This is a prospective, multi-center, observational registry to document the baseline, 24-hour and 30-day inflammatory response and procedural outcomes out to 12 month follow-up after femoropopliteal angioplasty or atherectomy-based revascularization procedures.
This is a prospective, multi-center, observational registry to document the baseline, 24-hour and 30-day inflammatory response and procedural outcomes out to 12 month follow-up after femoropopliteal angioplasty or atherectomy-based revascularization procedures. 1. To observe the femoropopliteal revascularization outcomes post-angioplasty and/or atherectomy and to observe potential correlation between patency outcomes and the levels of MCP-1, C-reactive protein and MMP-9 from baseline to 24 hours and 30 days post-procedure. 2. To provide a comparator dataset to the investigational DANCE trial, which has the same enrollment criteria as this observational trial but includes the investigational use of a local drug therapy to limit inflammation caused by mechanical revascularization.
Study Type
OBSERVATIONAL
Enrollment
31
Device: Balloon Angioplasty Selection is driven by preference of the operator
Device: Orbital or Directional or Laser Atherectomy Systems Atherectomy selection is driven by preference of the operator
Arkansas Heart Hospital
Little Rock, Arkansas, United States
Endovascular Technologies (Willis Knighton Medical Center)
Bossier City, Louisiana, United States
Hattiesburg Clinic
Hattiesburg, Mississippi, United States
Rex Hospital
Raleigh, North Carolina, United States
Change in inflammatory biomarkers
Change in inflammatory biomarkers (hs-CRP, MCP-1 and MMP-9) from baseline to 24 hours post-procedure and 30-days post-revascularization procedure.
Time frame: Baseline to 24-hours post-procedure and 30-days post-procedure
Target Lesion Revascularization
This registry will prospectively collect data from patients diagnosed with peripheral arterial disease to observe the restenosis rates in peripheral arteries compared with subjects enrolled in the DANCE trial (Mercator MedSystems TSP0149).
Time frame: 6 and 12 months post-procedure
Comparing biomarker (hs-CRP, MCP-1 and MMP-9) results
This registry will prospectively collect data from patients diagnosed with peripheral arterial disease to observe the correlation between the levels of MCP-1, C-reactive protein and MMP-9 after angioplasty or atherectomy procedures in peripheral arteries compared with subjects enrolled in the DANCE trial (Mercator MedSystems TSP0149). Objective measurement of biomarkers will be performed by a contract laboratory to avoid bias.
Time frame: Baseline to 24 hours post-procedure and 30-days post-revascularization procedure
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Mission Research Institute
New Braunfels, Texas, United States
Palestine Regional Medical Center
Palestine, Texas, United States