March 2, 2021
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March 10, 2021
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April 15, 2024
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August 2, 2021
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August 2025 (Final data collection date for primary outcome measure)
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Same as current
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Not Provided
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Not Provided
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- Change in the RV-to-LV diameter ratio as measured by echocardiography [ Time Frame: Between baseline and 48±6 hours ]
- PE-related death [ Time Frame: Within 7 days ]
Death cause by pulmonary embolism (PE)
- Cardiorespiratory decompensation [ Time Frame: Within 7 days ]
- Placement on ECMO or mechanical ventilation [ Time Frame: Within 7 days ]
- GUSTO major (moderate and severe) bleeding [ Time Frame: Within 7 days ]
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) .
- International Society on Thrombosis and Hemostasis (ISTH) major bleeding [ Time Frame: Within 7 days, 30 days, and 6 months ]
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.
- Ischemic or hemorrhagic stroke [ Time Frame: Within 7 days and 30 days ]
- All-cause mortality [ Time Frame: Within 7 days, 30 days, 6 months, and 12 months ]
Death due to any cause
- Serious adverse events [ Time Frame: Within 30 days ]
- All-cause mortality, cardiorespiratory collapse or recurrence of PE [ Time Frame: Within 30 days ]
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.
- Symptomatic PE recurrence [ Time Frame: Within 30 days and 6 months ]
- Change from baseline in RV dysfunction on echocardiography [ Time Frame: 6 months ]
Right ventricle to left ventricle end diastolic diameter ratio (RV/LV)
- Duration of hospitalization for the index PE event [ Time Frame: Within 30 days ]
Time from admission to discharge from hospital
- Duration of stay at the intensive, intermediate or coronary care unit during hospitalization for the index PE event [ Time Frame: Within 30 days ]
Time from admission to discharge from ICU, intermediate, or ICC
- Functional status as measured by World Health Organization (WHO) functional class [ Time Frame: Up to 7 days, 30 days, 6 and 12 months ]
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.
- Functional status as measured by 6-Minute Walk Test (6MWT) [ Time Frame: 30 days, 6 and 12 months ]
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.
- Functional status as measured by Post-Venous Thromboembolism Functional Status (PVFS) scale [ Time Frame: 30 days, 6 and 12 months ]
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,
- Quality of life using PEmb-QOL [ Time Frame: 6 and 12 months ]
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.
- Quality of life using SF-36 [ Time Frame: 6 and 12 months ]
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.
- Quality of life using EQ-5D scale [ Time Frame: 6 and 12 months ]
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.
- Diagnosis of chronic thromboembolic pulmonary hypertension (CTEPH) [ Time Frame: Within 12 months ]
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.
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- Change in the RV-to-LV diameter ratio as measured by echocardiography [ Time Frame: Between baseline and 48±6 hours ]
- PE-related death [ Time Frame: Within 7 days ]
- Cardiorespiratory decompensation [ Time Frame: Within 7 days ]
- Placement on ECMO or mechanical ventilation [ Time Frame: Within 7 days ]
- GUSTO major (moderate and severe) bleeding [ Time Frame: Within 7 days ]
- International Society on Thrombosis and Hemostasis (ISTH) major bleeding [ Time Frame: Within 7 days, 30 days, and 6 months ]
- Ischemic or hemorrhagic stroke [ Time Frame: Within 7 days and 30 days ]
- All-cause mortality [ Time Frame: Within 7 days, 30 days, 6 months, and 12 months ]
- Serious adverse events [ Time Frame: Within 30 days ]
- All-cause mortality, cardiorespiratory collapse or recurrence of PE [ Time Frame: Within 30 days ]
- Symptomatic PE recurrence [ Time Frame: Within 30 days and 6 months ]
- Change from baseline in RV dysfunction on echocardiography [ Time Frame: 6 months ]
Right ventricle to left ventricle end diastolic diameter ratio (RV/LV)
- Duration of hospitalization for the index PE event [ Time Frame: Within 30 days ]
Time from admission to discharge from hospital
- Duration of stay at the intensive, intermediate or coronary care unit during hospitalization for the index PE event [ Time Frame: Within 30 days ]
Time from admission to discharge from ICU, intermediate, or ICC
- Functional status: World Health Organization (WHO) functional class [ Time Frame: Up to 7 days, 30 days, 6 and 12 months ]
- 6-Minute Walk Test (6MWT) [ Time Frame: 30 days, 6 and 12 months ]
- Post-Venous Thromboembolism Functional Status (PVFS) scale [ Time Frame: 30 days, 6 and 12 months ]
- Quality of life using PEmb-QOL [ Time Frame: 6 and 12 months ]
- Quality of life using SF-36 [ Time Frame: 6 and 12 months ]
- Quality of life using EQ-5D scale [ Time Frame: 6 and 12 months ]
- Diagnosis of chronic thromboembolic pulmonary hypertension (CTEPH) [ Time Frame: Within 12 months ]
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Ultrasound-facilitated, Catheter-directed, Thrombolysis in Intermediate-high Risk Pulmonary Embolism
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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
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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.
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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.
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Interventional
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Phase 4
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Allocation: Randomized Intervention Model: Parallel Assignment Intervention Model Description: 1:1 randomization Masking: Single (Outcomes Assessor) Masking Description: Blinded adjudication of primary composite outcome Primary Purpose: Treatment
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Pulmonary Embolism
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- Drug: Anticoagulation with heparin
Low-molecular weight heparin (LMWH) or unfractionated heparin (UFH)
Other Name: 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 Name: EKOS, USCDT, CDT, thrombolysis, fibrinolysis
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- Active Comparator: Anticoagulation
Low-molecular weight heparin (LMWH) or unfractionated heparin (UFH)
Intervention: Drug: Anticoagulation with heparin
- 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]
Interventions:
- Drug: Anticoagulation with heparin
- Device: EkoSonicTM Endovascular System
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- Barco S, Vicaut E, Klok FA, Lankeit M, Meyer G, Konstantinides SV; PEITHO Investigators. Improved identification of thrombolysis candidates amongst intermediate-risk pulmonary embolism patients: implications for future trials. Eur Respir J. 2018 Jan 18;51(1):1701775. doi: 10.1183/13993003.01775-2017. Print 2018 Jan. No abstract available.
- Marti C, John G, Konstantinides S, Combescure C, Sanchez O, Lankeit M, Meyer G, Perrier A. Systemic thrombolytic therapy for acute pulmonary embolism: a systematic review and meta-analysis. Eur Heart J. 2015 Mar 7;36(10):605-14. doi: 10.1093/eurheartj/ehu218. Epub 2014 Jun 10.
- Kearon C, Akl EA, Ornelas J, Blaivas A, Jimenez D, Bounameaux H, Huisman M, King CS, Morris TA, Sood N, Stevens SM, Vintch JRE, Wells P, Woller SC, Moores L. Antithrombotic Therapy for VTE Disease: CHEST Guideline and Expert Panel Report. Chest. 2016 Feb;149(2):315-352. doi: 10.1016/j.chest.2015.11.026. Epub 2016 Jan 7. Erratum In: Chest. 2016 Oct;150(4):988.
- Jaff MR, McMurtry MS, Archer SL, Cushman M, Goldenberg N, Goldhaber SZ, Jenkins JS, Kline JA, Michaels AD, Thistlethwaite P, Vedantham S, White RJ, Zierler BK; American Heart Association Council on Cardiopulmonary, Critical Care, Perioperative and Resuscitation; American Heart Association Council on Peripheral Vascular Disease; American Heart Association Council on Arteriosclerosis, Thrombosis and Vascular Biology. Management of massive and submassive pulmonary embolism, iliofemoral deep vein thrombosis, and chronic thromboembolic pulmonary hypertension: a scientific statement from the American Heart Association. Circulation. 2011 Apr 26;123(16):1788-830. doi: 10.1161/CIR.0b013e318214914f. Epub 2011 Mar 21. Erratum In: Circulation. 2012 Aug 14;126(7):e104. Circulation. 2012 Mar 20;125(11):e495.
- Becattini C, Agnelli G, Lankeit M, Masotti L, Pruszczyk P, Casazza F, Vanni S, Nitti C, Kamphuisen P, Vedovati MC, De Natale MG, Konstantinides S. Acute pulmonary embolism: mortality prediction by the 2014 European Society of Cardiology risk stratification model. Eur Respir J. 2016 Sep;48(3):780-6. doi: 10.1183/13993003.00024-2016. Epub 2016 May 12.
- 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.
- Bajaj NS, Kalra R, Arora P, Ather S, Guichard JL, Lancaster WJ, Patel N, Raman F, Arora G, Al Solaiman F, Clark DT 3rd, Dell'Italia LJ, Leesar MA, Davies JE, McGiffin DC, Ahmed MI. Catheter-directed treatment for acute pulmonary embolism: Systematic review and single-arm meta-analyses. Int J Cardiol. 2016 Dec 15;225:128-139. doi: 10.1016/j.ijcard.2016.09.036. Epub 2016 Sep 20.
- Kucher N, Boekstegers P, Muller OJ, Kupatt C, Beyer-Westendorf J, Heitzer T, Tebbe U, Horstkotte J, Muller R, Blessing E, Greif M, Lange P, Hoffmann RT, Werth S, Barmeyer A, Hartel D, Grunwald H, Empen K, Baumgartner I. Randomized, controlled trial of ultrasound-assisted catheter-directed thrombolysis for acute intermediate-risk pulmonary embolism. Circulation. 2014 Jan 28;129(4):479-86. doi: 10.1161/CIRCULATIONAHA.113.005544. Epub 2013 Nov 13.
- 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.
- Kuo WT, Banerjee A, Kim PS, DeMarco FJ Jr, Levy JR, Facchini FR, Unver K, Bertini MJ, Sista AK, Hall MJ, Rosenberg JK, De Gregorio MA. Pulmonary Embolism Response to Fragmentation, Embolectomy, and Catheter Thrombolysis (PERFECT): Initial Results From a Prospective Multicenter Registry. Chest. 2015 Sep;148(3):667-673. doi: 10.1378/chest.15-0119.
- Tapson VF, Sterling K, Jones N, Elder M, Tripathy U, Brower J, Maholic RL, Ross CB, Natarajan K, Fong P, Greenspon L, Tamaddon H, Piracha AR, Engelhardt T, Katopodis J, Marques V, Sharp ASP, Piazza G, Goldhaber SZ. A Randomized Trial of the Optimum Duration of Acoustic Pulse Thrombolysis Procedure in Acute Intermediate-Risk Pulmonary Embolism: The OPTALYSE PE Trial. JACC Cardiovasc Interv. 2018 Jul 23;11(14):1401-1410. doi: 10.1016/j.jcin.2018.04.008.
- 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.
- Mehran R, Rao SV, Bhatt DL, Gibson CM, Caixeta A, Eikelboom J, Kaul S, Wiviott SD, Menon V, Nikolsky E, Serebruany V, Valgimigli M, Vranckx P, Taggart D, Sabik JF, Cutlip DE, Krucoff MW, Ohman EM, Steg PG, White H. Standardized bleeding definitions for cardiovascular clinical trials: a consensus report from the Bleeding Academic Research Consortium. Circulation. 2011 Jun 14;123(23):2736-47. doi: 10.1161/CIRCULATIONAHA.110.009449. No abstract available.
- GUSTO investigators. An international randomized trial comparing four thrombolytic strategies for acute myocardial infarction. N Engl J Med. 1993 Sep 2;329(10):673-82. doi: 10.1056/NEJM199309023291001.
- 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.
- Rudski LG, Lai WW, Afilalo J, Hua L, Handschumacher MD, Chandrasekaran K, Solomon SD, Louie EK, Schiller NB. Guidelines for the echocardiographic assessment of the right heart in adults: a report from the American Society of Echocardiography endorsed by the European Association of Echocardiography, a registered branch of the European Society of Cardiology, and the Canadian Society of Echocardiography. J Am Soc Echocardiogr. 2010 Jul;23(7):685-713; quiz 786-8. doi: 10.1016/j.echo.2010.05.010. No abstract available.
- Liu VX, Lu Y, Carey KA, Gilbert ER, Afshar M, Akel M, Shah NS, Dolan J, Winslow C, Kipnis P, Edelson DP, Escobar GJ, Churpek MM. Comparison of Early Warning Scoring Systems for Hospitalized Patients With and Without Infection at Risk for In-Hospital Mortality and Transfer to the Intensive Care Unit. JAMA Netw Open. 2020 May 1;3(5):e205191. doi: 10.1001/jamanetworkopen.2020.5191.
- Smith GB, Prytherch DR, Meredith P, Schmidt PE, Featherstone PI. The ability of the National Early Warning Score (NEWS) to discriminate patients at risk of early cardiac arrest, unanticipated intensive care unit admission, and death. Resuscitation. 2013 Apr;84(4):465-70. doi: 10.1016/j.resuscitation.2012.12.016. Epub 2013 Jan 4.
- Quiroz R, Kucher N, Schoepf UJ, Kipfmueller F, Solomon SD, Costello P, Goldhaber SZ. Right ventricular enlargement on chest computed tomography: prognostic role in acute pulmonary embolism. Circulation. 2004 May 25;109(20):2401-4. doi: 10.1161/01.CIR.0000129302.90476.BC. Epub 2004 May 17.
- Stein PD, Matta F, Yaekoub AY, Goodman LR, Sostman HD, Weg JG, Hales CA, Hull RD, Leeper KV Jr, Beemath A, Saeed IM, Woodard PK. Reconstructed 4-chamber views compared with axial imaging for assessment of right ventricular enlargement on CT pulmonary angiograms. J Thromb Thrombolysis. 2009 Oct;28(3):342-7. doi: 10.1007/s11239-009-0331-5. Epub 2009 Mar 27.
- ATS Committee on Proficiency Standards for Clinical Pulmonary Function Laboratories. ATS statement: guidelines for the six-minute walk test. Am J Respir Crit Care Med. 2002 Jul 1;166(1):111-7. doi: 10.1164/ajrccm.166.1.at1102. No abstract available. Erratum In: Am J Respir Crit Care Med. 2016 May 15;193(10):1185.
- Klok FA, Cohn DM, Middeldorp S, Scharloo M, Buller HR, van Kralingen KW, Kaptein AA, Huisman MV. Quality of life after pulmonary embolism: validation of the PEmb-QoL Questionnaire. J Thromb Haemost. 2010 Mar;8(3):523-32. doi: 10.1111/j.1538-7836.2009.03726.x. Epub 2009 Dec 15.
- Ware JE Jr, Sherbourne CD. The MOS 36-item short-form health survey (SF-36). I. Conceptual framework and item selection. Med Care. 1992 Jun;30(6):473-83.
- Burnett AE, Mahan CE, Vazquez SR, Oertel LB, Garcia DA, Ansell J. Guidance for the practical management of the direct oral anticoagulants (DOACs) in VTE treatment. J Thromb Thrombolysis. 2016 Jan;41(1):206-32. doi: 10.1007/s11239-015-1310-7.
- Cech DJ, Martin ST. Evaluation of function, activity, and participation. Functional Movement Development Across the Life Span (Third Edition), 2012.
- Saris-Baglama RN, Dewey CJ, Chisholm GB, et al. QualityMetric health outcomes™ scoring software 4.0. Lincoln, RI: QualityMetric Incorporated, 2010, p. 138.
- Konstantinides SV, Meyer G, Becattini C, Bueno H, Geersing GJ, Harjola VP, Huisman MV, Humbert M, Jennings CS, Jimenez D, Kucher N, Lang IM, Lankeit M, Lorusso R, Mazzolai L, Meneveau N, Ni Ainle F, Prandoni P, Pruszczyk P, Righini M, Torbicki A, Van Belle E, Zamorano JL; ESC Scientific Document Group. 2019 ESC Guidelines for the diagnosis and management of acute pulmonary embolism developed in collaboration with the European Respiratory Society (ERS). Eur Heart J. 2020 Jan 21;41(4):543-603. doi: 10.1093/eurheartj/ehz405. No abstract available.
- Klok FA, Piazza G, Sharp ASP, Ni Ainle F, Jaff MR, Chauhan N, Patel B, Barco S, Goldhaber SZ, Kucher N, Lang IM, Schmidtmann I, Sterling KM, Becker D, Martin N, Rosenfield K, Konstantinides SV. Ultrasound-facilitated, catheter-directed thrombolysis vs anticoagulation alone for acute intermediate-high-risk pulmonary embolism: Rationale and design of the HI-PEITHO study. Am Heart J. 2022 Sep;251:43-53. doi: 10.1016/j.ahj.2022.05.011. Epub 2022 May 16.
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Recruiting
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544
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406
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August 2026
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August 2025 (Final data collection date for primary outcome measure)
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Inclusion Criteria:
Exclusion Criteria:
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Sexes Eligible for Study: |
All |
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18 Years to 80 Years (Adult, Older Adult)
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No
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Austria, France, Germany, Ireland, Netherlands, Poland, Switzerland, United Kingdom, United States
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NCT04790370
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S2479
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Yes
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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 |
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Boston Scientific Corporation
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Same as current
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Boston Scientific Corporation
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Same as current
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- National PERT Consortium, Inc.
- University Medical Center Mainz
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Principal Investigator: |
Stavros Konstantinides, MD |
University Medical Center Mainz, Mainz, Germany |
Principal Investigator: |
Kenneth Rosenfield, MD |
Massachusetts General Hospital, Boston, Massachusetts, USA |
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Boston Scientific Corporation
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April 2024
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