DANCE Partner: Inflammatory Biomarker Analysis by Femoropopliteal Revascularization Method and Treatment Outcomes

Study Overview
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Brief Summary
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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.

Detailed Description
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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. 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. 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.

Official Title
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DANCE Partner: Inflammatory Biomarker Analysis by Femoropopliteal Revascularization Method and Treatment Outcomes

Conditions
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Peripheral Arterial Disease

Intervention / Treatment
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* Device: Balloon Angioplasty
* Device: Atherectomy System


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Screening Criteria Male or non-pregnant female ≥18 years of age Rutherford Clinical Category 2-4 Clinical diagnosis of PAD requiring revascularization, secondary to atherosclerosis affecting a lower limb. Patient is willing to provide informed consent and comply with the required follow up visits Procedural Criteria De novo or nonstented restenotic lesions >90 days from prior angioplasty and/or atherectomy, at least 3 cm from any previously placed stent or vascular surgery site >70% diameter stenosis up to 15 cm in total length (with no greater than 3 cm length of contiguous intervening normal artery) in the superficial femoral and/or popliteal artery (between the profunda and tibioperoneal trunk) Reference vessel diameter ≥3mm and ≤ 8mm Successful wire crossing of lesion A patent artery proximal to the index lesion free from significant stenosis (significant stenosis is defined as >50% in iliac or >30% stenosis in common femoral artery) as confirmed by angiography (treatment of target lesion after successful treatment of iliac or common femoral artery lesions is acceptable) Exclusion Criteria: Screening Criteria Pregnant, nursing or planning on becoming pregnant in < 2years Life expectancy of <2 years Known active malignancy History of solid organ transplantation Patient actively participating in another investigational device or drug study History of hemorrhagic stroke within 3 months Previous or planned surgical or interventional procedure within 30 days of index procedure Chronic renal insufficiency with eGFR <29 Prior bypass surgery, drug-coated balloon or stenting of the target lesion Contra-indication or known hypersensitivity to contrast media or physician prescribed antiplatelet regimen as applicable Systemic fungal infection Anticipated use of IIb/IIIa inhibitor prior to index lesion treatment Acute or sub-acute thrombus, acute vessel occlusion or sudden symptom onset Acute limb ischemia Inability to ambulate (e.g. from prior ipsilateral or contralateral amputation) Patient is receiving steroids already, however locally acting inhaled steroids for asthma treatment do not exclude patients from the trial Procedural Criteria Lesions extending into the trifurcation or above the profunda Heavy eccentric or moderate circumferential calcification at index lesion Lesion length is >15 cm as measured from proximal normal vessel to distal normal vessel, or there is no normal proximal arterial segment in which duplex ultrasound velocity ratios can be measured Inadequate distal outflow defined as absence of at least one patent tibial artery (no lesion >50% stenosis) with flow into the foot Use of adjunctive therapies other than angioplasty, atherectomy (mechanical or laser) or bare metal stenting (i.e. scoring/cutting balloon, drug-eluting stent, drug-coated balloon, cryoplasty, etc.)

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Atherectomy<br>Up to 20 atherectomy procedures at up to 5 sites in the United States. Change in inflammatory biomarkers (hs-CRP, MCP-1 and MMP-9) from baseline to 24 hours post-procedure and 30-days post-revascularization procedure. This registry will also observe outcomes (target lesion revascularization rates, 6 and 12 month duplex ultrasound-detected binary restenosis with PSVR>2.4) post-atherectomy revascularization procedures. | Device: Atherectomy System<br>* Device: Orbital or Directional or Laser Atherectomy Systems Atherectomy selection is driven by preference of the operator<br>|
| Angioplasty<br>Up to 20 angioplasty procedures at up to 5 sites in the United States. Change in inflammatory biomarkers (hs-CRP, MCP-1 and MMP-9) from baseline to 24 hours post-procedure and 30-days post-revascularization procedure. This registry will also observe outcomes (target lesion revascularization rates, 6 and 12 month duplex ultrasound-detected binary restenosis with PSVR>2.4) post-angioplasty revascularization procedures. | Device: Balloon Angioplasty<br>* Device: Balloon Angioplasty Selection is driven by preference of the operator<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | Baseline to 24-hours post-procedure and 30-days post-procedure | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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). | 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. | Baseline to 24 hours post-procedure and 30-days post-revascularization procedure |