ALTo endogrAft Italian Registry

Study Overview
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Brief Summary
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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
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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.

Official Title
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ALTo endogrAft Italian Registry

Conditions
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Abdominal Aortic Aneurysm

Intervention / Treatment
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* Device: ALTO endograft implantation


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| EVAR group<br>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. | Device: ALTO endograft implantation<br>* Implantantion of aorto-bisiliac ALTO endograft to exclude Abdominal Aortic Aneurysms<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Technical success | 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. | 90 days | 
| Technical success | 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. | 1 year | 
| Technical success | 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. | 5 years | 
| Clinical success | 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. | 90 days | 
| Clinical success | 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. | 1 year | 
| Clinical success | 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. | 5 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Operative time | Duration of procedure | Immediately after the procedure | 
| Radiation exposure | Radiation exposure during endovascular procedure | Immediately after the procedure | 
| Contrast medium usage | Amount of contrast medium usage during procedure | Immediately after the procedure | 
| Abdominal Aortic Aneurysm Shrinkage | AAA diameter reduction after EVAR | 1 year | 
| Abdominal Aortic Aneurysm Shrinkage | AAA diameter reduction after EVAR | 5 year | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Abdominal Aortic Aneurysm, AAA, Endovascular Aneurysm Repair, EVAR, Endograft