Active — Not RecruitingNot Applicable

Registry in Patients With Aorto-iliac or Iliac Aneurysms

Germany298 participantsStarted 2018-07-15

Plain-language summary

The PLIANT II registry is undertaken to examine the real-world outcome after treatment of consecutive patients with uni- or bilateral aorto-iliac or iliac aneurysms using the E-liac Stent Graft System.

Who can participate

Age range

18 Years – 85 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Freedom from endoleak type I or III and patency of EIA and IIA on E-liac implantation side(s)

Timeframe: 12 months

Trial details

NCT IDNCT03606083

SponsorJOTEC GmbH

Sponsor typeINDUSTRY

Study typeOBSERVATIONAL

Primary completion2028-09-30

View on ClinicalTrials.gov More Vascular Aneurysm trials

Who can participate

Age range

18 Years – 85 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.