Registry of Catheter Intervention in Pulmonary Embolism

NCT ID: NCT06348459

Last Updated: 2025-04-25

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Total Enrollment

300 participants

Study Classification

OBSERVATIONAL

Study Start Date

2018-09-18

Study Completion Date

2030-12-31

Brief Summary

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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.

Detailed Description

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Conditions

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Pulmonary Embolism Pulmonary Embolism Acute Massive Pulmonary Embolism Acute Pulmonary Embolism and Thrombosis Pulmonary Thromboembolisms

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Asociación de Cardiología Intervencionista de la Sociedad Española de Cardiología

UNKNOWN

Sponsor Role collaborator

Hospital San Carlos, Madrid

OTHER

Sponsor Role lead

Responsible Party

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Pablo Salinas

MD, PhD

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Hospital Clinico San Carlos

Madrid, Madrid, Spain

Site Status RECRUITING

Countries

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Spain

Central Contacts

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Pablo Salinas, MD, PhD

Role: CONTACT

+34 913303000

Facility Contacts

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Pablo Salinas, MD, PhD

Role: primary

+34913303000

References

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Ramos-Lopez N, Ferrera C, Luque T, Enriquez-Vazquez D, Mahia-Casado P, Galvan-Herraez L, Pedrajas JM, Salinas P; working group. Impact of a pulmonary embolism response team initiative on hospital mortality of patients with bilateral pulmonary embolism. Med Clin (Barc). 2023 Jun 9;160(11):469-475. doi: 10.1016/j.medcli.2022.12.017. Epub 2023 Feb 16. English, Spanish.

Reference Type BACKGROUND
PMID: 36801109 (View on PubMed)

Salinas P, Vazquez-Alvarez ME, Salvatella N, Ruiz Quevedo V, Velazquez Martin M, Valero E, Rumiz E, Jurado-Roman A, Lozano I, Gallardo F, Amat-Santos IJ, Lorenzo O, Portero Portaz JJ, Huanca M, Nombela-Franco L, Vaquerizo B, Ramallal Martinez R, Maneiro Melon NM, Sanchis J, Berenguer A, Gallardo-Lopez A, Gutierrez-Ibanes E, Mejia-Renteria H, Cordoba-Soriano JG, Jimenez-Mazuecos JM. Catheter-directed therapy for acute pulmonary embolism: results of a multicenter national registry. Rev Esp Cardiol (Engl Ed). 2024 Feb;77(2):138-147. doi: 10.1016/j.rec.2023.06.005. Epub 2023 Jun 22. English, Spanish.

Reference Type BACKGROUND
PMID: 37354942 (View on PubMed)

Other Identifiers

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18/010-E

Identifier Type: -

Identifier Source: org_study_id

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