Trial Outcomes & Findings for SHIELD II Clinical Investigation (NCT NCT02468778)
NCT ID: NCT02468778
Last Updated: 2022-06-28
Results Overview
The primary endpoint, including the following components representing important safety and effectiveness endpoints will be evaluated using the difference in event rates in the ITT population. * Cardiovascular Death * Myocardial infarction (MI) * Stroke * Any unplanned repeat revascularization (PCI or CABG) * Bleeding (BARC 3 or 5) up to 14 days post-device removal * Severe hypotension, defined as: systolic blood pressure (SBP) or augmented diastolic pressure (whichever is greater) \<90 mmHg while on device support requiring (1) more than one administration of OR (2) continuous infusion of inotropic/pressor medications to restore hemodynamics * Change in aortic insufficiency from baseline to 90 days by echocardiographic assessment.
Recruitment status
TERMINATED
Study phase
NA
Target enrollment
54 participants
Primary outcome timeframe
90 Days
Results posted on
2022-06-28
Participant Flow
A total of 18 PHP roll-in and 36 randomized subjects were registered at 15 sites in the pivotal phase of the study.
Participant milestones
| Measure |
HeartMate PHP (Roll-in)
Participants who receive a HeartMate PHP device without randomisation will be included in this arm
HeartMate PHP: The HeartMate PHP System is a temporary (\<6 hours) ventricular assist device indicated for use during high-risk percutaneous coronary interventions (PCI) performed electively or urgently in hemodynamically stable patients with severe coronary artery disease, when a heart team, including a cardiac surgeon, has determined high-risk PCI is an acceptable therapeutic option. Use of the HeartMate PHP Systems in these patients may prevent hemodynamic instability, which can result from repeat episodes of reversible myocardial ischemia that occur during planned temporary coronary occlusions and may reduce peri-and post-procedural adverse events.
|
HeartMate PHP (Randomised)
Participants who receive a HeartMate PHP device after randomisation will be included in this arm
HeartMate PHP: The HeartMate PHP System is a temporary (\<6 hours) ventricular assist device indicated for use during high-risk percutaneous coronary interventions (PCI) performed electively or urgently in hemodynamically stable patients with severe coronary artery disease, when a heart team, including a cardiac surgeon, has determined high-risk PCI is an acceptable therapeutic option. Use of the HeartMate PHP Systems in these patients may prevent hemodynamic instability, which can result from repeat episodes of reversible myocardial ischemia that occur during planned temporary coronary occlusions and may reduce peri-and post-procedural adverse events.
|
Any Abiomed Impella® (Randomised)
Participants who receive any Abiomed Impella® Device approved for use in high-risk PCI after randomisation will be included in this arm
Any Abiomed Impella® device approved for use in high-risk PCI: Any Abiomed Impella® device approved for use in high-risk PCI.
|
|---|---|---|---|
|
Overall Study
STARTED
|
18
|
26
|
10
|
|
Overall Study
COMPLETED
|
15
|
22
|
7
|
|
Overall Study
NOT COMPLETED
|
3
|
4
|
3
|
Reasons for withdrawal
| Measure |
HeartMate PHP (Roll-in)
Participants who receive a HeartMate PHP device without randomisation will be included in this arm
HeartMate PHP: The HeartMate PHP System is a temporary (\<6 hours) ventricular assist device indicated for use during high-risk percutaneous coronary interventions (PCI) performed electively or urgently in hemodynamically stable patients with severe coronary artery disease, when a heart team, including a cardiac surgeon, has determined high-risk PCI is an acceptable therapeutic option. Use of the HeartMate PHP Systems in these patients may prevent hemodynamic instability, which can result from repeat episodes of reversible myocardial ischemia that occur during planned temporary coronary occlusions and may reduce peri-and post-procedural adverse events.
|
HeartMate PHP (Randomised)
Participants who receive a HeartMate PHP device after randomisation will be included in this arm
HeartMate PHP: The HeartMate PHP System is a temporary (\<6 hours) ventricular assist device indicated for use during high-risk percutaneous coronary interventions (PCI) performed electively or urgently in hemodynamically stable patients with severe coronary artery disease, when a heart team, including a cardiac surgeon, has determined high-risk PCI is an acceptable therapeutic option. Use of the HeartMate PHP Systems in these patients may prevent hemodynamic instability, which can result from repeat episodes of reversible myocardial ischemia that occur during planned temporary coronary occlusions and may reduce peri-and post-procedural adverse events.
|
Any Abiomed Impella® (Randomised)
Participants who receive any Abiomed Impella® Device approved for use in high-risk PCI after randomisation will be included in this arm
Any Abiomed Impella® device approved for use in high-risk PCI: Any Abiomed Impella® device approved for use in high-risk PCI.
|
|---|---|---|---|
|
Overall Study
Death
|
2
|
1
|
0
|
|
Overall Study
Lost to Follow-up
|
1
|
2
|
2
|
|
Overall Study
Withdrawal by Subject
|
0
|
1
|
1
|
Baseline Characteristics
SHIELD II Clinical Investigation
Baseline characteristics by cohort
| Measure |
HeartMate PHP (Roll-in)
n=18 Participants
Participants who receive a HeartMate PHP device without randomisation will be included in this arm
HeartMate PHP: The HeartMate PHP System is a temporary (\<6 hours) ventricular assist device indicated for use during high-risk percutaneous coronary interventions (PCI) performed electively or urgently in hemodynamically stable patients with severe coronary artery disease, when a heart team, including a cardiac surgeon, has determined high-risk PCI is an acceptable therapeutic option. Use of the HeartMate PHP Systems in these patients may prevent hemodynamic instability, which can result from repeat episodes of reversible myocardial ischemia that occur during planned temporary coronary occlusions and may reduce peri-and post-procedural adverse events.
|
HeartMate PHP (Randomised)
n=26 Participants
Participants who receive a HeartMate PHP device after randomisation will be included in this arm
HeartMate PHP: The HeartMate PHP System is a temporary (\<6 hours) ventricular assist device indicated for use during high-risk percutaneous coronary interventions (PCI) performed electively or urgently in hemodynamically stable patients with severe coronary artery disease, when a heart team, including a cardiac surgeon, has determined high-risk PCI is an acceptable therapeutic option. Use of the HeartMate PHP Systems in these patients may prevent hemodynamic instability, which can result from repeat episodes of reversible myocardial ischemia that occur during planned temporary coronary occlusions and may reduce peri-and post-procedural adverse events.
|
Any Abiomed Impella® (Randomised)
n=10 Participants
Participants who receive any Abiomed Impella® Device approved for use in high-risk PCI after randomisation will be included in this arm
Any Abiomed Impella® device approved for use in high-risk PCI: Any Abiomed Impella® device approved for use in high-risk PCI.
|
Total
n=54 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Continuous
|
73.3 years
STANDARD_DEVIATION 8.7 • n=99 Participants
|
67.8 years
STANDARD_DEVIATION 8.8 • n=107 Participants
|
72.2 years
STANDARD_DEVIATION 6.7 • n=206 Participants
|
70.5 years
STANDARD_DEVIATION 8.7 • n=157 Participants
|
|
Sex: Female, Male
Female
|
3 Participants
n=99 Participants
|
5 Participants
n=107 Participants
|
2 Participants
n=206 Participants
|
10 Participants
n=157 Participants
|
|
Sex: Female, Male
Male
|
15 Participants
n=99 Participants
|
21 Participants
n=107 Participants
|
8 Participants
n=206 Participants
|
44 Participants
n=157 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
2 Participants
n=99 Participants
|
5 Participants
n=107 Participants
|
1 Participants
n=206 Participants
|
8 Participants
n=157 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
15 Participants
n=99 Participants
|
14 Participants
n=107 Participants
|
6 Participants
n=206 Participants
|
35 Participants
n=157 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
1 Participants
n=99 Participants
|
7 Participants
n=107 Participants
|
3 Participants
n=206 Participants
|
11 Participants
n=157 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
1 Participants
n=99 Participants
|
1 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
2 Participants
n=157 Participants
|
|
Race (NIH/OMB)
Asian
|
1 Participants
n=99 Participants
|
4 Participants
n=107 Participants
|
3 Participants
n=206 Participants
|
8 Participants
n=157 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
1 Participants
n=206 Participants
|
1 Participants
n=157 Participants
|
|
Race (NIH/OMB)
Black or African American
|
3 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
1 Participants
n=206 Participants
|
4 Participants
n=157 Participants
|
|
Race (NIH/OMB)
White
|
12 Participants
n=99 Participants
|
17 Participants
n=107 Participants
|
4 Participants
n=206 Participants
|
33 Participants
n=157 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=157 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
1 Participants
n=99 Participants
|
4 Participants
n=107 Participants
|
1 Participants
n=206 Participants
|
6 Participants
n=157 Participants
|
|
Region of Enrollment
United States
|
18 Participants
n=99 Participants
|
26 Participants
n=107 Participants
|
10 Participants
n=206 Participants
|
54 Participants
n=157 Participants
|
|
Percutaneous Coronary Intervention (PCI)
|
12 Participants
n=99 Participants
|
11 Participants
n=107 Participants
|
6 Participants
n=206 Participants
|
29 Participants
n=157 Participants
|
PRIMARY outcome
Timeframe: 90 DaysPopulation: The number of participants analyzed includes subjects who were available at that time of analysis
The primary endpoint, including the following components representing important safety and effectiveness endpoints will be evaluated using the difference in event rates in the ITT population. * Cardiovascular Death * Myocardial infarction (MI) * Stroke * Any unplanned repeat revascularization (PCI or CABG) * Bleeding (BARC 3 or 5) up to 14 days post-device removal * Severe hypotension, defined as: systolic blood pressure (SBP) or augmented diastolic pressure (whichever is greater) \<90 mmHg while on device support requiring (1) more than one administration of OR (2) continuous infusion of inotropic/pressor medications to restore hemodynamics * Change in aortic insufficiency from baseline to 90 days by echocardiographic assessment.
Outcome measures
| Measure |
HeartMate PHP (Roll-in)
n=17 Participants
Participants who receive a HeartMate PHP device without randomisation will be included in this arm
HeartMate PHP: The HeartMate PHP System is a temporary (\<6 hours) ventricular assist device indicated for use during high-risk percutaneous coronary interventions (PCI) performed electively or urgently in hemodynamically stable patients with severe coronary artery disease, when a heart team, including a cardiac surgeon, has determined high-risk PCI is an acceptable therapeutic option. Use of the HeartMate PHP Systems in these patients may prevent hemodynamic instability, which can result from repeat episodes of reversible myocardial ischemia that occur during planned temporary coronary occlusions and may reduce peri-and post-procedural adverse events.
|
HeartMate PHP (Randomised)
n=21 Participants
Participants who receive a HeartMate PHP device after randomisation will be included in this arm
HeartMate PHP: The HeartMate PHP System is a temporary (\<6 hours) ventricular assist device indicated for use during high-risk percutaneous coronary interventions (PCI) performed electively or urgently in hemodynamically stable patients with severe coronary artery disease, when a heart team, including a cardiac surgeon, has determined high-risk PCI is an acceptable therapeutic option. Use of the HeartMate PHP Systems in these patients may prevent hemodynamic instability, which can result from repeat episodes of reversible myocardial ischemia that occur during planned temporary coronary occlusions and may reduce peri-and post-procedural adverse events.
|
Any Abiomed Impella® (Randomised)
n=4 Participants
Participants who receive any Abiomed Impella® Device approved for use in high-risk PCI after randomisation will be included in this arm
Any Abiomed Impella® device approved for use in high-risk PCI: Any Abiomed Impella® device approved for use in high-risk PCI.
|
|---|---|---|---|
|
Rate of Participants With Composite of Cardiovascular Death, Myocardial Infarction, Stroke, Any Unplanned Repeat Revascularization (PCI/CABG), Bleeding (BARC 3/5) up to 14 Days Post-device Removal, Severe Hypotension, and Change in Aortic Insufficiency
|
29.4 percentage of participants
|
19.0 percentage of participants
|
50.0 percentage of participants
|
Adverse Events
HeartMate PHP (Roll-in)
Serious events: 5 serious events
Other events: 8 other events
Deaths: 2 deaths
HeartMate PHP (Randomised)
Serious events: 9 serious events
Other events: 8 other events
Deaths: 1 deaths
Any Abiomed Impella® (Randomised)
Serious events: 5 serious events
Other events: 3 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
HeartMate PHP (Roll-in)
n=18 participants at risk
Participants who receive a HeartMate PHP device without randomisation will be included in this arm
HeartMate PHP: The HeartMate PHP System is a temporary (\<6 hours) ventricular assist device indicated for use during high-risk percutaneous coronary interventions (PCI) performed electively or urgently in hemodynamically stable patients with severe coronary artery disease, when a heart team, including a cardiac surgeon, has determined high-risk PCI is an acceptable therapeutic option. Use of the HeartMate PHP Systems in these patients may prevent hemodynamic instability, which can result from repeat episodes of reversible myocardial ischemia that occur during planned temporary coronary occlusions and may reduce peri-and post-procedural adverse events.
|
HeartMate PHP (Randomised)
n=26 participants at risk
Participants who receive a HeartMate PHP device after randomisation will be included in this arm
HeartMate PHP: The HeartMate PHP System is a temporary (\<6 hours) ventricular assist device indicated for use during high-risk percutaneous coronary interventions (PCI) performed electively or urgently in hemodynamically stable patients with severe coronary artery disease, when a heart team, including a cardiac surgeon, has determined high-risk PCI is an acceptable therapeutic option. Use of the HeartMate PHP Systems in these patients may prevent hemodynamic instability, which can result from repeat episodes of reversible myocardial ischemia that occur during planned temporary coronary occlusions and may reduce peri-and post-procedural adverse events.
|
Any Abiomed Impella® (Randomised)
n=10 participants at risk
Participants who receive any Abiomed Impella® Device approved for use in high-risk PCI after randomisation will be included in this arm
Any Abiomed Impella® device approved for use in high-risk PCI: Any Abiomed Impella® device approved for use in high-risk PCI.
|
|---|---|---|---|
|
Blood and lymphatic system disorders
Anaemia
|
5.6%
1/18 • 90 days
|
3.8%
1/26 • 90 days
|
0.00%
0/10 • 90 days
|
|
Cardiac disorders
Atrial Fibrillation
|
0.00%
0/18 • 90 days
|
3.8%
1/26 • 90 days
|
0.00%
0/10 • 90 days
|
|
Cardiac disorders
Cardiac Failure
|
5.6%
1/18 • 90 days
|
0.00%
0/26 • 90 days
|
0.00%
0/10 • 90 days
|
|
Cardiac disorders
Cardiac Failure Congestive
|
0.00%
0/18 • 90 days
|
0.00%
0/26 • 90 days
|
10.0%
1/10 • 90 days
|
|
Cardiac disorders
Cardiogenic Shock
|
0.00%
0/18 • 90 days
|
3.8%
1/26 • 90 days
|
0.00%
0/10 • 90 days
|
|
Cardiac disorders
Coronary Artery Thrombosis
|
5.6%
1/18 • 90 days
|
0.00%
0/26 • 90 days
|
0.00%
0/10 • 90 days
|
|
Cardiac disorders
Myocardial Infarction
|
0.00%
0/18 • 90 days
|
7.7%
2/26 • 90 days
|
0.00%
0/10 • 90 days
|
|
Cardiac disorders
Ventricular Tachycardia
|
0.00%
0/18 • 90 days
|
3.8%
1/26 • 90 days
|
0.00%
0/10 • 90 days
|
|
Gastrointestinal disorders
Abdominal Distension
|
5.6%
1/18 • 90 days
|
0.00%
0/26 • 90 days
|
0.00%
0/10 • 90 days
|
|
Gastrointestinal disorders
Haematochezia
|
0.00%
0/18 • 90 days
|
0.00%
0/26 • 90 days
|
10.0%
1/10 • 90 days
|
|
Infections and infestations
Arthritis Infective
|
0.00%
0/18 • 90 days
|
3.8%
1/26 • 90 days
|
0.00%
0/10 • 90 days
|
|
Infections and infestations
Corona Virus Infection
|
0.00%
0/18 • 90 days
|
0.00%
0/26 • 90 days
|
10.0%
1/10 • 90 days
|
|
Infections and infestations
Pneumonia
|
0.00%
0/18 • 90 days
|
3.8%
1/26 • 90 days
|
10.0%
1/10 • 90 days
|
|
Infections and infestations
Urinary Tract Infection
|
5.6%
1/18 • 90 days
|
0.00%
0/26 • 90 days
|
0.00%
0/10 • 90 days
|
|
Injury, poisoning and procedural complications
Hip Fracture
|
0.00%
0/18 • 90 days
|
0.00%
0/26 • 90 days
|
10.0%
1/10 • 90 days
|
|
Injury, poisoning and procedural complications
Subdural Haematoma
|
0.00%
0/18 • 90 days
|
3.8%
1/26 • 90 days
|
0.00%
0/10 • 90 days
|
|
Injury, poisoning and procedural complications
Vascular Access Complication
|
11.1%
2/18 • 90 days
|
0.00%
0/26 • 90 days
|
10.0%
1/10 • 90 days
|
|
Investigations
Troponin Increased
|
5.6%
1/18 • 90 days
|
0.00%
0/26 • 90 days
|
0.00%
0/10 • 90 days
|
|
Metabolism and nutrition disorders
Hyperkalaemia
|
5.6%
1/18 • 90 days
|
0.00%
0/26 • 90 days
|
0.00%
0/10 • 90 days
|
|
Nervous system disorders
Cerebrovascular Accident
|
5.6%
1/18 • 90 days
|
3.8%
1/26 • 90 days
|
0.00%
0/10 • 90 days
|
|
Nervous system disorders
Syncope
|
5.6%
1/18 • 90 days
|
0.00%
0/26 • 90 days
|
10.0%
1/10 • 90 days
|
|
Renal and urinary disorders
Renal Impairment
|
5.6%
1/18 • 90 days
|
3.8%
1/26 • 90 days
|
0.00%
0/10 • 90 days
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory Distress
|
0.00%
0/18 • 90 days
|
3.8%
1/26 • 90 days
|
0.00%
0/10 • 90 days
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory Failure
|
5.6%
1/18 • 90 days
|
0.00%
0/26 • 90 days
|
0.00%
0/10 • 90 days
|
|
Vascular disorders
Haemorrhage
|
0.00%
0/18 • 90 days
|
3.8%
1/26 • 90 days
|
0.00%
0/10 • 90 days
|
|
Vascular disorders
Hypertensive Crisis
|
0.00%
0/18 • 90 days
|
3.8%
1/26 • 90 days
|
0.00%
0/10 • 90 days
|
|
Vascular disorders
Hypotension
|
16.7%
3/18 • 90 days
|
7.7%
2/26 • 90 days
|
0.00%
0/10 • 90 days
|
|
Vascular disorders
Shock Haemorrhagic
|
5.6%
1/18 • 90 days
|
0.00%
0/26 • 90 days
|
0.00%
0/10 • 90 days
|
Other adverse events
| Measure |
HeartMate PHP (Roll-in)
n=18 participants at risk
Participants who receive a HeartMate PHP device without randomisation will be included in this arm
HeartMate PHP: The HeartMate PHP System is a temporary (\<6 hours) ventricular assist device indicated for use during high-risk percutaneous coronary interventions (PCI) performed electively or urgently in hemodynamically stable patients with severe coronary artery disease, when a heart team, including a cardiac surgeon, has determined high-risk PCI is an acceptable therapeutic option. Use of the HeartMate PHP Systems in these patients may prevent hemodynamic instability, which can result from repeat episodes of reversible myocardial ischemia that occur during planned temporary coronary occlusions and may reduce peri-and post-procedural adverse events.
|
HeartMate PHP (Randomised)
n=26 participants at risk
Participants who receive a HeartMate PHP device after randomisation will be included in this arm
HeartMate PHP: The HeartMate PHP System is a temporary (\<6 hours) ventricular assist device indicated for use during high-risk percutaneous coronary interventions (PCI) performed electively or urgently in hemodynamically stable patients with severe coronary artery disease, when a heart team, including a cardiac surgeon, has determined high-risk PCI is an acceptable therapeutic option. Use of the HeartMate PHP Systems in these patients may prevent hemodynamic instability, which can result from repeat episodes of reversible myocardial ischemia that occur during planned temporary coronary occlusions and may reduce peri-and post-procedural adverse events.
|
Any Abiomed Impella® (Randomised)
n=10 participants at risk
Participants who receive any Abiomed Impella® Device approved for use in high-risk PCI after randomisation will be included in this arm
Any Abiomed Impella® device approved for use in high-risk PCI: Any Abiomed Impella® device approved for use in high-risk PCI.
|
|---|---|---|---|
|
Blood and lymphatic system disorders
Anaemia
|
0.00%
0/18 • 90 days
|
3.8%
1/26 • 90 days
|
0.00%
0/10 • 90 days
|
|
Blood and lymphatic system disorders
Hemolysis
|
5.6%
1/18 • 90 days
|
0.00%
0/26 • 90 days
|
0.00%
0/10 • 90 days
|
|
Cardiac disorders
Atrial Fibrillation
|
11.1%
2/18 • 90 days
|
3.8%
1/26 • 90 days
|
0.00%
0/10 • 90 days
|
|
Cardiac disorders
Bradycardia
|
0.00%
0/18 • 90 days
|
3.8%
1/26 • 90 days
|
0.00%
0/10 • 90 days
|
|
Cardiac disorders
Myocardial Infarction
|
5.6%
1/18 • 90 days
|
0.00%
0/26 • 90 days
|
0.00%
0/10 • 90 days
|
|
Cardiac disorders
Ventricular Extrasystoles
|
0.00%
0/18 • 90 days
|
3.8%
1/26 • 90 days
|
0.00%
0/10 • 90 days
|
|
Cardiac disorders
Ventricular Tachycardia
|
0.00%
0/18 • 90 days
|
3.8%
1/26 • 90 days
|
0.00%
0/10 • 90 days
|
|
Gastrointestinal disorders
Dysphagia
|
5.6%
1/18 • 90 days
|
0.00%
0/26 • 90 days
|
0.00%
0/10 • 90 days
|
|
General disorders
Chest Pain
|
0.00%
0/18 • 90 days
|
3.8%
1/26 • 90 days
|
0.00%
0/10 • 90 days
|
|
Infections and infestations
Corona Virus Infection
|
0.00%
0/18 • 90 days
|
3.8%
1/26 • 90 days
|
0.00%
0/10 • 90 days
|
|
Infections and infestations
Pneumonia
|
0.00%
0/18 • 90 days
|
3.8%
1/26 • 90 days
|
0.00%
0/10 • 90 days
|
|
Infections and infestations
Urinary Tract Infection
|
0.00%
0/18 • 90 days
|
3.8%
1/26 • 90 days
|
0.00%
0/10 • 90 days
|
|
Injury, poisoning and procedural complications
Contusion
|
0.00%
0/18 • 90 days
|
3.8%
1/26 • 90 days
|
0.00%
0/10 • 90 days
|
|
Injury, poisoning and procedural complications
Incision Site Hemorrhage
|
0.00%
0/18 • 90 days
|
3.8%
1/26 • 90 days
|
0.00%
0/10 • 90 days
|
|
Injury, poisoning and procedural complications
Vascular Access Complication
|
11.1%
2/18 • 90 days
|
3.8%
1/26 • 90 days
|
10.0%
1/10 • 90 days
|
|
Investigations
Blood Lactate Dehydrogenase Increased
|
0.00%
0/18 • 90 days
|
7.7%
2/26 • 90 days
|
0.00%
0/10 • 90 days
|
|
Investigations
Cardiac Enzymes Increased
|
22.2%
4/18 • 90 days
|
30.8%
8/26 • 90 days
|
30.0%
3/10 • 90 days
|
|
Investigations
Free Hemoglobin Present
|
5.6%
1/18 • 90 days
|
7.7%
2/26 • 90 days
|
0.00%
0/10 • 90 days
|
|
Investigations
Hemoglobin Decreased
|
5.6%
1/18 • 90 days
|
0.00%
0/26 • 90 days
|
0.00%
0/10 • 90 days
|
|
Investigations
Platelet Count Decreased
|
0.00%
0/18 • 90 days
|
3.8%
1/26 • 90 days
|
0.00%
0/10 • 90 days
|
|
Investigations
Troponin Increased
|
5.6%
1/18 • 90 days
|
3.8%
1/26 • 90 days
|
0.00%
0/10 • 90 days
|
|
Musculoskeletal and connective tissue disorders
Back Pain
|
5.6%
1/18 • 90 days
|
0.00%
0/26 • 90 days
|
0.00%
0/10 • 90 days
|
|
Musculoskeletal and connective tissue disorders
Costochondritis
|
0.00%
0/18 • 90 days
|
3.8%
1/26 • 90 days
|
0.00%
0/10 • 90 days
|
|
Musculoskeletal and connective tissue disorders
Neck Pain
|
0.00%
0/18 • 90 days
|
0.00%
0/26 • 90 days
|
10.0%
1/10 • 90 days
|
|
Nervous system disorders
Headache
|
0.00%
0/18 • 90 days
|
3.8%
1/26 • 90 days
|
0.00%
0/10 • 90 days
|
|
Nervous system disorders
Neuropathy Peripheral
|
5.6%
1/18 • 90 days
|
0.00%
0/26 • 90 days
|
0.00%
0/10 • 90 days
|
|
Nervous system disorders
Syncope
|
0.00%
0/18 • 90 days
|
3.8%
1/26 • 90 days
|
0.00%
0/10 • 90 days
|
|
Psychiatric disorders
Major Depression
|
0.00%
0/18 • 90 days
|
3.8%
1/26 • 90 days
|
0.00%
0/10 • 90 days
|
|
Renal and urinary disorders
Haematuria
|
5.6%
1/18 • 90 days
|
0.00%
0/26 • 90 days
|
0.00%
0/10 • 90 days
|
|
Renal and urinary disorders
Renal Impairment
|
5.6%
1/18 • 90 days
|
0.00%
0/26 • 90 days
|
0.00%
0/10 • 90 days
|
|
Renal and urinary disorders
Urinary Retention
|
0.00%
0/18 • 90 days
|
0.00%
0/26 • 90 days
|
10.0%
1/10 • 90 days
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
0.00%
0/18 • 90 days
|
7.7%
2/26 • 90 days
|
0.00%
0/10 • 90 days
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
5.6%
1/18 • 90 days
|
0.00%
0/26 • 90 days
|
0.00%
0/10 • 90 days
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory Failure
|
5.6%
1/18 • 90 days
|
0.00%
0/26 • 90 days
|
0.00%
0/10 • 90 days
|
|
Skin and subcutaneous tissue disorders
Decubitus Ulcer
|
5.6%
1/18 • 90 days
|
0.00%
0/26 • 90 days
|
0.00%
0/10 • 90 days
|
|
Vascular disorders
Arterial Occlusive Disease
|
5.6%
1/18 • 90 days
|
0.00%
0/26 • 90 days
|
0.00%
0/10 • 90 days
|
|
Vascular disorders
Haematoma
|
5.6%
1/18 • 90 days
|
3.8%
1/26 • 90 days
|
0.00%
0/10 • 90 days
|
|
Vascular disorders
Haemorrhage
|
11.1%
2/18 • 90 days
|
3.8%
1/26 • 90 days
|
0.00%
0/10 • 90 days
|
|
Vascular disorders
Hypotension
|
5.6%
1/18 • 90 days
|
11.5%
3/26 • 90 days
|
0.00%
0/10 • 90 days
|
Additional Information
Sandeep Pingle, Principal Clinical Scientist
Abbott Vascular
Phone: 408-845-2111
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee Institution may publish or present results of its performance of the Study consistent with the terms of this section. If the Study is part of a multi-center clinical study, Institution agrees that the first publication of results will be made as a joint multi-center publication with investigators from all sites contributing data.
- Publication restrictions are in place
Restriction type: OTHER