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

Submassive Pulmonary Embolism Clinical Trial

— SPEAR  

Official title:

Submassive Pulmonary Embolism Treatment With Ultrasound-Accelerated Thrombolysis

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01899339
• Other study ID #: 2013-069
• Secondary ID: Ekos
• Status: Completed
• Start date: May 2013
• Est. completion date: February 2019

Study information

• Verified date: July 2023
• Source: Spectrum Health Hospitals
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 25
• Est. completion date: February 2019
• Est. primary completion date: February 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• Embolism
• Pulmonary Embolism
• Submassive Pulmonary Embolism

Intervention

Other:
• submassive PA treatment with Ekosonic endo device
Ultra Sound energy along with tPA to treat submassive pulmonary embolism

Locations

Country	Name	City	State
United States	Spectrum Health Hospitals	Grand Rapids	Michigan

Sponsors (2)

Lead Sponsor	Collaborator
Spectrum Health Hospitals	EKOS Corporation

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in Right Ventricular:Left Ventricular ratio	Treatment will show improved Right Ventricular:Left Ventricular ratio at 72 hours post.	baseline to 72 hours post
Secondary	recurrent pulmonary embolism	Will assess whether a recurrent Pulmonary Embolism has happened at 30 day post procedure or earlier	30 days post procedure