Aortic Aneurysm, Abdominal Clinical Trial
— CAESAROfficial 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
Verified date | December 2015 |
Source | University Of Perugia |
Contact | n/a |
Is FDA regulated | No |
Health authority | Italy: Ministry of Health |
Study type | Interventional |
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.
Status | Terminated |
Enrollment | 360 |
Est. completion date | September 2017 |
Est. primary completion date | May 2010 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 50 Years to 80 Years |
Eligibility |
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 |
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Factorial Assignment, Masking: Open Label, Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
Czech Republic | Vitkovice Hospital Ostrava and University Hospital Ostrava - Poruba | Ostrava | |
France | Hopital Cardiologique CHRU | Lille | |
Germany | University of Koeln | Koeln | |
Germany | Klinik Fuer Gefasschirurgie st.Franziskus Hospital | Muenster | |
Israel | Carmel Medical Center | Haifa | |
Italy | U.O.Chirurgia Vascolare Az Osp Carrara | Carrara | |
Italy | Dip Chirurgia Vascolare Osp S.Anna | Ferrara | |
Italy | Chirurgia Vascolare Az Osp Careggi | Firenze | |
Italy | Chirurgia Vascolare Ospedale San Giovanni di Dio | Firenze | |
Italy | Chirurgia Vascolare, Ospedale San Donato | Milano | |
Italy | Azienda Ospedaliera "Antonio Cardarelli" | Napoli | |
Italy | S.C. Chirurgia Vascolare - Università di Perugia | Perugia | |
Italy | S.C. Chirurgia Vascolare Az Osp. S.Maria Nuova | Reggio Emilia | |
Italy | Policlinico Le Scotte - U.O. Chirurgia Vascolare | Siena | |
Netherlands | Catharina Ziekenhuis | Eindhoven | |
Poland | Klinika Chirurgii ogolnej i Chorob Klatki Piersiowej Warsaw | Warsaw | |
Poland | Naczyniowej i Transplantacyjnej Akademii Medycznej | Warsaw | |
Spain | Institute of Cardiovascular Disease Hospital Clinic University of Barcelona | Barcelona | |
Spain | Complejo Hospitalario | Toledo | |
United Kingdom | St. Mary's Hospital | London |
Lead Sponsor | Collaborator |
---|---|
University Of Perugia | William Cook Europe |
Czech Republic, France, Germany, Israel, Italy, Netherlands, Poland, Spain, United Kingdom,
Alcorn HG, Wolfson SK Jr, Sutton-Tyrrell K, Kuller LH, O'Leary D. Risk factors for abdominal aortic aneurysms in older adults enrolled in The Cardiovascular Health Study. Arterioscler Thromb Vasc Biol. 1996 Aug;16(8):963-70. — View Citation
EVAR trial participants. Endovascular aneurysm repair versus open repair in patients with abdominal aortic aneurysm (EVAR trial 1): randomised controlled trial. Lancet. 2005 Jun 25-Jul 1;365(9478):2179-86. — View Citation
Lederle FA, Wilson SE, Johnson GR, Reinke DB, Littooy FN, Acher CW, Ballard DJ, Messina LM, Gordon IL, Chute EP, Krupski WC, Busuttil SJ, Barone GW, Sparks S, Graham LM, Rapp JH, Makaroun MS, Moneta GL, Cambria RA, Makhoul RG, Eton D, Ansel HJ, Freischlag JA, Bandyk D; Aneurysm Detection and Management Veterans Affairs Cooperative Study Group. Immediate repair compared with surveillance of small abdominal aortic aneurysms. N Engl J Med. 2002 May 9;346(19):1437-44. — View Citation
Mortality results for randomised controlled trial of early elective surgery or ultrasonographic surveillance for small abdominal aortic aneurysms. The UK Small Aneurysm Trial Participants. Lancet. 1998 Nov 21;352(9141):1649-55. — View Citation
Scott RA, Wilson NM, Ashton HA, Kay DN. Is surgery necessary for abdominal aortic aneurysm less than 6 cm in diameter? Lancet. 1993 Dec 4;342(8884):1395-6. — View Citation
United Kingdom Small Aneurysm Trial Participants. Long-term outcomes of immediate repair compared with surveillance of small abdominal aortic aneurysms. N Engl J Med. 2002 May 9;346(19):1445-52. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | all cause mortality at 3 years | 3 years | Yes | |
Secondary | aneurysm related mortality at 3 years | 3 years | Yes | |
Secondary | aneurysm rupture rates at 3 years | 3 years | Yes | |
Secondary | perioperative or late complications | 30 days and 3 years | Yes | |
Secondary | conversion to open repair | 30 days and 3 years | Yes | |
Secondary | loss of treatment options | 3 years | No | |
Secondary | risks associated with delayed treatment | 30 days and 3 years | Yes | |
Secondary | aneurysm growth rates | 3 years | No | |
Secondary | quality of life | 30 days, 6 month, 1 year, 3 years | No |
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