ELECT Trial - Embolization of the Lumbar Arteries Before EVAR

Aortic Aneurysm Clinical Trial

Official title:

Embolization of the Lumbar Arteries Before EVAR: A Prospectively Randomized Trial Comparing Platinum-Fibered Microcoils (Control Arm) With the MVP® Microvascular Plug (Study Arm)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03842930
• Other study ID #: CIP_18/002
• Status: Completed
• Phase: N/A
• Start date: March 1, 2019
• Est. completion date: December 1, 2021

Study information

• Verified date: May 2022
• Source: University of Leipzig
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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)"

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 60
• Est. completion date: December 1, 2021
• Est. primary completion date: December 1, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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)

Related Conditions & MeSH terms

• Aneurysm
• Aortic Aneurysm

Intervention

Procedure:
• Endovascular embolization
Endovascular embolization of the Lumbar Arteries

Locations

Country	Name	City	State
Germany	University Clinic Leipzig	Leipzig	Saxony

Sponsors (1)

Lead Sponsor	Collaborator
University of Leipzig

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Radiation dose for embolization of the lumbar arteries with the MVP plug or coils		through study completion, an average of 3-4 month
Secondary	Intervention time for embolization of the lumbar arteries with the MVP plug or coils		through study completion, an average of 3-4 month
Secondary	Success in complete occlusion of the targeted lumbar artery		through study completion, an average of 3-4 month