Aortic AneurysmNCT03842930
ELECT Trial - Embolization of the Lumbar Arteries Before EVAR
A study testing Endovascular embolization in people with Aortic Aneurysm, run by University of Leipzig at 1 site in Germany.
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)" Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Aortic Aneurysm
- What is being tested?
- Endovascular embolization
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteGermany
- Study dates
- 1 Mar 2019to 1 Dec 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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)
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- 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
- Receiving dialysis or immunosuppressant therapy
- Chronic kidney disease (serum creatinine > 2.5 mg/dL)
Trial locations and contacts
1 site in 1 country.
About this study
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)
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)"
Read the 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.
- Conditions
- Aortic Aneurysm
- Being tested
- Endovascular embolization
- Medical subject headings
- Aortic Aneurysm
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Endovascular embolizationProcedure or surgery
Endovascular embolization of the Lumbar Arteries
| Study group | Role | What they receive |
|---|---|---|
| Platinum-fibered Microcoils (FPC) | Other | Embolization using platinum fibred Coils (Cook Incorporated, Bloomington, IN, USA) Receives: Procedure: Endovascular embolization |
| MVP® Vascular Plug | Other | Embolization using MVP®-Plug (Medtronic Inc., Minneapolis, MI, USA). Receives: Procedure: Endovascular embolization |
What is being measured
The primary outcome is the main question the study is designed to answer.
Radiation dose for embolization of the lumbar arteries with the MVP plug or coils
Measured: 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
Measured: through study completion, an average of 3-4 month
Success in complete occlusion of the targeted lumbar artery
Measured: through study completion, an average of 3-4 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Feb 2019
- Study start1 Mar 2019
- Primary completion1 Dec 2021
- Study completion1 Dec 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Aortic AneurysmStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Leipzig
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dierk Scheinert, University of Leipzig
- Investigators
- Dierk Scheinert, Prof. Dr., Principal investigator, University Clinic Leipzig
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03842930
- Sponsor's protocol ID
- CIP_18/002
- Status last verified
- May 2022
- First submitted
- 21 Jan 2019
- Last updated
- 18 May 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
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.
PubMed 38700601
Study at a glance
From the registry record, last updated by the sponsor on 18 May 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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)
- ClinicalTrials.gov ID
- NCT03842930
- Acronym / sponsor ID
- CIP_18/002
- Conditions
- Aortic Aneurysm
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- University of LeipzigUniversity, hospital or other
- Study start
- 1 Mar 2019 (actual)
- Primary completion
- 1 Dec 2021 (actual)
- Study completion
- 1 Dec 2021 (actual)
- First posted
- 15 Feb 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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)"
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Platinum-fibered Microcoils (FPC) | Other | Procedure: Endovascular embolizationEmbolization using platinum fibred Coils (Cook Incorporated, Bloomington, IN, USA) |
| MVP® Vascular Plug | Other | Procedure: Endovascular embolizationEmbolization using MVP®-Plug (Medtronic Inc., Minneapolis, MI, USA). |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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 understands the duration of the study, agrees to attend the stentgraft implantation
- A microcatheter is successfully placed the target lumbar artery.
Key exclusion criteria (17 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Endovascular embolizationEndovascular embolization of the Lumbar Arteries | Procedure or surgery | MVP® Vascular Plug, Platinum-fibered Microcoils (FPC) |
Primary outcome
Radiation dose for embolization of the lumbar arteries with the MVP plug or coils
Time frame: through study completion, an average of 3-4 month
2 secondary outcomes
Intervention time for embolization of the lumbar arteries with the MVP plug or coils
Time frame: through study completion, an average of 3-4 month
Success in complete occlusion of the targeted lumbar artery
Time frame: through study completion, an average of 3-4 month
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 May 2022.
- Derived from this study: PubMed 38700601Konert 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.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Dierk Scheinert, Prof. Dr. principal investigator
University Clinic Leipzig
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Endovascular embolization in people with Aortic Aneurysm, run by University of Leipzig at 1 site in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 17 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 18 May 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Radiation dose for embolization of the lumbar arteries with the MVP plug or coils (time frame: through study completion, an average of 3-4 month). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03842930, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 May 2022.