ELECT Trial - Embolization of the Lumbar Arteries Before EVAR

NCT03842930 | Completed

• 1 other identifier: CIP_18/002
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief 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)"

Conditions

Aortic Aneurysm

Outcome Measures

Primary Outcomes (1)

• Radiation dose for embolization of the lumbar arteries with the MVP plug or coils

  through study completion, an average of 3-4 month

Secondary Outcomes (2)

• 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

Study Arms (2)

Platinum-fibered Microcoils (FPC)

OTHER

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

Procedure: Endovascular embolization

MVP® Vascular Plug

OTHER

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

Procedure: Endovascular embolization

Interventions

Endovascular embolization PROCEDURE

Endovascular embolization of the Lumbar Arteries

MVP® Vascular Plug; Platinum-fibered Microcoils (FPC)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Subject age ≥ 18
• Subject has been informed of the nature of the study, agrees to participate, and has signed a Medical Ethics Committee approved consent form.
• Indication for the occlusion of lumbar arteries due to:
• Subject has an abdominal aortic aneurysm and
• At least 2 patent lumbar arteries in the diseased area
• Subject understands the duration of the study, agrees to attend the stentgraft implantation
• A microcatheter is successfully placed the target lumbar artery.

You may not qualify if:

• Any surgical procedure or intervention performed within 30 days prior to or post index procedure
• Aortic aneurysm requires treatment with alternative therapies such as operation
• any other aortic pathology
• major untreated cardio-pulmonary disease
• life-expectancy of less than one year
• expected lack of compliance (e.g. if the patient may not be willing to have several sessions and the following repair done)
• pregnant or nursing women
• impaired thyroid function, if not under stable treatment
• women of child-bearing potential without highly effective contraceptive measures
• Enrolled in another investigational drug, device or biologic study
• Failure to successfully intubate an lumbar artery
• Stroke or heart attack within 3 months prior to enrollment
• 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
• Significant gastrointestinal bleeding or any coagulopathy that would contraindicate the use of anti-platelet therapy.
• Platelet count \<100,000 mm3 or \>600,000 mm3

Sponsors & Collaborators

• University of Leipzig: lead

Study Sites (1)

University Clinic Leipzig

Leipzig, Saxony, 04103, Germany

Location

Related Publications (1)

• Konert M, Schmidt A, Branzan D, Wittig T, Scheinert D, Steiner S. ELECT: prospective, randomized trial comparing microvascular plug versus platinum-fibered microcoils for embolization of aneurysm sac side branches before endovascular aortic aneurysm repair. CVIR Endovasc. 2024 May 3;7(1):42. doi: 10.1186/s42155-024-00454-6.

  PMID: 38700601 DERIVED

MeSH Terms

Conditions

Aortic Aneurysm

Condition Hierarchy (Ancestors)

Aneurysm; Vascular Diseases; Cardiovascular Diseases; Aortic Diseases

Study Officials

• Dierk Scheinert, Prof. Dr.

  University Clinic Leipzig

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: January 21, 2019
• First Posted: February 15, 2019
• Study Start: March 1, 2019
• Primary Completion: December 1, 2021
• Study Completion: December 1, 2021
• Last Updated: May 18, 2022

Record last verified: 2022-05

Locations

DE (1)