Comparison of Surveillance Versus Aortic Endografting for Small Aneurysm Repair

Study Overview
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Brief Summary
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Objective of the present study is to compare endovascular repair versus surveillance and, eventually delay treatment in patients with small abdominal aortic aneurysms (AAA), with respect to patient survival, AAA rupture and AAA related death risks.

Detailed Description
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The study will include patients with small AAA (diameter 4.1 to 5.4 cm defined by Computed Tomographic scan) suitable for endovascular repair (EVAR). Randomization is designed with equal probability of assignment to each of the two groups (ie, immediate endovascular repair or surveillance group) by means of a computer-generated -random-number list . After eligibility is verified, assignment will be made using a computer database held at the Coordinating Centre. In the immediate repair group, endovascular repair with introduction of an aortic endograft (Cook Zenith) will be performed within six weeks from randomization. In the surveillance group, patients are followed without repair until the aneurysm reaches 5.5 cm in diameter, or enlarges at least 1.0 cm in one year, or until patient develops symptoms that are attributed to the aneurysm by the attending investigator. When one of these criteria is met, endovascular repair (if the patient remains a candidate for EVAR), or open repair will be carried out.

Official Title
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Randomized Clinical Trial Comparing Surveillance and Selective Surgical Treatment for Abdominal Aortic Aneurysms Less Than 5.5 cm in Diameter Versus Early Endovascular Treatment

Conditions
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Aortic Aneurysm, Abdominal, Endovascular

Intervention / Treatment
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* Procedure: EVAR (Endovascular repair of Abdominal Aortic aneurysm)
* Procedure: Surveillance


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients of 50-80 years of age Non symptomatic infrarenal AAA of 4.1 to 5.4 cm in diameter measured by CT performed within 3 months before randomization Adequate infrarenal aortic neck (length > 15 mm diameter < 30 mm) and other anatomical configurations suitable for EVAR Patients have a life expectancy of at least 5 years Signed informed consent Exclusion Criteria: Ruptured or symptomatic AAA AAA maximum diameter >= 5.5 cm Suprarenal or thoracic aorta aneurysm of more than 4.0 cm Patient unsuitable for administration of contrast agent Severe heart, lung, liver or renal disease (serum creatinine >= 3mg/dl) Need for adjunctive major surgical or vascular procedures within 1 month High likelihood of non compliance with follow-up requirements

Ages Eligible for Study
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Minimum Age: 50 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Factorial Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: EVAR<br>AAA repair with endografting | Procedure: EVAR (Endovascular repair of Abdominal Aortic aneurysm)<br>* AAA repair with endografting<br>* Other names: repair of abdominal aneurysm by aortic endografting;|
| Active Comparator: Surveillance<br>Not AAA repair; surveillance | Procedure: Surveillance<br>* Surveillance of AAA without any repair until AAA will reach 5.5cm, become tender or rapidly grow<br>* Other names: monitoring abdominal aortic aneurysm without repair;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| all cause mortality at 3 years |  | 3 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| aneurysm related mortality at 3 years |  | 3 years | 
| aneurysm rupture rates at 3 years |  | 3 years | 
| perioperative or late complications |  | 30 days and 3 years | 
| conversion to open repair |  | 30 days and 3 years | 
| loss of treatment options |  | 3 years | 
| risks associated with delayed treatment |  | 30 days and 3 years | 
| aneurysm growth rates |  | 3 years | 
| quality of life |  | 30 days, 6 month, 1 year, 3 years | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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abdominal aortic aneurysm, randomized controlled trial, endovascular aneurysm repair