Standard vs. Ultrasound-assisted Catheter Thrombolysis for Submassive Pulmonary Embolism

NCT02758574 | Completed DMC

• 1 other identifier: PRO15090058
• Study Type: interventional
• Target: 77
• Locations: 1 country
• Sites: 4

Brief Summary

The study will compare standard catheter directed thrombolysis to ultrasound accelerated thrombolysis for the treatment of acute submassive pulmonary embolism (PE). The study population will include patients eligible for catheter directed thrombolysis (CDT) for submassive PE. Subjects will be randomized to, either, standard catheter-directed thrombolysis or ultrasound-accelerated thrombolysis (USAT).

Conditions

Pulmonary Embolism

Keywords

acute pulmonary embolism; submassive pulmonary embolism; thrombolysis; catheter directed thrombolysis; ultrasound assisted thrombolysis

Outcome Measures

Primary Outcomes (1)

• PE thrombus load reduction (CT obstruction index) from baseline to the termination of lysis

  48 hours

Secondary Outcomes (10)

• Mortality

  90 days

• Stroke

  30 days

• Major Bleeding

  30 days

• Echocardiographic Right Ventricular/Left Ventricular Diameter (ratio)

  12 months

• Functional status (6 min walk test)

  12 months

Study Arms (2)

CDT without ultrasound acceleration

ACTIVE COMPARATOR

Standard Catheter-Directed Thrombolysis: Utilization of a standard infusion catheter, placed at the site of pulmonary thrombus. The catheter will be used for the delivery of thrombolytic medications to treat/dissolve pulmonary embolus

Procedure: CDT without ultrasound acceleration

CDT ultrasound accelerated

EXPERIMENTAL

Ultrasound Accelerated Catheter-Directed Thrombolysis: Utilization of an infusion catheter that incorporates an ultrasound emitting wire both placed at the site of pulmonary thrombus. The catheter will be used for the delivery of thrombolytic medications with the ultrasound emitting wire activated to treat/dissolve pulmonary embolus

Procedure: CDT with ultrasound acceleration

Interventions

CDT without ultrasound acceleration PROCEDURE

A pulmonary arteriogram will be performed. Upon confirmation of the pulmonary embolus a standard infusion catheter will be placed within the clot. The catheter will be used for infusion of thrombolytics to treat/dissolve the pulmonary embolus.

Also known as: Standard CDT

CDT without ultrasound acceleration

CDT with ultrasound acceleration PROCEDURE

A pulmonary arteriogram will be performed. Upon confirmation of the pulmonary embolus an infusion catheter that incorporates an ultrasound emitting wire will be placed within the clot. The catheter will be used for infusion of thrombolytics to treat/dissolve the pulmonary embolus. The wire will be connected to an ultrasound generating device.

Also known as: Ultrasound assisted CDT

CDT ultrasound accelerated

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Subject is eligible for catheter directed thrombolysis per the study protocol for submassive PE (CT or echocardiographic RV strain (defined as RV/LV ratio \>1) without persisting hypotension \<90mmHg or drop of systolic blood pressure by at least 40mm Hg for at least 15 minutes with signs of end-organ hypoperfusion (cold extremities or low urinary output \<30 mL/h or mental confusion) and without the need of catecholamine support or cardiopulmonary resuscitation).

You may not qualify if:

• pregnancy;
• index PE symptom duration \>14 days;
• high bleeding rsk (any prior intracranial hemorrhage,
• known structural intracranial cerebrovascular disease or neoplasm,
• ischemic stroke within 3 months,
• suspected aortic dissection, active bleeding or bleeding diathesis,
• recent spinal or cranial/brain surgery,
• recent closed-head or facial trauma with bony fracture or brain injury);
• participation in any other investigational drug or device study;
• life expectancy \<90 days;
• inability to comply with study assessments.

Sponsors & Collaborators

• University of Pittsburgh: lead

Study Sites (4)

UPMC Presbyterian

Pittsburgh, Pennsylvania, 15213, United States

Location

UPMC Mercy

Pittsburgh, Pennsylvania, 15219, United States

Location

UPMC Shadyside

Pittsburgh, Pennsylvania, 15232, United States

Location

UPMC Passavant

Pittsburgh, Pennsylvania, 15237, United States

Location

Related Publications (43)

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MeSH Terms

Conditions

Pulmonary Embolism

Interventions

carbohydrate-deficient transferrin

Condition Hierarchy (Ancestors)

Lung Diseases; Respiratory Tract Diseases; Embolism; Embolism and Thrombosis; Vascular Diseases; Cardiovascular Diseases

Study Officials

• Efthymios Avgerinos, M.D.

  University of Pittsburgh

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor of Surgery

Study Record Dates

• First Submitted: March 22, 2016
• First Posted: May 2, 2016
• Study Start: May 1, 2016
• Primary Completion: August 1, 2021
• Study Completion: August 1, 2021
• Last Updated: September 5, 2021

Record last verified: 2021-09

Locations

US (4)