ALTo endogrAft Italian Registry
ALTo endogrAft Italian Registry
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.
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.
Observational [Patient Registry]
Abdominal Aortic Aneurysm
ALTO endograft implantation
Study Arms / Comparison Groups
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.
* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
January 1, 2022
December 31, 2028
Primary Completion Date
December 31, 2027
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
18 Years - N/A
Accepts Healthy Volunteers
Gianmarco de Donato, MD, PhD, +390577585123, [email protected]
Gianmarco de Donato
University of Roma La Sapienza
Gianmarco de Donato, MD, PhD, Principal Investigator, University of Siena