Status:
NOT_YET_RECRUITING
Technical Evaluation and Results of the Use of TREO® Modular Aortic Endografts for the Treatment of Abdominal Aortic Aneurysms
Lead Sponsor:
Vascutek Ltd.
Conditions:
Aortic Aneurysm Abdominal
Eligibility:
All Genders
45+ years
Brief Summary
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-...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
April 1 2025
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
December 1 2031
Estimated Enrollment :
209 Patients enrolled
Trial Details
Trial ID
NCT06893952
Start Date
April 1 2025
End Date
December 1 2031
Last Update
March 25 2025
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