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Prevention of Type II Endoleaks During Endovascular Treatment of Abdominal Aortic Aneurysm: Endovascular Treatment Versus Combination With Coil Embolisation of the Aneurysmal Sac (SCOPE1)

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ClinicalTrials.gov Identifier: NCT01878240
Recruitment Status : Recruiting
First Posted : June 14, 2013
Last Update Posted : May 23, 2017
Sponsor:
Collaborators:
Institut Mutualiste Montsouris
Henri Mondor University Hospital
Unité de Recherche Clinique du Centre chirurgical marie Lannelongue
Information provided by (Responsible Party):
Centre Chirurgical Marie Lannelongue

May 17, 2013
June 14, 2013
May 23, 2017
May 2013
April 2017   (Final data collection date for 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 ]
Same as current
Complete list of historical versions of study NCT01878240 on ClinicalTrials.gov Archive Site
  • • Evaluation at 6, 12 and 24 months by CT and doppler: -The rate of type II endoleak [ Time Frame: 6, 12 and 24 months ]
  • • Mortality and morbidity . [ Time Frame: 1, 6, 12 and 24 months ]
  • • Number of additional procedures -endovascular -surgical [ Time Frame: 1, 6, 12 and 24 months ]
  • • Complications of endovascular procedures away from the EVAR -Thrombosis of leg -Limb occlusion -Evolution of the aneurysmal neck [ Time Frame: 1, 6, 12 and 24 months ]
  • • Monitoring of renal function (creatinine clearance). [ Time Frame: 1, 6, 12 and 24 months ]
  • • Evaluation at 6, 12 and 24 months by CT and doppler: -Measurement of the maximum transverse aneurysm diameter [ Time Frame: 6, 12 and 24 months ]
  • • Evaluation at 6, 12 and 24 months by CT and doppler: -volumetric measurement of the sac aneurysmal [ Time Frame: 6, 12 and 24 months ]
Same as current
Not Provided
Not Provided
 
Prevention of Type II Endoleaks During Endovascular Treatment of Abdominal Aortic Aneurysm: Endovascular Treatment Versus Combination With Coil Embolisation of the Aneurysmal Sac
Prevention of Type II Endoleaks During Endovascular Treatment of Abdominal Aortic Aneurysm: Endovascular Treatment Versus Combination With Coil Embolisation of the Aneurysmal Sac

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.

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.

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.

Interventional
Not Applicable
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Abdominal Aortic Aneurysm
Procedure: EVAR without coils embolization/ Coils embolization during EVAR
Other Name: Coil embolization during endovascular Aortic Abdominal Aneurysm repair
  • Active Comparator: EVAR
    Endovascular repair of an Abdominal Aortic Aneurysm
    Intervention: Procedure: EVAR without coils embolization/ Coils embolization during EVAR
  • Experimental: Coil embolization during EVAR
    coil embolization during Endovascular repair
    Intervention: Procedure: EVAR without coils embolization/ Coils embolization during EVAR

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
100
Same as current
May 2019
April 2017   (Final data collection date for primary outcome measure)

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • 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
Sexes Eligible for Study: All
18 Years and older   (Adult, Older Adult)
No
Contact: Dominique FABRE, MD Vascular Surgeon + 33(0) 1 40 94 85 76 d.fabre@ccml.fr
Contact: Aminata TRAORE + 33 (0) 1 40 94 28 00 a.traore@ccml.fr
France
 
 
NCT01878240
P12-37813003/2012A01258-35
IDRCB 2012-A0125-35 ( Other Identifier: P12-37813003 )
Yes
Not Provided
Not Provided
Centre Chirurgical Marie Lannelongue
Centre Chirurgical Marie Lannelongue
  • Institut Mutualiste Montsouris
  • Henri Mondor University Hospital
  • Unité de Recherche Clinique du Centre chirurgical marie Lannelongue
Principal Investigator: Dominique FABRE, Vascular surgeon Centre Chirurgical Marie Lannelongue
Centre Chirurgical Marie Lannelongue
May 2017

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP