Standard vs Ultrasound-assisted Catheter Thrombolysis for Submassive Pulmonary Embolism

NCT03086317 | Completed Results DMC FDA Device

• 1 other identifier: IRB00093040
• Study Type: interventional
• Target: 18
• Locations: 1 country
• Sites: 4

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.

Conditions

Cardiovascular Diseases

Keywords

Pulmonary Medicine; Therapy Evaluation

Outcome Measures

Primary Outcomes (1)

• Percentage of Thrombus Obstruction

  Computed tomography angiography (CTA) will be performed before and after treatment. An independent radiologist will quantify the degree of obstruction from the thrombus by determining the vascular obstruction index. For determining the CT obstruction index, the arterial tree of each lung will be considered to have 10 segmental arteries (three to the upper lobes, two to both the middle lobe and the lingula, and five to the lower lobes).

  Baseline to end of lysis treatment (up to 72 hours)

Secondary Outcomes (17)

• In Hospital Mortality

  Until hospital discharge (an average of 6 days)

• 90-day Mortality

  Until 90 days post procedure

• Cardiac Decompensation Due to Massive Pulmonary Embolism

  Through follow up (12 months)

• Major Bleeding

  Through follow up (12 months)

• Minor Bleeding

  Through follow up (12 months)

Study Arms (2)

Standard Catheter-Directed Thrombolysis

ACTIVE COMPARATOR

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

Device: Standard Catheter-Directed Thrombolysis

Ultrasound-Accelerated Thrombolysis

ACTIVE COMPARATOR

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

Device: Ultrasound-Accelerated Thrombolysis

Interventions

Standard Catheter-Directed Thrombolysis 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.

Also known as: CDT

Standard Catheter-Directed Thrombolysis

Ultrasound-Accelerated Thrombolysis 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.

Also known as: USAT

Ultrasound-Accelerated Thrombolysis

Eligibility Criteria

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

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Emory University: lead

Study Sites (4)

Grady Health System

Atlanta, Georgia, 30303, United States

Location

Emory University Hospital Midtown

Atlanta, Georgia, 30308, United States

Location

Emory Clinic

Atlanta, Georgia, 30322, United States

Location

Emory University Hospital

Atlanta, Georgia, 30322, United States

Location

MeSH Terms

Conditions

Cardiovascular Diseases

Results Point of Contact

• Title: Dr. Wissam Jaber, Assistant Professor
• Organization: Emory University

wissam.jaber@emory.edu

4046861000

Study Officials

• Wissam Jaber, MD

  Emory University

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: Pre- and post-treatment computed tomography angiography (CTA) will be compared by independent radiologists who are blinded to the type treatment received. Pre- and post-treatment echocardiograms will be interpreted by independent cardiologists who are blinded to the type of treatment received.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Model Details: Participants will be randomized to receive one of two treatments for acute, submassive pulmonary embolism.

Study Record Dates

• First Submitted: March 10, 2017
• First Posted: March 22, 2017
• Study Start: October 19, 2017
• Primary Completion: December 8, 2020
• Study Completion: December 8, 2020
• Last Updated: June 27, 2023
• Results First Posted: March 10, 2022

Record last verified: 2023-06

Data Sharing

• IPD Sharing: Will not share

Locations

US (4)