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Prediction of Abdominal Aortic Aneurysm Shrinkage After Stent-placement With Artificial Intelligence (ARTinEVAR)

R

Rijnstate Hospital

Status

Enrolling

Conditions

AAA - Abdominal Aortic Aneurysm

Study type

Observational

Funder types

Other

Identifiers

NCT06250998
2021-1986

Details and patient eligibility

About

The goal of this observational study is to find out what factors contribute to a good treatment outcome in patients who have received a stent for their dilation of the main abdominal artery (abdominal aortic aneurysm or AAA). The primary goal of this study is to build a prediction model for abdominal aortic aneurysm shrinkage one year after the treatment.

Enrollment

1,000 estimated patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

  • Age ≥ 18 years;
  • Elective, initially technically successful (as described by the ESVS guidelines11), infrarenal EVAR for unruptured infrarenal AAA;
  • Implanted endograft is a Gore Excluder, Medtronic Endurant, Cook Zenith, Cordis Incraft, Endologix AFX, Jotec E-Tegra, or Vascutek Anaconda endograft;
  • Follow-up of the AAA of at least one year with imaging of the same modality as the preoperative imaging;
  • Axial reconstructions of preoperative CT angiography available, preferably in the arterial phase and with 3 mm or smaller slice thickness.

Exclusion criteria

  • Patients with ruptured or symptomatic AAA;
  • Patients that were treated with fenestrated or branched endografts, iliac branched devices, non-CE marked devices within trial setting, other endografts (EVAS cases) or chimney procedures;
  • Acute procedures;
  • Reintervention before one year follow-up;
  • Revision cases after previous open or endovascular aneurysm repair of an AAA;

Trial contacts and locations

5

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Central trial contact

Rianne E van Rijswijk, MSc

Data sourced from clinicaltrials.gov

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