Comparison of Surveillance Versus Aortic Endografting for Small Aneurysm Repair (CAESAR)
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|ClinicalTrials.gov Identifier: NCT00118573|
Recruitment Status : Terminated (lower than anticipated events;slow recruitment;larger than predicted sample size)
First Posted : July 11, 2005
Last Update Posted : December 10, 2015
|Condition or disease||Intervention/treatment||Phase|
|Aortic Aneurysm, Abdominal Endovascular||Procedure: EVAR (Endovascular repair of Abdominal Aortic aneurysm) Procedure: Surveillance||Phase 4|
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.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||360 participants|
|Intervention Model:||Factorial Assignment|
|Masking:||None (Open Label)|
|Official Title:||Randomized Clinical Trial Comparing Surveillance and Selective Surgical Treatment for Abdominal Aortic Aneurysms Less Than 5.5 cm in Diameter Versus Early Endovascular Treatment|
|Study Start Date :||September 2004|
|Actual Primary Completion Date :||May 2010|
|Estimated Study Completion Date :||September 2017|
AAA repair with endografting
Procedure: EVAR (Endovascular repair of Abdominal Aortic aneurysm)
AAA repair with endografting
Active Comparator: Surveillance
Not AAA repair; surveillance
Surveillance of AAA without any repair until AAA will reach 5.5cm, become tender or rapidly grow
Other Name: monitoring abdominal aortic aneurysm without repair
- all cause mortality at 3 years [ Time Frame: 3 years ]
- aneurysm related mortality at 3 years [ Time Frame: 3 years ]
- aneurysm rupture rates at 3 years [ Time Frame: 3 years ]
- perioperative or late complications [ Time Frame: 30 days and 3 years ]
- conversion to open repair [ Time Frame: 30 days and 3 years ]
- loss of treatment options [ Time Frame: 3 years ]
- risks associated with delayed treatment [ Time Frame: 30 days and 3 years ]
- aneurysm growth rates [ Time Frame: 3 years ]
- quality of life [ Time Frame: 30 days, 6 month, 1 year, 3 years ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00118573
|Principal Investigator:||Piergiorgio Cao, MD||University Of Perugia|