The Polymer-Based Technology in the Endovascular Treatment of Abdominal Aortic Aneurysms.
Gianmarco de Donato, Edoardo Pasqui, Claudia Panzano...
https://pubmed.ncbi.nlm.nih.gov/33917214Actively Recruiting
Age: 18Years +
All Genders
ID05234892
ALTo endogrAft Italian Registry for Elective Abdominal Aortic Aneurysm Repair Using the ALTO Endograft Device
Led by Gianmarco de Donato · Updated on 2023-07-20
300
Participants Needed
2
Research Sites
52 weeks
Total Duration
On this page
Sponsors
G
Gianmarco de Donato
Lead Sponsor
U
University of Roma La Sapienza
Collaborating Sponsor
AI-Summary
What this Trial Is About
Researchers are evaluating the outcomes of treating patients with elective Abdominal Aortic Aneurysm (AAA) using the ALTO stent graft device from Endologix Inc. This observational study focuses on assessing the results during and after the surgery, including early and late outcomes, in a multicenter experience. The study builds on decades of technological advancements in endovascular aneurysm repair, particularly highlighting the innovative sealing mechanism of the ALTO device. The ALTO device implantation involves placing an aorto-bisiliac endograft to exclude the aneurysm, using a low-profile platform designed for challenging anatomies. All eligible patients undergoing elective endovascular aneurysm repair (EVAR) with the ALTO device will be included based on their medical needs, anatomical suitability, and physician expertise. The study will collect data during the procedure and at set follow-up times to evaluate technical and clinical success. Participants will be monitored through follow-up visits lasting up to five years, during which researchers will assess technical and clinical success at 90 days, one year, and five years after treatment. Additional measures include operative time, radiation exposure, contrast medium usage immediately after the procedure, and aneurysm shrinkage at one and five years. Patients are expected to comply with follow-up evaluations to help researchers understand the device's performance and patient outcomes over time.
CONDITIONS
Brief Title
ALTo endogrAft Italian Registry
Who Can Participate
Age: 18Years +
All Genders
Eligibility Criteria
You may qualify if you...
- Elective abdominal aortic aneurysm patients suitable for standard endovascular aneurysm repair with the Endologix ALTO endograft device
- Willingness to comply with follow-up evaluations for the study duration
- Age over 18 years
- Ability to understand the procedure and provide written informed consent prior to enrollment
You will not qualify if you...
- Urgent or emergency endovascular aneurysm repair procedures
- Treatment outside the Endologix ALTO endograft device's approved instructions for use
- Refusal of treatment
- Contraindications to antiplatelet therapy, anticoagulants, or antihypertensive drugs
- History of life-threatening reaction to contrast medium
- Life expectancy less than the follow-up period required by the study
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
1
2
3
Your Study Journey
Screening
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Implementation
Duration - Day of procedure
Participants undergo the implantation of the ALTO endograft device to repair the abdominal aortic aneurysm.
1 procedure visit (in-person)
Post-operative Follow-up
Duration - Up to 5 years
Participants are monitored to evaluate technical and clinical success, aneurysm shrinkage, and other outcomes after the ALTO endograft implantation.
Follow-up visits at 90 days, 1 year, and annually up to 5 years
Trial Site Locations
Total: 2 locations
1
University La Sapienza of Rome
Rome, Italy, 00185
Actively Recruiting
2
University of Siena
Siena, Italy, 53100
Actively Recruiting
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Research Team
G
Gianmarco de Donato, MD, PhD
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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Published Research Related To This Trial
Ultra-low profile Ovation device: is it the definitive solution for EVAR?
G de Donato, F Setacci, P Sirignano...
https://pubmed.ncbi.nlm.nih.gov/24356044Early Experience with the New Ovation Alto Stent Graft in Endovascular Abdominal Aortic Aneurysm Repair.
Gianmarco de Donato, Edoardo Pasqui, Claudia Panzano...
https://pubmed.ncbi.nlm.nih.gov/34950916Endovascular aortic repair in patients with challenging anatomies: the EXTREME study.
Pasqualino Sirignano, Wassim Mansour, Laura Capoccia...
https://pubmed.ncbi.nlm.nih.gov/31793884Initial experience with polymer endovascular aneurysm repair using the Alto stent graft.
Andrew Holden, Sean Lyden
https://pubmed.ncbi.nlm.nih.gov/32025596Long-term outcomes of the Ovation Stent Graft System investigational device exemption trial for endovascular abdominal aortic aneurysm repair.
Andrew Barleben, Asma Mathlouthi, Manish Mehta...
https://pubmed.ncbi.nlm.nih.gov/32249041The use of a low-profile stent graft with a polymer ring sealing technology combined with bare renal stent (vent technique) in patients with juxtarenal aneurysm not eligible for open surgery and fenestrated endograft.
Gianmarco de Donato, Edoardo Pasqui, Mariagnese Mele...
https://pubmed.ncbi.nlm.nih.gov/31676183Endovascular Abdominal Aortic Aneurysm Repair With Ovation Alto Stent Graft: Protocol for the ALTAIR (ALTo endogrAft Italian Registry) Study.
Gianmarco de Donato, Edoardo Pasqui, Pasqualino Sirignano...
https://pubmed.ncbi.nlm.nih.gov/35816378