Comparison of Surveillance Versus Aortic Endografting for Small Aneurysm Repair (CAESAR)

The recruitment status of this study is unknown because the information has not been verified recently.
Verified May 2010 by University Of Perugia.
Recruitment status was  Active, not recruiting
Sponsor:
Collaborator:
William Cook Europe
Information provided by:
University Of Perugia
ClinicalTrials.gov Identifier:
NCT00118573
First received: June 30, 2005
Last updated: May 17, 2010
Last verified: May 2010
  Purpose

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.


Condition Intervention Phase
Aortic Aneurysm, Abdominal
Blood Vessel Prosthesis Implantation
Procedure: EVAR (Endovascular repair of Abdominal Aortic aneurysm)
Procedure: Surveillance
Phase 4

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

Resource links provided by NLM:


Further study details as provided by University Of Perugia:

Primary Outcome Measures:
  • all cause mortality at 3 years [ Time Frame: 3 years ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • aneurysm related mortality at 3 years [ Time Frame: 3 years ] [ Designated as safety issue: Yes ]
  • aneurysm rupture rates at 3 years [ Time Frame: 3 years ] [ Designated as safety issue: Yes ]
  • perioperative or late complications [ Time Frame: 30 days and 3 years ] [ Designated as safety issue: Yes ]
  • conversion to open repair [ Time Frame: 30 days and 3 years ] [ Designated as safety issue: Yes ]
  • loss of treatment options [ Time Frame: 3 years ] [ Designated as safety issue: No ]
  • risks associated with delayed treatment [ Time Frame: 30 days and 3 years ] [ Designated as safety issue: Yes ]
  • aneurysm growth rates [ Time Frame: 3 years ] [ Designated as safety issue: No ]
  • quality of life [ Time Frame: 30 days, 6 month, 1 year, 3 years ] [ Designated as safety issue: No ]

Enrollment: 360
Study Start Date: September 2004
Estimated Study Completion Date: September 2011
Primary Completion Date: May 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: EVAR
AAA repair with endografting
Procedure: EVAR (Endovascular repair of Abdominal Aortic aneurysm)
AAA repair with endografting
Other Names:
  • early endovascular repair of abdominal aortic aneurysm
  • repair of abdominal aneurysm by aortic endografting
Active Comparator: Surveillance
Not AAA repair; surveillance
Procedure: Surveillance
Surveillance of AAA without any repair until AAA will reach 5.5cm, become tender or rapidly grow
Other Name: monitoring abdominal aortic aneurysm without repair

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

Ages Eligible for Study:   50 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00118573

Locations
Czech Republic
Vitkovice Hospital Ostrava and University Hospital Ostrava - Poruba
Ostrava, Czech Republic
France
Hopital Cardiologique CHRU
Lille, France
Germany
University of Koeln
Koeln, Germany
Klinik Fuer Gefasschirurgie st.Franziskus Hospital
Muenster, Germany
Israel
Carmel Medical Center
Haifa, Israel
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, 80131
S.C. Chirurgia Vascolare - Università di Perugia
Perugia, Italy, 06122
S.C. Chirurgia Vascolare Az Osp. S.Maria Nuova
Reggio Emilia, Italy
Policlinico Le Scotte - U.O. Chirurgia Vascolare
Siena, Italy
Netherlands
Catharina Ziekenhuis
Eindhoven, Netherlands
Poland
Klinika Chirurgii ogolnej i Chorob Klatki Piersiowej Warsaw
Warsaw, Poland
Naczyniowej i Transplantacyjnej Akademii Medycznej
Warsaw, Poland
Spain
Institute of Cardiovascular Disease Hospital Clinic University of Barcelona
Barcelona, Spain
Complejo Hospitalario
Toledo, Spain
United Kingdom
St. Mary's Hospital
London, United Kingdom, W21NY
Sponsors and Collaborators
University Of Perugia
William Cook Europe
Investigators
Principal Investigator: Piergiorgio Cao, MD University Of Perugia
  More Information

Additional Information:
Publications:
Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Piergiorgio Cao, MD, University of Perugia
ClinicalTrials.gov Identifier: NCT00118573     History of Changes
Other Study ID Numbers: 384/03
Study First Received: June 30, 2005
Last Updated: May 17, 2010
Health Authority: Italy: Ministry of Health

Keywords provided by University Of Perugia:
abdominal aortic aneurysm
randomized controlled trial
endovascular aneurysm repair

Additional relevant MeSH terms:
Aortic Aneurysm
Aneurysm
Aortic Aneurysm, Abdominal
Vascular Diseases
Cardiovascular Diseases
Aortic Diseases

ClinicalTrials.gov processed this record on September 22, 2014