Registry of Catheter Intervention in Pulmonary Embolism

Pulmonary Embolism Clinical Trial

— RiTEP  

Official title:

Registry of Catheter Intervention in Pulmonary Embolism

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06348459
• Other study ID #: 18/010-E
• Status: Recruiting
• Start date: September 18, 2018
• Est. completion date: December 31, 2030

Study information

• Verified date: March 2024
• Source: Hospital San Carlos, Madrid
• Contact: Pablo Salinas, MD, PhD
• Phone: +34 913303000
• Email: salinas.pablo[@]gmail.com
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 300
• Est. completion date: December 31, 2030
• Est. primary completion date: December 31, 2029
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Embolism
• Embolism and Thrombosis
• Pulmonary Embolism
• Pulmonary Embolism and Thrombosis
• Pulmonary Thromboembolisms
• Thromboembolism
• Thrombosis

Locations

Country	Name	City	State
Spain	Hospital Clinico San Carlos	Madrid

Sponsors (2)

Lead Sponsor	Collaborator
Hospital San Carlos, Madrid	Asociación de Cardiología Intervencionista de la Sociedad Española de Cardiología

Country where clinical trial is conducted

Spain, 

References & 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. Me — View Citation

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 M — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	All cause-death		during hospital admission (up to day 10)
Secondary	all cause-death		48 hours
Secondary	all cause-death		30 days
Secondary	all cause-death		2 year
Secondary	procedural success	defined as technical procedure completed without procedural complications or 48-hour death	48 hours
Secondary	in-hospital complications		during hospital admission (up to day 10)