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NCT Number: NCT06893952

Technical Evaluation and Results of the Use of TREO® Modular Aortic Endografts for the Treatment of Abdominal Aortic Aneurysms

This study is a clinical investigation as part of the post-market clinical follow-up of the TREO® abdominal aortic graft in its initial use, French, observational, multicenter, non-randomized, single-arm. Information on patient's health and the implanted device will be collected over a period of 5 consecutive years. The data collected will be analyzed on the technical success and the absence of major events (death, stroke, myocardial infarction, visceral ischemia, paraplegia, respiratory failure, renal failure, intraoperative blood loss, thromboembolic event) and possible reinterventions related to the patient's operation.

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Key information

Age range

45 year and older

Sex eligibility

All sexes

Study type

Observational

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Patient who has confirmed his/her non-opposition to the use of his/her data in the study.
  • Patient aged 45 years or older.
  • Patient with AAA with one of the following criteria:
  • Maximum diameter ≥50 mm for women and ≥55 mm for men
  • Rapid growth (≥5 mm in 6 months or ≥10 mm in 12 months)
  • Unruptured AAA with clinical symptoms of abdominal pain
  • Adequate anatomy for TREO® stent graft implantation, including:
  • Adequate iliac and femoral arteries for the modular system
  • Suprarenal angle less than 45 degrees
  • Infrarenal aortic neck greater than or equal to 10 mm in length with an angle less than 60° and an internal diameter of 17mm-32mm, or an infrarenal aortic neck greater than or equal to 15 mm in length with an angle between 60 and 75° and an internal diameter of 16mm-30mm
  • Distal iliac sealing distance ≥ 10 mm and an iliac diameter between 8-13 mm or a distal iliac sealing distance ≥ 15 mm and a diameter between 13-21 mm
  • Ability to follow the entire protocol from 1 to 60 months
  • Life expectancy greater than 2 years

Exclusion criteria

  • Patients refusing treatment and follow-up as part of the study
  • Infected or ruptured aneurysm
  • Associated aortic lesion (thoracic or thoracoabdominal aneurysm) requiring management
  • Renal failure defined by creatinine > 2.5 mg/dL or patient in pre-dialysis status and impossibility of intervention with use of CO2 injection
  • New York Heart Association (NYHA) class IV
  • Aneurysmal, dissected distal implantation zone, or including calcifications and/or significant thrombus that could compromise sealing
  • Tortuous iliac and/or femoral access and/or including calcified stenosis
  • Systemic infection that could increase the risk of infection of the endoprosthesis
  • Pathology of the supporting tissues such as collagenosis (Marfan or Ehler-Danlos, etc.)
  • Known drug use
  • Known sensitivity or allergy to the materials to be implanted
  • Patients contraindicated for antiplatelet treatment
  • Patients with an uncontrolled hematological disorder or heparin-induced thrombocytopenia
  • Patients who are pregnant or planning to become pregnant
  • Patients considered hemodynamically unstable or requiring emergency treatment
  • Patients with severe arterial disease leading to a negative "outflow" that may degrade the permeability of implanted stents
  • Scheduled hybrid aortic technique (surgical and endovascular)
  • Patients with complex iliac access outside the manufacturer's indications and recommendations that may lead to procedural failure

Treatment and study plan

TREO Endograft

Device

Post Market collection data in use of TREO modular endografts

Primary outcomes

  1. The primary outcomes of this study are the rate of a composite measure of technical and clinical success at 1 and 12 months to assess efficacy, and the rate of a composite measure of free from major adverse events at 1 month to assess safety.

    Time frame: 12 months

    Definition of the composite of technical success:

    • Successful access to the arterial system using remote arterial exposure, percutaneous technique, surgical access, or open surgical conduits.
    • Successful delivery and deployment of all components of the modular stent graft.
    • Absence of type I or type III endoleaks at the end of angiography that extend beyond 30 days confirmed by imaging*.
    • Patency of all components of the modular stent graft.

    Definition of the composite of clinical success :

    • Technical success
    • No death during the initial procedure, related to the procedure or from aortic-related causes during the initial hospitalization
    • No type I and III endoleaks, at 1 and 12 months
    • No early migration (> 10 mm), at 1 and 12 months
    • No increase in maximum sac diameter of more than 5 mm between 1 and 12 months
    • No aneurysm rupture, at 1 and 12 months
    • No surgical conversion related to aneurysm treatment, at 1 and 12 months

Sponsors and collaborators

Lead sponsor

Vascutek Ltd.

Industry

Registry information

Acronym: RegisTREO

Important dates

Study start
2025
Primary completion
2025
Study completion
2031
First posted
Mar 25, 2025
Registry last updated
Mar 25, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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