Comparison of Surveillance Versus Aortic Endografting for Small Aneurysm Repair

Aortic Aneurysm, Abdominal Clinical Trial

— CAESAR  

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00118573
• Other study ID #: 384/03
• Status: Terminated
• Phase: Phase 4
• First received: June 30, 2005
• Last updated: December 9, 2015
• Start date: September 2004
• Est. completion date: September 2017

Study information

• Verified date: December 2015
• Source: University Of Perugia
• Contact: n/a
• Is FDA regulated: No
• Health authority: Italy: Ministry of Health
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• 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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Factorial Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Aneurysm
• Aortic Aneurysm
• Aortic Aneurysm, Abdominal
• Endovascular

Intervention

Procedure:
• 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

Locations

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

Sponsors (2)

Lead Sponsor	Collaborator
University Of Perugia	William Cook Europe

Countries where clinical trial is conducted

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

References & Publications (6)

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

Outcome

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