NCT02469532已完成不适用
DANCE Partner: Inflammatory Biomarker Analysis by Femoropopliteal Revascularization Method and Treatment Outcomes
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 31
- 试验地点
- 6
- 主要终点
- Change in inflammatory biomarkers
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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)
排除标准
- •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.)
结局指标
主要结局
Change in inflammatory biomarkers
时间窗: Baseline to 24-hours post-procedure and 30-days post-procedure
Change in inflammatory biomarkers (hs-CRP, MCP-1 and MMP-9) from baseline to 24 hours post-procedure and 30-days post-revascularization procedure.
次要结局
- Comparing biomarker (hs-CRP, MCP-1 and MMP-9) results(Baseline to 24 hours post-procedure and 30-days post-revascularization procedure)
- Target Lesion Revascularization(6 and 12 months post-procedure)
研究者
研究点 (6)
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