Elective Abdominal Aortic AneurysmACENCT00224718
Elective Abdominal Aortic Aneurism - Open Versus Endovascular Repair
A study testing Endovascular repair (with endograft) and Open repair in people with Elective Abdominal Aortic Aneurysm, run by Assistance Publique - Hôpitaux de Paris at 1 site in France.
Trial summary
Abdominal aortic aneurysm (AAA) is a life threatening disease. There is a consensus to propose surgical repair in patients with a reasonable operative risk when the AAA exceeds 5 cm in diameter. Read more about this study
- Who is it for?
- Ages 50 years and older
- Conditions the study is for
- Elective Abdominal Aortic Aneurysm
- What is being tested?
- Endovascular repair (with endograft) and Open repair
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 306 participants
- Where
- 1 siteFrance
- Study dates
- Jan 2003to Feb 2009
- Phase
- Interventional
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients aged 50 years old or more (more than 80 possible depending on physiological age)
- Level 0, 1, or 2 of operative risk
- Abdominal aortic aneurysm with a diameter > or equal to 50 mm or > or equal to 40 mm if rapid growing (10 mm or more in a year), or painful, or saccular aneurysms, or aneurisms of common iliac arteries with a diameter equal or superior to 30 mm; or women with a diameter equal to 45 mm;
- Aortic neck superior or equal to 1.5 cm
- No stenosis superior or equal to 75% of the superior mesenteric artery
- Proximal neck angulation inferior to 80°
- Diameter of the iliac arteries compatible with introducer sheath
- Inform consent signed
Who cannot join
- Aneurysm involving the renal arteries or with the length of the neck less than 1.5 cm
- Thrombus or major calcification in the neck
- Diameter of the iliac arteries not compatible with introducer sheath
- Level 3 of operative risk
- History of major iodine allergy (Quincke oedema, anaphylactic shock)
- Other comorbidity with life expectancy less than 6 months
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- Follow up impossible during the trial
- Participation in another trial
- Inform consent not signed
Trial locations and contacts
1 site in 1 country.
About this study
Official title: ACE Trial :Not Worn-Out Aneurism of the Abdominal Aorta Under Renal " Surgery Versus Endoprosthesis "
Abdominal aortic aneurysm (AAA) is a life threatening disease. There is a consensus to propose surgical repair in patients with a reasonable operative risk when the AAA exceeds 5 cm in diameter.
The aim of the study is to compare the mortality and the occurrence of severe general, vascular and local complications in two groups of patients treated by either by open surgery or by EVAR (EndoVascular Aneurysm Repair). The main outcome criteria and the secondary endpoint are respectively the survival without severe complications and minor morbidity.
Read the detailed description
ACE Trial :Not Worn-Out Aneurism of the Abdominal Aorta Under Renal " Surgery Versus Endoprosthesis Abdominal aortic aneurysm (AAA) is a life threatening disease. There is a consensus to propose surgical repair in patients with a reasonable operative risk when the AAA exceeds 5 cm in diameter.
The aim of the study is to compare the mortality and the occurrence of severe general, vascular and local complications in two groups of patients treated by either by open surgery or by EVAR (EndoVascular Aneurysm Repair). The main outcome criteria and the secondary endpoint are respectively the survival without severe complications and minor morbidity.
- Conditions
- Elective Abdominal Aortic Aneurysm
- Being tested
- Endovascular repair (with endograft), Open repair
- Keywords
- Abdominal aortic aneurysm, Endograft, Open repair, Endovascular repair, AAA
- 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.
Endovascular repair (with endograft)Procedure or surgery
An endovascular stent graft is a tube composed of fabric supported by a metal mesh called a stent. It can be used for a variety of conditions involving the blood vessels, but most commonly to reinforce a weak spot in an artery called an aneurysm. Over time, blood pressure and other factors can cause this weak area to bulge like a balloon and eventually enlarge and rupture. The stent graft seals tightly with your artery above and below the aneurysm. The graft is stronger than the weakened artery and allows blood to pass through it without pushing on the bulge. Physicians typically use endovascular stent grafting to treat abdominal aortic aneurysms (AAAs).
Open repairProcedure or surgery
Conventional repair consist in open repair. Different types of surgery can be done : minimal incision aortic surgery (MIAS), transperitoneal approach (TPA), retroperitoneal repair, or conventional median laparotomy.
| Study group | Role | What they receive |
|---|---|---|
| 1 | Active comparator | surgery - open repair Receives: Procedure: Open repair |
| 2 | Experimental | endovascular procedure Receives: Procedure: Endovascular repair (with endograft) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Death and major adverse events
Measured: 4 years
Secondary outcomes (1)
Minor adverse events (systemic vascular or non vascular complications)
Measured: 4 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Sep 2005 (estimated)
- Study startJan 2003
- Primary completionFeb 2008
- Study completionFeb 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Elective Abdominal Aortic AneurysmStudies of the same condition, open and under way.
- More trials run by Assistance Publique - Hôpitaux de ParisThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 306 participants (actual)
Sponsor and investigators
- Lead sponsor
- Assistance Publique - Hôpitaux de Paris
- Sponsor type
- University, hospital or other
- Investigators
- Yann JOUSSET, MD, Principal investigator, CHU Angers - Hôtel DieuJean M Pernes, MD, Principal investigator, Hôpital privé d'AntonyPierre Y Meaulle, MD, Principal investigator, Clinique mutualiste des Eaux Claires, GrenobleJean P Favre, MD, Principal investigator, CHU Hôpital Nord, Saint-EtienneJacques Watelet, MD, Principal investigator, Hôpital Charles Nicolle, RouenPatrick Lermusiaux, MD, Principal investigator, CHRU -Hôpital Trousseau, ToursJean F Heautot, MD, Principal investigator, CHU de Pontchaillou, RennesMohamad KOUSSA, MD, Principal investigator, Hôpital Cardiologique , Lille
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00224718
- Sponsor's protocol ID
- P000708
- Other IDs
- AOM 98167
- Acronym
- ACE
- Status last verified
- Feb 2009
- First submitted
- 16 Sep 2005
- Last updated
- 1 Apr 2009
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Lederle FA. Endovascular repair of abdominal aortic aneurysm--round two. N Engl J Med. 2005 Jun 9;352(23):2443-5. doi: 10.1056/NEJMe058126. No abstract available.
PubMed 15944430Becquemin JP, Pillet JC, Lescalie F, Sapoval M, Goueffic Y, Lermusiaux P, Steinmetz E, Marzelle J; ACE trialists. A randomized controlled trial of endovascular aneurysm repair versus open surgery for abdominal aortic aneurysms in low- to moderate-risk patients. J Vasc Surg. 2011 May;53(5):1167-1173.e1. doi: 10.1016/j.jvs.2010.10.124. Epub 2011 Jan 26.
PubMed 21276681
Study at a glance
From the registry record, last updated by the sponsor on 1 Apr 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- ACE Trial :Not Worn-Out Aneurism of the Abdominal Aorta Under Renal " Surgery Versus Endoprosthesis "
- ClinicalTrials.gov ID
- NCT00224718
- Acronym / sponsor ID
- ACE / P000708
- Conditions
- Elective Abdominal Aortic Aneurysm
- Keywords
- Abdominal aortic aneurysm, Endograft, Open repair, Endovascular repair, AAA
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 306 participants (actual)
- Lead sponsor
- Assistance Publique - Hôpitaux de ParisUniversity, hospital or other
- Study start
- Jan 2003
- Primary completion
- Feb 2008 (actual)
- Study completion
- Feb 2009 (actual)
- First posted
- 23 Sep 2005 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Abdominal aortic aneurysm (AAA) is a life threatening disease. There is a consensus to propose surgical repair in patients with a reasonable operative risk when the AAA exceeds 5 cm in diameter.
The aim of the study is to compare the mortality and the occurrence of severe general, vascular and local complications in two groups of patients treated by either by open surgery or by EVAR (EndoVascular Aneurysm Repair). The main outcome criteria and the secondary endpoint are respectively the survival without severe complications and minor morbidity.
Detailed description
ACE Trial :Not Worn-Out Aneurism of the Abdominal Aorta Under Renal " Surgery Versus Endoprosthesis Abdominal aortic aneurysm (AAA) is a life threatening disease. There is a consensus to propose surgical repair in patients with a reasonable operative risk when the AAA exceeds 5 cm in diameter.
The aim of the study is to compare the mortality and the occurrence of severe general, vascular and local complications in two groups of patients treated by either by open surgery or by EVAR (EndoVascular Aneurysm Repair). The main outcome criteria and the secondary endpoint are respectively the survival without severe complications and minor morbidity.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Active comparator | Procedure: Open repairsurgery - open repair |
| 2 | Experimental | Procedure: Endovascular repair (with endograft)endovascular procedure |
Who may qualify
- Ages
- 50 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Patients aged 50 years old or more (more than 80 possible depending on physiological age)
- Level 0, 1, or 2 of operative risk
- Abdominal aortic aneurysm with a diameter > or equal to 50 mm or > or equal to 40 mm if rapid growing (10 mm or more in a year), or painful, or saccular aneurysms, or aneurisms of common iliac arteries with a diameter equal or superior to 30 mm; or women with a diameter equal to 45 mm;
- Aortic neck superior or equal to 1.5 cm
- No stenosis superior or equal to 75% of the superior mesenteric artery
Key exclusion criteria (9 listed)
- Aneurysm involving the renal arteries or with the length of the neck less than 1.5 cm
- Thrombus or major calcification in the neck
- Diameter of the iliac arteries not compatible with introducer sheath
- Level 3 of operative risk
- History of major iodine allergy (Quincke oedema, anaphylactic shock)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Endovascular repair (with endograft)An endovascular stent graft is a tube composed of fabric supported by a metal mesh called a stent. It can be used for a variety of conditions involving the blood vessels, but most commonly to reinforce a weak spot in an artery called an aneurysm. Over time, blood pressure and other factors can cause this weak area to bulge like a balloon and eventually enlarge and rupture. The stent graft seals tightly with your artery above and below the aneurysm. The graft is stronger than the weakened artery and allows blood to pass through it without pushing on the bulge. Physicians typically use endovascular stent grafting to treat abdominal aortic aneurysms (AAAs). | Procedure or surgery | 2 |
| Open repairConventional repair consist in open repair. Different types of surgery can be done : minimal incision aortic surgery (MIAS), transperitoneal approach (TPA), retroperitoneal repair, or conventional median laparotomy. | Procedure or surgery | 1 |
Primary outcome
Death and major adverse events
Time frame: 4 years
1 secondary outcome
Minor adverse events (systemic vascular or non vascular complications)
Time frame: 4 years
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Apr 2009.
- Background: PubMed 15944430Lederle FA. Endovascular repair of abdominal aortic aneurysm--round two. N Engl J Med. 2005 Jun 9;352(23):2443-5. doi: 10.1056/NEJMe058126. No abstract available.
- Derived from this study: PubMed 21276681Becquemin JP, Pillet JC, Lescalie F, Sapoval M, Goueffic Y, Lermusiaux P, Steinmetz E, Marzelle J; ACE trialists. A randomized controlled trial of endovascular aneurysm repair versus open surgery for abdominal aortic aneurysms in low- to moderate-risk patients. J Vasc Surg. 2011 May;53(5):1167-1173.e1. doi: 10.1016/j.jvs.2010.10.124. Epub 2011 Jan 26.
- controversies and updates in vascular surgeryLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Yann JOUSSET, MD principal investigator
CHU Angers - Hôtel Dieu
Jean M Pernes, MD principal investigator
Hôpital privé d'Antony
Pierre Y Meaulle, MD principal investigator
Clinique mutualiste des Eaux Claires, Grenoble
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Endovascular repair (with endograft) and Open repair in people with Elective Abdominal Aortic Aneurysm, run by Assistance Publique - Hôpitaux de Paris at 1 site in France.
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 8 inclusion and 9 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: finished, as of the sponsor's last update on 1 Apr 2009. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. 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.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Death and major adverse events (time frame: 4 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 NCT00224718, which also lists 2 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 1 Apr 2009.