at hospital discharge, whichever is first (maximum of 33 assessment days with an anticipated average of 7 days)
Results posted on
2017-04-04
Participant Flow
Participant milestones
| Measure |
The Angel® Catheter
All eligible subjects will receive an Angel® Catheter.
The Angel® Catheter: The Angel® Catheter is a temporary device that combines the functions of an inferior vena cava (IVC) filter and a 3-lumen central venous catheter (CVC). The device can be placed at the bedside into the inferior vena cava via the femoral vein for the prevention of Pulmonary Embolism (PE) and for access to the central venous system. The device is intended for short-term (less than 30 days) vascular access via the femoral vein.
|
|---|---|
|
Overall Study
STARTED
|
172
|
|
Overall Study
Device Placed
|
163
|
|
Overall Study
COMPLETED
|
151
|
|
Overall Study
NOT COMPLETED
|
21
|
Reasons for withdrawal
| Measure |
The Angel® Catheter
All eligible subjects will receive an Angel® Catheter.
The Angel® Catheter: The Angel® Catheter is a temporary device that combines the functions of an inferior vena cava (IVC) filter and a 3-lumen central venous catheter (CVC). The device can be placed at the bedside into the inferior vena cava via the femoral vein for the prevention of Pulmonary Embolism (PE) and for access to the central venous system. The device is intended for short-term (less than 30 days) vascular access via the femoral vein.
|
|---|---|
|
Overall Study
Not eligible for device placement
|
6
|
|
Overall Study
Unable to obtain femoral access
|
3
|
|
Overall Study
Death
|
3
|
|
Overall Study
Device in place less than 48 hours
|
9
|
Baseline Characteristics
Number analyzed includes all trauma subjects that had an Angel® Catheter placed
Baseline characteristics by cohort
| Measure |
The Angel® Catheter
n=163 Participants
All eligible subjects received an Angel® Catheter.
The Angel® Catheter: The Angel® Catheter is a temporary device that combines the functions of an inferior vena cava (IVC) filter and a 3-lumen central venous catheter (CVC). The device can be placed at the bedside into the inferior vena cava via the femoral vein for the prevention of Pulmonary Embolism (PE) and for access to the central venous system. The device is intended for short-term (less than 30 days) vascular access via the femoral vein.
|
|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=163 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
139 Participants
n=163 Participants
|
|
Age, Categorical
>=65 years
|
24 Participants
n=163 Participants
|
|
Age, Continuous
|
44.07 years
STANDARD_DEVIATION 18.66 • n=163 Participants
|
|
Age, Customized
|
43 years
n=163 Participants
|
|
Sex: Female, Male
Female
|
122 Participants
n=163 Participants
|
|
Sex: Female, Male
Male
|
41 Participants
n=163 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
49 Participants
n=163 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
101 Participants
n=163 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
13 Participants
n=163 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=163 Participants
|
|
Race (NIH/OMB)
Asian
|
4 Participants
n=163 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=163 Participants
|
|
Race (NIH/OMB)
Black or African American
|
22 Participants
n=163 Participants
|
|
Race (NIH/OMB)
White
|
122 Participants
n=163 Participants
|
|
Race (NIH/OMB)
More than one race
|
5 Participants
n=163 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
10 Participants
n=163 Participants
|
|
Region of Enrollment
United States
|
163 participants
n=163 Participants
|
|
Time from admission to the hospital to admission to ICU
|
2.07 hours
n=163 Participants
|
|
Primary ICU Admission Diagnosis
Trauma
|
151 Participants
n=163 Participants
|
|
Primary ICU Admission Diagnosis
Surgical
|
2 Participants
n=163 Participants
|
|
Primary ICU Admission Diagnosis
Medical
|
6 Participants
n=163 Participants
|
|
Primary ICU Admission Diagnosis
Neurological
|
4 Participants
n=163 Participants
|
|
Type of trauma (for trauma subjects)
Head/Spinal Trauma
|
129 Participants
n=151 Participants • Number analyzed includes all trauma subjects that had an Angel® Catheter placed
|
|
Type of trauma (for trauma subjects)
Chest
|
63 Participants
n=151 Participants • Number analyzed includes all trauma subjects that had an Angel® Catheter placed
|
|
Type of trauma (for trauma subjects)
Abdomen
|
41 Participants
n=151 Participants • Number analyzed includes all trauma subjects that had an Angel® Catheter placed
|
|
Type of trauma (for trauma subjects)
Lower Extremity Trauma
|
54 Participants
n=151 Participants • Number analyzed includes all trauma subjects that had an Angel® Catheter placed
|
|
Type of trauma (for trauma subjects)
More than one area affected
|
80 Participants
n=151 Participants • Number analyzed includes all trauma subjects that had an Angel® Catheter placed
|
|
Type of trauma (for trauma subjects)
Head Bleed (Subcategory of Head/Spinal Trauma)
|
102 Participants
n=129 Participants • Number analyzed includes all trauma subjects that had an Angel® Catheter placed
|
|
Injury Severity Score (for trauma subjects)
|
26 Injury Severity Score
n=151 Participants • Number analyzed includes all trauma subjects that had an Angel® Catheter placed
|
|
Injury Classification
Minimal (1-9)
|
7 Participants
n=151 Participants • Number analyzed includes all trauma subjects that had the Angel® Catheter placed.
|
|
Injury Classification
Moderate (10-15)
|
11 Participants
n=151 Participants • Number analyzed includes all trauma subjects that had the Angel® Catheter placed.
|
|
Injury Classification
Severe (16-24)
|
41 Participants
n=151 Participants • Number analyzed includes all trauma subjects that had the Angel® Catheter placed.
|
|
Injury Classification
Critical (25+)
|
92 Participants
n=151 Participants • Number analyzed includes all trauma subjects that had the Angel® Catheter placed.
|
|
Bleeding Risk
Active bleeding
|
67 Participants
n=163 Participants
|
|
Bleeding Risk
History of bleeding
|
13 Participants
n=163 Participants
|
|
Bleeding Risk
At high risk for bleeding
|
69 Participants
n=163 Participants
|
|
Severity of Active Bleeding
Minor bleeding
|
11 Participants
n=67 Participants • Number analyzed includes all subjects with active bleeding at enrollment and subsequently had an Angel® Catheter placed.
|
|
Severity of Active Bleeding
Major bleeding
|
56 Participants
n=163 Participants • Number analyzed includes all subjects with active bleeding at enrollment and subsequently had an Angel® Catheter placed.
|
|
Medical History & Concomitant Conditions
Blood and lymphatic system disorders
|
53 Participants
n=163 Participants
|
|
Medical History & Concomitant Conditions
Cardiac disorders
|
43 Participants
n=163 Participants
|
|
Medical History & Concomitant Conditions
Endocrine disorders
|
7 Participants
n=163 Participants
|
|
Medical History & Concomitant Conditions
Ear and labyrinth disorders
|
2 Participants
n=163 Participants
|
|
Medical History & Concomitant Conditions
Eye disorders
|
2 Participants
n=163 Participants
|
|
Medical History & Concomitant Conditions
Gastrointestinal disorders
|
38 Participants
n=163 Participants
|
|
Medical History & Concomitant Conditions
General disorders and administration site conditio
|
37 Participants
n=163 Participants
|
|
Medical History & Concomitant Conditions
Hepatobiliary disorders
|
8 Participants
n=163 Participants
|
|
Medical History & Concomitant Conditions
Immune system disorders
|
2 Participants
n=163 Participants
|
|
Medical History & Concomitant Conditions
Infections and infestations
|
28 Participants
n=163 Participants
|
|
Medical History & Concomitant Conditions
Injury, poisoning, and procedural complications
|
149 Participants
n=163 Participants
|
|
Medical History & Concomitant Conditions
Investigations
|
43 Participants
n=163 Participants
|
|
Medical History & Concomitant Conditions
Metabolism and nutrition disorders
|
58 Participants
n=163 Participants
|
|
Medical History & Concomitant Conditions
Musculoskeletal and connective tissue disorders
|
26 Participants
n=163 Participants
|
|
Medical History & Concomitant Conditions
Neoplasms benign, malignant, and unspecified
|
12 Participants
n=163 Participants
|
|
Medical History & Concomitant Conditions
Nervous system disorders
|
111 Participants
n=163 Participants
|
|
Medical History & Concomitant Conditions
Psychiatric disorders
|
24 Participants
n=163 Participants
|
|
Medical History & Concomitant Conditions
Renal and urinary disorders
|
19 Participants
n=163 Participants
|
|
Medical History & Concomitant Conditions
Reproductive system and breast disorders
|
11 Participants
n=163 Participants
|
|
Medical History & Concomitant Conditions
Respiratory, thoracic and mediastinal disorders
|
101 Participants
n=163 Participants
|
|
Medical History & Concomitant Conditions
Skin and subcutaneous tissue disorders
|
5 Participants
n=163 Participants
|
|
Medical History & Concomitant Conditions
Social circumstances
|
3 Participants
n=163 Participants
|
|
Medical History & Concomitant Conditions
Surgical and medical procedures
|
78 Participants
n=163 Participants
|
|
Medical History & Concomitant Conditions
Vascular disorders
|
73 Participants
n=163 Participants
|
|
Subjects with Baseline Venous Thromboembolic (VTE) Disease per Site-reported Medical History
Pulmonary Embolism (PE)
|
3 Participants
n=163 Participants
|
|
Subjects with Baseline Venous Thromboembolic (VTE) Disease per Site-reported Medical History
Deep Vein Thrombosis (DVT)
|
16 Participants
n=163 Participants
|
|
Subjects with Baseline Venous Thromboembolic (VTE) Disease per Site-reported Medical History
PE and DVT
|
1 Participants
n=163 Participants
|
|
Use of mechanical DVT preventive devices
At least 1 type of preventive device used
|
145 Participants
n=163 Participants
|
|
Use of mechanical DVT preventive devices
Compressive stockings
|
10 Participants
n=163 Participants
|
|
Use of mechanical DVT preventive devices
Pneumatic compression
|
113 Participants
n=163 Participants
|
|
Use of mechanical DVT preventive devices
Other
|
27 Participants
n=163 Participants
|
|
Supplemental Oxygen at Enrollment
|
150 Participants
n=163 Participants
|
|
Type of supplemental oxygen
Mechanical ventilation
|
127 Participants
n=150 Participants • Number analyzed includes all patient receiving supplemental oxygen at enrollment that subsequently had an Angel® Catheter placed.
|
|
Type of supplemental oxygen
CPAP-BiPAP
|
0 Participants
n=150 Participants • Number analyzed includes all patient receiving supplemental oxygen at enrollment that subsequently had an Angel® Catheter placed.
|
|
Type of supplemental oxygen
Nasal cannula/face mask
|
20 Participants
n=150 Participants • Number analyzed includes all patient receiving supplemental oxygen at enrollment that subsequently had an Angel® Catheter placed.
|
|
Type of supplemental oxygen
Other
|
2 Participants
n=150 Participants • Number analyzed includes all patient receiving supplemental oxygen at enrollment that subsequently had an Angel® Catheter placed.
|
|
Need for vasopressors before Angel® Catheter insertion
|
40 Participants
n=163 Participants
|
|
Other Central Venous Catheter (CVC) in place prior to Angel® Catheter insertion
None
|
46 Participants
n=163 Participants
|
|
Other Central Venous Catheter (CVC) in place prior to Angel® Catheter insertion
Short term CVC
|
109 Participants
n=163 Participants
|
|
Other Central Venous Catheter (CVC) in place prior to Angel® Catheter insertion
Long term CVC
|
8 Participants
n=163 Participants
|
|
Indications for the Angel® Catheter Placement
Recognized contraindications to anticoagulation
|
160 Participants
n=163 Participants
|
|
Indications for the Angel® Catheter Placement
Acute LE DVT or PE & contraindicated to anticoagul
|
8 Participants
n=163 Participants
|
|
Indications for the Angel® Catheter Placement
Temporary interruption of anticoagulation
|
10 Participants
n=163 Participants
|
|
Indications for the Angel® Catheter Placement
Prophylactic Use of Indications for the Angel® Cat
|
160 Participants
n=163 Participants
|
|
Contraindications to anticoagulation
Active or high risk for bleeding
|
153 Participants
n=160 Participants • Number analyzed includes all subjects that had recognized contraindications to standard pharmacological thromboprophylaxis reported.
|
|
Contraindications to anticoagulation
Hypersensitivity to anticoagulation
|
0 Participants
n=160 Participants • Number analyzed includes all subjects that had recognized contraindications to standard pharmacological thromboprophylaxis reported.
|
|
Contraindications to anticoagulation
History of severe heparin induced thrombocytopenia
|
0 Participants
n=160 Participants • Number analyzed includes all subjects that had recognized contraindications to standard pharmacological thromboprophylaxis reported.
|
|
Contraindications to anticoagulation
Severe thrombocytopenia
|
1 Participants
n=160 Participants • Number analyzed includes all subjects that had recognized contraindications to standard pharmacological thromboprophylaxis reported.
|
|
Contraindications to anticoagulation
Other
|
11 Participants
n=160 Participants • Number analyzed includes all subjects that had recognized contraindications to standard pharmacological thromboprophylaxis reported.
|
PRIMARY outcome
Timeframe: Assessed daily from Baseline through Study Exit which occurs 3 days post-Angel Catheter Removal OR at hospital discharge, whichever is first (maximum of 33 assessment days with an anticipated average of 7 days)1. Clinically Significant PE: Subjects will be assessed daily for signs and symptoms of PE. If present and no alternative diagnosis is suspected, at least one of four defined diagnostic examinations will performed to confirm or rule out PE. 2. Fatal PE: Defined as unexpected death within 24 hours of onset of the acute event with a verified initial symptomatic DVT or PE where there is no other reasonable cause of death.
Outcome measures
| Measure |
The Angel® Catheter
n=163 Participants
All eligible subjects received an Angel® Catheter.
The Angel® Catheter: The Angel® Catheter is a temporary device that combines the functions of an inferior vena cava (IVC) filter and a 3-lumen central venous catheter (CVC). The device can be placed at the bedside into the inferior vena cava via the femoral vein for the prevention of Pulmonary Embolism (PE) and for access to the central venous system. The device is intended for short-term (less than 30 days) vascular access via the femoral vein.
|
|---|---|
|
Freedom From Clinically Significant PE or Fatal PE During Treatment Period
|
163 Participants
|
SECONDARY outcome
Timeframe: Assessed daily from Baseline through Study Exit which occurs 3 days post-Angel Catheter Removal OR at hospital discharge, whichever occurs first (maximum of 33 assessment days with an anticipated average of 7 days)Outcome measures
| Measure |
The Angel® Catheter
n=163 Participants
All eligible subjects received an Angel® Catheter.
The Angel® Catheter: The Angel® Catheter is a temporary device that combines the functions of an inferior vena cava (IVC) filter and a 3-lumen central venous catheter (CVC). The device can be placed at the bedside into the inferior vena cava via the femoral vein for the prevention of Pulmonary Embolism (PE) and for access to the central venous system. The device is intended for short-term (less than 30 days) vascular access via the femoral vein.
|
|---|---|
|
Incidence of Acute Proximal Deep Vein Thrombosis
|
30 Participants
|
SECONDARY outcome
Timeframe: Assessed daily from Baseline through Study Exit which occurs 3 days post-Angel Catheter Removal OR at hospital discharge, whichever occurs first (maximum of 33 assessment days with an anticipated average of 7 days)Outcome measures
| Measure |
The Angel® Catheter
n=163 Participants
All eligible subjects received an Angel® Catheter.
The Angel® Catheter: The Angel® Catheter is a temporary device that combines the functions of an inferior vena cava (IVC) filter and a 3-lumen central venous catheter (CVC). The device can be placed at the bedside into the inferior vena cava via the femoral vein for the prevention of Pulmonary Embolism (PE) and for access to the central venous system. The device is intended for short-term (less than 30 days) vascular access via the femoral vein.
|
|---|---|
|
Incidence of Catheter Related Thrombosis
|
20 Participants
|
SECONDARY outcome
Timeframe: Assessed daily from Baseline through Study Exit which occurs 3 days post-Angel Catheter Removal OR at hospital discharge, whichever occurs first (maximum of 33 assessment days with an anticipated average of 7 days)Outcome measures
| Measure |
The Angel® Catheter
n=163 Participants
All eligible subjects received an Angel® Catheter.
The Angel® Catheter: The Angel® Catheter is a temporary device that combines the functions of an inferior vena cava (IVC) filter and a 3-lumen central venous catheter (CVC). The device can be placed at the bedside into the inferior vena cava via the femoral vein for the prevention of Pulmonary Embolism (PE) and for access to the central venous system. The device is intended for short-term (less than 30 days) vascular access via the femoral vein.
|
|---|---|
|
Incidence of Catheter Related Blood Stream Infections
|
0 Participants
|
SECONDARY outcome
Timeframe: Assessed daily from Baseline through Study Exit which occurs 3 days post-Angel Catheter Removal OR at hospital discharge, whichever occurs first (maximum of 33 assessment days with an anticipated average of 7 days)Outcome measures
| Measure |
The Angel® Catheter
n=163 Participants
All eligible subjects received an Angel® Catheter.
The Angel® Catheter: The Angel® Catheter is a temporary device that combines the functions of an inferior vena cava (IVC) filter and a 3-lumen central venous catheter (CVC). The device can be placed at the bedside into the inferior vena cava via the femoral vein for the prevention of Pulmonary Embolism (PE) and for access to the central venous system. The device is intended for short-term (less than 30 days) vascular access via the femoral vein.
|
|---|---|
|
Incidence of Major Bleeding Event
|
5 Participants
|
SECONDARY outcome
Timeframe: During the pre-removal cavogram (An average of 6.8 days after device insertion)During the pre-removal cavogram, the presence of significant clot (\>25% of the volume of the filter) trapped by the Angel® Catheter will be assessed. The number of subjects with significant clot trapped by the device will be reported as the number of PEs averted.
Outcome measures
| Measure |
The Angel® Catheter
n=129 Participants
All eligible subjects received an Angel® Catheter.
The Angel® Catheter: The Angel® Catheter is a temporary device that combines the functions of an inferior vena cava (IVC) filter and a 3-lumen central venous catheter (CVC). The device can be placed at the bedside into the inferior vena cava via the femoral vein for the prevention of Pulmonary Embolism (PE) and for access to the central venous system. The device is intended for short-term (less than 30 days) vascular access via the femoral vein.
|
|---|---|
|
Incidence of PEs Averted
|
14 Participants
|
Adverse Events
The Angel® Catheter
Serious events: 49 serious events
Other events: 114 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
The Angel® Catheter
n=163 participants at risk
All eligible subjects received an Angel® Catheter.
The Angel® Catheter: The Angel® Catheter is a temporary device that combines the functions of an inferior vena cava (IVC) filter and a 3-lumen central venous catheter (CVC). The device can be placed at the bedside into the inferior vena cava via the femoral vein for the prevention of Pulmonary Embolism (PE) and for access to the central venous system. The device is intended for short-term (less than 30 days) vascular access via the femoral vein.
|
|---|---|
|
Cardiac disorders
Cardiac Arrest
|
2.5%
4/163 • Number of events 4 • From the time of Angel® Catheter insertion, through the entire catheter indwelling period (Mean±SD: 6.79±3.97 days; Median(Range: Min,Max): 5.94 (0.34,21.92) days), until death, discharge or 3 days post-removal, whichever occurs first.
|
|
Cardiac disorders
Supraventricular Tachycardia
|
0.61%
1/163 • Number of events 1 • From the time of Angel® Catheter insertion, through the entire catheter indwelling period (Mean±SD: 6.79±3.97 days; Median(Range: Min,Max): 5.94 (0.34,21.92) days), until death, discharge or 3 days post-removal, whichever occurs first.
|
|
General disorders
Brain Death
|
1.2%
2/163 • Number of events 2 • From the time of Angel® Catheter insertion, through the entire catheter indwelling period (Mean±SD: 6.79±3.97 days; Median(Range: Min,Max): 5.94 (0.34,21.92) days), until death, discharge or 3 days post-removal, whichever occurs first.
|
|
General disorders
Multi-Organ Failure
|
1.8%
3/163 • Number of events 3 • From the time of Angel® Catheter insertion, through the entire catheter indwelling period (Mean±SD: 6.79±3.97 days; Median(Range: Min,Max): 5.94 (0.34,21.92) days), until death, discharge or 3 days post-removal, whichever occurs first.
|
|
Hepatobiliary disorders
Chronic Hepatic Failure
|
0.61%
1/163 • Number of events 1 • From the time of Angel® Catheter insertion, through the entire catheter indwelling period (Mean±SD: 6.79±3.97 days; Median(Range: Min,Max): 5.94 (0.34,21.92) days), until death, discharge or 3 days post-removal, whichever occurs first.
|
|
Infections and infestations
Abdominal Sepsis
|
0.61%
1/163 • Number of events 1 • From the time of Angel® Catheter insertion, through the entire catheter indwelling period (Mean±SD: 6.79±3.97 days; Median(Range: Min,Max): 5.94 (0.34,21.92) days), until death, discharge or 3 days post-removal, whichever occurs first.
|
|
Infections and infestations
Lobar Pneumonia
|
0.61%
1/163 • Number of events 1 • From the time of Angel® Catheter insertion, through the entire catheter indwelling period (Mean±SD: 6.79±3.97 days; Median(Range: Min,Max): 5.94 (0.34,21.92) days), until death, discharge or 3 days post-removal, whichever occurs first.
|
|
Infections and infestations
Pneumonia
|
3.7%
6/163 • Number of events 6 • From the time of Angel® Catheter insertion, through the entire catheter indwelling period (Mean±SD: 6.79±3.97 days; Median(Range: Min,Max): 5.94 (0.34,21.92) days), until death, discharge or 3 days post-removal, whichever occurs first.
|
|
Infections and infestations
Sepsis
|
1.2%
2/163 • Number of events 2 • From the time of Angel® Catheter insertion, through the entire catheter indwelling period (Mean±SD: 6.79±3.97 days; Median(Range: Min,Max): 5.94 (0.34,21.92) days), until death, discharge or 3 days post-removal, whichever occurs first.
|
|
Infections and infestations
Septic Shock
|
0.61%
1/163 • Number of events 1 • From the time of Angel® Catheter insertion, through the entire catheter indwelling period (Mean±SD: 6.79±3.97 days; Median(Range: Min,Max): 5.94 (0.34,21.92) days), until death, discharge or 3 days post-removal, whichever occurs first.
|
|
Injury, poisoning and procedural complications
Craniocerebral Injury
|
2.5%
4/163 • Number of events 4 • From the time of Angel® Catheter insertion, through the entire catheter indwelling period (Mean±SD: 6.79±3.97 days; Median(Range: Min,Max): 5.94 (0.34,21.92) days), until death, discharge or 3 days post-removal, whichever occurs first.
|
|
Injury, poisoning and procedural complications
Post Procedural Haemorrhage
|
0.61%
1/163 • Number of events 1 • From the time of Angel® Catheter insertion, through the entire catheter indwelling period (Mean±SD: 6.79±3.97 days; Median(Range: Min,Max): 5.94 (0.34,21.92) days), until death, discharge or 3 days post-removal, whichever occurs first.
|
|
Injury, poisoning and procedural complications
Subdural Haematoma
|
0.61%
1/163 • Number of events 1 • From the time of Angel® Catheter insertion, through the entire catheter indwelling period (Mean±SD: 6.79±3.97 days; Median(Range: Min,Max): 5.94 (0.34,21.92) days), until death, discharge or 3 days post-removal, whichever occurs first.
|
|
Injury, poisoning and procedural complications
Subdural Haemorrhage
|
0.61%
1/163 • Number of events 1 • From the time of Angel® Catheter insertion, through the entire catheter indwelling period (Mean±SD: 6.79±3.97 days; Median(Range: Min,Max): 5.94 (0.34,21.92) days), until death, discharge or 3 days post-removal, whichever occurs first.
|
|
Nervous system disorders
Brain Hypoxia
|
0.61%
1/163 • Number of events 1 • From the time of Angel® Catheter insertion, through the entire catheter indwelling period (Mean±SD: 6.79±3.97 days; Median(Range: Min,Max): 5.94 (0.34,21.92) days), until death, discharge or 3 days post-removal, whichever occurs first.
|
|
Nervous system disorders
Brain Oedema
|
0.61%
1/163 • Number of events 1 • From the time of Angel® Catheter insertion, through the entire catheter indwelling period (Mean±SD: 6.79±3.97 days; Median(Range: Min,Max): 5.94 (0.34,21.92) days), until death, discharge or 3 days post-removal, whichever occurs first.
|
|
Nervous system disorders
Cerebrovascular Accident
|
0.61%
1/163 • Number of events 1 • From the time of Angel® Catheter insertion, through the entire catheter indwelling period (Mean±SD: 6.79±3.97 days; Median(Range: Min,Max): 5.94 (0.34,21.92) days), until death, discharge or 3 days post-removal, whichever occurs first.
|
|
Nervous system disorders
Haemorrhage Intracranial
|
0.61%
1/163 • Number of events 1 • From the time of Angel® Catheter insertion, through the entire catheter indwelling period (Mean±SD: 6.79±3.97 days; Median(Range: Min,Max): 5.94 (0.34,21.92) days), until death, discharge or 3 days post-removal, whichever occurs first.
|
|
Nervous system disorders
Intracranial Pressure Increased
|
3.1%
5/163 • Number of events 5 • From the time of Angel® Catheter insertion, through the entire catheter indwelling period (Mean±SD: 6.79±3.97 days; Median(Range: Min,Max): 5.94 (0.34,21.92) days), until death, discharge or 3 days post-removal, whichever occurs first.
|
|
Renal and urinary disorders
Renal Failure
|
0.61%
1/163 • Number of events 1 • From the time of Angel® Catheter insertion, through the entire catheter indwelling period (Mean±SD: 6.79±3.97 days; Median(Range: Min,Max): 5.94 (0.34,21.92) days), until death, discharge or 3 days post-removal, whichever occurs first.
|
|
Renal and urinary disorders
Renal Failure Acute
|
0.61%
1/163 • Number of events 1 • From the time of Angel® Catheter insertion, through the entire catheter indwelling period (Mean±SD: 6.79±3.97 days; Median(Range: Min,Max): 5.94 (0.34,21.92) days), until death, discharge or 3 days post-removal, whichever occurs first.
|
|
Respiratory, thoracic and mediastinal disorders
Acute Respiratory Distress Syndrome
|
0.61%
1/163 • Number of events 1 • From the time of Angel® Catheter insertion, through the entire catheter indwelling period (Mean±SD: 6.79±3.97 days; Median(Range: Min,Max): 5.94 (0.34,21.92) days), until death, discharge or 3 days post-removal, whichever occurs first.
|
|
Respiratory, thoracic and mediastinal disorders
Pleural Effusion
|
0.61%
1/163 • Number of events 1 • From the time of Angel® Catheter insertion, through the entire catheter indwelling period (Mean±SD: 6.79±3.97 days; Median(Range: Min,Max): 5.94 (0.34,21.92) days), until death, discharge or 3 days post-removal, whichever occurs first.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary Embolism
|
0.61%
1/163 • Number of events 1 • From the time of Angel® Catheter insertion, through the entire catheter indwelling period (Mean±SD: 6.79±3.97 days; Median(Range: Min,Max): 5.94 (0.34,21.92) days), until death, discharge or 3 days post-removal, whichever occurs first.
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory Failure
|
3.7%
6/163 • Number of events 6 • From the time of Angel® Catheter insertion, through the entire catheter indwelling period (Mean±SD: 6.79±3.97 days; Median(Range: Min,Max): 5.94 (0.34,21.92) days), until death, discharge or 3 days post-removal, whichever occurs first.
|
|
Vascular disorders
Deep Vein Thrombosis
|
6.1%
10/163 • Number of events 10 • From the time of Angel® Catheter insertion, through the entire catheter indwelling period (Mean±SD: 6.79±3.97 days; Median(Range: Min,Max): 5.94 (0.34,21.92) days), until death, discharge or 3 days post-removal, whichever occurs first.
|
|
Vascular disorders
Haemodynamic Instability
|
0.61%
1/163 • Number of events 1 • From the time of Angel® Catheter insertion, through the entire catheter indwelling period (Mean±SD: 6.79±3.97 days; Median(Range: Min,Max): 5.94 (0.34,21.92) days), until death, discharge or 3 days post-removal, whichever occurs first.
|
|
Vascular disorders
Hypotension
|
0.61%
1/163 • Number of events 1 • From the time of Angel® Catheter insertion, through the entire catheter indwelling period (Mean±SD: 6.79±3.97 days; Median(Range: Min,Max): 5.94 (0.34,21.92) days), until death, discharge or 3 days post-removal, whichever occurs first.
|
|
Vascular disorders
Pelvic Venous Thrombosis
|
1.2%
2/163 • Number of events 2 • From the time of Angel® Catheter insertion, through the entire catheter indwelling period (Mean±SD: 6.79±3.97 days; Median(Range: Min,Max): 5.94 (0.34,21.92) days), until death, discharge or 3 days post-removal, whichever occurs first.
|
|
Vascular disorders
Vena Cava Thrombosis
|
1.8%
3/163 • Number of events 3 • From the time of Angel® Catheter insertion, through the entire catheter indwelling period (Mean±SD: 6.79±3.97 days; Median(Range: Min,Max): 5.94 (0.34,21.92) days), until death, discharge or 3 days post-removal, whichever occurs first.
|
Other adverse events
| Measure |
The Angel® Catheter
n=163 participants at risk
All eligible subjects received an Angel® Catheter.
The Angel® Catheter: The Angel® Catheter is a temporary device that combines the functions of an inferior vena cava (IVC) filter and a 3-lumen central venous catheter (CVC). The device can be placed at the bedside into the inferior vena cava via the femoral vein for the prevention of Pulmonary Embolism (PE) and for access to the central venous system. The device is intended for short-term (less than 30 days) vascular access via the femoral vein.
|
|---|---|
|
Gastrointestinal disorders
Abdominal wall haematoma
|
0.61%
1/163 • Number of events 1 • From the time of Angel® Catheter insertion, through the entire catheter indwelling period (Mean±SD: 6.79±3.97 days; Median(Range: Min,Max): 5.94 (0.34,21.92) days), until death, discharge or 3 days post-removal, whichever occurs first.
|
|
Vascular disorders
Accelerated hypertension
|
0.61%
1/163 • Number of events 1 • From the time of Angel® Catheter insertion, through the entire catheter indwelling period (Mean±SD: 6.79±3.97 days; Median(Range: Min,Max): 5.94 (0.34,21.92) days), until death, discharge or 3 days post-removal, whichever occurs first.
|
|
Infections and infestations
Acinetobacter infection
|
0.61%
1/163 • Number of events 1 • From the time of Angel® Catheter insertion, through the entire catheter indwelling period (Mean±SD: 6.79±3.97 days; Median(Range: Min,Max): 5.94 (0.34,21.92) days), until death, discharge or 3 days post-removal, whichever occurs first.
|
|
Respiratory, thoracic and mediastinal disorders
Acute respiratory distress syndrome
|
0.61%
1/163 • Number of events 1 • From the time of Angel® Catheter insertion, through the entire catheter indwelling period (Mean±SD: 6.79±3.97 days; Median(Range: Min,Max): 5.94 (0.34,21.92) days), until death, discharge or 3 days post-removal, whichever occurs first.
|
|
Blood and lymphatic system disorders
Anaemia
|
2.5%
4/163 • Number of events 4 • From the time of Angel® Catheter insertion, through the entire catheter indwelling period (Mean±SD: 6.79±3.97 days; Median(Range: Min,Max): 5.94 (0.34,21.92) days), until death, discharge or 3 days post-removal, whichever occurs first.
|
|
Injury, poisoning and procedural complications
Anastomotic leak
|
0.61%
1/163 • Number of events 1 • From the time of Angel® Catheter insertion, through the entire catheter indwelling period (Mean±SD: 6.79±3.97 days; Median(Range: Min,Max): 5.94 (0.34,21.92) days), until death, discharge or 3 days post-removal, whichever occurs first.
|
|
Psychiatric disorders
Anxiety disorder
|
0.61%
1/163 • Number of events 1 • From the time of Angel® Catheter insertion, through the entire catheter indwelling period (Mean±SD: 6.79±3.97 days; Median(Range: Min,Max): 5.94 (0.34,21.92) days), until death, discharge or 3 days post-removal, whichever occurs first.
|
|
Cardiac disorders
Atrial flutter
|
0.61%
1/163 • Number of events 1 • From the time of Angel® Catheter insertion, through the entire catheter indwelling period (Mean±SD: 6.79±3.97 days; Median(Range: Min,Max): 5.94 (0.34,21.92) days), until death, discharge or 3 days post-removal, whichever occurs first.
|
|
Nervous system disorders
Autonomic nervous system imbalance
|
1.2%
2/163 • Number of events 2 • From the time of Angel® Catheter insertion, through the entire catheter indwelling period (Mean±SD: 6.79±3.97 days; Median(Range: Min,Max): 5.94 (0.34,21.92) days), until death, discharge or 3 days post-removal, whichever occurs first.
|
|
Vascular disorders
Axillary vein thrombosis
|
1.2%
2/163 • Number of events 2 • From the time of Angel® Catheter insertion, through the entire catheter indwelling period (Mean±SD: 6.79±3.97 days; Median(Range: Min,Max): 5.94 (0.34,21.92) days), until death, discharge or 3 days post-removal, whichever occurs first.
|
|
Infections and infestations
Bacteraemia
|
3.1%
5/163 • Number of events 5 • From the time of Angel® Catheter insertion, through the entire catheter indwelling period (Mean±SD: 6.79±3.97 days; Median(Range: Min,Max): 5.94 (0.34,21.92) days), until death, discharge or 3 days post-removal, whichever occurs first.
|
|
Infections and infestations
Bacterial vaginosis
|
1.2%
2/163 • Number of events 2 • From the time of Angel® Catheter insertion, through the entire catheter indwelling period (Mean±SD: 6.79±3.97 days; Median(Range: Min,Max): 5.94 (0.34,21.92) days), until death, discharge or 3 days post-removal, whichever occurs first.
|
|
Investigations
Blood albumin decreased
|
0.61%
1/163 • Number of events 1 • From the time of Angel® Catheter insertion, through the entire catheter indwelling period (Mean±SD: 6.79±3.97 days; Median(Range: Min,Max): 5.94 (0.34,21.92) days), until death, discharge or 3 days post-removal, whichever occurs first.
|
|
Investigations
Body temperature increased
|
1.2%
2/163 • Number of events 2 • From the time of Angel® Catheter insertion, through the entire catheter indwelling period (Mean±SD: 6.79±3.97 days; Median(Range: Min,Max): 5.94 (0.34,21.92) days), until death, discharge or 3 days post-removal, whichever occurs first.
|
|
Respiratory, thoracic and mediastinal disorders
Bronchial secretion retention
|
1.2%
2/163 • Number of events 2 • From the time of Angel® Catheter insertion, through the entire catheter indwelling period (Mean±SD: 6.79±3.97 days; Median(Range: Min,Max): 5.94 (0.34,21.92) days), until death, discharge or 3 days post-removal, whichever occurs first.
|
|
General disorders
Catheter site haemorrhage
|
0.61%
1/163 • Number of events 1 • From the time of Angel® Catheter insertion, through the entire catheter indwelling period (Mean±SD: 6.79±3.97 days; Median(Range: Min,Max): 5.94 (0.34,21.92) days), until death, discharge or 3 days post-removal, whichever occurs first.
|
|
Infections and infestations
Central nervous system infection
|
0.61%
1/163 • Number of events 1 • From the time of Angel® Catheter insertion, through the entire catheter indwelling period (Mean±SD: 6.79±3.97 days; Median(Range: Min,Max): 5.94 (0.34,21.92) days), until death, discharge or 3 days post-removal, whichever occurs first.
|
|
Nervous system disorders
Cerebral hypoperfusion
|
0.61%
1/163 • Number of events 1 • From the time of Angel® Catheter insertion, through the entire catheter indwelling period (Mean±SD: 6.79±3.97 days; Median(Range: Min,Max): 5.94 (0.34,21.92) days), until death, discharge or 3 days post-removal, whichever occurs first.
|
|
Nervous system disorders
Cerebral infarction
|
2.5%
4/163 • Number of events 4 • From the time of Angel® Catheter insertion, through the entire catheter indwelling period (Mean±SD: 6.79±3.97 days; Median(Range: Min,Max): 5.94 (0.34,21.92) days), until death, discharge or 3 days post-removal, whichever occurs first.
|
|
Hepatobiliary disorders
Cholecystitis
|
0.61%
1/163 • Number of events 1 • From the time of Angel® Catheter insertion, through the entire catheter indwelling period (Mean±SD: 6.79±3.97 days; Median(Range: Min,Max): 5.94 (0.34,21.92) days), until death, discharge or 3 days post-removal, whichever occurs first.
|
|
Infections and infestations
Clostridium difficile colitis
|
1.2%
2/163 • Number of events 2 • From the time of Angel® Catheter insertion, through the entire catheter indwelling period (Mean±SD: 6.79±3.97 days; Median(Range: Min,Max): 5.94 (0.34,21.92) days), until death, discharge or 3 days post-removal, whichever occurs first.
|
|
Infections and infestations
Clostridium difficile infection
|
0.61%
1/163 • Number of events 1 • From the time of Angel® Catheter insertion, through the entire catheter indwelling period (Mean±SD: 6.79±3.97 days; Median(Range: Min,Max): 5.94 (0.34,21.92) days), until death, discharge or 3 days post-removal, whichever occurs first.
|
|
Investigations
Clostridium test positive
|
1.8%
3/163 • Number of events 3 • From the time of Angel® Catheter insertion, through the entire catheter indwelling period (Mean±SD: 6.79±3.97 days; Median(Range: Min,Max): 5.94 (0.34,21.92) days), until death, discharge or 3 days post-removal, whichever occurs first.
|
|
Musculoskeletal and connective tissue disorders
Compartment syndrome
|
0.61%
1/163 • Number of events 1 • From the time of Angel® Catheter insertion, through the entire catheter indwelling period (Mean±SD: 6.79±3.97 days; Median(Range: Min,Max): 5.94 (0.34,21.92) days), until death, discharge or 3 days post-removal, whichever occurs first.
|
|
Gastrointestinal disorders
Constipation
|
0.61%
1/163 • Number of events 1 • From the time of Angel® Catheter insertion, through the entire catheter indwelling period (Mean±SD: 6.79±3.97 days; Median(Range: Min,Max): 5.94 (0.34,21.92) days), until death, discharge or 3 days post-removal, whichever occurs first.
|
|
Nervous system disorders
Convulsion
|
0.61%
1/163 • Number of events 1 • From the time of Angel® Catheter insertion, through the entire catheter indwelling period (Mean±SD: 6.79±3.97 days; Median(Range: Min,Max): 5.94 (0.34,21.92) days), until death, discharge or 3 days post-removal, whichever occurs first.
|
|
Investigations
Culture urine positive
|
0.61%
1/163 • Number of events 1 • From the time of Angel® Catheter insertion, through the entire catheter indwelling period (Mean±SD: 6.79±3.97 days; Median(Range: Min,Max): 5.94 (0.34,21.92) days), until death, discharge or 3 days post-removal, whichever occurs first.
|
|
Cardiac disorders
Cyanosis
|
0.61%
1/163 • Number of events 1 • From the time of Angel® Catheter insertion, through the entire catheter indwelling period (Mean±SD: 6.79±3.97 days; Median(Range: Min,Max): 5.94 (0.34,21.92) days), until death, discharge or 3 days post-removal, whichever occurs first.
|
|
Vascular disorders
Deep vein thrombosis
|
9.2%
15/163 • Number of events 15 • From the time of Angel® Catheter insertion, through the entire catheter indwelling period (Mean±SD: 6.79±3.97 days; Median(Range: Min,Max): 5.94 (0.34,21.92) days), until death, discharge or 3 days post-removal, whichever occurs first.
|
|
Psychiatric disorders
Delirium
|
0.61%
1/163 • Number of events 1 • From the time of Angel® Catheter insertion, through the entire catheter indwelling period (Mean±SD: 6.79±3.97 days; Median(Range: Min,Max): 5.94 (0.34,21.92) days), until death, discharge or 3 days post-removal, whichever occurs first.
|
|
Psychiatric disorders
Depression
|
0.61%
1/163 • Number of events 1 • From the time of Angel® Catheter insertion, through the entire catheter indwelling period (Mean±SD: 6.79±3.97 days; Median(Range: Min,Max): 5.94 (0.34,21.92) days), until death, discharge or 3 days post-removal, whichever occurs first.
|
|
General disorders
Device damage
|
0.61%
1/163 • Number of events 1 • From the time of Angel® Catheter insertion, through the entire catheter indwelling period (Mean±SD: 6.79±3.97 days; Median(Range: Min,Max): 5.94 (0.34,21.92) days), until death, discharge or 3 days post-removal, whichever occurs first.
|
|
General disorders
Device deployment issue
|
0.61%
1/163 • Number of events 1 • From the time of Angel® Catheter insertion, through the entire catheter indwelling period (Mean±SD: 6.79±3.97 days; Median(Range: Min,Max): 5.94 (0.34,21.92) days), until death, discharge or 3 days post-removal, whichever occurs first.
|
|
General disorders
Device dislocation
|
1.8%
3/163 • Number of events 3 • From the time of Angel® Catheter insertion, through the entire catheter indwelling period (Mean±SD: 6.79±3.97 days; Median(Range: Min,Max): 5.94 (0.34,21.92) days), until death, discharge or 3 days post-removal, whichever occurs first.
|
|
Endocrine disorders
Diabetes insipidus
|
0.61%
1/163 • Number of events 1 • From the time of Angel® Catheter insertion, through the entire catheter indwelling period (Mean±SD: 6.79±3.97 days; Median(Range: Min,Max): 5.94 (0.34,21.92) days), until death, discharge or 3 days post-removal, whichever occurs first.
|
|
Gastrointestinal disorders
Diarrhoea
|
1.2%
2/163 • Number of events 2 • From the time of Angel® Catheter insertion, through the entire catheter indwelling period (Mean±SD: 6.79±3.97 days; Median(Range: Min,Max): 5.94 (0.34,21.92) days), until death, discharge or 3 days post-removal, whichever occurs first.
|
|
Injury, poisoning and procedural complications
Diffuse axonal injury
|
0.61%
1/163 • Number of events 1 • From the time of Angel® Catheter insertion, through the entire catheter indwelling period (Mean±SD: 6.79±3.97 days; Median(Range: Min,Max): 5.94 (0.34,21.92) days), until death, discharge or 3 days post-removal, whichever occurs first.
|
|
Gastrointestinal disorders
Dysphagia
|
0.61%
1/163 • Number of events 1 • From the time of Angel® Catheter insertion, through the entire catheter indwelling period (Mean±SD: 6.79±3.97 days; Median(Range: Min,Max): 5.94 (0.34,21.92) days), until death, discharge or 3 days post-removal, whichever occurs first.
|
|
Nervous system disorders
Encephalopathy
|
0.61%
1/163 • Number of events 1 • From the time of Angel® Catheter insertion, through the entire catheter indwelling period (Mean±SD: 6.79±3.97 days; Median(Range: Min,Max): 5.94 (0.34,21.92) days), until death, discharge or 3 days post-removal, whichever occurs first.
|
|
Infections and infestations
Escherichia urinary tract infection
|
0.61%
1/163 • Number of events 1 • From the time of Angel® Catheter insertion, through the entire catheter indwelling period (Mean±SD: 6.79±3.97 days; Median(Range: Min,Max): 5.94 (0.34,21.92) days), until death, discharge or 3 days post-removal, whichever occurs first.
|
|
Vascular disorders
Femoral artery occlusion
|
0.61%
1/163 • Number of events 1 • From the time of Angel® Catheter insertion, through the entire catheter indwelling period (Mean±SD: 6.79±3.97 days; Median(Range: Min,Max): 5.94 (0.34,21.92) days), until death, discharge or 3 days post-removal, whichever occurs first.
|
|
Gastrointestinal disorders
Gastric hypomotility
|
0.61%
1/163 • Number of events 1 • From the time of Angel® Catheter insertion, through the entire catheter indwelling period (Mean±SD: 6.79±3.97 days; Median(Range: Min,Max): 5.94 (0.34,21.92) days), until death, discharge or 3 days post-removal, whichever occurs first.
|
|
Infections and infestations
Gastrointestinal bacterial infection
|
0.61%
1/163 • Number of events 1 • From the time of Angel® Catheter insertion, through the entire catheter indwelling period (Mean±SD: 6.79±3.97 days; Median(Range: Min,Max): 5.94 (0.34,21.92) days), until death, discharge or 3 days post-removal, whichever occurs first.
|
|
Gastrointestinal disorders
Gastrointestinal sounds abnormal
|
0.61%
1/163 • Number of events 1 • From the time of Angel® Catheter insertion, through the entire catheter indwelling period (Mean±SD: 6.79±3.97 days; Median(Range: Min,Max): 5.94 (0.34,21.92) days), until death, discharge or 3 days post-removal, whichever occurs first.
|
|
Metabolism and nutrition disorders
Glucose tolerance impaired
|
0.61%
1/163 • Number of events 1 • From the time of Angel® Catheter insertion, through the entire catheter indwelling period (Mean±SD: 6.79±3.97 days; Median(Range: Min,Max): 5.94 (0.34,21.92) days), until death, discharge or 3 days post-removal, whichever occurs first.
|
|
Renal and urinary disorders
Haematuria
|
0.61%
1/163 • Number of events 1 • From the time of Angel® Catheter insertion, through the entire catheter indwelling period (Mean±SD: 6.79±3.97 days; Median(Range: Min,Max): 5.94 (0.34,21.92) days), until death, discharge or 3 days post-removal, whichever occurs first.
|
|
Blood and lymphatic system disorders
Haemorrhagic anaemia
|
1.2%
2/163 • Number of events 2 • From the time of Angel® Catheter insertion, through the entire catheter indwelling period (Mean±SD: 6.79±3.97 days; Median(Range: Min,Max): 5.94 (0.34,21.92) days), until death, discharge or 3 days post-removal, whichever occurs first.
|
|
Respiratory, thoracic and mediastinal disorders
Haemothorax
|
0.61%
1/163 • Number of events 1 • From the time of Angel® Catheter insertion, through the entire catheter indwelling period (Mean±SD: 6.79±3.97 days; Median(Range: Min,Max): 5.94 (0.34,21.92) days), until death, discharge or 3 days post-removal, whichever occurs first.
|
|
Respiratory, thoracic and mediastinal disorders
Hyercapnia
|
0.61%
1/163 • Number of events 1 • From the time of Angel® Catheter insertion, through the entire catheter indwelling period (Mean±SD: 6.79±3.97 days; Median(Range: Min,Max): 5.94 (0.34,21.92) days), until death, discharge or 3 days post-removal, whichever occurs first.
|
|
Metabolism and nutrition disorders
Hyperglycaemia
|
0.61%
1/163 • Number of events 1 • From the time of Angel® Catheter insertion, through the entire catheter indwelling period (Mean±SD: 6.79±3.97 days; Median(Range: Min,Max): 5.94 (0.34,21.92) days), until death, discharge or 3 days post-removal, whichever occurs first.
|
|
Metabolism and nutrition disorders
Hyperkalaemia
|
0.61%
1/163 • Number of events 1 • From the time of Angel® Catheter insertion, through the entire catheter indwelling period (Mean±SD: 6.79±3.97 days; Median(Range: Min,Max): 5.94 (0.34,21.92) days), until death, discharge or 3 days post-removal, whichever occurs first.
|
|
Metabolism and nutrition disorders
Hypernatraemia
|
1.8%
3/163 • Number of events 3 • From the time of Angel® Catheter insertion, through the entire catheter indwelling period (Mean±SD: 6.79±3.97 days; Median(Range: Min,Max): 5.94 (0.34,21.92) days), until death, discharge or 3 days post-removal, whichever occurs first.
|
|
Vascular disorders
Hypertension
|
3.1%
5/163 • Number of events 5 • From the time of Angel® Catheter insertion, through the entire catheter indwelling period (Mean±SD: 6.79±3.97 days; Median(Range: Min,Max): 5.94 (0.34,21.92) days), until death, discharge or 3 days post-removal, whichever occurs first.
|
|
General disorders
Hyperthermia
|
1.2%
2/163 • Number of events 2 • From the time of Angel® Catheter insertion, through the entire catheter indwelling period (Mean±SD: 6.79±3.97 days; Median(Range: Min,Max): 5.94 (0.34,21.92) days), until death, discharge or 3 days post-removal, whichever occurs first.
|
|
Metabolism and nutrition disorders
Hypoglycaemia
|
0.61%
1/163 • Number of events 1 • From the time of Angel® Catheter insertion, through the entire catheter indwelling period (Mean±SD: 6.79±3.97 days; Median(Range: Min,Max): 5.94 (0.34,21.92) days), until death, discharge or 3 days post-removal, whichever occurs first.
|
|
Metabolism and nutrition disorders
Hypokalaemia
|
2.5%
4/163 • Number of events 4 • From the time of Angel® Catheter insertion, through the entire catheter indwelling period (Mean±SD: 6.79±3.97 days; Median(Range: Min,Max): 5.94 (0.34,21.92) days), until death, discharge or 3 days post-removal, whichever occurs first.
|
|
Metabolism and nutrition disorders
Hypomagnesaemia
|
0.61%
1/163 • Number of events 1 • From the time of Angel® Catheter insertion, through the entire catheter indwelling period (Mean±SD: 6.79±3.97 days; Median(Range: Min,Max): 5.94 (0.34,21.92) days), until death, discharge or 3 days post-removal, whichever occurs first.
|
|
Metabolism and nutrition disorders
Hypophosphataemia
|
0.61%
1/163 • Number of events 1 • From the time of Angel® Catheter insertion, through the entire catheter indwelling period (Mean±SD: 6.79±3.97 days; Median(Range: Min,Max): 5.94 (0.34,21.92) days), until death, discharge or 3 days post-removal, whichever occurs first.
|
|
Vascular disorders
Hypotension
|
5.5%
9/163 • Number of events 9 • From the time of Angel® Catheter insertion, through the entire catheter indwelling period (Mean±SD: 6.79±3.97 days; Median(Range: Min,Max): 5.94 (0.34,21.92) days), until death, discharge or 3 days post-removal, whichever occurs first.
|
|
Vascular disorders
Hypoxia
|
1.8%
3/163 • Number of events 3 • From the time of Angel® Catheter insertion, through the entire catheter indwelling period (Mean±SD: 6.79±3.97 days; Median(Range: Min,Max): 5.94 (0.34,21.92) days), until death, discharge or 3 days post-removal, whichever occurs first.
|
|
Gastrointestinal disorders
Impaired gastric emptying
|
0.61%
1/163 • Number of events 1 • From the time of Angel® Catheter insertion, through the entire catheter indwelling period (Mean±SD: 6.79±3.97 days; Median(Range: Min,Max): 5.94 (0.34,21.92) days), until death, discharge or 3 days post-removal, whichever occurs first.
|
|
Psychiatric disorders
Insomnia
|
0.61%
1/163 • Number of events 1 • From the time of Angel® Catheter insertion, through the entire catheter indwelling period (Mean±SD: 6.79±3.97 days; Median(Range: Min,Max): 5.94 (0.34,21.92) days), until death, discharge or 3 days post-removal, whichever occurs first.
|
|
Nervous system disorders
Intracranial pressure increased
|
1.2%
2/163 • Number of events 2 • From the time of Angel® Catheter insertion, through the entire catheter indwelling period (Mean±SD: 6.79±3.97 days; Median(Range: Min,Max): 5.94 (0.34,21.92) days), until death, discharge or 3 days post-removal, whichever occurs first.
|
|
Investigations
Klebsiella test positive
|
0.61%
1/163 • Number of events 1 • From the time of Angel® Catheter insertion, through the entire catheter indwelling period (Mean±SD: 6.79±3.97 days; Median(Range: Min,Max): 5.94 (0.34,21.92) days), until death, discharge or 3 days post-removal, whichever occurs first.
|
|
Blood and lymphatic system disorders
Leukocytosis
|
4.9%
8/163 • Number of events 8 • From the time of Angel® Catheter insertion, through the entire catheter indwelling period (Mean±SD: 6.79±3.97 days; Median(Range: Min,Max): 5.94 (0.34,21.92) days), until death, discharge or 3 days post-removal, whichever occurs first.
|
|
Blood and lymphatic system disorders
Leukopenia
|
0.61%
1/163 • Number of events 1 • From the time of Angel® Catheter insertion, through the entire catheter indwelling period (Mean±SD: 6.79±3.97 days; Median(Range: Min,Max): 5.94 (0.34,21.92) days), until death, discharge or 3 days post-removal, whichever occurs first.
|
|
Infections and infestations
Lobar pneumonia
|
1.2%
2/163 • Number of events 2 • From the time of Angel® Catheter insertion, through the entire catheter indwelling period (Mean±SD: 6.79±3.97 days; Median(Range: Min,Max): 5.94 (0.34,21.92) days), until death, discharge or 3 days post-removal, whichever occurs first.
|
|
General disorders
Local swelling
|
0.61%
1/163 • Number of events 1 • From the time of Angel® Catheter insertion, through the entire catheter indwelling period (Mean±SD: 6.79±3.97 days; Median(Range: Min,Max): 5.94 (0.34,21.92) days), until death, discharge or 3 days post-removal, whichever occurs first.
|
|
Infections and infestations
Lung infection
|
2.5%
4/163 • Number of events 4 • From the time of Angel® Catheter insertion, through the entire catheter indwelling period (Mean±SD: 6.79±3.97 days; Median(Range: Min,Max): 5.94 (0.34,21.92) days), until death, discharge or 3 days post-removal, whichever occurs first.
|
|
Gastrointestinal disorders
Melaena
|
0.61%
1/163 • Number of events 1 • From the time of Angel® Catheter insertion, through the entire catheter indwelling period (Mean±SD: 6.79±3.97 days; Median(Range: Min,Max): 5.94 (0.34,21.92) days), until death, discharge or 3 days post-removal, whichever occurs first.
|
|
Infections and infestations
Meningitis bacterial
|
0.61%
1/163 • Number of events 1 • From the time of Angel® Catheter insertion, through the entire catheter indwelling period (Mean±SD: 6.79±3.97 days; Median(Range: Min,Max): 5.94 (0.34,21.92) days), until death, discharge or 3 days post-removal, whichever occurs first.
|
|
Nervous system disorders
Mental impairment
|
0.61%
1/163 • Number of events 1 • From the time of Angel® Catheter insertion, through the entire catheter indwelling period (Mean±SD: 6.79±3.97 days; Median(Range: Min,Max): 5.94 (0.34,21.92) days), until death, discharge or 3 days post-removal, whichever occurs first.
|
|
Musculoskeletal and connective tissue disorders
Muscle haemorrhage
|
0.61%
1/163 • Number of events 1 • From the time of Angel® Catheter insertion, through the entire catheter indwelling period (Mean±SD: 6.79±3.97 days; Median(Range: Min,Max): 5.94 (0.34,21.92) days), until death, discharge or 3 days post-removal, whichever occurs first.
|
|
Musculoskeletal and connective tissue disorders
Muscle necrosis
|
0.61%
1/163 • Number of events 1 • From the time of Angel® Catheter insertion, through the entire catheter indwelling period (Mean±SD: 6.79±3.97 days; Median(Range: Min,Max): 5.94 (0.34,21.92) days), until death, discharge or 3 days post-removal, whichever occurs first.
|
|
Renal and urinary disorders
Myoglobinuria
|
0.61%
1/163 • Number of events 1 • From the time of Angel® Catheter insertion, through the entire catheter indwelling period (Mean±SD: 6.79±3.97 days; Median(Range: Min,Max): 5.94 (0.34,21.92) days), until death, discharge or 3 days post-removal, whichever occurs first.
|
|
Nervous system disorders
Neurological symptom
|
0.61%
1/163 • Number of events 1 • From the time of Angel® Catheter insertion, through the entire catheter indwelling period (Mean±SD: 6.79±3.97 days; Median(Range: Min,Max): 5.94 (0.34,21.92) days), until death, discharge or 3 days post-removal, whichever occurs first.
|
|
General disorders
Oedema peripheral
|
0.61%
1/163 • Number of events 1 • From the time of Angel® Catheter insertion, through the entire catheter indwelling period (Mean±SD: 6.79±3.97 days; Median(Range: Min,Max): 5.94 (0.34,21.92) days), until death, discharge or 3 days post-removal, whichever occurs first.
|
|
Gastrointestinal disorders
Oral disorder
|
0.61%
1/163 • Number of events 1 • From the time of Angel® Catheter insertion, through the entire catheter indwelling period (Mean±SD: 6.79±3.97 days; Median(Range: Min,Max): 5.94 (0.34,21.92) days), until death, discharge or 3 days post-removal, whichever occurs first.
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
0.61%
1/163 • Number of events 1 • From the time of Angel® Catheter insertion, through the entire catheter indwelling period (Mean±SD: 6.79±3.97 days; Median(Range: Min,Max): 5.94 (0.34,21.92) days), until death, discharge or 3 days post-removal, whichever occurs first.
|
|
Gastrointestinal disorders
Pancreatitis
|
0.61%
1/163 • Number of events 1 • From the time of Angel® Catheter insertion, through the entire catheter indwelling period (Mean±SD: 6.79±3.97 days; Median(Range: Min,Max): 5.94 (0.34,21.92) days), until death, discharge or 3 days post-removal, whichever occurs first.
|
|
Vascular disorders
Pelvic venous thrombosis
|
1.2%
2/163 • Number of events 2 • From the time of Angel® Catheter insertion, through the entire catheter indwelling period (Mean±SD: 6.79±3.97 days; Median(Range: Min,Max): 5.94 (0.34,21.92) days), until death, discharge or 3 days post-removal, whichever occurs first.
|
|
Infections and infestations
Peritonitis
|
0.61%
1/163 • Number of events 1 • From the time of Angel® Catheter insertion, through the entire catheter indwelling period (Mean±SD: 6.79±3.97 days; Median(Range: Min,Max): 5.94 (0.34,21.92) days), until death, discharge or 3 days post-removal, whichever occurs first.
|
|
Vascular disorders
Platelet count increased
|
0.61%
1/163 • Number of events 1 • From the time of Angel® Catheter insertion, through the entire catheter indwelling period (Mean±SD: 6.79±3.97 days; Median(Range: Min,Max): 5.94 (0.34,21.92) days), until death, discharge or 3 days post-removal, whichever occurs first.
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
1.8%
3/163 • Number of events 3 • From the time of Angel® Catheter insertion, through the entire catheter indwelling period (Mean±SD: 6.79±3.97 days; Median(Range: Min,Max): 5.94 (0.34,21.92) days), until death, discharge or 3 days post-removal, whichever occurs first.
|
|
Infections and infestations
Pneumonia
|
14.7%
24/163 • Number of events 24 • From the time of Angel® Catheter insertion, through the entire catheter indwelling period (Mean±SD: 6.79±3.97 days; Median(Range: Min,Max): 5.94 (0.34,21.92) days), until death, discharge or 3 days post-removal, whichever occurs first.
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonia aspiration
|
0.61%
1/163 • Number of events 1 • From the time of Angel® Catheter insertion, through the entire catheter indwelling period (Mean±SD: 6.79±3.97 days; Median(Range: Min,Max): 5.94 (0.34,21.92) days), until death, discharge or 3 days post-removal, whichever occurs first.
|
|
Infections and infestations
Pneumonia klebsiella
|
0.61%
1/163 • Number of events 1 • From the time of Angel® Catheter insertion, through the entire catheter indwelling period (Mean±SD: 6.79±3.97 days; Median(Range: Min,Max): 5.94 (0.34,21.92) days), until death, discharge or 3 days post-removal, whichever occurs first.
|
|
Infections and infestations
Pneumonia pneumococcal
|
0.61%
1/163 • Number of events 1 • From the time of Angel® Catheter insertion, through the entire catheter indwelling period (Mean±SD: 6.79±3.97 days; Median(Range: Min,Max): 5.94 (0.34,21.92) days), until death, discharge or 3 days post-removal, whichever occurs first.
|
|
Infections and infestations
Pneumonia psudomonal
|
0.61%
1/163 • Number of events 1 • From the time of Angel® Catheter insertion, through the entire catheter indwelling period (Mean±SD: 6.79±3.97 days; Median(Range: Min,Max): 5.94 (0.34,21.92) days), until death, discharge or 3 days post-removal, whichever occurs first.
|
|
Infections and infestations
Pneumonia staphylococcal
|
0.61%
1/163 • Number of events 1 • From the time of Angel® Catheter insertion, through the entire catheter indwelling period (Mean±SD: 6.79±3.97 days; Median(Range: Min,Max): 5.94 (0.34,21.92) days), until death, discharge or 3 days post-removal, whichever occurs first.
|
|
Respiratory, thoracic and mediastinal disorders
Pneumothorax
|
0.61%
1/163 • Number of events 1 • From the time of Angel® Catheter insertion, through the entire catheter indwelling period (Mean±SD: 6.79±3.97 days; Median(Range: Min,Max): 5.94 (0.34,21.92) days), until death, discharge or 3 days post-removal, whichever occurs first.
|
|
Infections and infestations
Postoperative wound infection
|
0.61%
1/163 • Number of events 1 • From the time of Angel® Catheter insertion, through the entire catheter indwelling period (Mean±SD: 6.79±3.97 days; Median(Range: Min,Max): 5.94 (0.34,21.92) days), until death, discharge or 3 days post-removal, whichever occurs first.
|
|
Psychiatric disorders
Post-traumatic stress disorder
|
0.61%
1/163 • Number of events 1 • From the time of Angel® Catheter insertion, through the entire catheter indwelling period (Mean±SD: 6.79±3.97 days; Median(Range: Min,Max): 5.94 (0.34,21.92) days), until death, discharge or 3 days post-removal, whichever occurs first.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary embolism
|
3.7%
6/163 • Number of events 6 • From the time of Angel® Catheter insertion, through the entire catheter indwelling period (Mean±SD: 6.79±3.97 days; Median(Range: Min,Max): 5.94 (0.34,21.92) days), until death, discharge or 3 days post-removal, whichever occurs first.
|
|
Investigations
Pulse absent
|
0.61%
1/163 • Number of events 1 • From the time of Angel® Catheter insertion, through the entire catheter indwelling period (Mean±SD: 6.79±3.97 days; Median(Range: Min,Max): 5.94 (0.34,21.92) days), until death, discharge or 3 days post-removal, whichever occurs first.
|
|
Infections and infestations
Pyelonephritis
|
0.61%
1/163 • Number of events 1 • From the time of Angel® Catheter insertion, through the entire catheter indwelling period (Mean±SD: 6.79±3.97 days; Median(Range: Min,Max): 5.94 (0.34,21.92) days), until death, discharge or 3 days post-removal, whichever occurs first.
|
|
General disorders
Pyrexia
|
8.6%
14/163 • Number of events 14 • From the time of Angel® Catheter insertion, through the entire catheter indwelling period (Mean±SD: 6.79±3.97 days; Median(Range: Min,Max): 5.94 (0.34,21.92) days), until death, discharge or 3 days post-removal, whichever occurs first.
|
|
Skin and subcutaneous tissue disorders
Rash
|
0.61%
1/163 • Number of events 1 • From the time of Angel® Catheter insertion, through the entire catheter indwelling period (Mean±SD: 6.79±3.97 days; Median(Range: Min,Max): 5.94 (0.34,21.92) days), until death, discharge or 3 days post-removal, whichever occurs first.
|
|
Renal and urinary disorders
Renal impairment
|
0.61%
1/163 • Number of events 1 • From the time of Angel® Catheter insertion, through the entire catheter indwelling period (Mean±SD: 6.79±3.97 days; Median(Range: Min,Max): 5.94 (0.34,21.92) days), until death, discharge or 3 days post-removal, whichever occurs first.
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory failure
|
3.7%
6/163 • Number of events 6 • From the time of Angel® Catheter insertion, through the entire catheter indwelling period (Mean±SD: 6.79±3.97 days; Median(Range: Min,Max): 5.94 (0.34,21.92) days), until death, discharge or 3 days post-removal, whichever occurs first.
|
|
Infections and infestations
Respiratory tract infection
|
1.2%
2/163 • Number of events 2 • From the time of Angel® Catheter insertion, through the entire catheter indwelling period (Mean±SD: 6.79±3.97 days; Median(Range: Min,Max): 5.94 (0.34,21.92) days), until death, discharge or 3 days post-removal, whichever occurs first.
|
|
Musculoskeletal and connective tissue disorders
Rhabdomyolysis
|
0.61%
1/163 • Number of events 1 • From the time of Angel® Catheter insertion, through the entire catheter indwelling period (Mean±SD: 6.79±3.97 days; Median(Range: Min,Max): 5.94 (0.34,21.92) days), until death, discharge or 3 days post-removal, whichever occurs first.
|
|
Eye disorders
Scleral oedema
|
0.61%
1/163 • Number of events 1 • From the time of Angel® Catheter insertion, through the entire catheter indwelling period (Mean±SD: 6.79±3.97 days; Median(Range: Min,Max): 5.94 (0.34,21.92) days), until death, discharge or 3 days post-removal, whichever occurs first.
|
|
Vascular disorders
Secondary hypertension
|
0.61%
1/163 • Number of events 1 • From the time of Angel® Catheter insertion, through the entire catheter indwelling period (Mean±SD: 6.79±3.97 days; Median(Range: Min,Max): 5.94 (0.34,21.92) days), until death, discharge or 3 days post-removal, whichever occurs first.
|
|
Infections and infestations
Sepsis
|
0.61%
1/163 • Number of events 1 • From the time of Angel® Catheter insertion, through the entire catheter indwelling period (Mean±SD: 6.79±3.97 days; Median(Range: Min,Max): 5.94 (0.34,21.92) days), until death, discharge or 3 days post-removal, whichever occurs first.
|
|
Infections and infestations
Sinusitis
|
1.8%
3/163 • Number of events 3 • From the time of Angel® Catheter insertion, through the entire catheter indwelling period (Mean±SD: 6.79±3.97 days; Median(Range: Min,Max): 5.94 (0.34,21.92) days), until death, discharge or 3 days post-removal, whichever occurs first.
|
|
Infections and infestations
Soft tissue infection
|
0.61%
1/163 • Number of events 1 • From the time of Angel® Catheter insertion, through the entire catheter indwelling period (Mean±SD: 6.79±3.97 days; Median(Range: Min,Max): 5.94 (0.34,21.92) days), until death, discharge or 3 days post-removal, whichever occurs first.
|
|
Infections and infestations
Staphylococcal infection
|
0.61%
1/163 • Number of events 1 • From the time of Angel® Catheter insertion, through the entire catheter indwelling period (Mean±SD: 6.79±3.97 days; Median(Range: Min,Max): 5.94 (0.34,21.92) days), until death, discharge or 3 days post-removal, whichever occurs first.
|
|
Vascular disorders
Subclavian vein thrombosis
|
0.61%
1/163 • Number of events 1 • From the time of Angel® Catheter insertion, through the entire catheter indwelling period (Mean±SD: 6.79±3.97 days; Median(Range: Min,Max): 5.94 (0.34,21.92) days), until death, discharge or 3 days post-removal, whichever occurs first.
|
|
Cardiac disorders
Supraventricular tachycardia
|
1.2%
2/163 • Number of events 2 • From the time of Angel® Catheter insertion, through the entire catheter indwelling period (Mean±SD: 6.79±3.97 days; Median(Range: Min,Max): 5.94 (0.34,21.92) days), until death, discharge or 3 days post-removal, whichever occurs first.
|
|
General disorders
Systemic inflammatory response syndrome
|
1.2%
2/163 • Number of events 2 • From the time of Angel® Catheter insertion, through the entire catheter indwelling period (Mean±SD: 6.79±3.97 days; Median(Range: Min,Max): 5.94 (0.34,21.92) days), until death, discharge or 3 days post-removal, whichever occurs first.
|
|
Cardiac disorders
Tachycardia
|
2.5%
4/163 • Number of events 4 • From the time of Angel® Catheter insertion, through the entire catheter indwelling period (Mean±SD: 6.79±3.97 days; Median(Range: Min,Max): 5.94 (0.34,21.92) days), until death, discharge or 3 days post-removal, whichever occurs first.
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
0.61%
1/163 • Number of events 1 • From the time of Angel® Catheter insertion, through the entire catheter indwelling period (Mean±SD: 6.79±3.97 days; Median(Range: Min,Max): 5.94 (0.34,21.92) days), until death, discharge or 3 days post-removal, whichever occurs first.
|
|
Vascular disorders
Thrombophlebitis superficial
|
1.8%
3/163 • Number of events 3 • From the time of Angel® Catheter insertion, through the entire catheter indwelling period (Mean±SD: 6.79±3.97 days; Median(Range: Min,Max): 5.94 (0.34,21.92) days), until death, discharge or 3 days post-removal, whichever occurs first.
|
|
Infections and infestations
Tracheobronchitis
|
1.2%
2/163 • Number of events 2 • From the time of Angel® Catheter insertion, through the entire catheter indwelling period (Mean±SD: 6.79±3.97 days; Median(Range: Min,Max): 5.94 (0.34,21.92) days), until death, discharge or 3 days post-removal, whichever occurs first.
|
|
General disorders
Unintentional medical device removal
|
7.4%
12/163 • Number of events 12 • From the time of Angel® Catheter insertion, through the entire catheter indwelling period (Mean±SD: 6.79±3.97 days; Median(Range: Min,Max): 5.94 (0.34,21.92) days), until death, discharge or 3 days post-removal, whichever occurs first.
|
|
Renal and urinary disorders
Urinary retention
|
0.61%
1/163 • Number of events 1 • From the time of Angel® Catheter insertion, through the entire catheter indwelling period (Mean±SD: 6.79±3.97 days; Median(Range: Min,Max): 5.94 (0.34,21.92) days), until death, discharge or 3 days post-removal, whichever occurs first.
|
|
Infections and infestations
Urinary tract infection
|
5.5%
9/163 • Number of events 9 • From the time of Angel® Catheter insertion, through the entire catheter indwelling period (Mean±SD: 6.79±3.97 days; Median(Range: Min,Max): 5.94 (0.34,21.92) days), until death, discharge or 3 days post-removal, whichever occurs first.
|
|
Vascular disorders
Vena cava thrombosis
|
1.2%
2/163 • Number of events 2 • From the time of Angel® Catheter insertion, through the entire catheter indwelling period (Mean±SD: 6.79±3.97 days; Median(Range: Min,Max): 5.94 (0.34,21.92) days), until death, discharge or 3 days post-removal, whichever occurs first.
|
|
Infections and infestations
Vulvovaginal mycotic infection
|
0.61%
1/163 • Number of events 1 • From the time of Angel® Catheter insertion, through the entire catheter indwelling period (Mean±SD: 6.79±3.97 days; Median(Range: Min,Max): 5.94 (0.34,21.92) days), until death, discharge or 3 days post-removal, whichever occurs first.
|
|
Injury, poisoning and procedural complications
Wound
|
0.61%
1/163 • Number of events 1 • From the time of Angel® Catheter insertion, through the entire catheter indwelling period (Mean±SD: 6.79±3.97 days; Median(Range: Min,Max): 5.94 (0.34,21.92) days), until death, discharge or 3 days post-removal, whichever occurs first.
|
|
Infections and infestations
Wound infection
|
0.61%
1/163 • Number of events 1 • From the time of Angel® Catheter insertion, through the entire catheter indwelling period (Mean±SD: 6.79±3.97 days; Median(Range: Min,Max): 5.94 (0.34,21.92) days), until death, discharge or 3 days post-removal, whichever occurs first.
|
|
Infections and infestations
Wound infection pseudomonas
|
0.61%
1/163 • Number of events 1 • From the time of Angel® Catheter insertion, through the entire catheter indwelling period (Mean±SD: 6.79±3.97 days; Median(Range: Min,Max): 5.94 (0.34,21.92) days), until death, discharge or 3 days post-removal, whichever occurs first.
|
|
Infections and infestations
Wound sepsis
|
0.61%
1/163 • Number of events 1 • From the time of Angel® Catheter insertion, through the entire catheter indwelling period (Mean±SD: 6.79±3.97 days; Median(Range: Min,Max): 5.94 (0.34,21.92) days), until death, discharge or 3 days post-removal, whichever occurs first.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: GT60