NCT00118573

Brief 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.

Trial Health

63
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
360

participants targeted

Target at P75+ for phase_4

Timeline
Completed

Started Sep 2004

Longer than P75 for phase_4

Geographic Reach
9 countries

20 active sites

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2004

Completed
10 months until next milestone

First Submitted

Initial submission to the registry

June 30, 2005

Completed
11 days until next milestone

First Posted

Study publicly available on registry

July 11, 2005

Completed
4.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2010

Completed
7.3 years until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2017

Completed
Last Updated

December 10, 2015

Status Verified

December 1, 2015

Enrollment Period

5.7 years

First QC Date

June 30, 2005

Last Update Submit

December 9, 2015

Conditions

Aortic Aneurysm, AbdominalEndovascular

Keywords

abdominal aortic aneurysmrandomized controlled trialendovascular aneurysm repair

Outcome Measures

Primary Outcomes (1)

  • all cause mortality at 3 years

    3 years

Secondary Outcomes (8)

  • aneurysm related mortality at 3 years

    3 years

  • aneurysm rupture rates at 3 years

    3 years

  • perioperative or late complications

    30 days and 3 years

  • conversion to open repair

    30 days and 3 years

  • loss of treatment options

    3 years

  • +3 more secondary outcomes

Study Arms (2)

EVAR

EXPERIMENTAL

AAA repair with endografting

Procedure: EVAR (Endovascular repair of Abdominal Aortic aneurysm)

Surveillance

ACTIVE COMPARATOR

Not AAA repair; surveillance

Procedure: Surveillance

Interventions

EVAR (Endovascular repair of Abdominal Aortic aneurysm)PROCEDURE

AAA repair with endografting

Also known as: early endovascular repair of abdominal aortic aneurysm, repair of abdominal aneurysm by aortic endografting
EVAR
SurveillancePROCEDURE

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

Also known as: monitoring abdominal aortic aneurysm without repair
Surveillance

Eligibility Criteria

Age50 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (20)

Vitkovice Hospital Ostrava and University Hospital Ostrava - Poruba

Ostrava, Czechia

Location

Hopital Cardiologique CHRU

Lille, France

Location

University of Koeln

Cologne, Germany

Location

Klinik Fuer Gefasschirurgie st.Franziskus Hospital

Münster, Germany

Location

Carmel Medical Center

Haifa, Israel

Location

U.O.Chirurgia Vascolare Az Osp Carrara

Carrara, Italy

Location

Dip Chirurgia Vascolare Osp S.Anna

Ferrara, Italy

Location

Chirurgia Vascolare Az Osp Careggi

Florence, Italy

Location

Chirurgia Vascolare Ospedale San Giovanni di Dio

Florence, Italy

Location

Chirurgia Vascolare, Ospedale San Donato

Milan, Italy

Location

Azienda Ospedaliera "Antonio Cardarelli"

Napoli, 80131, Italy

Location

S.C. Chirurgia Vascolare - Università di Perugia

Perugia, 06122, Italy

Location

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

Reggio Emilia, Italy

Location

Policlinico Le Scotte - U.O. Chirurgia Vascolare

Siena, Italy

Location

Catharina Ziekenhuis

Eindhoven, Netherlands

Location

Klinika Chirurgii ogolnej i Chorob Klatki Piersiowej Warsaw

Warsaw, Poland

Location

Naczyniowej i Transplantacyjnej Akademii Medycznej

Warsaw, Poland

Location

Institute of Cardiovascular Disease Hospital Clinic University of Barcelona

Barcelona, Spain

Location

Complejo Hospitalario

Toledo, Spain

Location

St. Mary's Hospital

London, W21NY, United Kingdom

Location

Related Publications (8)

  • 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.

    PMID: 8696960BACKGROUND

  • 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.

    PMID: 7901685BACKGROUND

  • 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.

    PMID: 12000814BACKGROUND

  • 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.

    PMID: 9853436BACKGROUND

  • 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.

    PMID: 12000813BACKGROUND

  • 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.

    PMID: 15978925BACKGROUND

  • 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.

    PMID: 21145269DERIVED

  • 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.

    PMID: 20869890DERIVED

MeSH Terms

Conditions

Aortic Aneurysm, Abdominal

Interventions

Wound Healing

Condition Hierarchy (Ancestors)

Aortic AneurysmAneurysmVascular DiseasesCardiovascular DiseasesAortic Diseases

Intervention Hierarchy (Ancestors)

RegenerationBiological Phenomena

Study Officials

  • Piergiorgio Cao, MD

    University Of Perugia

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
FACTORIAL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor of Vascular Surgery

Study Record Dates

First Submitted

June 30, 2005

First Posted

July 11, 2005

Study Start

September 1, 2004

Primary Completion

May 1, 2010

Study Completion

September 1, 2017

Last Updated

December 10, 2015

Record last verified: 2015-12

Locations

IT(9)GB(1)FR(1)NL(1)CZ(1)DE(2)PL(2)IL(1)ES(2)