Comparison of Surveillance Versus Aortic Endografting for Small Aneurysm Repair
NCT ID: NCT00118573
Last Updated: 2015-12-10
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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TERMINATED
PHASE4
360 participants
INTERVENTIONAL
2004-09-30
2017-09-30
Brief Summary
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Detailed Description
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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.
Conditions
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Keywords
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Study Design
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RANDOMIZED
FACTORIAL
TREATMENT
NONE
Study Groups
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EVAR
AAA repair with endografting
EVAR (Endovascular repair of Abdominal Aortic aneurysm)
AAA repair with endografting
Surveillance
Not AAA repair; surveillance
Surveillance
Surveillance of AAA without any repair until AAA will reach 5.5cm, become tender or rapidly grow
Interventions
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EVAR (Endovascular repair of Abdominal Aortic aneurysm)
AAA repair with endografting
Surveillance
Surveillance of AAA without any repair until AAA will reach 5.5cm, become tender or rapidly grow
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
* 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
50 Years
80 Years
ALL
No
Sponsors
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William Cook Europe
INDUSTRY
University Of Perugia
OTHER
Responsible Party
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Piergiorgio Cao, MD
Professor of Vascular Surgery
Principal Investigators
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Piergiorgio Cao, MD
Role: PRINCIPAL_INVESTIGATOR
University Of Perugia
Locations
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Vitkovice Hospital Ostrava and University Hospital Ostrava - Poruba
Ostrava, , Czechia
Hopital Cardiologique CHRU
Lille, , France
University of Koeln
Cologne, , Germany
Klinik Fuer Gefasschirurgie st.Franziskus Hospital
Münster, , Germany
Carmel Medical Center
Haifa, , Israel
U.O.Chirurgia Vascolare Az Osp Carrara
Carrara, , Italy
Dip Chirurgia Vascolare Osp S.Anna
Ferrara, , Italy
Chirurgia Vascolare Az Osp Careggi
Florence, , Italy
Chirurgia Vascolare Ospedale San Giovanni di Dio
Florence, , Italy
Chirurgia Vascolare, Ospedale San Donato
Milan, , 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, , Italy
Catharina Ziekenhuis
Eindhoven, , Netherlands
Klinika Chirurgii ogolnej i Chorob Klatki Piersiowej Warsaw
Warsaw, , Poland
Naczyniowej i Transplantacyjnej Akademii Medycznej
Warsaw, , Poland
Institute of Cardiovascular Disease Hospital Clinic University of Barcelona
Barcelona, , Spain
Complejo Hospitalario
Toledo, , Spain
St. Mary's Hospital
London, , United Kingdom
Countries
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References
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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. doi: 10.1161/01.atv.16.8.963.
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. doi: 10.1016/0140-6736(93)92756-j.
United Kingdom Small Aneurysm Trial Participants; Powell JT, Brady AR, Brown LC, Fowkes FG, Greenhalgh RM, Ruckley CV, Thompson SG. 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. doi: 10.1056/NEJMoa013527.
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.
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. doi: 10.1056/NEJMoa012573.
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. doi: 10.1016/S0140-6736(05)66627-5.
De Rango P, Verzini F, Parlani G, Cieri E, Romano L, Loschi D, Cao P; Comparison of surveillance vs. Aortic Endografting for Small Aneurysm Repair (CAESAR) Investigators. Quality of life in patients with small abdominal aortic aneurysm: the effect of early endovascular repair versus surveillance in the CAESAR trial. Eur J Vasc Endovasc Surg. 2011 Mar;41(3):324-31. doi: 10.1016/j.ejvs.2010.11.005. Epub 2010 Dec 9.
Cao P, De Rango P, Verzini F, Parlani G, Romano L, Cieri E; CAESAR Trial Group. Comparison of surveillance versus aortic endografting for small aneurysm repair (CAESAR): results from a randomised trial. Eur J Vasc Endovasc Surg. 2011 Jan;41(1):13-25. doi: 10.1016/j.ejvs.2010.08.026. Epub 2010 Sep 25.
Other Identifiers
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384/03
Identifier Type: -
Identifier Source: org_study_id