Health TrialsbyHealthPanel

Pulmonary Embolism - Thrombus Removal With Catheter-Directed Therapy

ConditionPulmonary Embolism
Trial statusRecruiting
Trial phasePhase 3
Trial typeInterventional
Biological sexAll
Age18+
SponsorNYU Langone Health

About this trial

PE-TRACT is an open-label, assessor-blinded, randomized trial, aiming to compare catheter-directed therapy (CDT) and anticoagulation (CDT group) with anticoagulation alone (No-CDT) in 500 patients with submassive PE, proximal pulmonary artery thrombus and right ventricular dilation.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Symptomatic PE diagnosed by contrast-enhanced CT angiography with involvement of a main or lobar pulmonary artery branch; and

Right ventricular (RV) dilation as defined by the presence of an RV/Left ventricular ratio > 1 on CT angiography

Disqualifiers

Age < 18 years

Systolic blood pressure < 90 mmHg for >15 consecutive minutes or > 40 mmHg drop from baseline, or vasopressor requirement for blood pressure support (i.e., massive PE), occurring within 1 hour prior to eligibility assessment.

Symptom duration > 14 days for the current PE episode

Irreversible INR > 3

Trial design

Design model

Parallel

Treatments tested in this trial

  • Anticoagulant Therapy

    Drug

    All subjects will receive anticoagulation for a minimum of 3 months.

  • Catheter-Directed Therapy

    Device

    The endovascular physician can choose to use either mechanical thrombectomy (MT) using a device cleared by the FDA to treat PE or catheter-directed thrombolysis (CDL) using an infusion catheter cleared by the FDA to administer thrombolytic drugs for the treatment of PE

Treatment groups

500 Participants
are divided into 2 treatment groups
Group A: Catheter-Directed Therapy (CDT) plus AnticoagulationExperimental treatment 2 interventions
Group B: No Catheter-Directed Therapy (No-CDT)Active comparator 1 intervention

Trial outcomes

Primary outcomes

1

Peak Oxygen Consumption (PVO2)

PVO2 measured during cardiopulmonary exercise test (CPET).

Time frame
Month 3
2

New York Heart Association (NYHA) Functional Classification

The NYHA classifies the extent of heart failure. It classifies patients in one of four categories based on their limitations during physical activity; the limitations/symptoms are in regards to normal breathing and varying degrees in shortness of breath and or angina pain: * Class I - No symptoms and no limitation with ordinary physical activity. * Class II - Mild symptoms and slight limitation during ordinary activity. * Class III - Moderate limitation in activity (even less than ordinary) due to symptoms. * Class IV - Symptoms occur at rest and severe limitation with any physical activity. * Class V - Dead.

Time frame
Month 12
3

Incidence of Major Bleeding at Day 7

International Society on Thrombosis and Haemostasis (ISTH) definition of "Major Bleeding" to be used. Per ISTH, Major Bleeding defined as: 1. Fatal bleeding, AND/OR; 2. Symptomatic bleeding in a critical area or organ, such as intracranial, intraspinal, intraocular, retroperitoneal, intraarticular or pericardial, or intramuscular with compartment syndrome, AND/OR; 3. Bleeding causing a fall in hemoglobin level of 2 g/dL (1.24 mmol/L) or more, or leading to transfusion of two or more units of whole blood or red cells.

Time frame
Up to Day 7

Secondary outcomes

1

Six-Minute Walk Distance (6MWD)

Time frame
Month 12
2

Short-Form Health Survey-36 (SF-36) Score

36-item questionnaire assessing general health. It measures 8 dimensions of health status: social function, physical function, emotional role, physical role, mental health, vitality, physical pain, and general health. Scores range from 0 (worst health status) to 100 (best health status).

Time frame
Month 12
3

Incidence of Clinical Deterioration (Fatal and Non-Fatal) at Day 7

Clinical deterioration defined as hemodynamic decompensation or respiratory decompensation requiring endotracheal intubation.

Time frame
Up to Day 7

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

NYU Langone Health

Lead sponsor

National Heart, Lung, and Blood Institute (NHLBI)

Collaborator

Source ClinicalTrials.gov
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