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RecruitingNCT06348459RiTEPUpdated Apr 25, 2025

Registry of Catheter Intervention in Pulmonary Embolism

An observational study in Pulmonary Embolism, Pulmonary Embolism Acute Massive and Pulmonary Embolism Acute, sponsored by Hospital San Carlos, Madrid. Recruiting at 1 site in Spain. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2025-04-25.

Sponsored by Hospital San Carlos, Madrid · Observational

Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
300
Ages
18 Years and older
Sex
All
01

Study 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.

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Conditions studied

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

Keywords

  • Aspiration Thrombectomy
  • Percutaneous Aspiration Thrombectomy
  • Local Thrombolysis
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Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
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.

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

Exclusion Criteria:

  • unconfirmed diagnosis of PE
  • undefined risk stratification, and
  • PE with uncertain chronology or beyond seven days of symptom initiation.
04

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
300 participants (estimated)
Target follow-up
2 Years
Patient registry
Yes
05

What researchers measure

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

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

    Time frame: 48 hours

  5. in-hospital complications

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

06

Study locations

1 of 1 sites recruiting
  • Hospital Clinico San Carlos
    Madrid, 28040, Spain
    Recruiting
07

References and documents

Publications

  • 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. PubMed 36801109 ↗
  • 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. PubMed 37354942 ↗

Individual participant data

Plan to share: No

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Registry details

Key details

Study ID
NCT06348459
Lead sponsor
Hospital San Carlos, Madrid
Collaborators
Asociación de Cardiología Intervencionista de la Sociedad Española de Cardiología
Responsible party
Pablo Salinas (MD, PhD, Hospital San Carlos, Madrid) — Principal investigator
First posted
Apr 4, 2024
Start date
Sep 18, 2018
Primary completion
Dec 31, 2029 (estimated)
Completion
Dec 31, 2030 (estimated)
Last update
Apr 25, 2025

Study contacts

Pablo Salinas, MD, PhD
Contact
salinas.pablo@gmail.com
+34 913303000

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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