Brief Title
ALTo endogrAft Italian Registry
Official Title
ALTo endogrAft Italian Registry
Brief Summary
The aim of present study is to evaluate intraoperative, peri-operative, and post-operative results in patients treated by the ALTO stent graft (Endologix Inc. Irvine, Calif) for elective Abdominal Aortic Aneurysm repair in a multicentric consecutive experience.
Detailed Description
Thirty years ago, Juan Parodi developed the first prototype of endograft for Endovascular Aneurysm Repair, a handmade device made of a tube-shaped aorto-aortic graft sutured at each end to a balloon-expandable stent based on the design of radiologist Julio Palmaz. This device was implanted in a human body for the first time on September 7, 1990, in Buenos Aires, Argentina. By 1994, the first commercially available devices had been launched onto the market. Stent-graft material and design changed in various ways to improve conformability, reduce fracture, and minimize device migration rates. Over the years Endovascular Aneurysm Repair has become an effective treatment of AAA in challenging anatomy as hostile neck and small access. These performances have been achieved thanks to continuous technological development to overcome the previous limitation in Endovascular Aneurysm Repair applicability. Since 2010, the Ovation Abdominal Stent Graft System (Endologix Inc. Irvine, Calif) has offered a new concept of sealing, achieved by a network of O-rings filled with a polymer that can treat a great variety of difficult anatomies through a low-profile platform. In the latest version of the stent-graft, called Ovation Alto, the conformable O-rings with CustomSealTM polymer have been repositioned near the top of the endograft, providing a seal just below the renal arteries. Very few papers were published highlighting the early and late outcomes of this new device. In this perspective, this study is intended to be the first multicenter prospective registry regarding the implantation of Alto stent graft.
Study Type
Observational [Patient Registry]
Primary Outcome
Technical success
Secondary Outcome
Operative time
Condition
Abdominal Aortic Aneurysm
Intervention
ALTO endograft implantation
Study Arms / Comparison Groups
EVAR group
Description: All consecutive eligible patients submitted to EVAR by Alto Endovascular AAA implantation will be included in analysis. Patients will be submitted to EVAR procedures on the basis of their own preferences, anatomical features, and operators experience.
Publications
* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
Recruitment Information
Recruitment Status
Device
Estimated Enrollment
300
Start Date
January 1, 2022
Completion Date
December 31, 2028
Primary Completion Date
December 31, 2027
Eligibility 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
Gender
All
Ages
18 Years - N/A
Accepts Healthy Volunteers
No
Contacts
Gianmarco de Donato, MD, PhD, +390577585123, [email protected]
Location Countries
Italy
Location Countries
Italy
Administrative Informations
NCT ID
NCT05234892
Organization ID
ALTAIR001
Responsible Party
Sponsor-Investigator
Study Sponsor
Gianmarco de Donato
Collaborators
University of Roma La Sapienza
Study Sponsor
Gianmarco de Donato, MD, PhD, Principal Investigator, University of Siena
Verification Date
February 2022