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NCT Number: NCT06348459

Registry of Catheter Intervention in Pulmonary Embolism

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.

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Key information

Conditions

Pulmonary Embolism Cardiovascular Diseases Embolism Embolism and Thrombosis Lung Diseases Pulmonary Embolism Acute Pulmonary Embolism Acute Massive Pulmonary Embolism and Thrombosis Pulmonary Thromboembolisms Respiratory Tract Diseases Thrombosis Vascular Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Hospital Clinico San Carlos

Madrid, 28040, Spain

Location status: Recruiting

Location contact

Pablo Salinas, MD, PhD

CONTACT

[email protected]

+34913303000

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Primary outcomes

  1. All cause-death

    Time frame: during hospital admission (up to day 10)

Secondary outcomes

  1. all cause-death

    Time frame: 48 hours

  2. all cause-death

    Time frame: 30 days

  3. all cause-death

    Time frame: 2 year

  4. procedural success

    Time frame: 48 hours

    defined as technical procedure completed without procedural complications or 48-hour death

  5. in-hospital complications

    Time frame: during hospital admission (up to day 10)

Study contacts

Contact information is provided by the study sponsor or research team.

Pablo Salinas, MD, PhD

CONTACT

[email protected]

+34 913303000

Sponsors and collaborators

Lead sponsor

Hospital San Carlos, Madrid

Other

Collaborators

  • Asociación de Cardiología Intervencionista de la Sociedad Española de Cardiología

Registry information

Acronym: RiTEP

Important dates

Study start
2018
Primary completion
2029
Study completion
2030
First posted
Apr 4, 2024
Registry last updated
Apr 25, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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