Iliac AneurysmNCT02209194
Post-market Registry in Patients With Iliac Aneurysm Undergoing Endovascular Stenting With the E-liac Stent Graft System
An observational study of Iliac Aneurysm, run by JOTEC GmbH at 12 sites in 4 countries.
Trial summary
The purpose of the study is to evaluate the clinical and technical success as well as safety and feasibility of the E-liac Stent Graft System used in endovascular treatment of uni- or bilateral aortoiliac or iliac aneurysm. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Iliac Aneurysm
- What is being tested?
- E-liac Stent Graft System
- Type of treatment
- Medical device
- How many people
- 47 participants
- Where
- 12 sitesin 4 countries
- Study dates
- Jun 2014to Sep 2019
- Phase
- Observational
- 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
Study population: Patients with uni- or bilateral aortoiliac or common iliac aneurysm
Who may be able to join
- Patients must comply with the indications for use
- Unilateral or bilateral common iliac aneurysm diameter equal or greater 25mm
- Unsuitable distal sealing site within the common iliac artery for traditional EVAR
Who cannot join
- Patients with a stenotic internal iliac ostium of < 4mm in diameter
- Patients with severe internal iliac atherosclerosis
- Patients that do not have a suitable landing area in the main stem of the IIA
- Patients with pseudoaneurysms
- Patients with symptomatic and ruptured iliac aneurysms
- Patients with one of the contraindications as indicated in the instructions for use
Show all 12Show fewer
- Patients pretreated with a bifurcated vascular graft
- Patient with thrombocytopenia
- Patient with creatinine >2.4 mg/dl immediately before the intervention
- Patient with malignancy needing chemotherapy or radiation
- Patients who are enrolled in another clinical study
- Patients with life expectancy of less than 36 months
Trial locations and contacts
12 sites in 4 countries.
12 sites in 4 countries
Germany7 sites
German Heart Center
Berlin, 13353
Klinikum Chemnitz
Chemnitz, 09113
Cologne University Hospital
Cologne, 50937
Uniklinikum Düsseldorf
Düsseldorf, 40225
UKSH Campus Kiel
Kiel, 24105
Krankenhaus Leonberg
Leonberg, 71229
Marienhospital
Osnabrück, 49074
Austria2 sites
Herzzentrum Hietzing
Vienna, 1130
Wilhelminenspital
Vienna, 1160
Spain2 sites
Hospital Universitario Donostia
Donostia / San Sebastian, 20080
Hospital Clínico Universitario de Valladolid
Valladolid, 47003
About this study
Official title: PLIANT - A Post-market Registry in Patients With Iliac Aneurysm Undergoing Endovascular Stenting With a New Generation of Low Profile E-liac Stent Graft System
The purpose of the study is to evaluate the clinical and technical success as well as safety and feasibility of the E-liac Stent Graft System used in endovascular treatment of uni- or bilateral aortoiliac or iliac aneurysm. Main study target is the exclusion of aneurysm with primary patency of the arteria iliaca interna and the arteria iliaca externa on iliac implantation side.
- Conditions
- Iliac Aneurysm
- Being tested
- E-liac Stent Graft System
- Keywords
- aneurysms, vascular disease, E-liac Stent Graft, E-liac Stent Graft System, iliac aneurysm, branched stent graft, self expanding stent graft
- Medical subject headings
- Iliac Aneurysm, Aneurysm, Vascular Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
E-liac Stent Graft SystemDevice
Implantation of the E-liac Stent Graft System in combination with a peripheral covered stent and in case of aortoiliac aneurysm in combination with a AAA Stent Graft
| Study group | Role | What they receive |
|---|---|---|
| Aortoiliac Aneurysms Iliac Aneurysms | Endovascular repair of aortoiliac or iliac aneurysms Receives: Device: E-liac Stent Graft System |
What is being measured
The primary outcome is the main question the study is designed to answer.
Primary patency
Primary patency of the arteria iliaca interna and the arteria iliaca externa on E-liac implantation side
Measured: within 30 days
Primary Patency
Measured: 12 months
Primary patency
Measured: 36 months
Endoleak Type I or III
Measured: within 30 days
Endoleak Type I or III
Measured: 12 months
Endoleak Type I or III
Measured: 36 months
Secondary outcomes (7)
Change in aneurysm size
Measured: within 30 days (baseline) and 36 months
Stent graft migration
Measured: within 30 days (baseline) and 36 months
Stent graft dislodgement
Measured: 36 months
Stent graft kinking
Measured: 36 months
Distal embolization
Measured: 36 months
Rate of death
Measured: 36 months
Rate of complications
Measured: 36 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Aug 2014 (estimated)
- Study startJun 2014
- Primary completionSep 2019
- Study completionSep 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Iliac AneurysmStudies of the same condition, open and under way.
- More trials run by JOTEC GmbHThe sponsor's other registered studies.
- 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 47 participants (actual)
Sponsor and investigators
- Lead sponsor
- JOTEC GmbH
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Jan Brunkwall, Professor, Principal investigator, Cologne University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02209194
- Sponsor's protocol ID
- PLIANT
- Status last verified
- Apr 2020
- First submitted
- 30 Jul 2014
- Last updated
- 1 May 2020
- Results posted
- No
- Data monitoring committee
- No
Publications
Brunkwall JS, Vaquero-Puerta C, Heckenkamp J, Egana Barrenechea JM, Szopinski P, Mertikian G, Seifert S, Rumenapf G, Buz S, Assadian A, Majd P, Mylonas S, Calavia AR, Theis T, de Blas Bravo M, Pleban E, Schupp J, Esche M, Kocaer C, Hirsch K, Oberhuber A, Schafer JP. Prospective Study of the Iliac Branch Device E-liac in Patients with Common Iliac Artery Aneurysms: 12 Month Results. Eur J Vasc Endovasc Surg. 2019 Dec;58(6):831-838. doi: 10.1016/j.ejvs.2019.06.020. Epub 2019 Oct 12.
PubMed 31615695Brunkwall J, Vaquero Puerta C, Heckenkamp J, Egana Barrenechea JM, Szopinski P, Mertikian G, Seifert S, Rumenapf G, Buz S, Assadian A, Majd P, Mylonas S, Revilla Calavia A, Theis T, de Blas Bravo M, Pleban E, Schupp J, Esche M, Kocaer C, Hirsch K, Oberhuber A, Schafer JP. Prospective study of the E-liac Stent Graft System in patients with common iliac artery aneurysms: 30-Day results. Vascular. 2018 Dec;26(6):647-656. doi: 10.1177/1708538118789510. Epub 2018 Jul 23.
PubMed 30037302Anton S, Wiedner M, Stahlberg E, Jacob F, Barkhausen J, Goltz JP. Initial Experience with the E-liac(R) Iliac Branch Device for the Endovascular Aortic Repair of Aorto-iliac Aneurysm. Cardiovasc Intervent Radiol. 2018 May;41(5):683-691. doi: 10.1007/s00270-017-1868-x. Epub 2018 Jan 3.
PubMed 29299625Mylonas SN, Rumenapf G, Schelzig H, Heckenkamp J, Youssef M, Schafer JP, Ahmad W, Brunkwall JS; E-liac Collaborative Group. A multicenter 12-month experience with a new iliac side-branched device for revascularization of hypogastric arteries. J Vasc Surg. 2016 Dec;64(6):1652-1659.e1. doi: 10.1016/j.jvs.2016.04.065. Epub 2016 Aug 1.
PubMed 27492764
Study at a glance
From the registry record, last updated by the sponsor on 1 May 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- PLIANT - A Post-market Registry in Patients With Iliac Aneurysm Undergoing Endovascular Stenting With a New Generation of Low Profile E-liac Stent Graft System
- ClinicalTrials.gov ID
- NCT02209194
- Acronym / sponsor ID
- PLIANT
- Conditions
- Iliac Aneurysm
- Keywords
- aneurysms, vascular disease, E-liac Stent Graft, E-liac Stent Graft System, iliac aneurysm, branched stent graft, self expanding stent graft
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 47 participants (actual)
- Lead sponsor
- JOTEC GmbHIndustry (pharma, biotech, devices)
- Study start
- Jun 2014
- Primary completion
- Sep 2019 (actual)
- Study completion
- Sep 2019 (actual)
- First posted
- 5 Aug 2014 (estimated)
- 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.
The purpose of the study is to evaluate the clinical and technical success as well as safety and feasibility of the E-liac Stent Graft System used in endovascular treatment of uni- or bilateral aortoiliac or iliac aneurysm. Main study target is the exclusion of aneurysm with primary patency of the arteria iliaca interna and the arteria iliaca externa on iliac implantation side.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Aortoiliac Aneurysms Iliac Aneurysms | – | Device: E-liac Stent Graft SystemEndovascular repair of aortoiliac or iliac aneurysms |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with uni- or bilateral aortoiliac or common iliac aneurysm
Key inclusion criteria (3 listed)
- Patients must comply with the indications for use
- Unilateral or bilateral common iliac aneurysm diameter equal or greater 25mm
- Unsuitable distal sealing site within the common iliac artery for traditional EVAR
Key exclusion criteria (12 listed)
- Patients with a stenotic internal iliac ostium of < 4mm in diameter
- Patients with severe internal iliac atherosclerosis
- Patients that do not have a suitable landing area in the main stem of the IIA
- Patients with pseudoaneurysms
- Patients with symptomatic and ruptured iliac aneurysms
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 |
|---|---|---|
| E-liac Stent Graft SystemImplantation of the E-liac Stent Graft System in combination with a peripheral covered stent and in case of aortoiliac aneurysm in combination with a AAA Stent Graft | Device | Aortoiliac Aneurysms Iliac Aneurysms |
Primary outcome
Primary patency
Time frame: within 30 days
Primary patency of the arteria iliaca interna and the arteria iliaca externa on E-liac implantation side
Primary Patency
Time frame: 12 months
Primary patency
Time frame: 36 months
Endoleak Type I or III
Time frame: within 30 days
Endoleak Type I or III
Time frame: 12 months
Endoleak Type I or III
Time frame: 36 months
7 secondary outcomes
Change in aneurysm size
Time frame: within 30 days (baseline) and 36 months
Stent graft migration
Time frame: within 30 days (baseline) and 36 months
Stent graft dislodgement
Time frame: 36 months
Stent graft kinking
Time frame: 36 months
Distal embolization
Time frame: 36 months
Rate of death
Time frame: 36 months
Rate of complications
Time frame: 36 months
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 1 May 2020.
- Background: PubMed 31615695Brunkwall JS, Vaquero-Puerta C, Heckenkamp J, Egana Barrenechea JM, Szopinski P, Mertikian G, Seifert S, Rumenapf G, Buz S, Assadian A, Majd P, Mylonas S, Calavia AR, Theis T, de Blas Bravo M, Pleban E, Schupp J, Esche M, Kocaer C, Hirsch K, Oberhuber A, Schafer JP. Prospective Study of the Iliac Branch Device E-liac in Patients with Common Iliac Artery Aneurysms: 12 Month Results. Eur J Vasc Endovasc Surg. 2019 Dec;58(6):831-838. doi: 10.1016/j.ejvs.2019.06.020. Epub 2019 Oct 12.
- Background: PubMed 30037302Brunkwall J, Vaquero Puerta C, Heckenkamp J, Egana Barrenechea JM, Szopinski P, Mertikian G, Seifert S, Rumenapf G, Buz S, Assadian A, Majd P, Mylonas S, Revilla Calavia A, Theis T, de Blas Bravo M, Pleban E, Schupp J, Esche M, Kocaer C, Hirsch K, Oberhuber A, Schafer JP. Prospective study of the E-liac Stent Graft System in patients with common iliac artery aneurysms: 30-Day results. Vascular. 2018 Dec;26(6):647-656. doi: 10.1177/1708538118789510. Epub 2018 Jul 23.
- Background: PubMed 29299625Anton S, Wiedner M, Stahlberg E, Jacob F, Barkhausen J, Goltz JP. Initial Experience with the E-liac(R) Iliac Branch Device for the Endovascular Aortic Repair of Aorto-iliac Aneurysm. Cardiovasc Intervent Radiol. 2018 May;41(5):683-691. doi: 10.1007/s00270-017-1868-x. Epub 2018 Jan 3.
- Background: PubMed 27492764Mylonas SN, Rumenapf G, Schelzig H, Heckenkamp J, Youssef M, Schafer JP, Ahmad W, Brunkwall JS; E-liac Collaborative Group. A multicenter 12-month experience with a new iliac side-branched device for revascularization of hypogastric arteries. J Vasc Surg. 2016 Dec;64(6):1652-1659.e1. doi: 10.1016/j.jvs.2016.04.065. Epub 2016 Aug 1.
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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.
Jan Brunkwall, Professor principal investigator
Cologne University Hospital
12 sites in 4 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Iliac Aneurysm, run by JOTEC GmbH at 12 sites in 4 countries.
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 3 inclusion and 12 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 1 May 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 12 sites in Germany, Austria, Spain, Poland. 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?
Primary patency (time frame: within 30 days). The study lists 6 primary outcomes in all. 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 NCT02209194, which also lists 4 linked publications.
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 1 May 2020.