NCT03426124

An International Pulmonary Embolism Registry Using EKOS

Study Contact:

Study Phase:

Recruitment Status:

COMPLETED

NCT ID:

NCT03426124

Principal Investigator:

Study Type:

OBSERVATIONAL

Official Title:

Retrospective and Prospective International EkoSonic® Registry of the Treatment and Clinical OUTcomes of Patients With Pulmonary Embolism

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.

Eligibility

Retrospective Inclusion Criteria:

* Treated with APT procedure between January 1, 2014 and one year prior to site activation
* RV/LV ≥ 1.0 from diagnostic computed tomographic angiography (CTA) or echocardiogram
* PE symptom duration ≤ 14 days
* Troponin elevation

Retrospective Exclusion Criteria:

* Enrollment into the OPTALYSE PE study

Prospective Inclusion Criteria:

* Male or female ≥ 18 years of age and ≤ 80 years of age
* RV/LV ≥ 1.0 from diagnostic computed tomographic angiography (CTA) or echocardiogram
* PE symptom duration ≤ 14 days
* Troponin elevation
* Signed informed consent obtained from participant or legally authorized representative
* Investigator has selected the EKOS device to treat participant with massive or submassive pulmonary embolism

Prospective Exclusion Criteria:

* High-risk for catastrophic bleeding
* Life expectancy \< one year

Disease(s) and\or Condition(s)

Pulmonary Embolism and Thrombosis

Primary Purpose

Intervention/Treatment

- Type: DEVICE
- Name: EkoSonic Endovascular System with thrombolytic
- Description: The device uses ultrasonic waves in combination with clot-dissolving thrombolytic drug to effectively dissolve clots.
- Arm Group Labels: Prospective, Retrospective

Sponsor

Boston Scientific Corporation