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ULTrasound Accelerated ThrombolysIs of PulMonAry Embolism (ULTIMA)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01166997
Recruitment Status : Completed
First Posted : July 21, 2010
Results First Posted : October 18, 2016
Last Update Posted : July 19, 2021
Sponsor:
Collaborator:
EKOS Corporation
Information provided by (Responsible Party):
Boston Scientific Corporation

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Single (Outcomes Assessor);   Primary Purpose: Treatment
Condition Submassive Pulmonary Embolism
Interventions Device: EkoSonic Endovascular System
Drug: Unfractionated heparin
Enrollment 59
Recruitment Details Multi-center, Phase III study at 8 tertiary care hospitals in Germany and Switzerland
Pre-assignment Details 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
Arm/Group Title Unfractionated Heparin (UFH) Alone Unfractionated Heparin (UFH) + EkoSonic Procedure
Hide Arm/Group Description Patients in this arm received the standard of care: intravenous unfractionated heparin used as anticoagulation treatment. 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.
Period Title: Overall Study
Started 29 30
Completed 27 30
Not Completed 2 0
Arm/Group Title UFH (Alone) UFH + EkoSonic Procedure Total
Hide Arm/Group Description Patients in this arm received the standard of care: intravenous unfractionated heparin used as anticoagulation treatment. 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 of all reporting groups
Overall Number of Baseline Participants 29 30 59
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 29 participants 30 participants 59 participants
62.0  (13.4) 64.1  (15.2) 63.1  (14.3)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 29 participants 30 participants 59 participants
Female
12
  41.4%
19
  63.3%
31
  52.5%
Male
17
  58.6%
11
  36.7%
28
  47.5%
1.Primary Outcome
Title Reduction of RV/LV Ratio
Hide Description Change in the end-diastolic RV/LV ratio from baseline to 24 hours by echocardiography.
Time Frame 24 hours
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Unfractionated Heparin (UFH) Alone Unfractionated Heprin + EkoSonic Procedure
Hide Arm/Group Description:
Patients in this arm received the standard of care: intravenous unfractionated heparin used as anticoagulation treatment.
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.
Overall Number of Participants Analyzed 28 25
Mean (Standard Deviation)
Unit of Measure: Ratio
0.03  (0.16) 0.30  (0.20)
2.Primary Outcome
Title Major Bleeding and Intracranial Bleeding at 30 Days.
Hide Description Bleeding 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.
Time Frame 30 days
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Ultrasound Accelerated Thrombolysis Intravenous Unfractionated Heparin
Hide Arm/Group Description:

Patients in this arm will receive anti-coagulation (intravenous unfractionated heparin) plus the EkoSonic Endovascular System will be used to deliver a low dose <20mg rt-PA (Actilyse) directly into the occlusive pulmonary thrombus.

EkoSonic Endovascular System: The EkoSonic Endovascular System will be used to deliver < 20 mg of rt-PA ( Actilyse) directly into the occlusive pulmonary thrombus.

Patients in this arm will receive the standard of care: intravenous unfractionated heparin used as anti-coagulation treatment.

Unfractionated heparin: Intravenous unfractionated heparin used for anticoagulation treatment
Overall Number of Participants Analyzed 29 30
Measure Type: Number
Unit of Measure: participants
0 0
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Unfractionated Heparin (UFH) Alone UFH + EkoSonic
Hide Arm/Group Description Patients in this arm received the standard of care: intravenous unfractionated heparin used as anticoagulation treatment. 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.
All-Cause Mortality
Unfractionated Heparin (UFH) Alone UFH + EkoSonic
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/-- 
Hide Serious Adverse Events
Unfractionated Heparin (UFH) Alone UFH + EkoSonic
Affected / at Risk (%) Affected / at Risk (%)
Total   4/29 (13.79%)   3/30 (10.00%) 
Gastrointestinal disorders     
Abdominal pain † 1  1/29 (3.45%)  0/30 (0.00%) 
Musculoskeletal and connective tissue disorders     
Radius fracture † 1  0/29 (0.00%)  1/30 (3.33%) 
Psychiatric disorders     
Depression † 1  1/29 (3.45%)  0/30 (0.00%) 
Respiratory, thoracic and mediastinal disorders     
Pneumonia † 1  0/29 (0.00%)  1/30 (3.33%) 
Supraventricular tachycardia † 1  1/29 (3.45%)  0/30 (0.00%) 
Bronchopneumonia † 1  1/29 (3.45%)  0/30 (0.00%) 
Surgical and medical procedures     
Postoperative wound infection † 1  0/29 (0.00%)  1/30 (3.33%) 
†
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA 14.0
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Unfractionated Heparin (UFH) Alone UFH + EkoSonic
Affected / at Risk (%) Affected / at Risk (%)
Total   2/29 (6.90%)   0/30 (0.00%) 
General disorders     
Oedema peripheral † 1  2/29 (6.90%)  0/30 (0.00%) 
†
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA 14.0
[Not Specified]
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Lynn Allen
Organization: EKOS Corporation
Phone: 4254153100
EMail: Lynn.Allen@ekoscorp.com
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Layout table for additonal information
Responsible Party: Boston Scientific Corporation
ClinicalTrials.gov Identifier: NCT01166997    
Other Study ID Numbers: EKOS Protocol Number 08
First Submitted: July 15, 2010
First Posted: July 21, 2010
Results First Submitted: August 23, 2016
Results First Posted: October 18, 2016
Last Update Posted: July 19, 2021