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

January 21, 2020 updated by: Centre Chirurgical Marie Lannelongue

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 Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Anticipated)

100

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
    • Ile De France
      • Creteil, Ile De France, France, 94000
        • Hôpital HENRI MONDOR - APHP
      • Le Plessis Robinson, Ile De France, France, 92350
        • Centre Chirurgical MarieLannelongue
      • Paris, Ile De France, France, 75014
        • Institut Mutualiste Montsouris

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: EVAR
Endovascular repair of an Abdominal Aortic Aneurysm
Procedure: EVAR without coils embolization/ Coils embolization during EVAR
Other Names:
  • Coil embolization during endovascular Aortic Abdominal Aneurysm repair
Experimental: Coil embolization during EVAR
coil embolization during Endovascular repair
Procedure: EVAR without coils embolization/ Coils embolization during EVAR
Other Names:
  • Coil embolization during endovascular Aortic Abdominal Aneurysm repair

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
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
1 month

Secondary Outcome Measures

Outcome Measure
Time Frame
• Evaluation at 6, 12 and 24 months by CT and doppler: -The rate of type II endoleak
Time Frame: 6, 12 and 24 months
6, 12 and 24 months
• Mortality and morbidity .
Time Frame: 1, 6, 12 and 24 months
1, 6, 12 and 24 months
• Number of additional procedures -endovascular -surgical
Time Frame: 1, 6, 12 and 24 months
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
1, 6, 12 and 24 months
• Monitoring of renal function (creatinine clearance).
Time Frame: 1, 6, 12 and 24 months
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
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
6, 12 and 24 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Centre Chirurgical Marie Lannelongue

Collaborators

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

Investigators

  • Principal Investigator: Dominique FABRE, Vascular surgeon, Centre Chirurgical Marie Lannelongue

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

May 1, 2013

Primary Completion (Actual)

April 1, 2017

Study Completion (Actual)

May 1, 2019

Study Registration Dates

First Submitted

May 17, 2013

First Submitted That Met QC Criteria

June 12, 2013

First Posted (Estimate)

June 14, 2013

Study Record Updates

Last Update Posted (Actual)

January 22, 2020

Last Update Submitted That Met QC Criteria

January 21, 2020

Last Verified

April 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • P12-37813003/2012A01258-35
  • IDRCB 2012-A0125-35 (Other Identifier: P12-37813003)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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