Please select the eligibility criteria that correspond to the clinical trial below.
Title: CSP #498 - Open Versus Endovascular Repair (OVER) Trial for Abdominal Aortic Aneurysms
Brief Summary: A multi-center, randomized clinical trial that will compare endovascular repair with standard open surgery in the repair of abdominal aortic aneurysms (AAA). Long and short-term results as well as the cost and quality of life associated with these two strategies for AAA repair will be compared.


Options:
A: 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
B: Inclusion Criteria:

* AAA with a maximum external diameter in any plane greater than or equal to 5 cm.
* An iliac aneurysm (associated with an AAA) with a maximum external diameter in any plane greater than or equal to 3 cm.
* AAA greater than or equal to 4.5 cm and the AAA has increased by greater than or equal to 0.7 cm in diameter in 6 months.
* An AAA greater than or equal to 4.5 cm and the AAA has increased by greater than or equal to 1 cm in diameter in 12 months.
* An AAA greater than or equal to 4.5 cm and the AAA is saccular (i.e., a portion of the circumference of the aorta at the level of the aneurysm is considered normal based on CT scan or MRI).
* An AAA greater than or equal to 4.5 cm and the AAA is associated with distal embolism.

  * as measured from two imaging studies (ultrasound CT scan or MRI) within the appropriate interval, the later one within 6 months of randomization.

Exclusion Criteria:

* Patient has had a previous AAA repair procedure
* Evidence of AAA rupture by imaging test
* AAA is not elective (i.e., urgent or emergent operation, usually due to suspected rupture)
* Likelihood of poor compliance to the protocol
* Patient refused randomization
* Physician refused randomization
C: Inclusion Criteria:

* 40 to 90 years of age
* Meet all indications for use as stated in the Medtronic Vascular AAA Endograft Instructions for Use
* Maximum aneurysm diameter of 4-5cm
* If female patient with child bearing potential, must have a documented negative pregnancy test within seven(7)days prior to inclusion
* Patient is willing and able to comply with the specified follow-up evaluation
* Life expectancy at least 3 years

Exclusion Criteria:

* Meet any of the Contraindications stated in the Medtronic Vascular AAA Endograft instructions for Use
* Known co-existing condition with a life expectancy of less than 3 years
* Major surgical or interventional procedure (vascular and/or non-vascular)within 30 days prior to study enrollment
* Subjects enrolled in another clinical trial or anticipated to be included into a trial, which may interfere with this study, or subjects already enrolled in this trial before.
* Planned conduit procedure for introduction of endograft
D: Inclusion Criteria:

* Asymptomatic, infrarenal AAA that requires surgery
* Adequate infrarenal neck
* Other aortic-iliac anatomical configuration suitable for EVAR according to the criteria of the device to be used
* Patient having a life expectation of at least 2 years and cleared for transabdominal intervention
* Signed informed consent

Exclusion Criteria:

* ruptured AAA or symptomatic AAA, which requires emergency surgery
* maximum aneurysm diameter\< 5.0 cm
* suprarenal AAA
* Inflammatory AAA (more than minimal wall thickening)
* infrarenal neck unsuitable for endovascular fixation or aortic-iliac anatomic configuration otherwise unsuitable for EVAR according to criteria of the device to be used
* bilateral retroperitoneal incision required for EVAR
* sacrifice of both hypogastric arteries required
* anatomical variations, i.e. horseshoe-kidney, arteries requiring reimplantation
* patient unsuitable for laparotomy
* administration of contrast agent not possible: proved, severe systemic reaction to contrast agent
* active infection present
* transplantation-patients
* limited life expectation due to other illness (\< 2 year)
* non-iatrogenic bleeding diathesis
* connective tissue disease

Answer: B