Registry of catheter interventions for pulmonary embolism
Registry of Catheter Intervention in Pulmonary Embolism
This study looks at how safe and effective different catheter treatments are for people with moderate to high-risk pulmonary embolism.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 300 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Hospital San Carlos, Madrid Academic / other |
| Locations | 1 site (Madrid, Madrid) |
| Trial ID | NCT06348459 on ClinicalTrials.gov |
What this trial studies
This observational study collects data from patients with moderate to high-risk pulmonary embolism who are treated with invasive catheter interventions. It includes both retrospective cases from 2014 and prospective cases starting from 2018. The aim is to evaluate the safety and effectiveness of various percutaneous interventions for acute pulmonary embolism based on established guidelines. By analyzing these cases, the study seeks to improve understanding of acute management strategies for this serious condition.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 and older with a confirmed diagnosis of acute pulmonary embolism who are classified as high-risk or intermediate-high risk.
Not a fit: Patients with unconfirmed diagnoses of pulmonary embolism or those whose condition is beyond seven days from symptom onset may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could enhance treatment protocols for patients suffering from acute pulmonary embolism, potentially improving outcomes.
How similar studies have performed: Other studies have shown success with similar approaches in managing pulmonary embolism, indicating that this methodology is supported by prior research.
Eligibility criteria
Show full inclusion / exclusion criteria
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.
Where this trial is running
Madrid, Madrid
- Hospital Clinico San Carlos — Madrid, Madrid, Spain (Recruiting)
Study contacts
- Study coordinator: Pablo Salinas, MD, PhD
- Email: salinas.pablo@gmail.com
- Phone: +34 913303000
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.