ALTo endogrAft Italian Registry (ALTAIR)

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.

Study Overview

• Status: Recruiting
• Conditions: Abdominal Aortic Aneurysm
• Intervention / Treatment: Device: ALTO endograft implantation

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 Type: Observational
• Enrollment (Estimated): 300

Contacts and Locations

• Study Contact: Name: Gianmarco de Donato, MD, PhD; Phone Number: +390577585123; Email: dedonato@unisi.it

Study Locations

• Italy
  • Rome, Italy, 00185
    • Recruiting
    • University La Sapienza of Rome
    • Contact: Pasqualino Sirignano, MD, PhD; Email: pasqualino.sirignano@uniroma1.it
  • Siena, Italy, 53100
    • Recruiting
    • University of Siena
    • Contact: Edoardo Pasqui, MD; Phone Number: +390577585127; Email: pasqui11@student.unisi.it

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

• 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.

Description

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 Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
EVAR group; 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; Implantantion of aorto-bisiliac ALTO endograft to exclude Abdominal Aortic Aneurysms

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Gianmarco de Donato
• Collaborators: University of Roma La Sapienza; University of Siena
• Investigators: Principal Investigator: Gianmarco de Donato, MD, PhD, University of Siena; Principal Investigator: Maurizio Taurino, MD, PhD, University La Sapienza of Rome; Principal Investigator: Francesco Talarico, MD, PhD, Ospedale Civico di Palermo

Publications and helpful links

General Publications

• 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.
• 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.
• 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.
• 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.
• 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.
• 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.
• 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.
• 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.

Study record dates

Study Major Dates

• Study Start (Actual): January 1, 2022
• Primary Completion (Estimated): December 31, 2027
• Study Completion (Estimated): December 31, 2028

Study Registration Dates

• First Submitted: January 28, 2022
• First Submitted That Met QC Criteria: February 8, 2022
• First Posted (Actual): February 10, 2022

Study Record Updates

• Last Update Posted (Actual): July 20, 2023
• Last Update Submitted That Met QC Criteria: July 19, 2023
• Last Verified: July 1, 2023

More Information

Terms related to this study

• Keywords: AAA; EVAR; Endograft; Abdominal Aortic Aneurysm; Endovascular Aneurysm Repair
• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Aortic Diseases; Aneurysm; Aortic Aneurysm; Aortic Aneurysm, Abdominal
• Other Study ID Numbers: ALTAIR001

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes