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Comparison of Surveillance Versus Aortic Endografting for Small Aneurysm Repair (CAESAR)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. 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
William Cook Europe
Information provided by (Responsible Party):
Piergiorgio Cao, MD, University Of Perugia

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.

Condition or disease Intervention/treatment Phase
Aortic Aneurysm, Abdominal Endovascular Procedure: EVAR (Endovascular repair of Abdominal Aortic aneurysm) Procedure: Surveillance Phase 4

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 360 participants
Allocation: Randomized
Intervention Model: Factorial Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
Experimental: EVAR
AAA repair with endografting
Procedure: EVAR (Endovascular repair of Abdominal Aortic aneurysm)
AAA repair with endografting
Other Names:
  • early endovascular repair of abdominal aortic aneurysm
  • repair of abdominal aneurysm by aortic endografting

Active Comparator: Surveillance
Not AAA repair; surveillance
Procedure: 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

Primary Outcome Measures :
  1. all cause mortality at 3 years [ Time Frame: 3 years ]

Secondary Outcome Measures :
  1. aneurysm related mortality at 3 years [ Time Frame: 3 years ]
  2. aneurysm rupture rates at 3 years [ Time Frame: 3 years ]
  3. perioperative or late complications [ Time Frame: 30 days and 3 years ]
  4. conversion to open repair [ Time Frame: 30 days and 3 years ]
  5. loss of treatment options [ Time Frame: 3 years ]
  6. risks associated with delayed treatment [ Time Frame: 30 days and 3 years ]
  7. aneurysm growth rates [ Time Frame: 3 years ]
  8. quality of life [ Time Frame: 30 days, 6 month, 1 year, 3 years ]

Information from the National Library of Medicine

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Ages Eligible for Study:   50 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts 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

Information from the National Library of Medicine

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 identifier (NCT number): NCT00118573

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Sponsors and Collaborators
University Of Perugia
William Cook Europe
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Principal Investigator: Piergiorgio Cao, MD University Of Perugia

Publications automatically indexed to this study by Identifier (NCT Number):
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Responsible Party: Piergiorgio Cao, MD, Professor of Vascular Surgery, University Of Perugia Identifier: NCT00118573    
Other Study ID Numbers: 384/03
First Posted: July 11, 2005    Key Record Dates
Last Update Posted: December 10, 2015
Last Verified: December 2015
Keywords provided by Piergiorgio Cao, MD, University Of Perugia:
abdominal aortic aneurysm
randomized controlled trial
endovascular aneurysm repair
Additional relevant MeSH terms:
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Aortic Aneurysm
Aortic Aneurysm, Abdominal
Vascular Diseases
Cardiovascular Diseases
Aortic Diseases