Registry of Catheter Intervention in Pulmonary Embolism

Recruiting

• Conditions: Pulmonary Embolism; Pulmonary Embolism Acute Massive; Pulmonary Embolism and Thrombosis; Pulmonary Embolism Acute; Pulmonary Thromboembolisms

• Registration Number: NCT06348459
• Lead Sponsor: Hospital San Carlos, Madrid

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2018-09-18
• Study First Submitted: 2023-11-09
• Study First Submitted QC: 2024-03-28
• Study First Posted: 2024-04-04
• Status Verified: 2025-04
• Last Update Submitted: 2025-04-23
• Last Update Posted: 2025-04-25
• Primary Completion: 2029-12-31
• Study Completion: 2030-12-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 300

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
All cause-death	during hospital admission (up to day 10)

Secondary Outcome Measures

Name	Time	Method
all cause-death	2 year
procedural success	48 hours	defined as technical procedure completed without procedural complications or 48-hour death
in-hospital complications	during hospital admission (up to day 10)

Trial Locations

Locations (1)

Hospital Clinico San Carlos; 🇪🇸 Madrid, Spain