Trial Outcomes & Findings for ULTrasound Accelerated ThrombolysIs of PulMonAry Embolism (NCT NCT01166997)
NCT ID: NCT01166997
Last Updated: 2021-07-19
Results Overview
Change in the end-diastolic RV/LV ratio from baseline to 24 hours by echocardiography.
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
59 participants
Primary outcome timeframe
24 hours
Results posted on
2021-07-19
Participant Flow
Multi-center, Phase III study at 8 tertiary care hospitals in Germany and Switzerland
Acute symptomatic PE confirmed by contrast-enhanced computed tomography (CT) with embolus located in at least 1 main or proximal lower lobe pulmonary artery RV to left ventricular dimension (RV/LV) ratio ≥1 obtained from the echocardiographic apical 4-chamber view
Participant milestones
| Measure |
Unfractionated Heparin (UFH) Alone
Patients in this arm received the standard of care: intravenous unfractionated heparin used as anticoagulation treatment.
|
Unfractionated Heparin (UFH) + EkoSonic Procedure
Patients in this arm received anticoagulation (intravenous unfractionated heparin) plus the EkoSonic Endovascular System was used to deliver a low dose of \<20mg rt-PA (Actilyse) directly into the occlusive pulmonary thrombus.
|
|---|---|---|
|
Overall Study
STARTED
|
29
|
30
|
|
Overall Study
COMPLETED
|
27
|
30
|
|
Overall Study
NOT COMPLETED
|
2
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
ULTrasound Accelerated ThrombolysIs of PulMonAry Embolism
Baseline characteristics by cohort
| Measure |
UFH (Alone)
n=29 Participants
Patients in this arm received the standard of care: intravenous unfractionated heparin used as anticoagulation treatment.
|
UFH + EkoSonic Procedure
n=30 Participants
Patients in this arm received anticoagulation (intravenous unfractionated heparin) plus the EkoSonic Endovascular System was used to deliver a low dose of \<20mg rt-PA (Actilyse) directly into the occlusive pulmonary thrombus.
|
Total
n=59 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
62.0 years
STANDARD_DEVIATION 13.4 • n=5 Participants
|
64.1 years
STANDARD_DEVIATION 15.2 • n=7 Participants
|
63.1 years
STANDARD_DEVIATION 14.3 • n=5 Participants
|
|
Sex: Female, Male
Female
|
12 Participants
n=5 Participants
|
19 Participants
n=7 Participants
|
31 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
17 Participants
n=5 Participants
|
11 Participants
n=7 Participants
|
28 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 24 hoursChange in the end-diastolic RV/LV ratio from baseline to 24 hours by echocardiography.
Outcome measures
| Measure |
Unfractionated Heparin (UFH) Alone
n=28 Participants
Patients in this arm received the standard of care: intravenous unfractionated heparin used as anticoagulation treatment.
|
Unfractionated Heprin + EkoSonic Procedure
n=25 Participants
Patients in this arm received anti-coagulation (intravenous unfractionated heparin) plus the EkoSonic Endovascular System was used to deliver a low dose of \<20mg rt-PA (Actilyse) directly into the occlusive pulmonary thrombus.
|
|---|---|---|
|
Reduction of RV/LV Ratio
|
0.03 Ratio
Standard Deviation 0.16
|
0.30 Ratio
Standard Deviation 0.20
|
PRIMARY outcome
Timeframe: 30 daysBleeding will be classified as major if it is associated with a fall in the hemoglobin level of at least 2.0 g/dl, transfusion of ≥ 2 units of red blood cells, or involvement of a critical site (e.g., intracranial, intraspinal). To aid in evaluating the relationship of bleeding events to rt-PA administration, they will also be categorized by whether they occurred within 3 days after the initiation of thrombolytic therapy.
Outcome measures
| Measure |
Unfractionated Heparin (UFH) Alone
n=29 Participants
Patients in this arm received the standard of care: intravenous unfractionated heparin used as anticoagulation treatment.
|
Unfractionated Heprin + EkoSonic Procedure
n=30 Participants
Patients in this arm received anti-coagulation (intravenous unfractionated heparin) plus the EkoSonic Endovascular System was used to deliver a low dose of \<20mg rt-PA (Actilyse) directly into the occlusive pulmonary thrombus.
|
|---|---|---|
|
Major Bleeding and Intracranial Bleeding at 30 Days.
|
0 participants
|
0 participants
|
Adverse Events
Unfractionated Heparin (UFH) Alone
Serious events: 4 serious events
Other events: 2 other events
Deaths: 0 deaths
UFH + EkoSonic
Serious events: 3 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Unfractionated Heparin (UFH) Alone
n=29 participants at risk
Patients in this arm received the standard of care: intravenous unfractionated heparin used as anticoagulation treatment.
|
UFH + EkoSonic
n=30 participants at risk
Patients in this arm received anticoagulation (intravenous unfractionated heparin) plus the EkoSonic Endovascular System was used to deliver a low dose of \<20mg rt-PA (Actilyse) directly into the occlusive pulmonary thrombus.
|
|---|---|---|
|
Surgical and medical procedures
Postoperative wound infection
|
0.00%
0/29
|
3.3%
1/30
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonia
|
0.00%
0/29
|
3.3%
1/30
|
|
Musculoskeletal and connective tissue disorders
Radius fracture
|
0.00%
0/29
|
3.3%
1/30
|
|
Respiratory, thoracic and mediastinal disorders
Supraventricular tachycardia
|
3.4%
1/29
|
0.00%
0/30
|
|
Gastrointestinal disorders
Abdominal pain
|
3.4%
1/29
|
0.00%
0/30
|
|
Psychiatric disorders
Depression
|
3.4%
1/29
|
0.00%
0/30
|
|
Respiratory, thoracic and mediastinal disorders
Bronchopneumonia
|
3.4%
1/29
|
0.00%
0/30
|
Other adverse events
| Measure |
Unfractionated Heparin (UFH) Alone
n=29 participants at risk
Patients in this arm received the standard of care: intravenous unfractionated heparin used as anticoagulation treatment.
|
UFH + EkoSonic
n=30 participants at risk
Patients in this arm received anticoagulation (intravenous unfractionated heparin) plus the EkoSonic Endovascular System was used to deliver a low dose of \<20mg rt-PA (Actilyse) directly into the occlusive pulmonary thrombus.
|
|---|---|---|
|
General disorders
Oedema peripheral
|
6.9%
2/29
|
0.00%
0/30
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: GT60