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

• Register: ClinicalTrials.gov
• Last refreshed on: 12 December 2020
• Main ID: NCT01878240
• Date of registration: 17/05/2013
• Prospective Registration: No
• Primary sponsor: Centre Chirurgical Marie Lannelongue
• Public title: Prevention of Type II Endoleaks During Endovascular Treatment of Abdominal Aortic Aneurysm: Endovascular Treatment Versus Combination With Coil Embolisation of the Aneurysmal Sac SCOPE1
• Scientific title: Prevention of Type II Endoleaks During Endovascular Treatment of Abdominal Aortic Aneurysm: Endovascular Treatment Versus Combination With Coil Embolisation of the Aneurysmal Sac
• Date of first enrolment: May 2013
• Target sample size: 100
• Recruitment status: Completed
• URL: https://clinicaltrials.gov/show/NCT01878240
• Study type: Interventional
• Study design: Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: None (Open Label).
• Phase: N/A

Countries of recruitment

France

Contacts

• Name: Dominique FABRE, Vascular surgeon
• Affiliation: Centre Chirurgical Marie Lannelongue

Key inclusion & exclusion 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



Age minimum: 18 Years
Age maximum: N/A
Gender: All

Health Condition(s) or Problem(s) studied

Abdominal Aortic Aneurysm

Intervention(s)

Procedure: EVAR without coils embolization/ Coils embolization during EVAR

Primary Outcome(s)

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 Outcome(s)

• 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]

• Number of additional procedures -endovascular -surgical [Time Frame: 1, 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]

• Evaluation at 6, 12 and 24 months by CT and doppler: -The rate of type II endoleak [Time Frame: 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]

• Mortality and morbidity . [Time Frame: 1, 6, 12 and 24 months]

Secondary ID(s)

IDRCB 2012-A0125-35

P12-37813003/2012A01258-35

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Secondary Sponsor(s)

Institut Mutualiste Montsouris

Unité de Recherche Clinique du Centre chirurgical marie Lannelongue

Henri Mondor University Hospital