This is a retrospective, multi-center study to assess the safety and performance by proactively reviewing pre-existing medical records and imaging of patients who had previous placement of FLUENCY® PLUS Vascular Stent Graft in iliac artery vessel(s) between January 2010 and March 2020.
The purpose of this study is to retrospectively collect and analyze data on the FLUENCY® PLUS Vascular Stent Graft to summarize and describe real-world experience, and long-term data regarding its safety and efficacy and to compare these findings with published data on stent-treatment in iliac artery disease. The present study aims to collect clinical data about FLUENCY® treatment of atherosclerotic disease (stenosis, occlusion, dissection) as well as to explore safety and effectiveness data for off-label use in additional indications in the iliac segment that have been described in the scientific literature (vessel rupture, aneurysm).
Study Type
OBSERVATIONAL
Enrollment
146
Endovascular revascularization of peripheral arteries involves placement of a self-expanding Nitinol Stent encapsulated with ePTFE in diseased vessel segments
Universitätsklinikum Hamburg-Eppendorf
Hamburg, Germany
Universitätsklinikum Regensburg
Regensburg, Germany
Klinikum Nordoberpfalz AG - Klinikum Weiden
Weiden, Germany
Medical University of Gdańsk
Gdansk, Poland
Freedom from major complications
Freedom from device- and/or procedure-related death or myocardial infarction (MI), or any Target Lesion Revascularization (TLR), or target limb major amputation (above the ankle) through 30 days following the index procedure.
Time frame: 30 days
Target Lesion Revascularization
Target Lesion Revascularization (TLR) through 12-months post-index procedure.
Time frame: 12 months
Technical Success
Proportions of lesions with technical success. Technical success is defined as the successful treatment of the target lesion at the index procedure using the FLUENCY® PLUS Vascular Stent Graft, as reported in the questionnaire by the Investigator.
Time frame: During Procedure
Procedural Success
Proportions of patients with technical success and no peri-procedural complications (death, stroke, myocardial infarction (MI), emergent surgical revascularization, significant distal embolization in target limb, and thrombosis of target vessel) prior to hospital discharge.
Time frame: From Procedure until patient is discharged from hospital (average of 2 days)
Target Lesion Revascularization
Target Lesion Revascularization (TLR) through 24 (if applicable)-, 36 (if applicable)-, and 60 (if applicable)-months post-index procedure.
Time frame: 24 months, 36 months, 60 months
Target Vessel Revascularization
Target Vessel Revascularization (TVR) through 12-, 24 (if applicable)-,36 (if applicable) and 60 (if applicable)-months post-index procedure. TVR is defined as the first revascularization procedure (e.g. PTA, stenting, surgical bypass, etc.) in the target vessel segment following the index procedure.
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Mazowiecki Szpital Specjalistyczny (MSS Ostroleka)
Ostrołęka, Poland
Mazowiecki Szpital Brodnowski
Warsaw, Poland
Time frame: 12 months, 24 months, 36 months, 60 months
Sustained Clinical Success
Proportions of patients with sustained cumulative improvement from baseline value of ≥ 1 Rutherford Category at 30-days and 12-, 24 (if applicable)-, 36 (if applicable) and 60 (if applicable)-months post-index procedure, as determined by the Investigator.
Time frame: 30 days, 12 months, 24 months, 36 months, 60 months
Primary Patency
Primary Patency at 12-, 24 (if applicable)-, 36 (if applicable)- and 60 (if applicable)- months post-index procedure (freedom from TLR and restenosis). Restenosis will be assessed by duplex ultrasonography (DUS) or angiography and is present when the target lesion is determined to have \>50% stenosis, as determined by the Investigator.
Time frame: 12 months, 24 months, 36 months, 60 months
Puncture site complications
Presence of peri procedural complications and/or significant post-operative hematoma at puncture site, as determined by the Investigator.
Time frame: From Procedure until patient is discharged from hospital (average of 2 days)