Ignite Creation Date:
2024-05-06 @ 5:14 PM
Last Modification Date:
2024-10-26 @ 2:24 PM
Study NCT ID:
NCT05234892
Status:
RECRUITING
Last Update Posted:
2023-07-20
First Post:
2022-01-28
Brief Title:
ALTo endogrAft Italian Registry
Sponsor:
Gianmarco de Donato
Organization:
Azienda Ospedaliera Universitaria Senese
Study Overview
Official Title:
ALTo endogrAft Italian Registry
Status:
RECRUITING
Status Verified Date:
2023-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
ALTAIR
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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
True
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None