Registry of Catheter Intervention in Pulmonary Embolism (RiTEP)

April 23, 2025 updated by: Pablo Salinas, Hospital San Carlos, Madrid
Multicenter longitudinal observational ambispective (retrospective cases from 2014 and prospective from 2018 onwards) cohort study. The registry recruits a series of consecutive patients admitted for moderate-high risk or high-risk pulmonary embolism (according to 2019 European Society of Cardiology guidelines) treated invasively. This study aims to describe the acute management of the safety and effectiveness of different percutaneous interventions for acute pulmonary embolism.

Study Overview

Status

Recruiting

Conditions

Study Type

Observational

Enrollment (Estimated)

300

Contacts and Locations

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

Study Contact

Study Locations

  • Spain
      • Madrid, Spain, 28040
        • Recruiting
        • Hospital Clinico San Carlos
        • Contact:

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

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

Consecutive patients admitted for moderate-high risk or high-risk PE and treated invasively with any kind of catheter-directed intervention.

Description

Inclusion Criteria:

  • adult patients (aged 18 years old or older)
  • confirmed diagnosis of acute PE (on computed tomography or echocardiogram plus pulmonary angiography)
  • high-risk PE or intermediate-high risk according to ESC risk stratification in the 2019 guidelines (briefly, elevated cardiac biomarkers [troponin or N-terminal pro-B-type natriuretic peptide], and right ventricle to left ventricle ratio > 0.9 [on computed tomography or echocardiogram], and PE severity index III to IV or simplified PE severity index=1
  • eligibility for catheter-directed intervention

Exclusion Criteria:

  • unconfirmed diagnosis of PE
  • undefined risk stratification, and
  • PE with uncertain chronology or beyond seven days of symptom initiation.

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
All cause-death
Time Frame: during hospital admission (up to day 10)
during hospital admission (up to day 10)

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
all cause-death
Time Frame: 48 hours
48 hours
all cause-death
Time Frame: 30 days
30 days
all cause-death
Time Frame: 2 year
2 year
procedural success
Time Frame: 48 hours
defined as technical procedure completed without procedural complications or 48-hour death
48 hours
in-hospital complications
Time Frame: during hospital admission (up to day 10)
during hospital admission (up to day 10)

Collaborators and Investigators

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

Sponsor

Hospital San Carlos, Madrid

Collaborators

Asociación de Cardiología Intervencionista de la Sociedad Española de Cardiología

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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)

September 18, 2018

Primary Completion (Estimated)

December 31, 2029

Study Completion (Estimated)

December 31, 2030

Study Registration Dates

First Submitted

November 9, 2023

First Submitted That Met QC Criteria

March 28, 2024

First Posted (Actual)

April 4, 2024

Study Record Updates

Last Update Posted (Actual)

April 25, 2025

Last Update Submitted That Met QC Criteria

April 23, 2025

Last Verified

April 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 18/010-E

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

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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