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
Recruitment status was Active, not recruiting
Sponsor:
University Of Perugia
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
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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:
|
|
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
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:
|
Aneurysm Aortic Aneurysm Aortic Aneurysm, Abdominal |
Vascular Diseases Cardiovascular Diseases Aortic Diseases |
ClinicalTrials.gov processed this record on May 23, 2013