An observational study in Vascular Diseases, Peripheral, sponsored by C. R. Bard. Completed at 6 sites in 2 countries. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2022-04-29.
Sponsored by C. R. Bard · Observational
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).
1,027 studies on the registry are indexed under Vascular Diseases; 167 are open to participants now.
This study's enrollment of 146 is below the median of 200 across 301 observational studies indexed under Vascular Diseases.
Browse Vascular Diseases studies →C. R. Bard is the lead sponsor of 113 studies on the registry; 6 are open to participants now.
Of its 17 completed or terminated interventional studies of FDA-regulated products, 12 (71%) have results posted.
Counted across the registry records on this site, refreshed daily.
Adult patients with iliac artery disease.
Exclusion Criteria:
Endovascular revascularization of peripheral arteries involves placement of a self-expanding Nitinol Stent encapsulated with ePTFE in diseased vessel segments
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.
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)
Plan to share: Undecided
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This study is completed, as verified in Apr 2022. You cannot join it, but the record below documents what was studied.
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C. R. Bard