- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03606083
Registry in Patients With Aorto-iliac or Iliac Aneurysms (PLIANTII)
Prospective Multicenter Registry to Examine the Real-world Performance of the E-liac Stent Graft System for Treatment of Uni- or Bilateral Aorto-iliac or Iliac Aneurysms
Study Overview
Detailed Description
In this study, patients will be observed who receive one or two E-liac Stent Graft(s) for aorto-iliac or iliac aneurysms. The E-liac Stent Graft(s) will be implanted at the discretion of the treating physician. Participating physicians will be asked to provide their observations collected during routine care for patients he/she had decided to treat with the E-liac Stent Graft System. Informed consent of the patients to allow the use of their clinical records for the purpose of this observational study will be obtained before intervention and before data are being collected.
The period of data collection will be 60 months starting from the intervention for each patient. 100% verification of patient informed consent and essential study documents will be performed at each study site. 60% of patient´s source documentation will be randomly monitored.
Study Type
Enrollment (Anticipated)
Contacts and Locations
Study Locations
-
-
NRW
-
Köln, NRW, Germany, 50937
- Recruiting
- Universitätsklinikum Köln
-
Contact:
- Jan Brunkwall, Prof.
- Phone Number: +4922147832498
- Email: gefaesszentrum@uk-koeln.de
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
Inclusion Criteria:
- Age between 18 and 85 years
- Patient must have an aorto-iliac or iliac aneurysm
- Patient must have a unilateral or bilateral iliac aneurysm
- Patient´s anatomy must be suitable for stent graft placement on preoperative angio CT scan
- Patient must be available for the appropriate follow-up times for the duration of the study
- Patient has been informed of the nature of the study, agrees to its provisions and has signed the informed consent form prior to intervention
Exclusion Criteria:
- Female of child bearing potential
- Patients with ruptured iliac aneurysms
- Patients with juxtarenal, pararenal or suprarenal aneurysms
- Patients pretreated with Nellix (Endologix) or Altura (Lombard Medical)
- Patient is currently participating in an investigational drug or device study that has not completed the primary endpoint or that clinically interferes with the current study endpoints
- Patient with malignancy needing chemotherapy or radiation
- Patients with life expectancy of less than 3 years
- Patient minor or under guardianship
Study Plan
How is the study designed?
Design Details
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Freedom from endoleak type I or III and patency of EIA and IIA on E-liac implantation side(s)
Time Frame: 12 months
|
Rate of patients that reach the primary endpoint
|
12 months
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Mortality
Time Frame: 24 hours
|
Rate of all cause mortality in peri-operative periods
|
24 hours
|
Survival rate
Time Frame: prior to discharge / 30 days, 12, 24, 36, 60 months
|
Rate of survival
|
prior to discharge / 30 days, 12, 24, 36, 60 months
|
Aneurysm size
Time Frame: 12, 24, 36, 60 months
|
Rate of patients with decreasing, stable, increasing aneurysm size
|
12, 24, 36, 60 months
|
Primary patency of EIA / IIA
Time Frame: prior to discharge / 30 days, 12, 24, 36, 60 months
|
Rate of patients with primary patency of EIA / IIA
|
prior to discharge / 30 days, 12, 24, 36, 60 months
|
Secondary patency of EIA / IIA
Time Frame: prior to discharge / 30 days, 12, 24, 36, 60 months
|
Rate of patients with secondary patency of EIA / IIA
|
prior to discharge / 30 days, 12, 24, 36, 60 months
|
Stent graft dislodgement
Time Frame: prior to discharge / 30 days, 12, 24, 36, 60 months
|
Rate of patients with stent graft dislodgement
|
prior to discharge / 30 days, 12, 24, 36, 60 months
|
Endoleak type I
Time Frame: prior to discharge / 30 days, 12, 24, 36, 60 months
|
Rate of patients with infrarenal type Ia endoleak
|
prior to discharge / 30 days, 12, 24, 36, 60 months
|
Endoleak type Ia in the CIA (isolated iliac aneurysm treatment)
Time Frame: prior to discharge / 30 days, 12, 24, 36, 60 months
|
Rate of patients with infrarenal type Ia endoleak
|
prior to discharge / 30 days, 12, 24, 36, 60 months
|
Endoleak type Ib in the CIA
Time Frame: prior to discharge / 30 days, 12, 24, 36, 60 months
|
Rate of patients with endoleak type Ib in the CIA
|
prior to discharge / 30 days, 12, 24, 36, 60 months
|
Endoleak type Ib in the EIA
Time Frame: prior to discharge / 30 days, 12, 24, 36, 60 months
|
Rate of patients with endoleak type Ib in the EIA
|
prior to discharge / 30 days, 12, 24, 36, 60 months
|
Endoleak type Ib in the IIA
Time Frame: prior to discharge / 30 days, 12, 24, 36, 60 months
|
Rate of patients with endoleak type Ib in the IIA
|
prior to discharge / 30 days, 12, 24, 36, 60 months
|
Endoleak type II
Time Frame: prior to discharge / 30 days, 12, 24, 36, 60 months
|
Rate of patients with endoleak type II
|
prior to discharge / 30 days, 12, 24, 36, 60 months
|
Endoleak type III
Time Frame: prior to discharge / 30 days, 12, 24, 36, 60 months
|
Rate of patients with endoleak type III
|
prior to discharge / 30 days, 12, 24, 36, 60 months
|
Stent fracture
Time Frame: prior to discharge / 30 days, 12, 24, 36, 60 months
|
Rate of patients with stent fracture
|
prior to discharge / 30 days, 12, 24, 36, 60 months
|
Reintervention
Time Frame: prior to discharge / 30 days, 12, 24, 36, 60 months
|
Rate patients with reintervention after E-liac Stent Graft implantation
|
prior to discharge / 30 days, 12, 24, 36, 60 months
|
Claudication
Time Frame: prior to discharge / 30 days, 12, 24, 36, 60 months
|
Rate of patients with increasing, stable, decreasing claudication (walking distance without pain)
|
prior to discharge / 30 days, 12, 24, 36, 60 months
|
Adverse Events
Time Frame: prior to discharge / 30 days, 12, 24, 36, 60 months
|
Rate of patients with adverse events (product-related, procedure-related, aneurysm-related)
|
prior to discharge / 30 days, 12, 24, 36, 60 months
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Jan Brunkwall, Prof., Cologne University Hospital
Publications and helpful links
General Publications
- Anton 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.
- Mylonas 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.
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- PLIANTII
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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