ALTo endogrAft Italian Registry

Abdominal Aortic Aneurysm Clinical Trial

— ALTAIR  

Official title:

ALTo endogrAft Italian Registry

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05234892
• Other study ID #: ALTAIR001
• Status: Recruiting
• Start date: January 1, 2022
• Est. completion date: December 31, 2028

Study information

• Verified date: July 2023
• Source: Azienda Ospedaliera Universitaria Senese
• Contact: Gianmarco de Donato, MD, PhD
• Phone: +390577585123
• Email: dedonato[@]unisi.it
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 300
• Est. completion date: December 31, 2028
• Est. primary completion date: December 31, 2027
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Abdominal Aortic Aneurysm
• Aneurysm
• Aortic Aneurysm
• Aortic Aneurysm, Abdominal

Intervention

Device:
• ALTO endograft implantation
Implantantion of aorto-bisiliac ALTO endograft to exclude Abdominal Aortic Aneurysms

Locations

Country	Name	City	State
Italy	University La Sapienza of Rome	Rome
Italy	University of Siena	Siena

Sponsors (3)

Lead Sponsor	Collaborator
Gianmarco de Donato	University of Roma La Sapienza, University of Siena

Country where clinical trial is conducted

Italy, 

References & Publications (7)

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 N — View 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 — View 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. — View 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. eCo — View 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. — View 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. — View 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. 202 — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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	Operative time	Duration of procedure	Immediately after the procedure
Secondary	Radiation exposure	Radiation exposure during endovascular procedure	Immediately after the procedure
Secondary	Contrast medium usage	Amount of contrast medium usage during procedure	Immediately after the procedure
Secondary	Abdominal Aortic Aneurysm Shrinkage	AAA diameter reduction after EVAR	1 year
Secondary	Abdominal Aortic Aneurysm Shrinkage	AAA diameter reduction after EVAR	5 year