Actively Recruiting
Standardized Physician-modified Fenestrated Endograft Registry for Complex Abdominal and Thoracoabdominal Aortic Aneurysms
Led by University Hospital Padova · Updated on 2024-04-16
50
Participants Needed
1
Research Sites
260 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating a standardized physician-modified fenestrated endograft (PMEG) approach for treating complex abdominal aortic aneurysms (AAA) and thoracoabdominal aortic aneurysms (TAAA) where standard endovascular repair is not suitable due to anatomy. This observational study focuses on patients treated with the Valiant Captivia thoracic endograft, modified by physicians to incorporate fenestrations for target vessels. The goal is to assess the safety and feasibility of this standardized modification technique compared to other treatments, particularly for urgent or symptomatic aneurysms. The treatment involves modifying a standard Valiant Captivia thoracic graft on a sterile back-table in a hybrid operating room. The graft is partially deployed, and fenestrations are created using cautery and reinforced with sutures and guidewire tips. A posterior constraining wire is added to reduce graft diameter temporarily, allowing rotation during deployment. Markers are adjusted for orientation, and the graft is re-sheathed before implantation. All patients in the study receive this 4-fenestrated PMEG endograft. Participants undergo a postoperative CT angiography within 30 days to assess technical success and early outcomes. Follow-up imaging is recommended at 6, 12, and 24 months, then yearly, to monitor freedom from target vessel and endograft instability and aneurysm sac changes over five years. The study includes evaluations of major adverse events and long-term device performance. Participant involvement consists of treatment, imaging assessments, and clinical monitoring over an extended period.
CONDITIONS
Brief Title
Standardized Physician-modified Fenestrated Endograft Registry
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Complex abdominal aortic aneurysm (short-neck AAA, juxta-renal AAA, para-renal AAA, extent IV thoracoabdominal aneurysm)
- Hemodynamic stability
- Proximal aortic neck above mid celiac trunk at least 25 mm in length, between 18 mm and 35 mm in diameter, healthy without calcifications or thrombus
- Visceral aorta maximum diameter no larger than 40 mm
- Age between 18 and 100 years
You will not qualify if you...
- Extent I-III thoracoabdominal aneurysm
- Hemorrhagic shock
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Day of procedure
Participants undergo physician-modification of the Valiant Captivia endograft on a sterile back-table, followed by endograft deployment.
1 procedural visit (in-person)
Duration - Up to 5 years
Participants have a postoperative CT angiography (CTA) within 30 days and further imaging follow-up at 6, 12, and 24 months, then yearly thereafter.
1 visit within 30 days, then imaging visits at 6, 12, 24 months and yearly thereafter
Trial Site Locations
Total: 1 location
1
Vascular and Endovascular Clinic - Padova University
Padova, Italy, 35020
Actively Recruiting
Research Team
M
Michele Piazza, MD
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
1
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