ALTo endogrAft Italian Registry

Brief Title

ALTo endogrAft Italian Registry

Official Title

ALTo endogrAft Italian Registry

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.
    

Study Type

Observational [Patient Registry]

Primary Outcome

Technical success

Secondary Outcome

 Operative time

Condition

Abdominal Aortic Aneurysm

Intervention

ALTO endograft implantation

Study Arms / Comparison Groups

 EVAR group

Description:  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.

Publications

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Status

Device

Estimated Enrollment

300

Start Date

January 1, 2022

Completion Date

December 31, 2028

Primary Completion Date

December 31, 2027

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
      

Gender

All

Ages

18 Years - N/A

Accepts Healthy Volunteers

No

Contacts

Gianmarco de Donato, MD, PhD, +390577585123, [email protected]

Location Countries

Italy

Location Countries

Italy

NCT ID

NCT05234892

Organization ID

ALTAIR001

Responsible Party

Sponsor-Investigator

Study Sponsor

Gianmarco de Donato

Collaborators

 University of Roma La Sapienza

Study Sponsor

Gianmarco de Donato, MD, PhD, Principal Investigator, University of Siena

Verification Date

February 2022