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

December 9, 2015 updated by: Piergiorgio Cao, MD, University Of Perugia

Randomized Clinical Trial Comparing Surveillance and Selective Surgical Treatment for Abdominal Aortic Aneurysms Less Than 5.5 cm in Diameter Versus Early Endovascular Treatment

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.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

360

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Czech Republic
      • Ostrava, Czech Republic
        • Vitkovice Hospital Ostrava and University Hospital Ostrava - Poruba
  • France
      • Lille, France
        • Hopital Cardiologique CHRU
  • Germany
      • Koeln, Germany
        • University of Koeln
      • Muenster, Germany
        • Klinik Fuer Gefasschirurgie st.Franziskus Hospital
  • Israel
      • Haifa, Israel
        • Carmel Medical Center
  • Italy
      • Carrara, Italy
        • U.O.Chirurgia Vascolare Az Osp Carrara
      • Ferrara, Italy
        • Dip Chirurgia Vascolare Osp S.Anna
      • Firenze, Italy
        • Chirurgia Vascolare Az Osp Careggi
      • Firenze, Italy
        • Chirurgia Vascolare Ospedale San Giovanni di Dio
      • Milano, Italy
        • Chirurgia Vascolare, Ospedale San Donato
      • Napoli, Italy, 80131
        • Azienda Ospedaliera "Antonio Cardarelli"
      • Perugia, Italy, 06122
        • S.C. Chirurgia Vascolare - Università di Perugia
      • Reggio Emilia, Italy
        • S.C. Chirurgia Vascolare Az Osp. S.Maria Nuova
      • Siena, Italy
        • Policlinico Le Scotte - U.O. Chirurgia Vascolare
  • Netherlands
      • Eindhoven, Netherlands
        • Catharina Ziekenhuis
  • Poland
      • Warsaw, Poland
        • Klinika Chirurgii ogolnej i Chorob Klatki Piersiowej Warsaw
      • Warsaw, Poland
        • Naczyniowej i Transplantacyjnej Akademii Medycznej
  • Spain
      • Barcelona, Spain
        • Institute of Cardiovascular Disease Hospital Clinic University of Barcelona
      • Toledo, Spain
        • Complejo Hospitalario
  • United Kingdom
      • London, United Kingdom, W21NY
        • St. Mary's Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

50 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Factorial Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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 Names:
  • monitoring abdominal aortic aneurysm without repair

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
all cause mortality at 3 years
Time Frame: 3 years
3 years

Secondary Outcome Measures

Outcome Measure
Time Frame
aneurysm related mortality at 3 years
Time Frame: 3 years
3 years
aneurysm rupture rates at 3 years
Time Frame: 3 years
3 years
perioperative or late complications
Time Frame: 30 days and 3 years
30 days and 3 years
conversion to open repair
Time Frame: 30 days and 3 years
30 days and 3 years
loss of treatment options
Time Frame: 3 years
3 years
risks associated with delayed treatment
Time Frame: 30 days and 3 years
30 days and 3 years
aneurysm growth rates
Time Frame: 3 years
3 years
quality of life
Time Frame: 30 days, 6 month, 1 year, 3 years
30 days, 6 month, 1 year, 3 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University Of Perugia

Collaborators

William Cook Europe

Investigators

  • Principal Investigator: Piergiorgio Cao, MD, University Of Perugia

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 2004

Primary Completion (Actual)

May 1, 2010

Study Completion (Anticipated)

September 1, 2017

Study Registration Dates

First Submitted

June 30, 2005

First Submitted That Met QC Criteria

June 30, 2005

First Posted (Estimate)

July 11, 2005

Study Record Updates

Last Update Posted (Estimate)

December 10, 2015

Last Update Submitted That Met QC Criteria

December 9, 2015

Last Verified

December 1, 2015

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 384/03

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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