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

Completed

• Conditions: Submassive Pulmonary Embolism
• Interventions: Other: submassive PA treatment with Ekosonic endo device

• Registration Number: NCT01899339
• Lead Sponsor: Spectrum Health Hospitals

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study Start: 2013-05
• Study First Submitted: 2013-07-10
• Study First Submitted QC: 2013-07-12
• Study First Posted: 2013-07-15
• Primary Completion: 2019-02
• Study Completion: 2019-02
• Status Verified: 2023-07
• Last Update Submitted: 2023-07-14
• Last Update Posted: 2023-07-18

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 25

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
pulmonary embolism	submassive PA treatment with Ekosonic endo device	patients with submassive pulmonary embolism

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

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

Trial Locations

Locations (1)

Spectrum Health Hospitals; 🇺🇸 Grand Rapids, Michigan, United States