Trials / Completed
CompletedNCT03426124
An International Pulmonary Embolism Registry Using EKOS
Retrospective and Prospective International EkoSonic® Registry of the Treatment and Clinical OUTcomes of Patients With Pulmonary Embolism
- Status
- Completed
- Phase
- —
- Study type
- Observational
- Enrollment
- 1,480 (actual)
- Sponsor
- Boston Scientific Corporation · Industry
- Sex
- All
- Age
- 18 Years – 80 Years
- Healthy volunteers
- Not accepted
Summary
This registry is designed to understand acoustic pulse thrombolysis (APT) treatment regimens used as standard of care globally for pulmonary embolism. The registry will include individuals who have already received the APT treatment and those that will undergo APT treatment.
Detailed description
For the prospective arm of the registry, a physician will have selected the APT procedure for the treatment of pulmonary embolism. The APT treatment and follow-up assessments are per clinical judgement and institutional standard of care which may vary at each clinical site. For the retrospective arm of the registry, the investigators will gather data from consecutive cases of individuals who received the APT treatment for pulmonary embolism. Specific baseline, treatment, and long-term health information is collected and de-identified.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DEVICE | EkoSonic Endovascular System with thrombolytic | The device uses ultrasonic waves in combination with clot-dissolving thrombolytic drug to effectively dissolve clots. |
Timeline
- Start date
- 2018-03-01
- Primary completion
- 2020-06-30
- Completion
- 2020-09-30
- First posted
- 2018-02-08
- Last updated
- 2023-02-22
- Results posted
- 2023-02-22
Locations
80 sites across 8 countries: United States, Austria, France, Germany, Netherlands, Switzerland, Turkey (Türkiye), United Kingdom
Regulatory
- FDA-regulated device study
Source: ClinicalTrials.gov record NCT03426124. Inclusion in this directory is not an endorsement.