Actively Recruiting

Age: 18Years +
All Genders
NCT05234892

ALTo endogrAft Italian Registry

Led by Gianmarco de Donato · Updated on 2023-07-20

300

Participants Needed

2

Research Sites

365 weeks

Total Duration

On this page

Sponsors

G

Gianmarco de Donato

Lead Sponsor

U

University of Roma La Sapienza

Collaborating Sponsor

AI-Summary

What this Trial Is About

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.

CONDITIONS

Official Title

ALTo endogrAft Italian Registry

Who Can Participate

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Elective AAA patients planned for treatment by standard EVAR using the Endologix ALTO endograft device as per 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 older than 18 years
  • Patient or legal representative understands the procedure and provides written informed consent before enrollment
Not Eligible

You will not qualify if you...

  • EVAR performed in urgent or emergency settings
  • Patients treated outside the Instructions For Use of the Endologix ALTO endograft device
  • Patients refusing treatment
  • Patients for whom antiplatelet therapy, anticoagulants, or antihypertensive drugs are contraindicated
  • Patients with a history of prior life-threatening reaction to contrast medium
  • Patients with a life expectancy shorter than the follow-up period

AI-Screening

AI-Powered Screening

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Trial Site Locations

Total: 2 locations

1

University La Sapienza of Rome

Rome, Italy, 00185

Actively Recruiting

2

University of Siena

Siena, Italy, 53100

Actively Recruiting

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Research Team

G

Gianmarco de Donato, MD, PhD

CONTACT

How is the study designed?

Study Type

OBSERVATIONAL

Masking

N/A

Allocation

N/A

Model

N/A

Primary Purpose

N/A

Number of Arms

1

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