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

Spectrum Health Hospitals

Status: Completed

Conditions: Submassive Pulmonary Embolism

Treatments: Other: submassive PA treatment with Ekosonic endo device

Study type: Observational

Funder types: Other; Industry

Identifiers

NCT01899339

2013-069

Ekos (Other Identifier)

Details and patient eligibility

About

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

Enrollment: 25 patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No 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

Trial design

25 participants in 1 patient group

pulmonary embolism

Description:

patients with submassive pulmonary embolism

Treatment:

Other: submassive PA treatment with Ekosonic endo device