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

July 29, 2023 updated by: Medical University of Warsaw
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.

Study Overview

Status

Completed

Conditions

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 Type

Observational

Enrollment (Actual)

145

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Poland
      • Warszawa, Poland, 02-005
        • Department of Internal Medicine & Cardiology with the Centre for Management of Venous Thromboembolic Disease, Medical University of Warsaw

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

Hospitalized patients.

Description

Inclusion Criteria:

  • acute pulmonary embolism
  • catheter-directed embolectomy

Exclusion Criteria:

  • appropriate data not available

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
PE patients treated with CDT
Acute pulmonary embolism patients undergoing catheter-directed embolectomy.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Survival
Time Frame: 30 days after the procedure
Short-time follow-up
30 days after the procedure

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Complications
Time Frame: During hospitalisation (estimated 10 days)

Any procedure-related complications, such as:

  • local hematoma,
  • hemoptysis,
  • pulmonary artery injury,
  • contrast-induced nephropathy,
  • renal replacement therapy.
During hospitalisation (estimated 10 days)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Medical University of Warsaw

Investigators

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

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

June 4, 2019

Primary Completion (Actual)

December 31, 2021

Study Completion (Actual)

March 31, 2022

Study Registration Dates

First Submitted

July 22, 2019

First Submitted That Met QC Criteria

July 29, 2019

First Posted (Actual)

July 30, 2019

Study Record Updates

Last Update Posted (Actual)

August 1, 2023

Last Update Submitted That Met QC Criteria

July 29, 2023

Last Verified

July 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • EuroPE-CDT

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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