Evaluating a new stent-graft for treating complex abdominal aortic aneurysms
Clinical Effectiveness of an Off-the-shelf Single REnal Scalloped sTent-graft for HOstile NEck Infrarenal Abdominal Aortic Aneurysm: Clinical Pivotal Trial
Azienda Ospedaliero-Universitaria di Modena · NCT05609539
This study is testing a new type of stent-graft to see if it helps people with complex abdominal aortic aneurysms feel better and stay healthy after treatment.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 50 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Azienda Ospedaliero-Universitaria di Modena (other) |
| Locations | 1 site (Baggiovara, Modena) |
| Trial ID | NCT05609539 on ClinicalTrials.gov |
What this trial studies
This multicenter observational cohort study aims to assess the clinical effectiveness of a custom-made single-renal scallop stent-graft (TREO) for treating infrarenal abdominal aortic aneurysms (AAA) with hostile neck anatomy. The study will include patients with AAA greater than 50mm who meet specific anatomical criteria and will follow them for a minimum of three months up to five years post-intervention. Participants will receive treatment as per best clinical practice, with regular follow-up examinations to monitor outcomes. The study does not include a comparison group, focusing instead on real-world clinical effectiveness.
Who should consider this trial
Good fit: Ideal candidates are adults over 18 with infrarenal AAA greater than 50mm and specific anatomical features suitable for the TREO stent-graft.
Not a fit: Patients with aortic conditions other than AAA, those with AAA smaller than 50mm, or those treated in urgent settings may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could improve treatment outcomes for patients with complex AAA anatomy who currently have limited options.
How similar studies have performed: While endovascular repair techniques have been explored, this specific approach using the TREO stent-graft for hostile neck anatomy is relatively novel.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Patients affected by infrarenal AAA \> 50mm * Treated in election for non-symptomatic AAA * Anatomy inside Treo (Terumo Aortic) instruction to use (IFU) * Distance between renal arteries \>10mm on aortic center-lumen-line * Age \> 18 * Patient fit to plead * Both sex * Written informed consent * Treated in the coordinator center or in one of the study's participating centers * Minimum follow-up requested: 3-months, 12-18 months and 5-years CTA; clinical and DUS examination at 6- and 12- and 36-months after the intervention and yearly thereafter Exclusion Criteria: * Patients with aortic pathologies different from AAA (aortic ulcers, dissection, pseudo-aneurysm etc) * Treated in urgent/emergent setting for symptomatic or ruptured AAA * AAA \< 50mm * Outside TREO (Terumo Aortic) IFU * With an inter-renal distance measured of the center-lumen-line \<10mm * Age \<18 * Unfit to plead * Refused to sign the informed consent * Treated outside the coordinator centers or in one of the study's participating center's * Refusal to adhere to the requested follow-up
Where this trial is running
Baggiovara, Modena
- AOU di Modena — Baggiovara, Modena, Italy (RECRUITING)
Study contacts
- Study coordinator: Francesco Andreoli, MD
- Email: francesco.andreolimd@gmail.com
- Phone: +393405794971
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.
Conditions: Abdominal Aortic Aneurysm, AAA, EVAR, Hostile Neck Anatomy