Skip to main content
OpenTrials
Completed

NCT Number: NCT01878240

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.

Completed

Looking for future studies?

Notify Me

Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Hopital Henri Mondor - APHP, Créteil, Île-de-France Region, France

Loading trial locations.

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

EVAR without coils embolization/ Coils embolization during EVAR

Procedure

Other names: Coil embolization during endovascular Aortic Abdominal Aneurysm repair

Primary outcomes

  1. 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

Secondary outcomes

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

    Time frame: 6, 12 and 24 months

  2. • Mortality and morbidity .

    Time frame: 1, 6, 12 and 24 months

  3. • Number of additional procedures -endovascular -surgical

    Time frame: 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

    Time frame: 1, 6, 12 and 24 months

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

    Time frame: 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

    Time frame: 6, 12 and 24 months

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

    Time frame: 6, 12 and 24 months

Sponsors and collaborators

Lead sponsor

Centre Chirurgical Marie Lannelongue

Other

Collaborators

  • Henri Mondor University Hospital
  • Institut Mutualiste Montsouris
  • Unité de Recherche Clinique du Centre chirurgical marie Lannelongue

Registry information

Acronym: SCOPE1

Important dates

Study start
2013
Primary completion
2017
Study completion
2019
First posted
Jun 14, 2013
Registry last updated
Jan 22, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.