NCT05234892

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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
300

participants targeted

Target at P75+ for all trials

Timeline
32mo left

Started Jan 2022

Longer than P75 for all trials

Geographic Reach
1 country

2 active sites

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress63%
Jan 2022Dec 2028

Study Start

First participant enrolled

January 1, 2022

Completed
27 days until next milestone

First Submitted

Initial submission to the registry

January 28, 2022

Completed
13 days until next milestone

First Posted

Study publicly available on registry

February 10, 2022

Completed
5.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2027

Expected
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2028

Last Updated

July 20, 2023

Status Verified

July 1, 2023

Enrollment Period

6 years

First QC Date

January 28, 2022

Last Update Submit

July 19, 2023

Conditions

Abdominal Aortic Aneurysm

Keywords

Abdominal Aortic AneurysmAAAEndovascular Aneurysm RepairEVAREndograft

Outcome Measures

Primary Outcomes (6)

  • 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 Outcomes (5)

  • Operative time

    Immediately after the procedure

  • Radiation exposure

    Immediately after the procedure

  • Contrast medium usage

    Immediately after the procedure

  • Abdominal Aortic Aneurysm Shrinkage

    1 year

  • Abdominal Aortic Aneurysm Shrinkage

    5 year

Study Arms (1)

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

Interventions

ALTO endograft implantationDEVICE

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

EVAR group

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability 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.

You may qualify if:

  • 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.

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

University La Sapienza of Rome

Rome, 00185, Italy

RECRUITING

University of Siena

Siena, 53100, Italy

RECRUITING

Related Publications (8)

  • 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.

    PMID: 33917214BACKGROUND

  • 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.

    PMID: 24356044RESULT

  • 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.

    PMID: 34950916RESULT

  • 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.

    PMID: 31793884RESULT

  • 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.

    PMID: 32025596RESULT

  • 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.

    PMID: 32249041RESULT

  • 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.

    PMID: 31676183RESULT

  • 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.

    PMID: 35816378DERIVED

MeSH Terms

Conditions

Aortic Aneurysm, Abdominal

Condition Hierarchy (Ancestors)

Aortic AneurysmAneurysmVascular DiseasesCardiovascular DiseasesAortic Diseases

Study Officials

  • 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

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Gianmarco de Donato, MD, PhD

CONTACT

+390577585123dedonato@unisi.it

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Target Duration
5 Years
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Associate Professor

Study Record Dates

First Submitted

January 28, 2022

First Posted

February 10, 2022

Study Start

January 1, 2022

Primary Completion (Estimated)

December 31, 2027

Study Completion (Estimated)

December 31, 2028

Last Updated

July 20, 2023

Record last verified: 2023-07

Data Sharing

IPD Sharing
Will not share

Locations

IT(2)