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Abdominal Aortic AneurysmSCOPE1NCT01878240

Prevention of Type II Endoleaks During Endovascular Treatment of Abdominal Aortic Aneurysm: Endovascular Treatment Versus Combination With Coil Embolisation of the Aneurysmal Sac

A study testing EVAR without coils embolization/ Coils embolization during EVAR in people with Abdominal Aortic Aneurysm, run by Centre Chirurgical Marie Lannelongue at 3 sites in France.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

Abdominal aortic aneurysms (AAAs) continue to be a leading cause of death in older age groups. In the 60-85 year-old population, AAA represents the 14th-leading cause of death. Federal funding through Medicare has been allocated for early detection using abdominal ultrasound screening programs. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Abdominal Aortic Aneurysm
What is being tested?
EVAR without coils embolization/ Coils embolization during EVAR
Type of treatment
Surgery or procedure
Could I receive a placebo?
No, everyone receives an active treatment
How many people
100 participants
Where
3 sitesFrance
Study dates
May 2013to May 2019
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 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Age > 18 years
  • Carrying a sub-renal AAA with a diameter of at least 5 cm at a rate of growth or greater 1cm/an diameter (according to Haute Autorité de Santé (HAS) recommendations toE VAR treatment),
  • Patients with high risk of type II endoleak (clouding of an aortic aneurysm sac by collateral branch), respondents with at least one of the following criteria on the scanner to be included:
  • The presence of a pair of permeable lumbar arteries.
  • The presence of a patent inferior mesenteric artery.

Who cannot join

  • Sub renal Collet <10 mm
  • Angulated > 60 °
  • No collateral arising from the aneurysmal sac
  • Iliac aneurysms associated
  • Ruptured AAA
  • Pregnant Women
  • Lack of consent
  • Lack of social security

Trial locations and contacts

3 sites in 1 country.

France3 sites

  • Hopital Henri Mondor - APHP

    Créteil, Île-de-France Region, 94000

  • Centre Chirurgical MarieLannelongue

    Le Plessis-Robinson, Île-de-France Region, 92350

  • Institut Mutualiste Montsouris

    Paris, Île-de-France Region, 75014

Other trials in France

About this study

Abdominal aortic aneurysms (AAAs) continue to be a leading cause of death in older age groups. In the 60-85 year-old population, AAA represents the 14th-leading cause of death. Federal funding through Medicare has been allocated for early detection using abdominal ultrasound screening programs. Despite these more aggressive screening programs and concerted efforts by surgeons for timely repair, the incidence of ruptured AAA has continued to increase.

Endovascular aneurysm repair (EVAR) has been the most common type of repair since 2006. Multiple studies reflecting decreased perioperative morbidity and mortality over open repair make this an attractive option for patients. EVAR requires more intensive follow-up than standard open surgical repair, however. Secondary interventions are more common to maintain "seal" of the endograft within the aorta and subsequent exclusion of the aneurysmal component.

Read more

The term endoleak is specific to EVAR, and describes the primary means by which endografts fail. Type I endoleaks occur because of inadequate graft seal proximally or distally, resulting in perigraft flow and aneurysm sac pressurization. Type II endoleaks occur when branch arteries arising from the aneurysmal aorta back-bleed into the aneurysm sac due to collateral flow. Type III endoleaks occur when flow persists between segments of a modular graft. Type IV endoleaks occur when flow persists through endograft material (graft porosity). Type V endoleaks have also been called "endotension", and occur when pressurization of the sac occurs in the absence of any demonstrable endoleak. Type I and Type III endoleaks are most concerning for rupture, although persistent Type II endoleaks can also lead to aneurysm rupture and premature death.

The most common method of EVAR follow-up is computed tomographic angiography (CTA). These studies allow accurate measurement of aneurysm sac diameters and volumes. They also are highly sensitive and specific for endoleaks. Type II endoleaks are treated if they remain persistent and are present in the setting of aneurysm sac enlargement. Type I and III endoleaks are immediately treated when identified. Type IV endoleaks are rarely seen with current endograft technology.

Read the detailed description

Study Objectives:

The purpose of the current study is to compare the level of endoleaks between group 1 and 2 at 1, 6, 12 and 24 months.

Study Design Prospective interventional study, multicenter, open, randomized trial comparing the type II endoleak level in patients who benefited the endovascular AAA repair (group 1: without coils) versus combination with coil embolization of the aneurysmal sac (group II: with coils).

The choice of treatment is randomized.

Being tested
EVAR without coils embolization/ Coils embolization during EVAR
Keywords
Vascular surgery, Abdominal Aortic aneurysm, endovascular
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 without coils embolization/ Coils embolization during EVARProcedure or surgery

    Also called Coil embolization during endovascular Aortic Abdominal Aneurysm repair

Study groups in NCT01878240
Study groupRoleWhat they receive
EVARActive comparatorEndovascular repair of an Abdominal Aortic Aneurysm
Receives: Procedure: EVAR without coils embolization/ Coils embolization during EVAR
Coil embolization during EVARExperimentalcoil embolization during Endovascular repair
Receives: Procedure: EVAR without coils embolization/ Coils embolization during EVAR

What is being measured

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

  1. Evaluation at one month the presence or absence of endoleak type II in all patients for each group by Computer Tomography and Doppler.

    Measured: 1 month

Secondary outcomes (7)

  1. • Evaluation at 6, 12 and 24 months by CT and doppler: -The rate of type II endoleak

    Measured: 6, 12 and 24 months

  2. • Mortality and morbidity .

    Measured: 1, 6, 12 and 24 months

  3. • Number of additional procedures -endovascular -surgical

    Measured: 1, 6, 12 and 24 months

  4. • Complications of endovascular procedures away from the EVAR -Thrombosis of leg -Limb occlusion -Evolution of the aneurysmal neck

    Measured: 1, 6, 12 and 24 months

  5. • Monitoring of renal function (creatinine clearance).

    Measured: 1, 6, 12 and 24 months

  6. • Evaluation at 6, 12 and 24 months by CT and doppler: -Measurement of the maximum transverse aneurysm diameter

    Measured: 6, 12 and 24 months

  7. • Evaluation at 6, 12 and 24 months by CT and doppler: -volumetric measurement of the sac aneurysmal

    Measured: 6, 12 and 24 months

Timeline

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

  1. First posted14 Jun 2013 (estimated)
  2. Study startMay 2013
  3. Primary completionApr 2017
  4. Study completionMay 2019

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 N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
100 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01878240
Sponsor's protocol ID
P12-37813003/2012A01258-35
Other IDs
IDRCB 2012-A0125-35
Acronym
SCOPE1
Status last verified
Apr 2019
First submitted
17 May 2013
Last updated
22 Jan 2020
Results posted
No
Data monitoring committee
Yes

Publications

  • Lederle FA, Freischlag JA, Kyriakides TC, Matsumura JS, Padberg FT Jr, Kohler TR, Kougias P, Jean-Claude JM, Cikrit DF, Swanson KM; OVER Veterans Affairs Cooperative Study Group. Long-term comparison of endovascular and open repair of abdominal aortic aneurysm. N Engl J Med. 2012 Nov 22;367(21):1988-97. doi: 10.1056/NEJMoa1207481.

    PubMed 23171095

  • Jackson RS, Chang DC, Freischlag JA. Comparison of long-term survival after open vs endovascular repair of intact abdominal aortic aneurysm among Medicare beneficiaries. JAMA. 2012 Apr 18;307(15):1621-8. doi: 10.1001/jama.2012.453.

    PubMed 22511690

  • Stather PW, Sidloff D, Dattani N, Choke E, Bown MJ, Sayers RD. Systematic review and meta-analysis of the early and late outcomes of open and endovascular repair of abdominal aortic aneurysm. Br J Surg. 2013 Jun;100(7):863-72. doi: 10.1002/bjs.9101. Epub 2013 Mar 8.

    PubMed 23475697

  • Piazza M, Frigatti P, Scrivere P, Bonvini S, Noventa F, Ricotta JJ 2nd, Grego F, Antonello M. Role of aneurysm sac embolization during endovascular aneurysm repair in the prevention of type II endoleak-related complications. J Vasc Surg. 2013 Apr;57(4):934-41. doi: 10.1016/j.jvs.2012.10.078. Epub 2013 Feb 4.

    PubMed 23384494

  • Schanzer A, Greenberg RK, Hevelone N, Robinson WP, Eslami MH, Goldberg RJ, Messina L. Predictors of abdominal aortic aneurysm sac enlargement after endovascular repair. Circulation. 2011 Jun 21;123(24):2848-55. doi: 10.1161/CIRCULATIONAHA.110.014902. Epub 2011 Apr 10.

    PubMed 21478500

  • Fabre D, Mougin J, Mitilian D, Cochennec F, Garcia Alonso C, Becquemin JP, Desgranges P, Allaire E, Hamdi S, Brenot P, Bourkaib R, Haulon S. Prospective, Randomised Two Centre Trial of Endovascular Repair of Abdominal Aortic Aneurysm With or Without Sac Embolisation. Eur J Vasc Endovasc Surg. 2021 Feb;61(2):201-209. doi: 10.1016/j.ejvs.2020.11.028. Epub 2020 Dec 17.

    PubMed 33342658

Questions about this trial

What is this clinical trial studying?

A study testing EVAR without coils embolization/ Coils embolization during EVAR in people with Abdominal Aortic Aneurysm, run by Centre Chirurgical Marie Lannelongue at 3 sites 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 5 inclusion and 8 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 22 Jan 2020. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 3 sites 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?

Evaluation at one month the presence or absence of endoleak type II in all patients for each group by Computer Tomography and Doppler. (time frame: 1 month). 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 NCT01878240, which also lists 6 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 22 Jan 2020.

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