Clinical trial NCT05234892: ALTo endogrAft Italian Registry
Official title: ALTo endogrAft Italian Registry
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Abdominal Aortic Aneurysm
Keywords: Abdominal Aortic Aneurysm
AAA
Endovascular Aneurysm Repair
EVAR
Endograft
Lead sponsor: Azienda Ospedaliera Universitaria Senese
Sponsor class: OTHER
Collaborators: name: University of Roma La Sapienza
name: University of Siena
First posted: 2022-02-10
Enrollment: 300
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: 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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Technical success
timeFrame: 90 days
measure: Technical success
timeFrame: 1 year
measure: Technical success
timeFrame: 5 years
measure: Clinical success
timeFrame: 90 days
measure: Clinical success
timeFrame: 1 year
measure: Clinical success
timeFrame: 5 years
Secondary outcomes:
measure: Operative time
timeFrame: Immediately after the procedure
measure: Radiation exposure
timeFrame: Immediately after the procedure
measure: Contrast medium usage
timeFrame: Immediately after the procedure
measure: Abdominal Aortic Aneurysm Shrinkage
timeFrame: 1 year
measure: Abdominal Aortic Aneurysm Shrinkage
timeFrame: 5 year
Other outcomes:
Locations:
city: Rome
country: Italy
facility: University La Sapienza of Rome
city: Siena
country: Italy
facility: University of Siena
Study officials:
affiliation: University of Siena
name: Gianmarco de Donato, MD, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: University La Sapienza of Rome
name: Maurizio Taurino, MD, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Ospedale Civico di Palermo
name: Francesco Talarico, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: de Donato G, Pasqui E, Panzano C, Brancaccio B, Grottola G, Galzerano G, Benevento D, Palasciano G. The Polymer-Based Technology in the Endovascular Treatment of Abdominal Aortic Aneurysms. Polymers (Basel). 2021 Apr 7;13(8):1196. doi: 10.3390/polym13081196.
citation: de Donato G, Setacci F, Sirignano P, Galzerano G, Borrelli MP, di Marzo L, Setacci C. Ultra-low profile Ovation device: is it the definitive solution for EVAR? J Cardiovasc Surg (Torino). 2014 Feb;55(1):33-40.
citation: de Donato G, Pasqui E, Panzano C, Galzerano G, Cappelli A, Palasciano G. Early Experience with the New Ovation Alto Stent Graft in Endovascular Abdominal Aortic Aneurysm Repair. EJVES Vasc Forum. 2021 Nov 27;54:7-12. doi: 10.1016/j.ejvsvf.2021.11.003. eCollection 2022.
citation: Sirignano P, Mansour W, Capoccia L, Cuozzo S, Camparini S, de Donato G, Mangialardi N, Ronchey S, Talarico F, Setacci C, Speziale F; Collaborators. Endovascular aortic repair in patients with challenging anatomies: the EXTREME study. EuroIntervention. 2021 Apr 2;16(18):e1544-e1550. doi: 10.4244/EIJ-D-19-00547.
citation: Holden A, Lyden S. Initial experience with polymer endovascular aneurysm repair using the Alto stent graft. J Vasc Surg Cases Innov Tech. 2020 Feb 1;6(1):6-11. doi: 10.1016/j.jvscit.2019.04.007. eCollection 2020 Mar.
citation: Barleben A, Mathlouthi A, Mehta M, Nolte T, Valdes F, Malas MB; Ovation trial investigators. Long-term outcomes of the Ovation Stent Graft System investigational device exemption trial for endovascular abdominal aortic aneurysm repair. J Vasc Surg. 2020 Nov;72(5):1667-1673.e1. doi: 10.1016/j.jvs.2020.01.066. Epub 2020 Apr 2.
citation: de Donato G, Pasqui E, Mele M, Panzano C, Giannace G, Setacci F, Benevento D, Setacci C, Palasciano G. The use of a low-profile stent graft with a polymer ring sealing technology combined with bare renal stent (vent technique) in patients with juxtarenal aneurysm not eligible for open surgery and fenestrated endograft. J Vasc Surg. 2020 Jun;71(6):1843-1850. doi: 10.1016/j.jvs.2019.06.220. Epub 2019 Oct 31.
citation: de Donato G, Pasqui E, Sirignano P, Talarico F, Palasciano G, Taurino M; ALTAIR collaborators. Endovascular Abdominal Aortic Aneurysm Repair With Ovation Alto Stent Graft: Protocol for the ALTAIR (ALTo endogrAft Italian Registry) Study. JMIR Res Protoc. 2022 Jul 11;11(7):e36995. doi: 10.2196/36995.