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EuroPE-CDT: European Database on Catheter-directed Treatment of Pulmonary Embolism.

Sponsor
Medical University of Warsaw (Other)
Overall Status
Unknown status
CT.gov ID
NCT04037423
Collaborator
(none)
200
Enrollment
1
Location
17.9
Anticipated Duration (Months)
11.1
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

The main goals of EuroPE-CDT is to assess the currently applied catheter-directed treatment (CTD) techniques and strategies in pulmonary embolism (PE) patients and to determine the short term efficacy and safety of this invasive procedure.

Condition or Disease Intervention/Treatment Phase

    Detailed Description

    This is a prospective (and retrospective, if required data are available), non-interventional, multicenter study. We intend to obtain data on basic patients characteristics, pulmonary embolism severity, catheter-directed treatment procedures and short term outcome. We are planning to include approximately 150-200 patients suitable for analysis by the end of 2020. Anonymized data of consecutive PE patients treated with CTD in European centers will be collected in the database.

    Study Design

    Study Type:
    Observational [Patient Registry]
    Anticipated Enrollment :
    200 participants
    Observational Model:
    Cohort
    Time Perspective:
    Other
    Official Title:
    European Database on Catheter-directed Treatment of Pulmonary Embolism.
    Actual Study Start Date :
    Jun 4, 2019
    Anticipated Primary Completion Date :
    Dec 1, 2020
    Anticipated Study Completion Date :
    Dec 1, 2020

    Arms and Interventions

    Arm Intervention/Treatment
    PE patients treated with CDT

    Acute pulmonary embolism patients undergoing catheter-directed embolectomy.

    Outcome Measures

    Primary Outcome Measures

    1. Survival [30 days after the procedure]

      Short-time follow-up

    Secondary Outcome Measures

    1. Complications [During hospitalisation (estimated 10 days)]

      Any procedure-related complications, such as: local hematoma, hemoptysis, pulmonary artery injury, contrast-induced nephropathy, renal replacement therapy.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:

    • acute pulmonary embolism

    • catheter-directed embolectomy

    Exclusion Criteria:
    • appropriate data not available

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Department of Internal Medicine & Cardiology with the Centre for Management of Venous Thromboembolic Disease, Medical University of Warsaw Warszawa Poland 02-005

    Sponsors and Collaborators

    • Medical University of Warsaw

    Investigators

    • Study Chair: Piotr Purszczyk, prof., Medical University of Warsaw

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Medical University of Warsaw
    ClinicalTrials.gov Identifier:
    NCT04037423
    Other Study ID Numbers:
    • EuroPE-CDT
    First Posted:
    Jul 30, 2019
    Last Update Posted:
    Apr 17, 2020
    Last Verified:
    Jul 1, 2019
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Additional relevant MeSH terms:
    Pulmonary Embolism
    Embolism

    Study Results

    No Results Posted as of Apr 17, 2020