Long Term Effects of Treating Submassive Pulmonary Embolism With Ultra-sound Accelerated Thrombolysis

Submassive Pulmonary Embolism Treatment With Ultrasound-Accelerated Thrombolysis

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT01899339

Acronym

SPEAR

Enrollment

Registered

2013-07-15

Start date

2013-05-31

Completion date

2019-02-28

Last updated

2023-07-18

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Submassive Pulmonary Embolism

Keywords

submassive pulmonary embolism, Ultrasonic energy, Ekosonic Endovascular Device, RV:LV function after Pulmonary Embolism

Brief summary

Patients with Submassive Pulmonary Embolism treated with ultra-sound therapy will have an improved right ventricular function 72 hours post treatment.

Interventions

OTHERsubmassive PA treatment with Ekosonic endo device

Ultra Sound energy along with tPA to treat submassive pulmonary embolism

Study design

Observational model

CASE_ONLY

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to 80 Years

Healthy volunteers

Inclusion criteria

* Patients with acute (\< or = 14 days)symptomatic pulmonary embolism by CT Angiogram of the thorax with embolus involving at least one main or lower lobe pulmonary artery and RV:LV ratio \> 0.9

Exclusion criteria

* age \> 80 * Recent thrombolytic therapy (with in 4 days) * Active bleeding or know bleeding diathesis * Known coagulopathy (including treatment with vitamin K antagonists) INR \> 3 and/or PTT \> 50 * Thrombocytopenia (PLT cound \< 100,000) * History of any intracranial or intraspinal surgery, trauma or bleed * Intracranial neoplasms, AVM, or aneurysm * Recent (\< 1 month) GI bleed * Recent (\< 3 months) internal eye surgery or hemorrhagic retinopathy * Recent (\< 7 days) major surgery, trauma, or obstetrical delivery * Renal insufficiency with eGFR \< 45 ml/min * Known allergy, hypersensitivity, or thrombocytopenia from heparin or tPA * Hemodynamic instability defined as need for cardiopulmonay resuscitation, Systolic BP \> 90 mm Hg for \> 15 min or need for pressor agents to maintain BP \> 90. * Severe Hypertension (sustained systolic \> 180 mm Hg or diastolic \> 90 mm Hg. * Pregnant patients * known right to left shunt * Large (\>10 mm)intracardiac thrombus * Use of thrombolytics or glycoprotein IIb/IIIa antangonists within 3 days of inclusion. * Life expectancy \< 30 days

Design outcomes

Primary

Measure	Time frame	Description
Change in Right Ventricular:Left Ventricular ratio	baseline to 72 hours post	Treatment will show improved Right Ventricular:Left Ventricular ratio at 72 hours post.

Secondary

Measure	Time frame	Description
recurrent pulmonary embolism	30 days post procedure	Will assess whether a recurrent Pulmonary Embolism has happened at 30 day post procedure or earlier

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026