Overview

This trial is active, not recruiting.

Condition iliac aneurysm
Treatment e-liac stent graft system
Sponsor JOTEC GmbH
Start date June 2014
End date July 2019
Trial size 47 participants
Trial identifier NCT02209194, PLIANT

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. 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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Observational model cohort
Time perspective prospective
Arm
Endovascular repair of aortoiliac or iliac aneurysms
e-liac stent graft system
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

Primary Outcomes

Measure
Primary patency
time frame: within 30 days
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

Secondary Outcomes

Measure
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

Eligibility Criteria

Male or female participants at least 18 years old.

Inclusion Criteria: - 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 Exclusion Criteria: - 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 - 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

Additional Information

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
Principal investigator Jan Brunkwall, Professor
Trial information was received from ClinicalTrials.gov and was last updated in July 2016.
Information provided to ClinicalTrials.gov by JOTEC GmbH.