Universitätsklinikum Köln
Cologne, North Rhine-Westphalia, 50937, Germany
NCT Number: NCT03606083
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.
This study is active but is not currently recruiting participants.
Notify Me18 year–85 year
All sexes
Observational
Cologne, North Rhine-Westphalia, 50937, Germany
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Endovascular repair of aorto-iliac or iliac aneurysms using an iliac branch device (IBD)
Time frame: 12 months
Rate of patients that reach the primary endpoint
Time frame: 24 hours
Rate of all cause mortality in peri-operative periods
Time frame: prior to discharge / 30 days, 12, 24, 36, 60 months
Rate of survival
Time frame: 12, 24, 36, 60 months
Rate of patients with decreasing, stable, increasing aneurysm size
Time frame: prior to discharge / 30 days, 12, 24, 36, 60 months
Rate of patients with primary 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
Time frame: prior to discharge / 30 days, 12, 24, 36, 60 months
Rate of patients with stent graft dislodgement
Time frame: prior to discharge / 30 days, 12, 24, 36, 60 months
Rate of patients with infrarenal type Ia endoleak
Time frame: prior to discharge / 30 days, 12, 24, 36, 60 months
Rate of patients with infrarenal type Ia endoleak
Time frame: prior to discharge / 30 days, 12, 24, 36, 60 months
Rate of patients with 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 EIA
Time frame: prior to discharge / 30 days, 12, 24, 36, 60 months
Rate of patients with endoleak type Ib in the IIA
Time frame: prior to discharge / 30 days, 12, 24, 36, 60 months
Rate of patients with endoleak type II
Time frame: prior to discharge / 30 days, 12, 24, 36, 60 months
Rate of patients with endoleak type III
Time frame: prior to discharge / 30 days, 12, 24, 36, 60 months
Rate of patients with stent fracture
Time frame: prior to discharge / 30 days, 12, 24, 36, 60 months
Rate patients with reintervention after E-liac Stent Graft implantation
Time frame: prior to discharge / 30 days, 12, 24, 36, 60 months
Rate of patients with increasing, stable, decreasing claudication (walking distance without pain)
Time frame: prior to discharge / 30 days, 12, 24, 36, 60 months
Rate of patients with adverse events (product-related, procedure-related, aneurysm-related)
JOTEC GmbH
Industry
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
Acronym: PLIANTII
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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