Observing mortality and complications in endovascular procedures with new low-profile devices
Mortality and Complications in Endovascular Procedures Performed With New Generation Low-profile Devices
This study looks at how safe and effective new low-profile devices are for patients undergoing a specific type of heart surgery called TEVAR.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 200 (estimated) |
| Sex | All |
| Sponsor | Fondazione Policlinico Universitario Agostino Gemelli IRCCS Academic / other |
| Locations | 1 site (Roma, RM) |
| Trial ID | NCT04016545 on ClinicalTrials.gov |
What this trial studies
This observational study aims to monitor and analyze mortality rates and complications associated with the use of new generation low-profile endoprothesis during elective thoracic endovascular aortic repair (TEVAR) procedures. By focusing on these specific devices, the study seeks to gather data that could inform future practices and improve patient outcomes. The study will include patients who are eligible for TEVAR and will exclude those who cannot provide consent or are not suitable for the procedure.
Who should consider this trial
Good fit: Ideal candidates for this study are patients who are scheduled for elective TEVAR procedures.
Not a fit: Patients who are not eligible for TEVAR or those who cannot provide consent will not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved safety and outcomes for patients undergoing endovascular procedures.
How similar studies have performed: While this study focuses on a specific new generation device, similar observational studies have shown promise in improving procedural outcomes in endovascular interventions.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Patients with indications for elective TEVAR Exclusion Criteria: * Incapability to provide consent * Patients not eligible for TEVAR * Pregnancy
Where this trial is running
Roma, RM
- Fondazione Policlinico Universitario A. Gemelli IRCCS — Roma, Rm, Italy (Recruiting)
Study contacts
- Study coordinator: Giovanni Tinelli
- Email: giovanni.tinelli@policlinicogemelli.it
- Phone: 0039 0630157205
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.