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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register.

Register:	ClinicalTrials.gov
Last refreshed on:	12 December 2020
Main ID:	NCT02209194
Date of registration:	30/07/2014
Prospective Registration:	No
Primary sponsor:	JOTEC GmbH
Public title:	Post-market Registry in Patients With Iliac Aneurysm Undergoing Endovascular Stenting With the E-liac Stent Graft System
Scientific 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
Date of first enrolment:	June 2014
Target sample size:	47
Recruitment status:	Completed
URL:	https://clinicaltrials.gov/show/NCT02209194
Study type:	Observational
Study design:
Phase:

Countries of recruitment
Austria	Germany	Poland	Spain

Contacts

Name:	Jan Brunkwall, Professor
Address:
Telephone:
Email:
Affiliation:	Cologne University Hospital

Key inclusion & exclusion criteria

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

Age minimum: 18 Years
Age maximum: N/A
Gender: All

Health Condition(s) or Problem(s) studied

Iliac Aneurysm

Intervention(s)

Device: E-liac Stent Graft System

Primary Outcome(s)

Endoleak Type I or III [Time Frame: 12 months]

Primary patency [Time Frame: 36 months]

Endoleak Type I or III [Time Frame: 36 months]

Endoleak Type I or III [Time Frame: within 30 days]

Primary patency [Time Frame: within 30 days]

Primary Patency [Time Frame: 12 months]

Secondary Outcome(s)

Rate of death [Time Frame: 36 months]

Stent graft kinking [Time Frame: 36 months]

Rate of complications [Time Frame: 36 months]

Stent graft dislodgement [Time Frame: 36 months]

Change in aneurysm size [Time Frame: within 30 days (baseline) and 36 months]

Distal embolization [Time Frame: 36 months]

Stent graft migration [Time Frame: within 30 days (baseline) and 36 months]

Secondary ID(s)

PLIANT

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Secondary Sponsor(s)

Ethics review

Results

Results available:
Date Posted:
Date Completed:
URL:

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