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| Name | Class |
|---|---|
| Cromsource | INDUSTRY |
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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).
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Endovascular revascularization of peripheral arteries | Device | Endovascular revascularization of peripheral arteries involves placement of a self-expanding Nitinol Stent encapsulated with ePTFE in diseased vessel segments |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 30 days |
| Target Lesion Revascularization | Target Lesion Revascularization (TLR) through 12-months post-index procedure. | 12 months |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | During Procedure |
| Procedural Success |
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Inclusion Criteria:
Exclusion Criteria:
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Adult patients with iliac artery disease.
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| Name | Affiliation | Role |
|---|---|---|
| Grzegorz Halena, Prof. | Medical University of Gdansk | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Universitätsklinikum Hamburg-Eppendorf | Hamburg | 20246 | Germany | |||
| Universitätsklinikum Regensburg |
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| ID | Term |
|---|---|
| D016491 | Peripheral Vascular Diseases |
| ID | Term |
|---|---|
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
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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. |
| 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. | 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. | 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. | 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. | 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. | From Procedure until patient is discharged from hospital (average of 2 days) |
| Regensburg |
| 93053 |
| Germany |
| Klinikum Nordoberpfalz AG - Klinikum Weiden | Weiden | 92637 | Germany |
| Medical University of Gdańsk | Gdansk | 80-214 | Poland |
| Mazowiecki Szpital Specjalistyczny (MSS Ostroleka) | Ostrołęka | 07-410 | Poland |
| Mazowiecki Szpital Brodnowski | Warsaw | 03-242 | Poland |