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Aortic Aneurysm, AbdominalPhase 4CAESARNCT00118573

Comparison of Surveillance Versus Aortic Endografting for Small Aneurysm Repair

A Phase 4 study testing EVAR (Endovascular repair of Abdominal Aortic aneurysm) and Surveillance in people with Aortic Aneurysm, Abdominal and Endovascular, run by University Of Perugia at 20 sites in 9 countries.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record
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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. Read more about this study

Who is it for?
Ages 50 to 80 years
Conditions the study is for
Aortic Aneurysm, Abdominal, Endovascular
What is being tested?
EVAR (Endovascular repair of Abdominal Aortic aneurysm) and Surveillance
Type of treatment
Surgery or procedure
Could I receive a placebo?
No, everyone receives an active treatment
How many people
360 participants
Where
20 sitesin 9 countries
Study dates
Sep 2004to Sep 2017
Phase
Phase 4
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 50 to 80 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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

Trial locations and contacts

20 sites in 9 countries.

20 sites in 9 countries

Italy9 sites

  • U.O.Chirurgia Vascolare Az Osp Carrara

    Carrara

  • Dip Chirurgia Vascolare Osp S.Anna

    Ferrara

  • Chirurgia Vascolare Az Osp Careggi

    Florence

  • Chirurgia Vascolare Ospedale San Giovanni di Dio

    Florence

  • Chirurgia Vascolare, Ospedale San Donato

    Milan

  • Azienda Ospedaliera "Antonio Cardarelli"

    Naples, 80131

  • S.C. Chirurgia Vascolare - Università di Perugia

    Perugia, 06122

  • S.C. Chirurgia Vascolare Az Osp. S.Maria Nuova

    Reggio Emilia

  • Policlinico Le Scotte - U.O. Chirurgia Vascolare

    Siena

Other trials in Italy

Germany2 sites

  • University of Koeln

    Cologne

  • Klinik Fuer Gefasschirurgie st.Franziskus Hospital

    Münster

Other trials in Germany

Poland2 sites

  • Klinika Chirurgii ogolnej i Chorob Klatki Piersiowej Warsaw

    Warsaw

  • Naczyniowej i Transplantacyjnej Akademii Medycznej

    Warsaw

Other trials in Poland

Spain2 sites

  • Institute of Cardiovascular Disease Hospital Clinic University of Barcelona

    Barcelona

  • Complejo Hospitalario

    Toledo

Other trials in Spain

Czechia1 site

  • Vitkovice Hospital Ostrava and University Hospital Ostrava - Poruba

    Ostrava

Other trials in Czechia

France1 site

  • Hopital Cardiologique CHRU

    Lille

Other trials in France

Israel1 site

  • Carmel Medical Center

    Haifa

Other trials in Israel

Netherlands1 site

  • Catharina Ziekenhuis

    Eindhoven

Other trials in Netherlands

United Kingdom1 site

  • St. Mary's Hospital

    London, W21NY

Other trials in United Kingdom

About this study

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

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.

Read the 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.

Being tested
EVAR (Endovascular repair of Abdominal Aortic aneurysm), Surveillance
Keywords
abdominal aortic aneurysm, randomized controlled trial, endovascular aneurysm repair
Medical subject headings
Aortic Aneurysm, Abdominal

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • EVAR (Endovascular repair of Abdominal Aortic aneurysm)Procedure or surgery

    Also called early endovascular repair of abdominal aortic aneurysm, repair of abdominal aneurysm by aortic endografting

    AAA repair with endografting

  • SurveillanceProcedure or surgery

    Also called monitoring abdominal aortic aneurysm without repair

    Surveillance of AAA without any repair until AAA will reach 5.5cm, become tender or rapidly grow

Study groups in NCT00118573
Study groupRoleWhat they receive
EVARExperimentalAAA repair with endografting
Receives: Procedure: EVAR (Endovascular repair of Abdominal Aortic aneurysm)
SurveillanceActive comparatorNot AAA repair; surveillance
Receives: Procedure: Surveillance

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. all cause mortality at 3 years

    Measured: 3 years

Secondary outcomes (8)

  1. aneurysm related mortality at 3 years

    Measured: 3 years

  2. aneurysm rupture rates at 3 years

    Measured: 3 years

  3. perioperative or late complications

    Measured: 30 days and 3 years

  4. conversion to open repair

    Measured: 30 days and 3 years

  5. loss of treatment options

    Measured: 3 years

  6. risks associated with delayed treatment

    Measured: 30 days and 3 years

  7. aneurysm growth rates

    Measured: 3 years

  8. quality of life

    Measured: 30 days, 6 month, 1 year, 3 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted11 Jul 2005 (estimated)
  2. Study startSep 2004
  3. Primary completionMay 2010
  4. Study completionSep 2017 (estimated)

Why it stopped: lower than anticipated events;slow recruitment;larger than predicted sample size

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 4
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Factorial
Masking
None (open label)
Enrolment
360 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00118573
Sponsor's protocol ID
384/03
Acronym
CAESAR
Status last verified
Dec 2015
First submitted
30 Jun 2005
Last updated
10 Dec 2015
Results posted
No
Data monitoring committee
Yes

Publications

  • 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.

    PubMed 8696960

  • 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.

    PubMed 7901685

  • 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.

    PubMed 12000814

  • 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.

    PubMed 9853436

  • 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.

    PubMed 12000813

  • 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.

    PubMed 15978925

  • 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.

    PubMed 21145269

  • 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.

    PubMed 20869890

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing EVAR (Endovascular repair of Abdominal Aortic aneurysm) and Surveillance in people with Aortic Aneurysm, Abdominal and Endovascular, run by University Of Perugia at 20 sites in 9 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: stopped early, as of the sponsor's last update on 10 Dec 2015. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 20 sites in Italy, Germany, Poland, Spain, Czechia and 4 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study was stopped early (reason given: lower than anticipated events;slow recruitment;larger than predicted sample size). Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

all cause mortality at 3 years (time frame: 3 years). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00118573, which also lists 8 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Dec 2015.

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