Abdominal Aortic Aneurysm
Conditions
Keywords
Abdominal Aortic Aneurysm, AAA, Endovascular Aneurysm Repair, EVAR, Endograft
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.
Interventions
DEVICEALTO endograft implantation
Implantantion of aorto-bisiliac ALTO endograft to exclude Abdominal Aortic Aneurysms
Sponsors
University of Roma La Sapienza
University of Siena
Gianmarco de Donato
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Technical success | 90 days | 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 | 90 days | 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
| Measure | Time frame | Description |
|---|---|---|
| Operative time | Immediately after the procedure | Duration of procedure |
| Radiation exposure | Immediately after the procedure | Radiation exposure during endovascular procedure |
| Contrast medium usage | Immediately after the procedure | Amount of contrast medium usage during procedure |
| Abdominal Aortic Aneurysm Shrinkage | 1 year | AAA diameter reduction after EVAR |
Countries
Italy
Contacts
Primary ContactGianmarco de Donato, MD, PhD
Outcome results
None listed