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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified May 2010 by University Of Perugia.
Recruitment status was  Active, not recruiting
Sponsor:
Collaborator:
William Cook Europe
Information provided by:
University Of Perugia
ClinicalTrials.gov Identifier:
NCT00118573
First received: June 30, 2005
Last updated: May 17, 2010
Last verified: May 2010

June 30, 2005
May 17, 2010
September 2004
May 2010   (final data collection date for primary outcome measure)
all cause mortality at 3 years [ Time Frame: 3 years ] [ Designated as safety issue: Yes ]
all cause mortality at 3 years
Complete list of historical versions of study NCT00118573 on ClinicalTrials.gov Archive Site
  • aneurysm related mortality at 3 years [ Time Frame: 3 years ] [ Designated as safety issue: Yes ]
  • aneurysm rupture rates at 3 years [ Time Frame: 3 years ] [ Designated as safety issue: Yes ]
  • perioperative or late complications [ Time Frame: 30 days and 3 years ] [ Designated as safety issue: Yes ]
  • conversion to open repair [ Time Frame: 30 days and 3 years ] [ Designated as safety issue: Yes ]
  • loss of treatment options [ Time Frame: 3 years ] [ Designated as safety issue: No ]
  • risks associated with delayed treatment [ Time Frame: 30 days and 3 years ] [ Designated as safety issue: Yes ]
  • aneurysm growth rates [ Time Frame: 3 years ] [ Designated as safety issue: No ]
  • quality of life [ Time Frame: 30 days, 6 month, 1 year, 3 years ] [ Designated as safety issue: No ]
  • aneurysm related mortality at 3 years
  • aneurysm rupture rates at 3 years
  • perioperative or late complications
  • conversion to open repair
  • loss of treatment options
  • risks associated with delayed treatment
  • aneurysm growth rates
  • quality of life
Not Provided
Not Provided
 
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

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.

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.

Interventional
Phase 4
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Factorial Assignment
Masking: Open Label
Primary Purpose: Treatment
  • Aortic Aneurysm, Abdominal
  • Blood Vessel Prosthesis Implantation
  • 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
  • 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
  • Experimental: EVAR
    AAA repair with endografting
    Intervention: Procedure: EVAR (Endovascular repair of Abdominal Aortic aneurysm)
  • Active Comparator: Surveillance
    Not AAA repair; surveillance
    Intervention: Procedure: Surveillance

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
360
September 2011
May 2010   (final data collection date for primary outcome measure)

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
Both
50 Years to 80 Years
No
Contact information is only displayed when the study is recruiting subjects
Italy,   Israel,   Netherlands,   Spain,   France,   Germany,   Poland,   United Kingdom,   Czech Republic
 
NCT00118573
384/03
Yes
Piergiorgio Cao, MD, University of Perugia
University Of Perugia
William Cook Europe
Principal Investigator: Piergiorgio Cao, MD University Of Perugia
University Of Perugia
May 2010

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP