Registry for physician-modified endografts in aortic aneurysm treatment
Standardized Physician-modified Fenestrated Endograft Registry
University Hospital Padova · NCT06358248
This study looks at how well a special type of modified stent works for people with complex abdominal aortic aneurysms that can't be treated with regular methods.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 50 (estimated) |
| Ages | 18 Years to 100 Years |
| Sex | All |
| Sponsor | University Hospital Padova (other) |
| Locations | 1 site (Padova) |
| Trial ID | NCT06358248 on ClinicalTrials.gov |
What this trial studies
This observational study collects data from multiple centers on patients treated with physician-modified endografts using a standardized technique. It focuses on patients with complex abdominal aortic aneurysms that cannot be treated with standard endovascular repair due to anatomical challenges. The study aims to evaluate the effectiveness and safety of the Valiant Captivia endograft modified by physicians to accommodate specific vascular anatomy. By analyzing outcomes from these procedures, the study seeks to improve treatment strategies for urgent cases of aortic aneurysms.
Who should consider this trial
Good fit: Ideal candidates include patients with complex abdominal aortic aneurysms who are hemodynamically stable and meet specific anatomical criteria.
Not a fit: Patients with extent I-III thoracoabdominal aneurysms or those in hemorrhagic shock may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could enhance treatment options for patients with complex aortic aneurysms, potentially leading to better outcomes and reduced complications.
How similar studies have performed: Previous studies have shown promising results with physician-modified endografts, indicating a potential for success in this approach.
Eligibility criteria
Show full inclusion / exclusion criteria
INCLUSION CRITERIA * Complex AAA (including short-neck AAA, JRAA, PRAA, extent IV TAAA) * Haemodynamic stability * Anatomical feasibility is based on the presence of a proximal aortic neck above the mid celiac trunk of ≥25 mm in length and between 18 mm and 35 mm in diameter; the neck needs to be "healthy" with no parietal calcifications or thrombus with a cylindrical shape. The visceral aorta is required to be no larger than 40 mm in maximum diameter. EXCLUSION CRITERIA * Extent I-III TAAA * Hemorrhagic shock
Where this trial is running
Padova
- Vascular and Endovascular Clinic - Padova University — Padova, Italy (RECRUITING)
Study contacts
- Principal investigator: Michele Piazza, MD — University Hospital Padova
- Study coordinator: Michele Piazza, MD
- Email: michele.piazza@unipd.it
- Phone: 0498218154
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: Aortic Aneurysm, Thoracoabdominal, Aortic Diseases, Aortic Aneurysm, Thoracoabdominal Aneurysm, Endovascular aortic repair