ALTo endogrAft Italian Registry

Recruiting

• Conditions: Abdominal Aortic Aneurysm

• Registration Number: NCT05234892
• Lead Sponsor: Gianmarco de Donato

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 Timeline

• Study Start: 2022-01-01
• Study First Submitted: 2022-01-28
• Study First Submitted QC: 2022-02-08
• Study First Posted: 2022-02-10
• Status Verified: 2023-07
• Last Update Submitted: 2023-07-19
• Last Update Posted: 2023-07-20
• Primary Completion: 2027-12-31
• Study Completion: 2028-12-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 300

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Technical success	5 years	correct graft deployment without any unintentional occlusion of the aortic visceral branches and/or both hypogastric arteries, with aneurysm exclusion confirmed by the intraoperative angiography, without signs of type I/III endoleak a conversion to open surgery.
Clinical success	5 years	Successful deployment of the endovascular device at the intended location without death as a result of aneurysm-related treatment, type I or III endoleak, or graft infection or thrombosis, aneurysm expansion (\>5 mm), aneurysm rupture, or conversion to open repair. Moreover, the presence of graft dilatation of 20% or more by diameter, graft migration, or a failure of device integrity.

Secondary Outcome Measures

Name	Time	Method
Radiation exposure	Immediately after the procedure	Radiation exposure during endovascular procedure
Abdominal Aortic Aneurysm Shrinkage	5 year	AAA diameter reduction after EVAR
Contrast medium usage	Immediately after the procedure	Amount of contrast medium usage during procedure
Operative time	Immediately after the procedure	Duration of procedure

Trial Locations

Locations (2)

University La Sapienza of Rome; 🇮🇹 Rome, Italy

University of Siena; 🇮🇹 Siena, Italy