NCT05234892

ALTo endogrAft Italian Registry

• Status: Recruiting
• Phase: —
• Study type: Observational
• Enrollment: 300 (estimated)
• Sponsor: Gianmarco de Donato · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Abdominal Aortic Aneurysm

Interventions

Type	Name	Description
DEVICE	ALTO endograft implantation	Implantantion of aorto-bisiliac ALTO endograft to exclude Abdominal Aortic Aneurysms

Timeline

• Start date: 2022-01-01
• Primary completion: 2027-12-31
• Completion: 2028-12-31
• First posted: 2022-02-10
• Last updated: 2023-07-20

Locations

2 sites across 1 country: Italy

Regulatory

• FDA-regulated device study