Evaluating outcomes of custom-made aortic devices
Results From a Multicenter Registry on the Outcomes of the Terumo Custom-made Aortic Endograft
This study looks at how well custom-made aortic devices work for people with thoracic aortic disease after they've had a specific repair procedure.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 60 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Fondazione Policlinico Universitario Agostino Gemelli IRCCS Academic / other |
| Locations | 1 site (Roma, RM) |
| Trial ID | NCT05777460 on ClinicalTrials.gov |
What this trial studies
This observational study focuses on assessing the mid- and long-term outcomes of patients who have undergone Thoracic Endovascular Aortic Repair (TEVAR) using custom-made devices. By monitoring these patients over time, the study aims to gather data on the effectiveness and safety of these specialized aortic devices. The study will include individuals diagnosed with thoracic aortic disease while excluding those requiring urgent or emergent treatment. The findings could provide valuable insights into the durability and performance of custom aortic devices.
Who should consider this trial
Good fit: Ideal candidates for this study are individuals diagnosed with thoracic aortic disease who are not in need of urgent or emergent treatment.
Not a fit: Patients requiring urgent or emergent treatment for their aortic condition may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could enhance the understanding of long-term outcomes for patients with aortic diseases, leading to improved treatment strategies.
How similar studies have performed: While this study focuses on custom-made devices, similar approaches in evaluating aortic repair outcomes have shown promise in previous research.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Thoracic Aortic Disease Exclusion Criteria: * Urgent/Emergent treatment
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: +39 347 4864020
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.