Comparison of Surveillance Versus Aortic Endografting for Small Aneurysm Repair

• Register: ClinicalTrials.gov
• Last refreshed on: 21 December 2015
• Main ID: NCT00118573
• Date of registration: 30/06/2005
• Prospective Registration: No
• Primary sponsor: University Of Perugia
• Public title: Comparison of Surveillance Versus Aortic Endografting for Small Aneurysm Repair CAESAR
• Scientific 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
• Date of first enrolment: September 2004
• Target sample size: 360
• Recruitment status: Terminated
• URL: https://clinicaltrials.gov/show/NCT00118573
• Study type: Interventional
• Study design: Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Factorial Assignment, Masking: Open Label, Primary Purpose: Treatment
• Phase: Phase 4

Countries of recruitment

Czech Republic, France, Germany, Israel, Italy, Netherlands, Poland, Spain, United Kingdom

Contacts

• Name: Piergiorgio Cao, MD
• Affiliation: University Of Perugia

Key inclusion & exclusion criteria

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



Age minimum: 50 Years
Age maximum: 80 Years
Gender: Both

Health Condition(s) or Problem(s) studied

Endovascular

Aortic Aneurysm, Abdominal

Intervention(s)

Procedure: EVAR (Endovascular repair of Abdominal Aortic aneurysm)

Procedure: Surveillance

Primary Outcome(s)

all cause mortality at 3 years [Time Frame: 3 years]

Secondary Outcome(s)

aneurysm related mortality at 3 years [Time Frame: 3 years]

perioperative or late complications [Time Frame: 30 days and 3 years]

risks associated with delayed treatment [Time Frame: 30 days and 3 years]

aneurysm growth rates [Time Frame: 3 years]

aneurysm rupture rates at 3 years [Time Frame: 3 years]

conversion to open repair [Time Frame: 30 days and 3 years]

loss of treatment options [Time Frame: 3 years]

quality of life [Time Frame: 30 days, 6 month, 1 year, 3 years]

Secondary ID(s)

384/03

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Secondary Sponsor(s)

William Cook Europe