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

This study is currently recruiting participants. (see Contacts and Locations)
Verified July 2014 by Centre Chirurgical Marie Lannelongue
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
ClinicalTrials.gov Identifier:
NCT01878240
First received: May 17, 2013
Last updated: July 21, 2014
Last verified: July 2014
  Purpose

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.


Condition Intervention
Abdominal Aortic Aneurysm
Procedure: EVAR without coils embolization/ Coils embolization during EVAR

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Prevention of Type II Endoleaks During Endovascular Treatment of Abdominal Aortic Aneurysm: Endovascular Treatment Versus Combination With Coil Embolisation of the Aneurysmal Sac

Resource links provided by NLM:


Further study details as provided by Centre Chirurgical Marie Lannelongue:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • • Evaluation at 6, 12 and 24 months by CT and doppler: -The rate of type II endoleak [ Time Frame: 6, 12 and 24 months ] [ Designated as safety issue: Yes ]
  • • Mortality and morbidity . [ Time Frame: 1, 6, 12 and 24 months ] [ Designated as safety issue: Yes ]
  • • Number of additional procedures -endovascular -surgical [ Time Frame: 1, 6, 12 and 24 months ] [ Designated as safety issue: Yes ]
  • • 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 ] [ Designated as safety issue: Yes ]
  • • Monitoring of renal function (creatinine clearance). [ Time Frame: 1, 6, 12 and 24 months ] [ Designated as safety issue: Yes ]
  • • 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 ] [ Designated as safety issue: Yes ]
  • • Evaluation at 6, 12 and 24 months by CT and doppler: -volumetric measurement of the sac aneurysmal [ Time Frame: 6, 12 and 24 months ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 100
Study Start Date: May 2013
Estimated Study Completion Date: May 2017
Estimated Primary Completion Date: November 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: EVAR
Endovascular repair of an Abdominal Aortic Aneurysm
Procedure: EVAR without coils embolization/ Coils embolization during EVAR
Other Name: 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 Name: Coil embolization during endovascular Aortic Abdominal Aneurysm repair

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01878240

Contacts
Contact: Dominique FABRE, MD Vascular Surgeon + 33(0) 1 40 94 85 76 d.fabre@ccml.fr
Contact: Mansouria MERAD BOUDIA, PharmD, PhD, Project Manager + 33 (0) 1 40 94 25 96 m.merad@ccml.fr

Locations
France
Hopital Henri Mondor - APHP Recruiting
Creteil, Ile de France, France, 94000
Contact: Frederic COCHENNEC-PALIWODA, MD, Vascular Surgeon       cochennecf@gmail.com   
Contact: Mansouria MERAD BOUDIA, PharmD PhD Project Manager    + 33 (0) 1 40 94 85 76    m.merad@ccml.fr   
Sub-Investigator: Frederic COCHENNEC-PALIWADA, MD, Vascular Surgeon         
Centre Chirurgical MarieLannelongue Recruiting
Le Plessis Robinson, Ile de France, France, 92350
Contact: Dominique FABRE, MD, Vascular Surgeon    + 33 (0) 1 40 94 85 76    d.fabre@ccml.fr   
Contact: Mansouria MERAD BOUDIA, PhamD, PhD, Project Manager    +33 (0) 1 40 94 25 96      
Principal Investigator: Dominique FABRE, MD, Vascular Surgeon         
Sub-Investigator: Claude Angel, MD, Radiologist         
Institut Mutualiste Montsouris Not yet recruiting
Paris, Ile de France, France, 75014
Contact: Myriam COMBES, MD, Vascular Surgeon       myriam.combes@imm.fr   
Contact: Mansouria MERAD BOUDIA, PharD, PhD, Project Manager    + 33 (0) 1 40 94 25 96    m.merad@ccml.fr   
Sub-Investigator: Myriam COMBES, MD, Vascular Surgeon         
Sub-Investigator: Benoit BOURA, MD, Vascular Surgeon         
Sponsors and Collaborators
Centre Chirurgical Marie Lannelongue
Institut Mutualiste Montsouris
Henri Mondor University Hospital
Unité de Recherche Clinique du Centre chirurgical marie Lannelongue
Investigators
Principal Investigator: Dominique FABRE, Vascular surgeon Centre Chirurgical Marie Lannelongue
  More Information

Additional Information:
Publications:
Responsible Party: Centre Chirurgical Marie Lannelongue
ClinicalTrials.gov Identifier: NCT01878240     History of Changes
Other Study ID Numbers: P12-37813003/2012A01258-35, IDRCB 2012-A0125-35
Study First Received: May 17, 2013
Last Updated: July 21, 2014
Health Authority: France: Agence Nationale de Sécurité du Médicament et des produits de santé

Keywords provided by Centre Chirurgical Marie Lannelongue:
Vascular surgery
Abdominal Aortic aneurysm
endovascular

Additional relevant MeSH terms:
Aortic Aneurysm
Aortic Aneurysm, Abdominal
Aneurysm
Vascular Diseases
Cardiovascular Diseases
Aortic Diseases

ClinicalTrials.gov processed this record on September 16, 2014