ELECT Trial - Embolization of the Lumbar Arteries Before EVAR

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

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)"

Study Overview

• Status: Completed
• Conditions: Aortic Aneurysm
• Intervention / Treatment: Procedure: Endovascular embolization

Detailed 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.

• Study Type: Interventional
• Enrollment (Actual): 60
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Germany
  • Saxony
    • Leipzig, Saxony, Germany, 04103
      • University Clinic Leipzig

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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)

Study Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: Platinum-fibered Microcoils (FPC); Embolization using platinum fibred Coils (Cook Incorporated, Bloomington, IN, USA)	Procedure: Endovascular embolization; Endovascular embolization of the Lumbar Arteries
Other: MVP® Vascular Plug; Embolization using MVP®-Plug (Medtronic Inc., Minneapolis, MI, USA).	Procedure: Endovascular embolization; Endovascular embolization of the Lumbar Arteries

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Radiation dose for embolization of the lumbar arteries with the MVP plug or coils	through study completion, an average of 3-4 month

Secondary Outcome Measures

Outcome Measure	Time Frame
Intervention time for embolization of the lumbar arteries with the MVP plug or coils	through study completion, an average of 3-4 month
Success in complete occlusion of the targeted lumbar artery	through study completion, an average of 3-4 month

Collaborators and Investigators

• Sponsor: University of Leipzig
• Investigators: Principal Investigator: Dierk Scheinert, Prof. Dr., University Clinic Leipzig

Study record dates

Study Major Dates

• Study Start (Actual): March 1, 2019
• Primary Completion (Actual): December 1, 2021
• Study Completion (Actual): December 1, 2021

Study Registration Dates

• First Submitted: January 21, 2019
• First Submitted That Met QC Criteria: February 14, 2019
• First Posted (Actual): February 15, 2019

Study Record Updates

• Last Update Posted (Actual): May 18, 2022
• Last Update Submitted That Met QC Criteria: May 17, 2022
• Last Verified: May 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Aortic Diseases; Aneurysm; Aortic Aneurysm
• Other Study ID Numbers: CIP_18/002

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Undecided

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No