Thrombectomy in Pulmonary Embolism

NCT07650435 | Recruiting DMC

• 2 other identifiers: 24RAD100362530
• Study Type: observational
• Target: 2,000
• Locations: 1 country
• Sites: 1

Brief Summary

Pulmonary embolism is a blood clot on the lung, which can cause death or significant reduced quality of life. Sucking the clot out with a special tube (catheter) is a relatively new procedure that can be performed but doesn't have the data required to properly support its use in some patients. We know this procedure works in patients who have no other options and would almost certainly die without intervention. We currently don't know how well this procedure is tolerated, how well it works and what its complications are in patients who are moderately to severely unwell. The National Institute of Clinical Excellence (NICE), an advisory body, suggests more data is required to support its use in patients who are sick or very sick. This registry aims to support this growing evidence base to workout if the treatment is effective and the associated risks that come with using it. We are collecting data about this procedure and other treatments patients get offered to better inform clinicians and researchers.

Conditions

Pulmonary Embolism and Thrombosis

Keywords

PE; Thrombectomy

Outcome Measures

Primary Outcomes (2)

• LV/RV ratio

  1\. To evaluate the effectiveness of PE CAVT as a treatment for intermediate and high-risk PE as measured by change pulmonary arterial pressure and in RV/LV (Right Ventricle to Left Ventricle diameter) ratio at 48 (+ 48 /- 24) hours post procedure.

  48 (+ 48 /- 24) hours post procedure.

• Morbidity and mortality

  Ascertain the mortality and morbidity profile for CAVT within intermediate and high-risk PE, within 48 (± 12) hours post procedure, 30 (± 7) days, 90 (± 14) days and at 6months (+/- 30 days).

  within 48 (± 12) hours post procedure, 30 (± 7) days, 90 (± 14) days and at 6months (+/- 30 days).

Study Arms (2)

CAVT thrombectomy

PE with evidence of right heart strain and thrombectomy with 16Fr CAVT

PE with evidence of right heart strain

PE with evidence of right heart strain

Eligibility Criteria

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

Study Population

Patients with PE \<14 days and evidence of right heart strain

You may qualify if:

• Clinical signs and symptoms consistent with acute pulmonary embolism with duration of 14 days or less
• Patients who present with computed tomography confirmed pulmonary embolism
• Defined as intermediate or high-risk pulmonary embolism (according to European Society of Cardiology guidelines)
• Date of computed tomography imaging from within a two-year period
• Patient is greater than or equal to 18 years of age
• Informed consent obtained
• Evidence of cardiac dysfunction (either biochemical or imaging features of right heart strain)

You may not qualify if:

• Known serious, uncontrolled sensitivity to radiographic agents
• Computed tomography not available to evaluate pulmonary embolism
• Low-risk pulmonary embolism as defined by European Society of Cardiology guidelines
• Current participation in another investigational drug or device study that may confound the results of this study. Studies requiring extended follow-up for products that were investigational but have since become commercially available are not considered investigational
• Other medical, social, or psychological conditions that, in the opinion of the investigator, preclude the patient from appropriate consent, could limit the patient's ability to participate in the study, including compliance with follow-up requirements, or that could impact the scientific integrity of the study
• Clinical signs and symptoms consistent with acute PE with duration of 14 days or less
• Patients who present with CT confirmed PE
• Defined as intermediate or high-risk PE (according to ESC guidelines1)
• Date of CT imaging from within a two-year period
• Patient is ≥ 18 years of age
• Informed consent obtained
• Evidence of cardiac dysfunction (Either biochemical or imaging features of RHS)
• \. Known serious, uncontrolled sensitivity to radiographic agents 2. CT not available to evaluate PE 3. Low Risk PE as defined by ESC guidelines1 4. Current participation in another investigational drug or device study that may confound the results of this study. Studies requiring extended follow-up for products that were investigational but have since become commercially available are not considered investigational studies 5. Other medical, social, or psychological conditions that, in the opinion of the Investigator, precludes the patient from appropriate consent, could limit the patient's ability to participate in the study, including compliance with follow-up requirements, or that could impact the scientific integrity of the study

Sponsors & Collaborators

• University Hospital Plymouth NHS Trust: lead

Study Sites (1)

University Hospital Plymouth NHS Trust

Plymouth, United Kingdom

RECRUITING

Related Publications (11)

• 11. National institute of Clinical Excellence. Pulmonary embolism: what are the risk factors. NICE guidelines. https://cks.nice.org.uk/topics/pulmonary-embolism/background-information/risk-factors/

  BACKGROUND

• Noble S, Lewis R, Whithers J, Lewis S, Bennett P. Long-term psychological consequences of symptomatic pulmonary embolism: a qualitative study. BMJ Open. 2014 Apr 2;4(4):e004561. doi: 10.1136/bmjopen-2013-004561.

  PMID: 24694625 BACKGROUND

• Danielsbacka JS, Rostberg L, Olsen MF, Mannerkorpi K. "Whole life changed" - Experiences of how symptoms derived from acute pulmonary embolism affects life. A qualitative interview study. Thromb Res. 2021 Sep;205:56-62. doi: 10.1016/j.thromres.2021.07.004. Epub 2021 Jul 5.

  PMID: 34247098 BACKGROUND

• 8. Perkowski, Paul et al Computer-aided Mechanical Aspiration Thrombectomy with the Indigo Lightning 12 Aspiration System for the Treatment of Acute Pulmonary Embolism: Interim Analysis of the STRIKE-PE Study.Journal of Vascular Surgery, Volume 77, Issue 4, 52S - 53S

  BACKGROUND

• Moriarty JM, Dohad SY, Schiro BJ, Tamaddon H, Heithaus RE, Iliadis EA, Dexter DJ 2nd, Shavelle DM, Leal SRN, Attallah AS, West FM, Keeling WB, Sharp ASP, Weinberg I. Clinical, Functional, and Quality-of-Life Outcomes after Computer Assisted Vacuum Thrombectomy for Pulmonary Embolism: Interim Analysis of the STRIKE-PE Study. J Vasc Interv Radiol. 2024 Aug;35(8):1154-1165.e6. doi: 10.1016/j.jvir.2024.04.028. Epub 2024 May 9.

  PMID: 38729421 BACKGROUND

• Mathews SJ. Mechanical Thrombectomy of Pulmonary Emboli With Use of the Indigo System and Lightning 12 Intelligent Aspiration. Tex Heart Inst J. 2021 Nov 1;48(5):e217571. doi: 10.14503/THIJ-21-7571. No abstract available.

  PMID: 34911082 BACKGROUND

• Gotzinger F, Lauder L, Sharp ASP, Lang IM, Rosenkranz S, Konstantinides S, Edelman ER, Bohm M, Jaber W, Mahfoud F. Interventional therapies for pulmonary embolism. Nat Rev Cardiol. 2023 Oct;20(10):670-684. doi: 10.1038/s41569-023-00876-0. Epub 2023 May 12.

  PMID: 37173409 BACKGROUND

• Giri J, Sista AK, Weinberg I, Kearon C, Kumbhani DJ, Desai ND, Piazza G, Gladwin MT, Chatterjee S, Kobayashi T, Kabrhel C, Barnes GD. Interventional Therapies for Acute Pulmonary Embolism: Current Status and Principles for the Development of Novel Evidence: A Scientific Statement From the American Heart Association. Circulation. 2019 Nov 12;140(20):e774-e801. doi: 10.1161/CIR.0000000000000707. Epub 2019 Oct 4.

  PMID: 31585051 BACKGROUND

• Sista AK, Miller LE, Kahn SR, Kline JA. Persistent right ventricular dysfunction, functional capacity limitation, exercise intolerance, and quality of life impairment following pulmonary embolism: Systematic review with meta-analysis. Vasc Med. 2017 Feb;22(1):37-43. doi: 10.1177/1358863X16670250. Epub 2016 Oct 5.

  PMID: 27707980 BACKGROUND

• Konstantinides SV, Barco S, Lankeit M, Meyer G. Management of Pulmonary Embolism: An Update. J Am Coll Cardiol. 2016 Mar 1;67(8):976-990. doi: 10.1016/j.jacc.2015.11.061.

  PMID: 26916489 BACKGROUND

• 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.

  PMID: 31504429 BACKGROUND

MeSH Terms

Conditions

Pulmonary Embolism; Thrombosis

Condition Hierarchy (Ancestors)

Lung Diseases; Respiratory Tract Diseases; Embolism; Embolism and Thrombosis; Vascular Diseases; Cardiovascular Diseases

Central Study Contacts

Paul Jenkins

CONTACT

01752438000; plh-tr.tipe@nhs.net

Thomas Mindos Trial Manager

CONTACT

01752438000; plh-tr.tipe@nhs.net

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 10, 2026
• First Posted: June 16, 2026
• Study Start: May 11, 2026
• Primary Completion (Estimated): December 11, 2029
• Study Completion (Estimated): December 11, 2029
• Last Updated: June 25, 2026

Record last verified: 2026-06

Locations

GB (1)