ELECT Trial - Embolization of the Lumbar Arteries Before EVAR

University of Leipzig

Status: Completed

Conditions: Aortic Aneurysm

Treatments: Procedure: Endovascular embolization

Study type: Interventional

Funder types: Other

Identifiers

NCT03842930

CIP_18/002

Details and patient eligibility

About

Prospective, Randomized, Single-center Study for the Treatment of Subjects with Abdominal Aortic Aneurysm: Embolization of the Lumbar Arteries Before EVAR: A Prospectively Randomized Trial Comparing Platinum-Fibered Microcoils (control arm) with the MVP® Microvascular Plug (study arm)"

Full description

This study is a prospective, single-center, 1:1 randomized trial to investigate the difference in radiation dose and intervention time between the embolization with FCP and MVP-Plug.

Enrollment: 60 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. Subject age ≥ 18

2. Subject has been informed of the nature of the study, agrees to participate, and has signed a Medical Ethics Committee approved consent form.

3. Indication for the occlusion of lumbar arteries due to:

   1. Subject has an abdominal aortic aneurysm and
   2. At least 2 patent lumbar arteries in the diseased area

4. Subject understands the duration of the study, agrees to attend the stentgraft implantation

5. A microcatheter is successfully placed the target lumbar artery.

Exclusion criteria

1. Any surgical procedure or intervention performed within 30 days prior to or post index procedure
2. Aortic aneurysm requires treatment with alternative therapies such as operation
3. any other aortic pathology
4. major untreated cardio-pulmonary disease
5. life-expectancy of less than one year
6. expected lack of compliance (e.g. if the patient may not be willing to have several sessions and the following repair done)
7. pregnant or nursing women
8. impaired thyroid function, if not under stable treatment
9. women of child-bearing potential without highly effective contraceptive measures
10. Enrolled in another investigational drug, device or biologic study
11. Failure to successfully intubate an lumbar artery
12. Stroke or heart attack within 3 months prior to enrollment
13. Known allergies or sensitivity to heparin, aspirin, other anticoagulant/ antiplatelet therapies, paclitaxel or contrast media that cannot be adequately pre-treated prior to index procedure
14. Significant gastrointestinal bleeding or any coagulopathy that would contraindicate the use of anti-platelet therapy.
15. Platelet count <100,000 mm3 or >600,000 mm3
16. Receiving dialysis or immunosuppressant therapy
17. Chronic kidney disease (serum creatinine > 2.5 mg/dL)

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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60 participants in 2 patient groups

Platinum-fibered Microcoils (FPC)

Other group

Description:

Embolization using platinum fibred Coils (Cook Incorporated, Bloomington, IN, USA)

Treatment:

Procedure: Endovascular embolization

MVP® Vascular Plug

Other group

Description:

Embolization using MVP®-Plug (Medtronic Inc., Minneapolis, MI, USA).

Treatment:

Procedure: Endovascular embolization