European Database on Catheter-directed Treatment of Pulmonary Embolism.

Acute Pulmonary Embolism Clinical Trial

— EuroPE-CDT  

Official title:

European Database on Catheter-directed Treatment of Pulmonary Embolism.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04037423
• Other study ID #: EuroPE-CDT
• Status: Completed
• Start date: June 4, 2019
• Est. completion date: March 31, 2022

Study information

• Verified date: July 2023
• Source: Medical University of Warsaw
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 145
• Est. completion date: March 31, 2022
• Est. primary completion date: December 31, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• acute pulmonary embolism
• catheter-directed embolectomy

Exclusion Criteria:

• appropriate data not available

Related Conditions & MeSH terms

• Acute Pulmonary Embolism
• Embolism
• Pulmonary Embolism

Locations

Country	Name	City	State
Poland	Department of Internal Medicine & Cardiology with the Centre for Management of Venous Thromboembolic Disease, Medical University of Warsaw	Warszawa

Sponsors (1)

Lead Sponsor	Collaborator
Medical University of Warsaw

Country where clinical trial is conducted

Poland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Survival	Short-time follow-up	30 days after the procedure
Secondary	Complications	Any procedure-related complications, such as: local hematoma,; hemoptysis,; pulmonary artery injury,; contrast-induced nephropathy,; renal replacement therapy.	During hospitalisation (estimated 10 days)