Long Term Effects of Treating Submassive Pulmonary Emboli... | NCT01899339

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

NCT01899339

Sponsor

Corewell Health West

Status

Completed

Last Update Posted

Jul 18, 2023Actual

Enrollment

25Actual

Phase

Not provided

Conditions

Submassive Pulmonary Embolism

Interventions

submassive PA treatment with Ekosonic endo device

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

ID	Type	Description	Link
Ekos	Other Identifier	spectrum health

Status Module

Record Verification Date

Jul 2023

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

May 2013

Primary Completion Date

Feb 2019Actual

Completion Date

Feb 2019Actual

First Submitted Date

Jul 10, 2013

First Submission Date that Met QC Criteria

Jul 12, 2013

First Posted Date

Jul 15, 2013Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jul 14, 2023

Last Update Posted Date

Jul 18, 2023Actual

Name	Class
EKOS Corporation	INDUSTRY

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

25Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
pulmonary embolism		patients with submassive pulmonary embolism	Other: submassive PA treatment with Ekosonic endo device

Interventions

Name	Type	Description	Arm Group Labels	Other Names
submassive PA treatment with Ekosonic endo device	Other	Ultra Sound energy along with tPA to treat submassive pulmonary embolism	pulmonary embolism

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
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 Outcomes

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

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

80 Years

Standard Ages

AdultOlder Adult

Study Population

All patient presenting to the Emergency Department with submassive pulmonary hypertension over the age of 18.

Sampling Method

Probability Sample