ALTo endogrAft Italian Registry

NCT ID: NCT05234892

Last Updated: 2023-07-20

Basic Information

• Recruitment Status: RECRUITING
• Total Enrollment: 300 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2022-01-01
• Study Completion Date: 2028-12-31

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.

Conditions

Abdominal Aortic Aneurysm

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

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.

ALTO endograft implantation

Intervention Type: DEVICE

Implantantion of aorto-bisiliac ALTO endograft to exclude Abdominal Aortic Aneurysms

Interventions

ALTO endograft implantation

Implantantion of aorto-bisiliac ALTO endograft to exclude Abdominal Aortic Aneurysms

Intervention Type: DEVICE

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of Roma La Sapienza

OTHER

Sponsor Role: collaborator

University of Siena

OTHER

Sponsor Role: collaborator

Gianmarco de Donato

OTHER

Sponsor Role: lead

Responsible Party

Gianmarco de Donato

Associate Professor

Responsibility Role: SPONSOR_INVESTIGATOR

Principal Investigators

Gianmarco de Donato, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

University of Siena

Maurizio Taurino, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

University La Sapienza of Rome

Francesco Talarico, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Ospedale Civico di Palermo

Locations

University La Sapienza of Rome

Rome, , Italy

Site Status: RECRUITING

University of Siena

Siena, , Italy

Site Status: RECRUITING

Countries

Italy

Central Contacts

Gianmarco de Donato, MD, PhD

Role: CONTACT

dedonato@unisi.it

+390577585123

Facility Contacts

Pasqualino Sirignano, MD, PhD

Role: primary

pasqualino.sirignano@uniroma1.it

Edoardo Pasqui, MD

Role: primary

pasqui11@student.unisi.it

+390577585127

References

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.

Reference Type: BACKGROUND

PMID: 33917214 (View on PubMed)

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.

Reference Type: RESULT

PMID: 24356044 (View on PubMed)

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.

Reference Type: RESULT

PMID: 34950916 (View on PubMed)

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.

Reference Type: RESULT

PMID: 31793884 (View on PubMed)

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.

Reference Type: RESULT

PMID: 32025596 (View on PubMed)

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.

Reference Type: RESULT

PMID: 32249041 (View on PubMed)

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.

Reference Type: RESULT

PMID: 31676183 (View on PubMed)

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.

Reference Type: DERIVED

PMID: 35816378 (View on PubMed)

Other Identifiers

ALTAIR001

Identifier Type: -

Identifier Source: org_study_id