Aortic Aneurysm, Abdominal, Endovascular
Conditions
Keywords
abdominal aortic aneurysm, randomized controlled trial, endovascular aneurysm repair
Brief summary
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
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.
Interventions
PROCEDUREEVAR (Endovascular repair of Abdominal Aortic aneurysm)
AAA repair with endografting
PROCEDURESurveillance
Surveillance of AAA without any repair until AAA will reach 5.5cm, become tender or rapidly grow
Sponsors
William Cook Europe
University Of Perugia
Study design
Allocation
RANDOMIZED
Intervention model
FACTORIAL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
50 Years to 80 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| all cause mortality at 3 years | 3 years |
Secondary
| Measure | Time frame |
|---|---|
| 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 |
| aneurysm related mortality at 3 years | 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 |
| loss of treatment options | 3 years |
Countries
Czechia, France, Germany, Israel, Italy, Netherlands, Poland, Spain, United Kingdom
Outcome results
None listed