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ULTrasound Accelerated ThrombolysIs of PulMonAry Embolism (ULTIMA)

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ClinicalTrials.gov Identifier: NCT01166997
Recruitment Status : Completed
First Posted : July 21, 2010
Results First Posted : October 18, 2016
Last Update Posted : October 18, 2016
Sponsor:
Information provided by (Responsible Party):
EKOS 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

  Participant Flow

Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
Multi-center, Phase III study at 8 tertiary care hospitals in Germany and Switzerland

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
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

Reporting Groups
  Description
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.

Participant Flow:   Overall Study
    Unfractionated Heparin (UFH) Alone   Unfractionated Heparin (UFH) + EkoSonic Procedure
STARTED   29   30 
COMPLETED   27   30 
NOT COMPLETED   2   0 



  Baseline Characteristics

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
  Description
UFH (Alone) Patients in this arm received the standard of care: intravenous unfractionated heparin used as anticoagulation treatment.
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.
Total Total of all reporting groups

Baseline Measures
   UFH (Alone)   UFH + EkoSonic Procedure   Total 
Overall Participants Analyzed 
[Units: Participants]
 29   30   59 
Age 
[Units: Years]
Mean (Standard Deviation)
 62.0  (13.4)   64.1  (15.2)   63.1  (14.3) 
Gender 
[Units: Participants]
     
Female   12   19   31 
Male   17   11   28 


  Outcome Measures

1.  Primary:   Reduction of RV/LV Ratio   [ Time Frame: 24 hours ]

2.  Primary:   Major Bleeding and Intracranial Bleeding at 30 Days.   [ Time Frame: 30 days ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats

Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
No text entered.


  More Information

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.
The agreement is:
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 60 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
unchecked Other disclosure agreement that restricts the right of the PI to discuss or publish trial results after the trial is completed.


Results Point of Contact:  
Name/Title: Lynn Allen
Organization: EKOS Corporation
phone: 4254153100
e-mail: Lynn.Allen@ekoscorp.com


Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Responsible Party: EKOS Corporation
ClinicalTrials.gov Identifier: NCT01166997     History of Changes
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: October 18, 2016