Standard vs Ultrasound-assisted Catheter Thrombolysis for Submassive Pulmonary Embolism

NCT ID: NCT03086317

Last Updated: 2023-06-27

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 18 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2017-10-19
• Study Completion Date: 2020-12-08

Brief Summary

The study is an investigator-initiated trial comparing two different catheters (standard versus ultrasound assisted) for the treatment of acute high risk pulmonary embolism (blood clots in lung arteries with evidence or heart strain). Patients already planned for the procedure will be randomized to standard catheter-directed thrombolysis (CDT) or to ultrasound-assisted catheter thrombolysis (USAT). Both catheters are currently used routinely in practice for the treatment of pulmonary embolism, but it is not known if USAT is superior to standard CDT, the former being much more expensive and more commonly used.

The purpose of the study is to learn about which catheter-directed therapy is more suitable for patients with pulmonary embolism (PE), who are candidates for both standard catheter directed therapy (CDT), and ultrasound-assisted catheter directed therapy (USAT), and to provide information regarding the cost effectiveness of the two different types of treatment. A total of 80 patients are planned to be recruited. All medication administration, procedures or in-hospital tests will be performed as routine clinical practice. The study will compare short term and long term outcomes: resolution of blood clots on CT scan, right ventricular size improvement, quality of life and symptoms at 3 and 12 months, and cost effectiveness.

Detailed Description

Acute pulmonary embolism (PE) accounts for 5-10% of in-hospital deaths. Systemic anticoagulation (AC) is the standard of care and thrombolysis is recommended for those at a higher mortality risk. Catheter-directed therapies, mainly standard catheter-directed thrombolysis (CDT) and ultrasound-accelerated thrombolysis (USAT), have been introduced as new, more effective, and safer treatment modalities. USAT is a modification of standard catheter thrombolysis, utilizing a system of local ultrasound to dissociate the fibrin matrix of the thrombus, allowing deeper penetration of lytics. However, there is limited data comparing the two treatments. More rapid clearance of pulmonary thrombus by USAT compared to standard CDT may prove to be more effective regarding clinical outcomes and cost (e.g. via reduced length of ICU and hospital stay). Alternatively, if thrombus clearance is similar, the cost of USAT may exceed the cost of CDT (equipment and disposables), without offering any potential advantage.

This controlled, randomized study seeks to determine if ultrasound acceleration adds any benefits in the outcomes and costs of catheter-directed thrombolysis for patients with acute submassive PE. The treatment with CDT or USAT are standard of care for submassive PE and participants will be randomized to receive one treatment or the other. Participants will have follow up visits at 3 months and 12 months post procedure. All the procedures, tests, and follow up visits are according to current standard of care.

Conditions

Cardiovascular Diseases

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Standard Catheter-Directed Thrombolysis

Participants randomized to this arm will receive standard catheter-directed thrombolysis, per standard of care, as treatment for acute submassive pulmonary embolism.

Group Type: ACTIVE_COMPARATOR

Standard Catheter-Directed Thrombolysis

Intervention Type: DEVICE

Catheter-directed thrombolysis requires placement of a multi-sidehole infusion catheter within the pulmonary arterial thrombus burden, under angiographic guidance. Thrombolytic medications are slowly infused through the catheter, which is left in place for the duration of the treatment. The treatment will be performed according to current standard of care and all technical considerations will be left to the discretion of the operator performing the procedure. All follow up is according to standard of care.

Ultrasound-Accelerated Thrombolysis

Participants randomized to this arm will receive ultrasound-accelerated thrombolysis, per standard of care, as treatment for acute submassive pulmonary embolism.

Group Type: ACTIVE_COMPARATOR

Ultrasound-Accelerated Thrombolysis

Intervention Type: DEVICE

USAT is a modification of standard catheter-directed thrombolysis utilizing a proprietary system of local high frequency, low-power ultrasound to dissociate the fibrin matrix of the thrombus, allowing deeper penetration of lytic medication. The treatment will be performed according to current standard of care and all technical considerations will be left to the discretion of the operator performing the procedure. All follow up is according to standard of care.

Interventions

Standard Catheter-Directed Thrombolysis

Catheter-directed thrombolysis requires placement of a multi-sidehole infusion catheter within the pulmonary arterial thrombus burden, under angiographic guidance. Thrombolytic medications are slowly infused through the catheter, which is left in place for the duration of the treatment. The treatment will be performed according to current standard of care and all technical considerations will be left to the discretion of the operator performing the procedure. All follow up is according to standard of care.

Intervention Type: DEVICE

Ultrasound-Accelerated Thrombolysis

USAT is a modification of standard catheter-directed thrombolysis utilizing a proprietary system of local high frequency, low-power ultrasound to dissociate the fibrin matrix of the thrombus, allowing deeper penetration of lytic medication. The treatment will be performed according to current standard of care and all technical considerations will be left to the discretion of the operator performing the procedure. All follow up is according to standard of care.

Intervention Type: DEVICE

Other Intervention Names

CDT; USAT

Eligibility Criteria

Inclusion Criteria

• Patients eligible for catheter directed thrombolysis per the study protocol for submassive pulmonary embolism (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)
• without the need of catecholamine support
• without the need of cardiopulmonary resuscitation

Exclusion Criteria

• Pregnancy
• Index PE symptom duration >14 days
• High bleeding risk (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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Emory University

OTHER

Sponsor Role: lead

Responsible Party

Wissam Jaber

Associate Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Wissam Jaber, MD

Role: PRINCIPAL_INVESTIGATOR

Emory University

Locations

Grady Health System

Atlanta, Georgia, United States

Emory University Hospital Midtown

Atlanta, Georgia, United States

Emory Clinic

Atlanta, Georgia, United States

Emory University Hospital

Atlanta, Georgia, United States

Countries

United States

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

IRB00093040

Identifier Type: -

Identifier Source: org_study_id