Trials / Completed
CompletedNCT01513759
Submassive and Massive Pulmonary Embolism Treatment With Ultrasound Accelerated Thrombolysis Therapy
A Prospective, Single-Arm, Multi-Center Trial of EkoSonic® Endovascular System and Activase for Treatment of Acute Pulmonary Embolism (PE)
- Status
- Completed
- Phase
- Phase 3
- Study type
- Interventional
- Enrollment
- 150 (actual)
- Sponsor
- Boston Scientific Corporation · Industry
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
Summary
The purpose of this study is to determine if the EKOS EkoSonic® Endovascular Device when used in conjunction with recombinant tissue plasminogen activator (t-PA) as a treatment for acute PE will decrease the ratio of right ventricle (RV) to left ventricle (LV) diameter within 48 =/- 6 hours in participants with massive or submassive PE.
Conditions
- Pulmonary Embolism
- Acute Pulmonary Embolism
- Sub-massive Pulmonary Embolism
- Massive Pulmonary Embolism
- Pulmonary Thromboembolism
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | recombinant tissue plasminogen activator | Participants will receive 24 mg of r-tPA delivered via the EkoSonic Endovascular Device. |
| DEVICE | EKOS EkoSonic Endovascular System | 24 mg of r-tPA will be delivered through the EkoSonic Endovascular System. |
Timeline
- Start date
- 2012-06-07
- Primary completion
- 2013-02-17
- Completion
- 2013-02-17
- First posted
- 2012-01-20
- Last updated
- 2021-07-19
- Results posted
- 2019-07-05
Locations
22 sites across 1 country: United States
Source: ClinicalTrials.gov record NCT01513759. Inclusion in this directory is not an endorsement.