Status:
TERMINATED
Comparison of Surveillance Versus Aortic Endografting for Small Aneurysm Repair
Lead Sponsor:
University Of Perugia
Collaborating Sponsors:
William Cook Europe
Conditions:
Aortic Aneurysm, Abdominal
Endovascular
Eligibility:
All Genders
50-80 years
Phase:
PHASE4
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 su...
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 ...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
September 1 2004
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 1 2017
Estimated Enrollment :
360 Patients enrolled
Trial Details
Trial ID
NCT00118573
Start Date
September 1 2004
End Date
September 1 2017
Last Update
December 10 2015
Active Locations (20)
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1
Vitkovice Hospital Ostrava and University Hospital Ostrava - Poruba
Ostrava, Czechia
2
Hopital Cardiologique CHRU
Lille, France
3
University of Koeln
Cologne, Germany
4
Klinik Fuer Gefasschirurgie st.Franziskus Hospital
Münster, Germany