NCT00118573

Comparison of Surveillance Versus Aortic Endografting for Small Aneurysm Repair

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

• Status: Terminated
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 360 (actual)
• Sponsor: University Of Perugia · Academic / Other
• Sex: All
• Age: 50 Years – 80 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Aortic Aneurysm, Abdominal
• Endovascular

Interventions

Type	Name	Description
PROCEDURE	EVAR (Endovascular repair of Abdominal Aortic aneurysm)	AAA repair with endografting
PROCEDURE	Surveillance	Surveillance of AAA without any repair until AAA will reach 5.5cm, become tender or rapidly grow

Timeline

• Start date: 2004-09-01
• Primary completion: 2010-05-01
• Completion: 2017-09-01
• First posted: 2005-07-11
• Last updated: 2015-12-10

Locations

20 sites across 9 countries: Czechia, France, Germany, Israel, Italy, Netherlands, Poland, Spain, United Kingdom