Ultrasound-facilitated, Catheter-directed, Thrombolysis in Intermediate-high Risk Pulmonary Embolism (HI-PEITHO)

A Randomized Trial of Ultrasound-facilitated, Catheter-directed, Thrombolysis Versus Anticoagulation for Acute Intermediate-high Risk Pulmonary Embolism: The Higher-risk Pulmonary Embolism Thrombolysis Study

There are many available treatments for pulmonary embolism (PE), but the best treatment for this condition is not known. The HI-PEITHO study will compare two treatment options that are both available on the market for the treatment of PE.

Patients will be randomized 1:1 to receive either blood thinners (anticoagulation) or blood thinners (anticoagulation) in combination with a device called the EkoSonicTM Endovascular device to dissolve blood clots. Patients will be followed for 12 months after randomization and have assessments while in the hospital as well as at 7 days, 30 days, 6 months and 12 months after randomization. The study will try to find out if one of these treatments is better than the other at reducing the risk of death and other serious problems.

Study Overview

• Status: Recruiting
• Conditions: Pulmonary Embolism
• Intervention / Treatment: Drug: Anticoagulation with heparin; Device: EkoSonicTM Endovascular System

Detailed Description

This study will assess whether ultrasound-facilitated, catheter-directed thrombolysis and standard anticoagulation are associated with a significant reduction in the composite outcome of pulmonary embolism (PE)-related mortality, cardiorespiratory decompensation or collapse, or nonfatal symptomatic and objectively confirmed recurrence of PE compared to anticoagulation alone within seven days of randomization

The HI-PEITHO study has been designed to address the important gaps in clinical evidence by comparing the clinical benefit of the ultrasound-facilitated local delivery of a low dose thrombolytic agent and anticoagulation with those of anticoagulation alone in patients with intermediate-high risk PE at a higher estimated risk of early decompensation based on clinical parameters at presentation.

This study has a focus on improving the safety of thrombolysis and advancing the concept of intermediate-high risk and the PE severity criteria, to better identify patients who may clinically benefit from thrombolysis.

The results of this study will contribute further evidence to the existing data on the treatment and outcomes of acute, intermediate-high risk PE and provide controlled data related to catheter-based interventions.

Data will be entered by the site into an electronic database. The database will include data checks to compare data entered into the database against predefined rules for ranges and consistency with other data fields in the database.

Site monitoring will take place with source data verification to assess the accuracy and completeness of registry data by comparing the data to medical records and study assessments.

• Study Type: Interventional
• Enrollment (Estimated): 544
• Phase: Phase 4

Contacts and Locations

• Study Contact: Name: Jackie Lin, M.S.; Phone Number: 612-360-8544; Email: Jackie.Lin@bsci.com
• Study Contact Backup: Name: Chrislee Leyco; Phone Number: 763-494-1141; Email: Chrislee.Leyco@bsci.com

Study Locations

• Austria
  • Innsbruck, Austria
    • Recruiting
    • A.o. LKH Univ.-Kliniken Innsbruck
  • St. Pölten, Austria
    • Recruiting
    • Universitätsklinikum St. Pölten
  • Vienna, Austria
    • Recruiting
    • Austria Klinik Ottakring Vienna
  • Wien, Austria
    • Recruiting
    • Allgemeines Krankenhaus AKH
• France
  • Besançon, France
    • Recruiting
    • CHU de Besançon
  • Marseille, France
    • Recruiting
    • Hôpital Nord de Marseille
  • Paris, France
    • Recruiting
    • Hôpital Européen Georges Pompidou (HEGP)
• Germany
  • Aachen, Germany
    • Recruiting
    • Uniklinik Aachen
  • Bielefeld, Germany
    • Recruiting
    • Klinikum Bielefeld
  • Bonn, Germany
    • Recruiting
    • GFO Kliniken Bonn
  • Chemnitz, Germany
    • Recruiting
    • Klinikum Chemnitz
  • Coburg, Germany
    • Recruiting
    • Klinikum Coburg GmbH
  • Freiburg, Germany
    • Recruiting
    • Universitaetsklinikum Freiburg
  • Immenstädt, Germany
    • Recruiting
    • Klinik Immenstadt
  • Mainz, Germany
    • Recruiting
    • Johannes Gutenberg Universitaet Mainz
  • Munich, Germany
    • Recruiting
    • Klinikum rechts der Isar
  • Tuebingen, Germany
    • Recruiting
    • Universitaetsklinikum Tuebingen
  • Würzburg, Germany
    • Recruiting
    • Universitaetsklinikum Wuerzburg
• Ireland
  • Dublin, Ireland
    • Recruiting
    • Mater Misericordiae University Hospital
  • Galway, Ireland
    • Recruiting
    • University Hospital Galway
• Netherlands
  • Leiden, Netherlands
    • Recruiting
    • Leiden University Medical Center
  • Nieuwegein, Netherlands
    • Recruiting
    • St. Antonius Ziekenhuis
  • Utrecht, Netherlands
    • Recruiting
    • Universitair Medisch Centrum
• Poland
  • Kraków, Poland
    • Recruiting
    • John Paul II Hospital
  • Warsaw, Poland
    • Recruiting
    • Medical University of Warsaw
• Switzerland
  • Basel, Switzerland
    • Recruiting
    • University Hospital Basel
  • Lausanne, Switzerland
    • Recruiting
    • Centre Hospitalier Universitaire Vaudois
  • Zürich, Switzerland
    • Recruiting
    • University Hospital Zurich
• United Kingdom
  • Cardiff, United Kingdom
    • Recruiting
    • University Hospital of Wales
  • London, United Kingdom
    • Recruiting
    • Guys and St. Thomas NHS Foundation Trust
  • London, United Kingdom
    • Recruiting
    • The Royal Free Hospital
  • Middlesex, United Kingdom
    • Recruiting
    • Northwick Park Hospital
• United States
  • Alabama
    • Birmingham, Alabama, United States, 35294
      • Recruiting
      • University of Alabama at Birmingham
  • California
    • Los Angeles, California, United States, 90048
      • Recruiting
      • Cedars - Sinai Medical Center
  • Delaware
    • Newark, Delaware, United States, 19718
      • Recruiting
      • Christiana Hospital
  • District of Columbia
    • Washington, District of Columbia, United States, 20010
      • Withdrawn
      • Washington Hospital Center
  • Georgia
    • Atlanta, Georgia, United States, 30309
      • Recruiting
      • Piedmont Hospital
    • Atlanta, Georgia, United States, 30322
      • Recruiting
      • Emory University Hospital
    • Augusta, Georgia, United States, 30904
      • Recruiting
      • Augusta University
  • Indiana
    • Indianapolis, Indiana, United States, 46260
      • Withdrawn
      • St. Vincent Heart Center of Indiana
  • Kentucky
    • Louisville, Kentucky, United States, 40207
      • Recruiting
      • Baptist Health East Louisville
  • Maryland
    • Baltimore, Maryland, United States, 21201
      • Recruiting
      • University of Maryland School of Medicine
  • Massachusetts
    • Boston, Massachusetts, United States, 02114
      • Recruiting
      • Massachusetts General Hospital
  • Michigan
    • Ann Arbor, Michigan, United States, 48109
      • Recruiting
      • University Of Michigan Hospitals
    • Detroit, Michigan, United States, 48202
      • Recruiting
      • Henry Ford Hospital
    • Detroit, Michigan, United States, 48236
      • Withdrawn
      • St. John Hospital & Medical Center
  • Mississippi
    • Tupelo, Mississippi, United States, 38801
      • Recruiting
      • North Mississippi Medical Center
  • Nebraska
    • Omaha, Nebraska, United States, 68114
      • Recruiting
      • Nebraska Methodist Hospital
  • New Hampshire
    • Lebanon, New Hampshire, United States, 03756
      • Recruiting
      • Dartmouth-Hitchcock Medical Center
  • New Jersey
    • Newark, New Jersey, United States, 07112
      • Recruiting
      • Newark Beth Israel Medical Center
  • New York
    • New York, New York, United States, 10075
      • Recruiting
      • Lenox Hill Hospital
    • New York, New York, United States, 10032
      • Recruiting
      • Columbia University Medical Center
    • New York, New York, United States, 10029
      • Recruiting
      • Mount Sinai Medical Center
    • Roslyn, New York, United States, 11576
      • Withdrawn
      • St. Francis Hospital
  • Ohio
    • Cleveland, Ohio, United States, 44106
      • Recruiting
      • University Hospitals of Cleveland
    • Kettering, Ohio, United States, 45429
      • Recruiting
      • Kettering Health
  • Oklahoma
    • Oklahoma City, Oklahoma, United States, 73104
      • Withdrawn
      • University of Oklahoma Health Science Center
  • Tennessee
    • Kingsport, Tennessee, United States, 37660
      • Recruiting
      • Wellmont Holston Valley Medical Center
    • Nashville, Tennessee, United States, 37232
      • Terminated
      • Vanderbilt University Medical Center
  • Texas
    • Austin, Texas, United States, 78705
      • Recruiting
      • Seton Medical Center
    • Houston, Texas, United States, 77479
      • Recruiting
      • Houston Methodist Sugarland Hospital
    • Plano, Texas, United States, 75093
      • Terminated
      • The Heart Hospital Baylor Plano
  • Virginia
    • Charlottesville, Virginia, United States, 22908
      • Recruiting
      • University of Virginia Medical Center
  • Wisconsin
    • Madison, Wisconsin, United States, 53792
      • Recruiting
      • University of Wisconsin Hospitals

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Age 18-80 years, inclusive
• Objectively confirmed acute PE, based on computed tomography pulmonary angiography (CTPA) showing a filling defect in at least one main or proximal lobar pulmonary artery

• Elevated risk of early death/hemodynamic collapse, indicated by at least two of the following new-onset clinical criteria:

  1. ECG-documented tachycardia with heart rate ≥100 beats per minute, not due to hypovolemia, arrhythmia, or sepsis;
  2. SBP ≤ 110 mm Hg for at least 15 minutes;
  3. respiratory rate > 20 x min-1 or oxygen saturation on pulse oximetry (SpO2) < 90% (or partial arterial oxygen pressure < 60 mmHg) at rest while breathing room air;
• Right-to-left ventricular (RV/LV) diameter ratio ≥ 1.0 on CTPA
• Serum troponin I or T levels above the upper limit of normal
• Signed informed consent

Exclusion Criteria:

• Hemodynamic instability*, i.e. at least one of the following present:

  1. cardiac arrest or need for cardiopulmonary resuscitation;
  2. need for ECMO, or ECMO initiated before randomization
  3. PE-related shock, defined as: (i) SBP < 90 mmHg, or vasopressors required to achieve SBP ≥ 90 mmHg, despite an adequate volume status; and (ii) end-organ hypoperfusion (altered mental status; oliguria/anuria; increased serum lactate);
  4. isolated persistent hypotension (SBP < 90 mmHg, or a systolic pressure drop by at least 40 mmHg for at least 15 minutes), not caused by new-onset arrhythmia, hypovolemia, or sepsis * Patients who presented with temporary need for fluid resuscitation and/or low-dose catecholamines may be included, provided that they could be stabilized within 2 hours of admission and maintain SBP of ≥ 90 mmHg and adequate organ perfusion without catecholamine infusion.
• Need for admission to an intensive care unit for a reason other than the index PE episode. NB: Patients who test positive for SARS-CoV-2 can be enrolled where the investigator believes that the pulmonary embolism is the dominant pathology in the patient's clinical presentation and qualifying cardiorespiratory parameters.
• Temperature above 39 degrees C / 102.2 degrees F
• Logistical reasons limiting the rapid availability of interventional procedures to treat acute PE (e.g., during the outbreak of an epidemic)
• Index PE symptom duration > 14 days
• Active bleeding
• History of intracranial or intraocular bleeding at any time
• Stroke or transient ischemic attack within the past 6 months, or previous stroke at any time if associated with permanent disability
• Central nervous system neoplasm, or metastatic cancer
• Major neurologic, ophthalmologic, abdominal, cardiac, thoracic, vascular or orthopedic surgery or trauma (including syncope-associated with head strike or skeletal fracture) within the past 3 weeks
• Platelet count < 100 x 109 x L-1
• Patients who have received a once-daily therapeutic dose of LMWH or a therapeutic dose of fondaparinux within 24 hours prior to randomization
• Patients who have received one of the direct oral anticoagulants apixaban or rivaroxaban within 12 hours prior to randomization
• Patients who have received one of the direct oral anticoagulants dabigatran or edoxaban for the index PE episode, as these drugs are not approved for patients who have not received heparin for at least 5 days
• Administration of a thrombolytic agent or a glycoprotein IIb/IIIa receptor antagonist during the current hospital stay and/or within 30 days, for any reason
• Chronic treatment with antiplatelet agents other than low-dose acetylsalicylic acid or clopidogrel 75 mg once daily (but not both). Dual antiplatelet therapy is excluded.
• Chronic treatment with a direct oral anticoagulant (apixaban, dabigatran, edoxaban or rivaroxaban)
• Chronic treatment with a vitamin K antagonist, or known coagulopathy including severe hepatic dysfunction, with an International Normalized Ratio (INR) > 1.5
• Pregnancy or lactation
• Previous inclusion in the study
• Known hypersensitivity to alteplase, LMWH or UFH, or to any of the excipients
• Life expectancy less than 6 months

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Anticoagulation; Low-molecular weight heparin (LMWH) or unfractionated heparin (UFH)	Drug: Anticoagulation with heparin; Low-molecular weight heparin (LMWH) or unfractionated heparin (UFH); Other Names: heparin, LMWH, UFH, anticoag, antiplatelet
Active Comparator: Anticoagulation and EkoSonicTM Endovascular System; Low-molecular weight heparin (LMWH) or unfractionated heparin (UFH) and EkoSonicTM Endovascular System [ultrasound-facilitated catheter-directed delivery of thrombolytic: 2 mg bolus/catheter + 1 mg/hour/catheter for 7 hours (total of 9 or 18 mg]	Drug: Anticoagulation with heparin; Low-molecular weight heparin (LMWH) or unfractionated heparin (UFH); Other Names: heparin, LMWH, UFH, anticoag, antiplatelet; Device: EkoSonicTM Endovascular System; EkoSonicTM Endovascular System [ultrasound-facilitated catheter-directed delivery of thrombolytic: 2 mg bolus/catheter + 1 mg/hour/catheter for 7 hours (total of 9 or 18 mg]; Other Names: EKOS, USCDT, CDT, thrombolysis, fibrinolysis

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
PE-related mortality	death resulting from PE	Within seven days of randomization
PE recurrence	nonfatal symptomatic and objectively confirmed recurrence of PE	Within seven days of randomization
Cardiorespiratory decompensation or collapse	Cardiorespiratory collapse or decompensation is defined as at least one of the following criteria: cardiac arrest or need for CPR at any time between randomization and day 7;; signs of shock: new-onset persistent arterial hypotension (systolic blood pressure (SBP) below 90 mmHg or SBP drop by at least 40 mm Hg, over at least 15 minutes and despite an adequate volume status; or need for vasopressors to maintain SBP of at least 90 mmHg), accompanied by end-organ hypoperfusion (altered mental status; oliguria/anuria; or increased serum lactate) at any time between randomization and day 7;; placement on extracorporeal membrane oxygenation (ECMO) at any time between randomization and day 7;; intubation, or initiation of noninvasive mechanical ventilation at any time between randomization and day 7;; National Early Warning Score (NEWS) of 9 or higher, between 24 hours and 7 days after randomization, confirmed on consecutive measurements taken twice, 15 minutes apart.	Within seven days of randomization

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in the RV-to-LV diameter ratio as measured by echocardiography		Between baseline and 48±6 hours
PE-related death	Death cause by pulmonary embolism (PE)	Within 7 days
Cardiorespiratory decompensation		Within 7 days
Placement on ECMO or mechanical ventilation		Within 7 days
GUSTO major (moderate and severe) bleeding	Major bleeding will be adjudicated according to the GUSTO criteria: GUSTO severe or life-threatening bleeding: A bleeding episode that leads to hemodynamic compromise requiring emergency intervention (such as replacement of fluid and/or blood products, inotropic support, or surgical treatment), or is life-threatening or fatal.; GUSTO moderate bleeding (a bleeding episode requiring blood transfusion(s), but which is not deemed life-threatening and does not lead to hemodynamic compromise requiring emergency fluid replacement, inotropic support, or interventional treatment) .	Within 7 days
International Society on Thrombosis and Hemostasis (ISTH) major bleeding	Major bleeding will also be adjudicated according to the ISTH criteria: Fatal bleeding and/or; Symptomatic bleeding in a critical area or organ (intracranial, intraspinal, intraocular, retroperitoneal, intra-articular or pericardial, or intramuscular with compartment syndrome) and/or; Bleeding causing a fall in hemoglobin level of 20 g/L (2 g/dL) or more, or leading to transfusion of two or more units of whole blood or red blood cells.	Within 7 days, 30 days, and 6 months
Ischemic or hemorrhagic stroke		Within 7 days and 30 days
All-cause mortality	Death due to any cause	Within 7 days, 30 days, 6 months, and 12 months
Serious adverse events		Within 30 days
All-cause mortality, cardiorespiratory collapse or recurrence of PE	Death due to any cause, Cardiorespiratory collapse or decompensation should fulfill at least one of the following criteria: cardiac arrest or need for CPR at any time between randomization and day 7;; signs of shock: new-onset persistent arterial hypotension (SBP below 90 mmHg or SBP drop by at least 40 mmHg over at least 15 minutes, and despite an adequate filling status; or need for vasopressors to maintain SBP of at least 90 mmHg), accompanied by end-organ hypoperfusion (altered mental status; oliguria/anuria; or increased serum lactate) at any time between randomization and day 7;; placement on ECMO at any time between randomization and day 7;; intubation, or initiation of non-invasive mechanical ventilation at any time between randomization and day 7;; National Early Warning Score (NEWS) of 9 or higher, between 24 hours and 7 days after randomization, confirmed on consecutive measurements, taken twice.	Within 30 days
Symptomatic PE recurrence		Within 30 days and 6 months
Change from baseline in RV dysfunction on echocardiography	Right ventricle to left ventricle end diastolic diameter ratio (RV/LV)	6 months
Duration of hospitalization for the index PE event	Time from admission to discharge from hospital	Within 30 days
Duration of stay at the intensive, intermediate or coronary care unit during hospitalization for the index PE event	Time from admission to discharge from ICU, intermediate, or ICC	Within 30 days
Functional status as measured by World Health Organization (WHO) functional class	The World Health Organization (WHO) Functional Class assessment is a system for assessing the severity of dyspnea in patients with pulmonary hypertension. Subjects will be classified as Class 1-4 at time points throughout their participation in the study.	Up to 7 days, 30 days, 6 and 12 months
Functional status as measured by 6-Minute Walk Test (6MWT)	The 6MWT measures the distance a patient can walk on a flat surface in a period of 6 minutes. A 100 meter distance is measured in a hallway and the patient is asked to walk quickly as many laps as they can over the course of the timed test. The total distance is measured. The patient's baseline vitals and symptoms are compared to their condition at the completion of the test.	30 days, 6 and 12 months
Functional status as measured by Post-Venous Thromboembolism Functional Status (PVFS) scale	The Post-Venous Thromboembolism (VTE) Functional Status (PVFS) scale focuses on relevant aspects of daily life during follow-up after a venous thromboembolic event. The scale is neither intended to solely focus on VTE-associated functional limitations nor to diagnose post-VTE syndrome. In contrast, the scale has been developed to help users become aware of current functional limitations in patients who have suffered a VTE, whether or not as a result of the specific VTE, and to objectively determine the degree of disability,	30 days, 6 and 12 months
Quality of life using PEmb-QOL	PEmb-QOL is a questionnaire that assesses post-pulmonary embolism quality of life in the context of pulmonary-specific symptoms. The PEmb-QOL questionnaire contains six dimensions based on the contents of the items: frequency of complaints, limitations in activities of daily living, work-related problems, social limitations, intensity of complaints and emotional complaints. Higher scores indicate worse outcome.	6 and 12 months
Quality of life using SF-36	The SF-36 questionnaire is a generic quality of life measure containing eight health domains (physical functioning, physical role, pain, general health, vitality, social function, emotional role functioning, and mental health). The scoring is on a 0-100 scale, with a higher score indicating better health. Scores are combined into two overall summary scores: physical health summary score and mental health summary score.	6 and 12 months
Quality of life using EQ-5D scale	The EQ-5D is a patient reported outcome that provides a simple descriptive profile and single index value for health status. The questionnaire consists of 5 questions pertaining to specific health dimensions, including mobility, self-care, usual activities, pain/discomfort, anxiety/depression, and overall health status rating scale.	6 and 12 months
Diagnosis of chronic thromboembolic pulmonary hypertension (CTEPH)	CTEPH will be diagnosed by the investigational site according to presence of all of the following criteria: At least one mismatched segmental perfusion defect demonstrated by ventilation/perfusion scanning after 3 months of adequate therapeutic anticoagulation; Resting mean pulmonary arterial pressure (mPAP) ≥25 mmHg measured by invasive right heart catheterization; Pulmonary capillary wedge pressure ≤15 mmHg.	Within 12 months

Collaborators and Investigators

• Sponsor: Boston Scientific Corporation
• Collaborators: University Medical Center Mainz; National PERT Consortium, Inc.
• Investigators: Principal Investigator: Stavros Konstantinides, MD, University Medical Center Mainz, Mainz, Germany; Principal Investigator: Kenneth Rosenfield, MD, Massachusetts General Hospital, Boston, Massachusetts, USA

Publications and helpful links

General Publications

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• Meyer G, Vicaut E, Danays T, Agnelli G, Becattini C, Beyer-Westendorf J, Bluhmki E, Bouvaist H, Brenner B, Couturaud F, Dellas C, Empen K, Franca A, Galie N, Geibel A, Goldhaber SZ, Jimenez D, Kozak M, Kupatt C, Kucher N, Lang IM, Lankeit M, Meneveau N, Pacouret G, Palazzini M, Petris A, Pruszczyk P, Rugolotto M, Salvi A, Schellong S, Sebbane M, Sobkowicz B, Stefanovic BS, Thiele H, Torbicki A, Verschuren F, Konstantinides SV; PEITHO Investigators. Fibrinolysis for patients with intermediate-risk pulmonary embolism. N Engl J Med. 2014 Apr 10;370(15):1402-11. doi: 10.1056/NEJMoa1302097.
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• Schulman S, Kearon C; Subcommittee on Control of Anticoagulation of the Scientific and Standardization Committee of the International Society on Thrombosis and Haemostasis. Definition of major bleeding in clinical investigations of antihemostatic medicinal products in non-surgical patients. J Thromb Haemost. 2005 Apr;3(4):692-4. doi: 10.1111/j.1538-7836.2005.01204.x.
• Piazza G, Hohlfelder B, Jaff MR, Ouriel K, Engelhardt TC, Sterling KM, Jones NJ, Gurley JC, Bhatheja R, Kennedy RJ, Goswami N, Natarajan K, Rundback J, Sadiq IR, Liu SK, Bhalla N, Raja ML, Weinstock BS, Cynamon J, Elmasri FF, Garcia MJ, Kumar M, Ayerdi J, Soukas P, Kuo W, Liu PY, Goldhaber SZ; SEATTLE II Investigators. A Prospective, Single-Arm, Multicenter Trial of Ultrasound-Facilitated, Catheter-Directed, Low-Dose Fibrinolysis for Acute Massive and Submassive Pulmonary Embolism: The SEATTLE II Study. JACC Cardiovasc Interv. 2015 Aug 24;8(10):1382-1392. doi: 10.1016/j.jcin.2015.04.020.
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• Steering Committee. Single-bolus tenecteplase plus heparin compared with heparin alone for normotensive patients with acute pulmonary embolism who have evidence of right ventricular dysfunction and myocardial injury: rationale and design of the Pulmonary Embolism Thrombolysis (PEITHO) trial. Am Heart J. 2012 Jan;163(1):33-38.e1. doi: 10.1016/j.ahj.2011.10.003.
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Study record dates

Study Major Dates

• Study Start (Actual): August 2, 2021
• Primary Completion (Estimated): August 1, 2025
• Study Completion (Estimated): August 1, 2026

Study Registration Dates

• First Submitted: March 2, 2021
• First Submitted That Met QC Criteria: March 5, 2021
• First Posted (Actual): March 10, 2021

Study Record Updates

• Last Update Posted (Estimated): April 15, 2024
• Last Update Submitted That Met QC Criteria: April 12, 2024
• Last Verified: April 1, 2024

More Information

Terms related to this study

• Keywords: Thrombolysis; Acute intermediate-high risk pulmonary embolism; Ultrasound-facilitated, catheter-directed thrombolysis
• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Respiratory Tract Diseases; Lung Diseases; Embolism and Thrombosis; Embolism; Pulmonary Embolism; Molecular Mechanisms of Pharmacological Action; Fibrinolytic Agents; Fibrin Modulating Agents; Anticoagulants; Heparin; Calcium heparin
• Other Study ID Numbers: S2479

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: Yes