Clinical trial NCT00118573: Comparison of Surveillance Versus Aortic Endografting for Small Aneurysm Repair
Official 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
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE4
Conditions: Aortic Aneurysm, Abdominal
Endovascular
Keywords: abdominal aortic aneurysm
randomized controlled trial
endovascular aneurysm repair
Lead sponsor: University Of Perugia
Sponsor class: OTHER
Collaborators: name: William Cook Europe
First posted: 2005-07-11
Enrollment: 360
Sex: ALL
Minimum age (years): 50
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: FACTORIAL
Primary purpose: TREATMENT

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 survival, AAA rupture and AAA related death risks.

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 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.

Eligibility 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

Primary outcomes:
measure: all cause mortality at 3 years
timeFrame: 3 years
Secondary outcomes:
measure: aneurysm related mortality at 3 years
timeFrame: 3 years
measure: aneurysm rupture rates at 3 years
timeFrame: 3 years
measure: perioperative or late complications
timeFrame: 30 days and 3 years
measure: conversion to open repair
timeFrame: 30 days and 3 years
measure: loss of treatment options
timeFrame: 3 years
measure: risks associated with delayed treatment
timeFrame: 30 days and 3 years
measure: aneurysm growth rates
timeFrame: 3 years
measure: quality of life
timeFrame: 30 days, 6 month, 1 year, 3 years
Other outcomes:
Locations:
city: Ostrava
country: Czech Republic
facility: Vitkovice Hospital Ostrava and University Hospital Ostrava - Poruba
city: Lille
country: France
facility: Hopital Cardiologique CHRU
city: Koeln
country: Germany
facility: University of Koeln
city: Muenster
country: Germany
facility: Klinik Fuer Gefasschirurgie st.Franziskus Hospital
city: Haifa
country: Israel
facility: Carmel Medical Center
city: Carrara
country: Italy
facility: U.O.Chirurgia Vascolare Az Osp Carrara
city: Ferrara
country: Italy
facility: Dip Chirurgia Vascolare Osp S.Anna
city: Firenze
country: Italy
facility: Chirurgia Vascolare Az Osp Careggi
city: Firenze
country: Italy
facility: Chirurgia Vascolare Ospedale San Giovanni di Dio
city: Milano
country: Italy
facility: Chirurgia Vascolare, Ospedale San Donato
city: Napoli
country: Italy
facility: Azienda Ospedaliera "Antonio Cardarelli"
city: Perugia
country: Italy
facility: S.C. Chirurgia Vascolare - Università di Perugia
city: Reggio Emilia
country: Italy
facility: S.C. Chirurgia Vascolare Az Osp. S.Maria Nuova
city: Siena
country: Italy
facility: Policlinico Le Scotte - U.O. Chirurgia Vascolare
city: Eindhoven
country: Netherlands
facility: Catharina Ziekenhuis
city: Warsaw
country: Poland
facility: Klinika Chirurgii ogolnej i Chorob Klatki Piersiowej Warsaw
city: Warsaw
country: Poland
facility: Naczyniowej i Transplantacyjnej Akademii Medycznej
city: Barcelona
country: Spain
facility: Institute of Cardiovascular Disease Hospital Clinic University of Barcelona
city: Toledo
country: Spain
facility: Complejo Hospitalario
city: London
country: United Kingdom
facility: St. Mary's Hospital
Study officials:
affiliation: University Of Perugia
name: Piergiorgio Cao, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
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. doi: 10.1016/0140-6736(93)92756-j.
citation: 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.
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.
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. doi: 10.1056/NEJMoa012573.
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. doi: 10.1016/S0140-6736(05)66627-5.
citation: 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.
citation: 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.