Catheter-Directed Therapy for Pulmonary Embolism
(PE-TRACT Trial)
Recruiting in Palo Alto (17 mi)
+46 other locations
Age: 18+
Sex: Any
Travel: May Be Covered
Time Reimbursement: Varies
Trial Phase: Phase 3
Recruiting
Sponsor: NYU Langone Health
Must not be taking: Heparin
Disqualifiers: Pregnancy, Low blood pressure, others
No Placebo Group
Pivotal Trial (Near Approval)
Prior Safety Data
Approved in 6 Jurisdictions
Trial Summary
What is the purpose of 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.
Do I have to stop taking my current medications for this trial?
The trial protocol does not specify if you need to stop taking your current medications. However, if you have an allergy to heparin or a history of Heparin-Induced Thrombocytopenia (HIT), you may not be eligible to participate.
What data supports the idea that Catheter-Directed Therapy for Pulmonary Embolism is an effective treatment?
The available research shows that traditional anticoagulant therapy, which includes drugs like heparin and vitamin K antagonists, has been effective in reducing mortality from pulmonary embolism from 25% to 6%. However, the research does not provide specific data on the effectiveness of Catheter-Directed Therapy for Pulmonary Embolism compared to these traditional treatments. Instead, it highlights the effectiveness of anticoagulant drugs in general, with a low recurrence rate of about 5% and very rare lethal recurrences. While Catheter-Directed Therapy might be used in certain cases, the data provided focuses on the success of anticoagulant drugs in treating pulmonary embolism.
12345What safety data exists for catheter-directed therapy for pulmonary embolism?
Catheter-directed therapy (CDT) is considered a promising option for treating pulmonary embolism, particularly for minimizing bleeding risk compared to other interventions. While systemic thrombolysis is the mainstay for hemodynamically unstable patients, CDT offers a targeted approach that may reduce bleeding complications. The safety of CDT, including ultrasound-assisted catheter-directed thrombolysis (USAT), is still being evaluated, but it is seen as a potentially safer alternative to systemic thrombolysis, especially for intermediate-risk patients. The data on reduced-dose intravenous thrombolysis is still preliminary, and the use of non-vitamin K-dependent oral anticoagulants has been shown to reduce major bleeding risk in long-term anticoagulation.
678910Is the drug Anticoagulant Therapy a promising treatment for Pulmonary Embolism?
Anticoagulant Therapy is a standard treatment for Pulmonary Embolism and is effective for many patients. However, for some patients who do not respond well to it, Catheter-Directed Therapy has shown promising results.
111121314Eligibility Criteria
This trial is for adults with a type of lung blockage called submassive pulmonary embolism, who have certain heart measurements on a CT scan. They must be able to walk independently before the current episode and not have severe kidney issues, allergies to specific clot-dissolving drugs or contrast agents, very low blood counts, or be pregnant.Inclusion Criteria
I have a blood clot in my lung confirmed by a CT scan.
Your right ventricle is too big compared to your left ventricle, as seen on a CT scan.
Exclusion Criteria
You are pregnant, or could be pregnant, based on a recent test.
I am not allergic to rt-PA or iodinated contrast, or I can take steroids for mild-moderate contrast allergies.
Your blood clotting test shows a high level that cannot be reversed.
+11 more
Trial Timeline
Screening
Participants are screened for eligibility to participate in the trial
2-4 weeks
Treatment
Participants receive either catheter-directed therapy (CDT) plus anticoagulation or anticoagulation alone for pulmonary embolism
Up to 7 days
In-hospital treatment
Follow-up
Participants are monitored for safety and effectiveness after treatment, including assessments of peak oxygen consumption and NYHA functional classification
12 months
Regular follow-up visits
Participant Groups
The PE-TRACT study is testing if using catheter-directed therapy (CDT) along with standard blood thinners helps more than just blood thinners alone in patients with a serious lung blockage condition. Participants are randomly chosen to receive either both treatments or only the blood thinner.
2Treatment groups
Experimental Treatment
Active Control
Group I: Catheter-Directed Therapy (CDT) plus AnticoagulationExperimental Treatment2 Interventions
Participants will receive CDT consisting of mechanical thrombectomy (MT) or intrathrombus catheter-directed thrombolysis (CDL) using FDA-cleared devices for pulmonary embolism (PE). The exact technique and devices used will be at the discretion of the endovascular physician, within parameters defined by the PE-TRACT Manual of Operations (MOP) and accepted standard care. Before and after CDT, patients will receive standard PE therapy as in the no-CDT Arm.
Group II: No Catheter-Directed Therapy (No-CDT)Active Control1 Intervention
Standard anticoagulant therapy (FDA-approved regimen) for the treatment of PE.
Anticoagulant Therapy is already approved in European Union, United States, Canada, Japan, China, Switzerland for the following indications:
🇪🇺 Approved in European Union as Various Anticoagulants for:
- Venous thromboembolism (VTE)
- Non-valvular atrial fibrillation (NVAF)
- Pulmonary embolism
- Deep vein thrombosis
🇺🇸 Approved in United States as Various Anticoagulants for:
- Venous thromboembolism (VTE)
- Non-valvular atrial fibrillation (NVAF)
- Pulmonary embolism
- Deep vein thrombosis
🇨🇦 Approved in Canada as Various Anticoagulants for:
- Venous thromboembolism (VTE)
- Non-valvular atrial fibrillation (NVAF)
- Pulmonary embolism
- Deep vein thrombosis
🇯🇵 Approved in Japan as Various Anticoagulants for:
- Venous thromboembolism (VTE)
- Non-valvular atrial fibrillation (NVAF)
- Pulmonary embolism
- Deep vein thrombosis
🇨🇳 Approved in China as Various Anticoagulants for:
- Venous thromboembolism (VTE)
- Non-valvular atrial fibrillation (NVAF)
- Pulmonary embolism
- Deep vein thrombosis
🇨🇭 Approved in Switzerland as Various Anticoagulants for:
- Venous thromboembolism (VTE)
- Non-valvular atrial fibrillation (NVAF)
- Pulmonary embolism
- Deep vein thrombosis
Find a Clinic Near You
Research Locations NearbySelect from list below to view details:
Columbia UniversityNew York, NY
Boston Medical CenterBoston, MA
Christiana Care Health SystemNewark, DE
Carilion ClinicRoanoke, VA
More Trial Locations
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Who Is Running the Clinical Trial?
NYU Langone HealthLead Sponsor
National Heart, Lung, and Blood Institute (NHLBI)Collaborator
References
Acute pulmonary embolism: risk assessment, risk stratification and treatment options. [2019]Pulmonary embolism (PE) is a potentially life-threatening cardiovascular emergency with a high mortality rate. Rapid diagnosis and treatment are important in optimising clinical outcomes in patients with PE, and anticoagulants are the mainstay of treatment. Traditionally, anticoagulant therapy involves parenteral anticoagulants, overlapping with and followed by oral vitamin K antagonists. Direct oral anticoagulants (DOACs), including the factor Xa inhibitors rivaroxaban, apixaban and edoxaban, and the direct thrombin inhibitor dabigatran etexilate, have been developed to address limitations associated with traditional anticoagulant therapy. Apixaban, dabigatran and rivaroxaban have recently been approved for the treatment of acute deep vein thrombosis (DVT) and PE and prevention of recurrent DVT or PE. Edoxaban is approved in the United States but not currently in the European Union for the treatment of DVT and PE; approval of edoxaban in Europe is anticipated in the near future.
[Anticoagulant therapy in pulmonary embolism]. [2017]Venous thrombosis and pulmonary embolism are the two faces of thromboembolic disease. In over 90% of cases, the initial treatment of the pulmonary embolism is anticoagulant therapy, the necessity and efficacy of which were demonstrated over 30 years ago with a reduction of mortality of 25 to 6%. Intravenous heparin relayed rapidly (1st to 3rd day) is still the conventional treatment protocol. Heparin therapy adapted to the result of the activated cephalin time (two to three times the control value) and oral vitamin K antagonists with a dosage adapted to keep the International Normalized Ratio between 2 and 3 is the safest and most effective treatment to date. The efficacy is shown by the low rate of recurrency, about 5% under anticoagulant therapy, lethal recurrence being very rare (less than 1%), and safety is attested by the low rate of severe bleeding complications (3 to 5%). The introduction of low molecular weight heparin and the excellent results observed in the treatment of deep vein thrombosis will probably lead to rapid extension of its indications to mild or moderate but haemodynamically well-tolerated pulmonary embolism. Hirudine and heparinoids will probably be the next step in the treatment of pulmonary embolism.
New oral anticoagulants in the treatment of pulmonary embolism: efficacy, bleeding risk, and monitoring. [2023]Anticoagulation therapy is mandatory in patients with pulmonary embolism to prevent significant morbidity and mortality. The mainstay of therapy has been vitamin-K antagonist therapy bridged with parenteral anticoagulants. The recent approval of new oral anticoagulants (NOACs: apixaban, dabigatran, and rivaroxaban) has generated significant interest in their role in managing venous thromboembolism, especially pulmonary embolism due to their improved pharmacokinetic and pharmacodynamic profiles, predictable anticoagulant response, and lack of required efficacy monitoring. This paper addresses the available literature, on-going clinical trials, highlights critical points, and discusses potential advantages and disadvantages of the new oral anticoagulants in patients with pulmonary embolism.
Pulmonary embolism in the critically ill. [2007]Pulmonary embolism in the critically ill requires considerations beyond anticoagulant therapy. Measurements of chamber size by echocardiography and CT and of circulating biomarkers identify higher-risk patients with moderate accuracy and may aid determination of patient acuity. Preserving right ventricular function requires judicious use of volume administration, vasopressor, and perhaps vasodilator therapies. Obstructing thrombus can be treated with fibrinolytic drugs, percutaneous instrumentation, or surgically, but these treatments may not be equally effective or safe. Anticoagulant therapy in critically ill patients is likely best administered IV. Bleeding complications should be assiduously sought but do not necessitate anticoagulant discontinuation in every case. The antidotes protamine, desmopressin acetate, factor VIII inhibitory bypass activity, and recombinant factor VIIa may each have a place in controlling anticoagulant-related bleeding. The grave prognosis of heparin-induced thrombocytopenia warrants close surveillance, with rapid switching to lepirudin, argatroban, or fondaparinux necessary if it is suspected. Retrievable vena cava filters can be lifesaving, and at least one type may be safely removed after residence of nearly 1 year.
Thrombolysis versus anticoagulation for the initial treatment of moderate pulmonary embolism: a meta-analysis of randomized controlled trials. [2014]Randomized trials and meta-analyses have reached conflicting conclusions regarding the risk benefit ratio of thrombolytic therapy or anticoagulant therapy in patients with moderate pulmonary embolism. To investigate the effect of initial thrombolysis and anticoagulant therapy in patients with moderate pulmonary embolism, we performed an updated meta-analysis.
Association of type of oral anticoagulation with risk of bleeding in 45,114 patients with venous thromboembolism during initial and extended treatment-A nationwide register-based study. [2023]Safety data for different anticoagulant medications in venous thromboembolism (VTE) are scarce, in particular for extended treatment.
Treatment of venous thromboembolic disease. A pragmatic approach to anticoagulation and thrombolysis. [2019]Heparin (Lipo-Hepin, Liquaemin Sodium) and warfarin sodium (Coumadin, Panwarfin) are the classic anticoagulants in use for venous thromboembolic disease. They work by modifying the coagulation mechanism, heparin having an immediate effect and warfarin having a more delayed effect. The most common adverse effects of anticoagulation therapy are hemorrhagic complications. Thrombolytic therapy should be considered in all patients with massive pulmonary embolism with hypotension and in patients with deep venous thrombosis in the popliteal area or higher. Such therapy has been shown to help preserve the pulmonary microcirculation after pulmonary embolism and to decrease the incidence of the postthrombotic syndrome following deep venous thrombosis. If certain clinical guidelines are followed rigidly, the incidence of significant bleeding complications is low. Although the use of tissue plasminogen activator in venoocclusive disease has been limited to isolated cases, results have been very promising.
Prevalence of Hemorrhagic Complications in Hospitalized Patients with Pulmonary Embolism. [2022]The prevalence of anticoagulant therapy-associated hemorrhagic complications in hospitalized patients with pulmonary embolism (PE) has been scarcely investigated.
Comparison of interventions for intermediate to high-risk pulmonary embolism: A network meta-analysis. [2023]Multiple interventions, including catheter-directed therapy (CDT), systemic thrombolysis (ST), surgical embolectomy (SE), and therapeutic anticoagulation (AC) have been used to treat intermediate to high-risk pulmonary embolism (PE), but the most effective and safest treatment remains unclear. Our study aimed to investigate the efficacy and safety outcomes of each intervention.
Risk-adapted management of pulmonary embolism. [2022]The presence and severity of right ventricular (RV) dysfunction is a key determinant of prognosis in the acute phase of pulmonary embolism (PE). Risk-adapted treatment strategies continue to evolve, tailoring initial management to the clinical presentation and the functional status of the RV. Beyond pharmacological and, if necessary, mechanical circulatory support, systemic thrombolysis remains the mainstay of treatment for hemodynamically unstable patients; in contrast, it is not routinely recommended for intermediate-risk PE. Catheter-directed pharmacomechanical reperfusion treatment represents a promising option for minimizing bleeding risk; for reduced-dose intravenous thrombolysis, the data are still preliminary. Non-vitamin K-dependent oral anticoagulants, directly inhibiting factor Xa (rivaroxaban, apixaban, edoxaban) or thrombin (dabigatran), have simplified initial and long-term anticoagulation for PE while reducing major bleeding risk. Use of vena cava filters should be restricted to selected patients with absolute contraindications to anticoagulation, or PE recurrence despite adequately dosed anticoagulants.
Catheter-directed therapy for submassive pulmonary embolism after unsuccessful systemic thrombolysis. [2020]Catheter-directed therapy (CDT) has emerged as an important treatment for pulmonary embolism (PE). We present a patient with life-threatening submassive PE with transient hypotension, progressive right ventricular dysfunction, and respiratory failure who failed anticoagulation and had little improvement with systemic thrombolysis, but responded well to catheter-directed therapy.
Contemporary Management of Acute Pulmonary Embolism: Evolution of Catheter-based Therapy. [2022]Acute pulmonary embolism (PE) affects more than 100 000 people in the United States annually and is the third leading cardiovascular cause of death. The standard management for PE is systemic anticoagulation therapy. However, a subset of patients experience hemodynamic decompensation, despite conservative measures. Traditionally, these patients have been treated with systemic administration of thrombolytic agents or open cardiac surgery, although attempts at endovascular treatment have a long history that dates back to the 1960s. The technology for catheter-based therapy for acute PE is rapidly evolving, with multiple devices approved over the past decade. Currently available devices fall into two broad categories of treatment methods: catheter-directed thrombolysis and percutaneous suction thrombectomy. Catheter-directed thrombolysis is the infusion of thrombolytic agents directly into the occluded pulmonary arteries to increase local delivery and decrease the total dose. Suction thrombectomy involves the use of small- or large-bore catheters to mechanically aspirate a clot from the pulmonary arteries without the need for a thrombolytic agent. A thorough understanding of the various risk stratification schemes and the available evidence for each device is critical for optimal treatment of this complex entity. Multiple ongoing studies will improve our understanding of the role of catheter-based therapy for acute PE in the next 5-10 years. A multidisciplinary approach through PE response teams has become the management standard at most institutions. An invited commentary by Bulman and Weinstein is available online. Online supplemental material is available for this article. ©RSNA, 2022.
Initial results of investigator initiated international database on catheter directed therapy of acute pulmonary embolism. [2023]Catheter directed therapies (CDT) are widely used in the treatment of acute pulmonary embolism (PE). A multicenter registry was organized to evaluate their application in real life and to determine efficacy and safety of these procedures. Local experience of participating centers in percutaneous techniques for PE treatment was assessed.
Catheter-directed therapy for acute pulmonary embolism: results of a multicenter national registry. [2023]Catheter-directed therapy (CDT) for acute pulmonary embolism (PE) is an emerging therapy that combines heterogeneous techniques. The aim of the study was to provide a nationwide contemporary snapshot of clinical practice and CDT-related outcomes.