Registry for patients treated with ALTO endograft for abdominal aortic aneurysm
ALTo endogrAft Italian Registry
This study looks at how well the ALTO stent graft works for people having surgery to fix abdominal aortic aneurysms and what outcomes they experience afterward.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 300 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Azienda Ospedaliera Universitaria Senese Academic / other |
| Locations | 2 sites (Rome and 1 other locations) |
| Trial ID | NCT05234892 on ClinicalTrials.gov |
What this trial studies
This observational study aims to evaluate the intraoperative, peri-operative, and post-operative outcomes of patients undergoing elective repair of abdominal aortic aneurysms (AAA) using the ALTO stent graft. The study will collect data from multiple centers to assess the effectiveness and safety of this innovative endograft device. By analyzing the results from a diverse patient population, the study seeks to provide insights into the performance of the ALTO endograft in various anatomical challenges. The research will focus on long-term outcomes and complications associated with the use of this device.
Who should consider this trial
Good fit: Ideal candidates for this study are adults over 18 years old who are scheduled for elective endovascular aneurysm repair using the ALTO endograft.
Not a fit: Patients requiring urgent or emergent repair of AAA or those with contraindications to the ALTO endograft will not benefit from this study.
Why it matters
Potential benefit: If successful, this study could enhance the understanding of the ALTO endograft's effectiveness, potentially leading to improved treatment options for patients with AAA.
How similar studies have performed: While there have been studies on endovascular aneurysm repair, this specific evaluation of the ALTO endograft is relatively novel and has limited published outcomes.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Elective AAA patients that should be treated by standard EVAR, according to Endologix Alto endograft device's Instructions For Use; * Patient is willing to comply with specified follow-up evaluations at the specified times for the duration of the study; * Patient is \>18 years old; * Patient, or their legal representative, understands the nature of the procedure and provides written informed consent, prior to enrollment in the study. Exclusion Criteria: * EVAR performed in Urgent/Emergent setting; * Patients treated outside Endologix Alto endograft device's Instructions For Use; * Patients refusing treatment; * Patients for whom antiplatelet therapy, anticoagulants or antihypertensive drug are contraindicated; * Patients with a history of prior life-threatening contrast medium reaction; * Life expectancy of less than follow-up period. AAA: abdominal aortic aneurysm; EVAR: abdominal endovascular aneurysm
Where this trial is running
Rome and 1 other locations
- University La Sapienza of Rome — Rome, Italy (Recruiting)
- University of Siena — Siena, Italy (Recruiting)
Study contacts
- Principal investigator: Gianmarco de Donato, MD, PhD — University of Siena
- Study coordinator: Gianmarco de Donato, MD, PhD
- Email: dedonato@unisi.it
- Phone: +390577585123
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.