Trial Outcomes & Findings for Submassive and Massive Pulmonary Embolism Treatment With Ultrasound Accelerated Thrombolysis Therapy (NCT NCT01513759)
NCT ID: NCT01513759
Last Updated: 2021-07-19
Results Overview
Change from baseline in RV diameter/LV diameter ratio was determined by contrast-enhanced chest computed tomography (CT) within 48 +/- 6 hours after initiating ultrasound-accelerated catheter-directed fibrinolysis.
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
150 participants
Primary outcome timeframe
Baseline, within 48 +/- 6 hours of initiation of therapy
Results posted on
2021-07-19
Participant Flow
Participant milestones
| Measure |
EkoSonic® Endovascular System
Participants received a total of 24 milligrams (mg) of recombinant tissue plasminogen activator (r-tPA) infusion, at an infusion rate of 1 milligrams/hour (mg/hr) per device (2 mg/hour for bilateral pulmonary embolism \[PE\]) delivered through the EkoSonic® Endovascular System. This regimen allowed for a r-tPA infusion time of 24 hours for one catheter and 12 hours for two catheters, respectively.
|
|---|---|
|
Overall Study
STARTED
|
150
|
|
Overall Study
At Least One Device Successfully Placed
|
149
|
|
Overall Study
COMPLETED
|
145
|
|
Overall Study
NOT COMPLETED
|
5
|
Reasons for withdrawal
| Measure |
EkoSonic® Endovascular System
Participants received a total of 24 milligrams (mg) of recombinant tissue plasminogen activator (r-tPA) infusion, at an infusion rate of 1 milligrams/hour (mg/hr) per device (2 mg/hour for bilateral pulmonary embolism \[PE\]) delivered through the EkoSonic® Endovascular System. This regimen allowed for a r-tPA infusion time of 24 hours for one catheter and 12 hours for two catheters, respectively.
|
|---|---|
|
Overall Study
Protocol Violation
|
4
|
|
Overall Study
Death during catheter placement
|
1
|
Baseline Characteristics
Submassive and Massive Pulmonary Embolism Treatment With Ultrasound Accelerated Thrombolysis Therapy
Baseline characteristics by cohort
| Measure |
EkoSonic® Endovascular System
n=150 Participants
Participants received a total of 24 mg of r-tPA infusion at an infusion rate of 1 mg/hr per device (2 mg/hour for bilateral PE) delivered through the EkoSonic® Endovascular System. This regimen allowed for a r-tPA infusion time of 24 hours for one catheter and 12 hours for two catheters, respectively.
|
|---|---|
|
Age, Continuous
|
59.0 Years
STANDARD_DEVIATION 16.1 • n=5 Participants
|
|
Sex: Female, Male
Female
|
73 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
77 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Caucasian, Not of Hispanic Origin
|
119 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
African American, Not of Hispanic Origin
|
22 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Hispanic or Latino
|
9 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Baseline, within 48 +/- 6 hours of initiation of therapyPopulation: Efficacy analysis set included all participants who started the ultrasound accelerated thrombolysis therapy. Here, 'Overall number of participants analyzed' signifies participants with available data at both baseline and post-baseline. 'Number analyzed' signifies participants with available data at specified timepoint.
Change from baseline in RV diameter/LV diameter ratio was determined by contrast-enhanced chest computed tomography (CT) within 48 +/- 6 hours after initiating ultrasound-accelerated catheter-directed fibrinolysis.
Outcome measures
| Measure |
EkoSonic® Endovascular System
n=150 Participants
Participants received a total of 24 mg of r-tPA infusion, at an infusion rate of 1 mg/hr per device (2 mg/hour for bilateral PE) delivered through the EkoSonic® Endovascular System. This regimen allowed for a r-tPA infusion time of 24 hours for one catheter and 12 hours for two catheters, respectively.
|
|---|---|
|
Change From Baseline in the Right Ventricle (RV) Diameter-to-Left Ventricle (LV) Diameter Ratio Within 48 +/- 6 Hours of Initiation of Therapy
Baseline
|
1.55 ratio
Standard Deviation 0.39
|
|
Change From Baseline in the Right Ventricle (RV) Diameter-to-Left Ventricle (LV) Diameter Ratio Within 48 +/- 6 Hours of Initiation of Therapy
Change within 48 +/- 6 hours
|
-0.42 ratio
Standard Deviation 0.36
|
PRIMARY outcome
Timeframe: From start of study drug infusion up to 72 hoursPopulation: Safety analysis set included all participants who started the EkoSonic device placement procedure.
Bleeding adverse events were graded (severe or life-threatening, moderate or mild bleeding) according to the Global Use of Strategies to Open Occluded Coronary Arteries (GUSTO) classification. The participant incidence of major bleeding events was defined as GUSTO moderate and severe events occurring within 72 hours after starting the ultrasound-accelerated catheter-directed fibrinolysis procedure. Mild: Does not meet criteria for moderate or severe; Moderate: Requires transfusion - No hemodynamic compromise; and Severe: Bleeding causes hemodynamic compromise and required intervention or intracranial hemorrhage. A summary of serious and all other non-serious adverse events regardless of causality is located in the Reported Adverse Events module.
Outcome measures
| Measure |
EkoSonic® Endovascular System
n=150 Participants
Participants received a total of 24 mg of r-tPA infusion, at an infusion rate of 1 mg/hr per device (2 mg/hour for bilateral PE) delivered through the EkoSonic® Endovascular System. This regimen allowed for a r-tPA infusion time of 24 hours for one catheter and 12 hours for two catheters, respectively.
|
|---|---|
|
Number of Participants With Major Bleeding
|
14 Participants
|
SECONDARY outcome
Timeframe: Baseline, Hour 48 after initiation of therapyPopulation: Efficacy analysis set included all participants who started the ultrasound accelerated thrombolysis therapy. Here, 'Number analyzed' signifies participants with available data at specified timepoint.
Change in pulmonary artery systolic pressure was assessed by baseline right-heart catheterization compared with right-heart catheterization at the conclusion of ultrasound-accelerated catheter-directed fibrinolysis and estimated by post-procedure transthoracic echocardiography within 48 hours after initiating the procedure.
Outcome measures
| Measure |
EkoSonic® Endovascular System
n=150 Participants
Participants received a total of 24 mg of r-tPA infusion, at an infusion rate of 1 mg/hr per device (2 mg/hour for bilateral PE) delivered through the EkoSonic® Endovascular System. This regimen allowed for a r-tPA infusion time of 24 hours for one catheter and 12 hours for two catheters, respectively.
|
|---|---|
|
Change From Baseline in Pulmonary Artery Systolic Pressure at 48 Hours After Start of Therapy
Baseline
|
51.4 millimeters of mercury (mmHg)
Standard Deviation 16
|
|
Change From Baseline in Pulmonary Artery Systolic Pressure at 48 Hours After Start of Therapy
Change at Hour 48
|
-14.4 millimeters of mercury (mmHg)
Standard Deviation 15.4
|
SECONDARY outcome
Timeframe: Baseline up to Day 30Population: Efficacy analysis set included all participants who started the ultrasound accelerated thrombolysis therapy. One participant was excluded from this analysis due to lost to follow-up after discharge.
Percentage of participants with symptomatic recurrent PE up to 30 days following the conclusion of the ultrasound-accelerated catheter-directed fibrinolysis procedure, were reported with a Wilson score 95% confidence interval. A summary of serious and all other non-serious adverse events regardless of causality is located in the Reported Adverse Events module.
Outcome measures
| Measure |
EkoSonic® Endovascular System
n=149 Participants
Participants received a total of 24 mg of r-tPA infusion, at an infusion rate of 1 mg/hr per device (2 mg/hour for bilateral PE) delivered through the EkoSonic® Endovascular System. This regimen allowed for a r-tPA infusion time of 24 hours for one catheter and 12 hours for two catheters, respectively.
|
|---|---|
|
Percentage of Participants With Symptomatic Recurrent Pulmonary Embolism (PE)
|
0 percentage of participants
Interval 0.0 to 2.5
|
SECONDARY outcome
Timeframe: Baseline up to Day 30Population: Efficacy analysis set included all participants who started the ultrasound accelerated thrombolysis therapy. One participant was excluded from this analysis due to lost to follow-up after discharge.
Number of participants who died due to any cause for up to 30 days following the conclusion of the ultrasound-accelerated catheter-directed fibrinolysis procedure, were reported.
Outcome measures
| Measure |
EkoSonic® Endovascular System
n=149 Participants
Participants received a total of 24 mg of r-tPA infusion, at an infusion rate of 1 mg/hr per device (2 mg/hour for bilateral PE) delivered through the EkoSonic® Endovascular System. This regimen allowed for a r-tPA infusion time of 24 hours for one catheter and 12 hours for two catheters, respectively.
|
|---|---|
|
Number of Participants Who Died Due to Any Cause
|
4 Participants
|
SECONDARY outcome
Timeframe: Baseline up to Day 30Population: Safety analysis set included all participants who started the EkoSonic device placement procedure.
Technical complications associated with the use of the EkoSonic device was recorded during catheter placement in the pulmonary artery and during the infusion procedure.
Outcome measures
| Measure |
EkoSonic® Endovascular System
n=285 devices
Participants received a total of 24 mg of r-tPA infusion, at an infusion rate of 1 mg/hr per device (2 mg/hour for bilateral PE) delivered through the EkoSonic® Endovascular System. This regimen allowed for a r-tPA infusion time of 24 hours for one catheter and 12 hours for two catheters, respectively.
|
|---|---|
|
Number of Devices That Could Not be Successfully Used for Infusion
|
7 devices
|
Adverse Events
EkoSonic® Endovascular System
Serious events: 28 serious events
Other events: 59 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
EkoSonic® Endovascular System
n=150 participants at risk
Participants received a total of 24 mg of r-tPA infusion, at an infusion rate of 1 mg/hr per device (2 mg/hour for bilateral PE) delivered through the EkoSonic® Endovascular System. This regimen allowed for a r-tPA infusion time of 24 hours for one catheter and 12 hours for two catheters, respectively.
|
|---|---|
|
Blood and lymphatic system disorders
Anemia
|
2.0%
3/150 • Baseline up to Day 30
Safety analysis set included all participants who started the EkoSonic device placement procedure.
|
|
Cardiac disorders
Atrial flutter
|
0.67%
1/150 • Baseline up to Day 30
Safety analysis set included all participants who started the EkoSonic device placement procedure.
|
|
General disorders
Chest Pain
|
0.67%
1/150 • Baseline up to Day 30
Safety analysis set included all participants who started the EkoSonic device placement procedure.
|
|
Infections and infestations
Sepsis
|
0.67%
1/150 • Baseline up to Day 30
Safety analysis set included all participants who started the EkoSonic device placement procedure.
|
|
Injury, poisoning and procedural complications
Vascular pseudoaneurysm
|
0.67%
1/150 • Baseline up to Day 30
Safety analysis set included all participants who started the EkoSonic device placement procedure.
|
|
Renal and urinary disorders
Haematuria
|
1.3%
2/150 • Baseline up to Day 30
Safety analysis set included all participants who started the EkoSonic device placement procedure.
|
|
Respiratory, thoracic and mediastinal disorders
Acute respiratory failure
|
1.3%
2/150 • Baseline up to Day 30
Safety analysis set included all participants who started the EkoSonic device placement procedure.
|
|
Vascular disorders
Deep vein thrombosis
|
2.0%
3/150 • Baseline up to Day 30
Safety analysis set included all participants who started the EkoSonic device placement procedure.
|
|
Blood and lymphatic system disorders
Heparin-induced thrombocytopenia
|
0.67%
1/150 • Baseline up to Day 30
Safety analysis set included all participants who started the EkoSonic device placement procedure.
|
|
Cardiac disorders
Atrial fibrillation
|
0.67%
1/150 • Baseline up to Day 30
Safety analysis set included all participants who started the EkoSonic device placement procedure.
|
|
Cardiac disorders
Pericardial effusion
|
0.67%
1/150 • Baseline up to Day 30
Safety analysis set included all participants who started the EkoSonic device placement procedure.
|
|
Investigations
Electroencephalogram abnormal
|
0.67%
1/150 • Baseline up to Day 30
Safety analysis set included all participants who started the EkoSonic device placement procedure.
|
|
Renal and urinary disorders
Renal failure acute
|
1.3%
2/150 • Baseline up to Day 30
Safety analysis set included all participants who started the EkoSonic device placement procedure.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
1.3%
2/150 • Baseline up to Day 30
Safety analysis set included all participants who started the EkoSonic device placement procedure.
|
|
Respiratory, thoracic and mediastinal disorders
Hypoxia
|
0.67%
1/150 • Baseline up to Day 30
Safety analysis set included all participants who started the EkoSonic device placement procedure.
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
0.67%
1/150 • Baseline up to Day 30
Safety analysis set included all participants who started the EkoSonic device placement procedure.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary arterial hypertension
|
0.67%
1/150 • Baseline up to Day 30
Safety analysis set included all participants who started the EkoSonic device placement procedure.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary embolism
|
0.67%
1/150 • Baseline up to Day 30
Safety analysis set included all participants who started the EkoSonic device placement procedure.
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory failure
|
1.3%
2/150 • Baseline up to Day 30
Safety analysis set included all participants who started the EkoSonic device placement procedure.
|
|
Vascular disorders
Haematoma
|
2.0%
3/150 • Baseline up to Day 30
Safety analysis set included all participants who started the EkoSonic device placement procedure.
|
|
Vascular disorders
Hypotension
|
0.67%
1/150 • Baseline up to Day 30
Safety analysis set included all participants who started the EkoSonic device placement procedure.
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
0.67%
1/150 • Baseline up to Day 30
Safety analysis set included all participants who started the EkoSonic device placement procedure.
|
|
Blood and lymphatic system disorders
Haemorrhagic anaemia
|
0.67%
1/150 • Baseline up to Day 30
Safety analysis set included all participants who started the EkoSonic device placement procedure.
|
Other adverse events
| Measure |
EkoSonic® Endovascular System
n=150 participants at risk
Participants received a total of 24 mg of r-tPA infusion, at an infusion rate of 1 mg/hr per device (2 mg/hour for bilateral PE) delivered through the EkoSonic® Endovascular System. This regimen allowed for a r-tPA infusion time of 24 hours for one catheter and 12 hours for two catheters, respectively.
|
|---|---|
|
Blood and lymphatic system disorders
Anemia
|
4.0%
6/150 • Baseline up to Day 30
Safety analysis set included all participants who started the EkoSonic device placement procedure.
|
|
Blood and lymphatic system disorders
Haemorrhagic anaemia
|
0.67%
1/150 • Baseline up to Day 30
Safety analysis set included all participants who started the EkoSonic device placement procedure.
|
|
Blood and lymphatic system disorders
Heparin-induced thrombocytopenia
|
0.67%
1/150 • Baseline up to Day 30
Safety analysis set included all participants who started the EkoSonic device placement procedure.
|
|
Blood and lymphatic system disorders
Leukocytosis
|
0.67%
1/150 • Baseline up to Day 30
Safety analysis set included all participants who started the EkoSonic device placement procedure.
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
2.7%
4/150 • Baseline up to Day 30
Safety analysis set included all participants who started the EkoSonic device placement procedure.
|
|
Cardiac disorders
Atrial fibrillation
|
1.3%
2/150 • Baseline up to Day 30
Safety analysis set included all participants who started the EkoSonic device placement procedure.
|
|
Cardiac disorders
Ventricular arrhythmia
|
0.67%
1/150 • Baseline up to Day 30
Safety analysis set included all participants who started the EkoSonic device placement procedure.
|
|
Gastrointestinal disorders
Abdominal pain
|
1.3%
2/150 • Baseline up to Day 30
Safety analysis set included all participants who started the EkoSonic device placement procedure.
|
|
Gastrointestinal disorders
Abdominal wall haematoma
|
0.67%
1/150 • Baseline up to Day 30
Safety analysis set included all participants who started the EkoSonic device placement procedure.
|
|
Gastrointestinal disorders
Constipation
|
1.3%
2/150 • Baseline up to Day 30
Safety analysis set included all participants who started the EkoSonic device placement procedure.
|
|
Gastrointestinal disorders
Diarrhoea
|
1.3%
2/150 • Baseline up to Day 30
Safety analysis set included all participants who started the EkoSonic device placement procedure.
|
|
Gastrointestinal disorders
Gastrointestinal haemorrhage
|
0.67%
1/150 • Baseline up to Day 30
Safety analysis set included all participants who started the EkoSonic device placement procedure.
|
|
Gastrointestinal disorders
Nausea
|
0.67%
1/150 • Baseline up to Day 30
Safety analysis set included all participants who started the EkoSonic device placement procedure.
|
|
Gastrointestinal disorders
Vomiting
|
0.67%
1/150 • Baseline up to Day 30
Safety analysis set included all participants who started the EkoSonic device placement procedure.
|
|
General disorders
Chest discomfort
|
2.7%
4/150 • Baseline up to Day 30
Safety analysis set included all participants who started the EkoSonic device placement procedure.
|
|
Cardiac disorders
Chest pain
|
0.67%
1/150 • Baseline up to Day 30
Safety analysis set included all participants who started the EkoSonic device placement procedure.
|
|
Cardiac disorders
Pyrexia
|
1.3%
2/150 • Baseline up to Day 30
Safety analysis set included all participants who started the EkoSonic device placement procedure.
|
|
Infections and infestations
Cellulitis
|
1.3%
2/150 • Baseline up to Day 30
Safety analysis set included all participants who started the EkoSonic device placement procedure.
|
|
Infections and infestations
Pneumonia
|
1.3%
2/150 • Baseline up to Day 30
Safety analysis set included all participants who started the EkoSonic device placement procedure.
|
|
Infections and infestations
Urinary Tract Infection
|
3.3%
5/150 • Baseline up to Day 30
Safety analysis set included all participants who started the EkoSonic device placement procedure.
|
|
Injury, poisoning and procedural complications
Arterial injury
|
0.67%
1/150 • Baseline up to Day 30
Safety analysis set included all participants who started the EkoSonic device placement procedure.
|
|
Injury, poisoning and procedural complications
Contusion
|
0.67%
1/150 • Baseline up to Day 30
Safety analysis set included all participants who started the EkoSonic device placement procedure.
|
|
Injury, poisoning and procedural complications
Operative haemorrhage
|
0.67%
1/150 • Baseline up to Day 30
Safety analysis set included all participants who started the EkoSonic device placement procedure.
|
|
Injury, poisoning and procedural complications
Wound secretion
|
0.67%
1/150 • Baseline up to Day 30
Safety analysis set included all participants who started the EkoSonic device placement procedure.
|
|
Investigations
Blood creatinine increased
|
0.67%
1/150 • Baseline up to Day 30
Safety analysis set included all participants who started the EkoSonic device placement procedure.
|
|
Investigations
Blood glucose increased
|
0.67%
1/150 • Baseline up to Day 30
Safety analysis set included all participants who started the EkoSonic device placement procedure.
|
|
Investigations
Blood pressure decreased
|
0.67%
1/150 • Baseline up to Day 30
Safety analysis set included all participants who started the EkoSonic device placement procedure.
|
|
Investigations
Electrocardiogram abnormal
|
1.3%
2/150 • Baseline up to Day 30
Safety analysis set included all participants who started the EkoSonic device placement procedure.
|
|
Metabolism and nutrition disorders
Diabetes mellitus
|
0.67%
1/150 • Baseline up to Day 30
Safety analysis set included all participants who started the EkoSonic device placement procedure.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
0.67%
1/150 • Baseline up to Day 30
Safety analysis set included all participants who started the EkoSonic device placement procedure.
|
|
Musculoskeletal and connective tissue disorders
Facial asymmetry
|
0.67%
1/150 • Baseline up to Day 30
Safety analysis set included all participants who started the EkoSonic device placement procedure.
|
|
Musculoskeletal and connective tissue disorders
Groin pain
|
0.67%
1/150 • Baseline up to Day 30
Safety analysis set included all participants who started the EkoSonic device placement procedure.
|
|
Musculoskeletal and connective tissue disorders
Muscle haemorrhage
|
0.67%
1/150 • Baseline up to Day 30
Safety analysis set included all participants who started the EkoSonic device placement procedure.
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
0.67%
1/150 • Baseline up to Day 30
Safety analysis set included all participants who started the EkoSonic device placement procedure.
|
|
Nervous system disorders
Convulsion
|
0.67%
1/150 • Baseline up to Day 30
Safety analysis set included all participants who started the EkoSonic device placement procedure.
|
|
Vascular disorders
Haematoma
|
6.7%
10/150 • Baseline up to Day 30
Safety analysis set included all participants who started the EkoSonic device placement procedure.
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
2.0%
3/150 • Baseline up to Day 30
Safety analysis set included all participants who started the EkoSonic device placement procedure.
|
|
Skin and subcutaneous tissue disorders
Ecchymosis
|
1.3%
2/150 • Baseline up to Day 30
Safety analysis set included all participants who started the EkoSonic device placement procedure.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
1.3%
2/150 • Baseline up to Day 30
Safety analysis set included all participants who started the EkoSonic device placement procedure.
|
|
Respiratory, thoracic and mediastinal disorders
Haemoptysis
|
3.3%
5/150 • Baseline up to Day 30
Safety analysis set included all participants who started the EkoSonic device placement procedure.
|
|
Renal and urinary disorders
Haematuria
|
0.67%
1/150 • Baseline up to Day 30
Safety analysis set included all participants who started the EkoSonic device placement procedure.
|
|
Vascular disorders
Deep vein thrombosis
|
2.0%
3/150 • Baseline up to Day 30
Safety analysis set included all participants who started the EkoSonic device placement procedure.
|
|
Psychiatric disorders
Mental status changes
|
0.67%
1/150 • Baseline up to Day 30
Safety analysis set included all participants who started the EkoSonic device placement procedure.
|
|
Skin and subcutaneous tissue disorders
Rash erythematous
|
0.67%
1/150 • Baseline up to Day 30
Safety analysis set included all participants who started the EkoSonic device placement procedure.
|
|
Renal and urinary disorders
Renal failure acute
|
2.0%
3/150 • Baseline up to Day 30
Safety analysis set included all participants who started the EkoSonic device placement procedure.
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal pain
|
0.67%
1/150 • Baseline up to Day 30
Safety analysis set included all participants who started the EkoSonic device placement procedure.
|
|
Vascular disorders
Hypertension
|
0.67%
1/150 • Baseline up to Day 30
Safety analysis set included all participants who started the EkoSonic device placement procedure.
|
|
Vascular disorders
Hypotension
|
0.67%
1/150 • Baseline up to Day 30
Safety analysis set included all participants who started the EkoSonic device placement procedure.
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
2.0%
3/150 • Baseline up to Day 30
Safety analysis set included all participants who started the EkoSonic device placement procedure.
|
|
Renal and urinary disorders
Renal failure chronic
|
1.3%
2/150 • Baseline up to Day 30
Safety analysis set included all participants who started the EkoSonic device placement procedure.
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal stiffness
|
0.67%
1/150 • Baseline up to Day 30
Safety analysis set included all participants who started the EkoSonic device placement procedure.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary oedema
|
0.67%
1/150 • Baseline up to Day 30
Safety analysis set included all participants who started the EkoSonic device placement procedure.
|
|
Renal and urinary disorders
Nephrolithiasis
|
0.67%
1/150 • Baseline up to Day 30
Safety analysis set included all participants who started the EkoSonic device placement procedure.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: GT60