NCT06348459

Brief Summary

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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
300

participants targeted

Target at P75+ for all trials

Timeline
57mo left

Started Sep 2018

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress62%
Sep 2018Dec 2030

Study Start

First participant enrolled

September 18, 2018

Completed
5.1 years until next milestone

First Submitted

Initial submission to the registry

November 9, 2023

Completed
5 months until next milestone

First Posted

Study publicly available on registry

April 4, 2024

Completed
5.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2029

Expected
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2030

Last Updated

April 25, 2025

Status Verified

April 1, 2025

Enrollment Period

11.3 years

First QC Date

November 9, 2023

Last Update Submit

April 23, 2025

Conditions

Pulmonary EmbolismPulmonary Embolism Acute MassivePulmonary Embolism AcutePulmonary Embolism and ThrombosisPulmonary Thromboembolisms

Keywords

Aspiration ThrombectomyPercutaneous Aspiration ThrombectomyLocal Thrombolysis

Outcome Measures

Primary Outcomes (1)

  • All cause-death

    during hospital admission (up to day 10)

Secondary Outcomes (5)

  • all cause-death

    48 hours

  • all cause-death

    30 days

  • all cause-death

    2 year

  • procedural success

    48 hours

  • in-hospital complications

    during hospital admission (up to day 10)

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-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.

You may qualify if:

  • 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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hospital Clinico San Carlos

Madrid, Madrid, 28040, Spain

RECRUITING

Related Publications (2)

  • 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.

    PMID: 36801109BACKGROUND

  • 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.

    PMID: 37354942BACKGROUND

MeSH Terms

Conditions

Pulmonary EmbolismThrombosis

Condition Hierarchy (Ancestors)

Lung DiseasesRespiratory Tract DiseasesEmbolismEmbolism and ThrombosisVascular DiseasesCardiovascular Diseases

Central Study Contacts

Pablo Salinas, MD, PhD

CONTACT

+34 913303000salinas.pablo@gmail.com

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Target Duration
2 Years
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MD, PhD

Study Record Dates

First Submitted

November 9, 2023

First Posted

April 4, 2024

Study Start

September 18, 2018

Primary Completion (Estimated)

December 31, 2029

Study Completion (Estimated)

December 31, 2030

Last Updated

April 25, 2025

Record last verified: 2025-04

Data Sharing

IPD Sharing
Will not share

Locations

ES(1)