Delivery of Dexamethasone to the Adventitia to eNhance Clinical Efficacy After Femoropopliteal Revascularization
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 285
- 试验地点
- 38
- 主要终点
- MALE-POD
研究概览
简要总结
To assess the safety and effectiveness of adventitial deposition of the Study Drug in reducing inflammation and restenosis in patients with clinical evidence of claudication or critical limb ischemia and an angiographically significant lesion in the superficial femoral and/or popliteal arteries.
Study Drug and Dose: Dexamethasone Sodium Phosphate Injection, USP, 4 mg/ml, with dilute contrast (17%) administered to the adventitia in a dose of 1.6 mg per cm of desired vessel treatment length.
详细描述
This trial will examine the ability for adventitial dexamethasone to safely delay restenosis in patients at least 18 years of age, who have peripheral atherosclerotic lesions involving the superficial femoral and/or popliteal arteries. These patients have no current therapeutic alternatives beyond the procedure used to open, or revascularize, their superficial femoral and/or popliteal arteries. Metal stents have the potential to fracture when implanted in this artery segment due to continual flexion and bending of the knee. It is desirable to improve the patency of this artery after percutaneous transluminal angioplasty (PTA) and/or atherectomy-based revascularization.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
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, testing schedule, and medication regimen
- •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 < 2 years
- •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, stenting of the target lesion
- •Inability to take required study medications
- •Contra-indication or known hypersensitivity to dexamethasone sodium phosphate, contrast media, or Physician prescribed antiplatelet regimen as indicated
- •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
- •Prior participation of the index limb in the current study (contralateral treatment is allowed)
- •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, which in the judgment of the investigator would prevent penetration of the Micro-Infusion Catheter needle through the vessel wall
- •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.)
研究组 & 干预措施
Adventitial Dexamethasone
In patients receiving either angioplasty or atherectomy-based revascularization (pre-stratified to each by 50% of the total study), dexamethasone will be delivered to the adventitia following revascularization.
干预措施: Dexamethasone Sodium Phosphate Injection, USP (Drug)
结局指标
主要结局
MALE-POD
时间窗: 30 days
Acute safety safety outcomes will be determined by evaluating the type, frequency, severity, and relatedness of Major Adverse Limb Events or Peri-Operative Death (MALE+POD) within 30 days from the procedure for all subjects.
Duplex ultrasound index lesion binary restenosis
时间窗: 12 months
Binary restenosis will be judged by core laboratory interpretation with peak systolic velocity ratio (PSVR) greater than 2.4.
次要结局
- Long term safety(30 days to 6 months)
- Duplex ultrasound index lesion flow limiting restenosis(6 and 12 months)
- Change in inflammatory biomarkers(Baseline and 24 hours)
- Vascular patency(6, 12, 18 and 24 months)
- Clinical outcome measures(1, 6, 12, 18 and 24 months)
- Infusion Technical Success(Intraprocedural)
- Procedural Success(Intraprocedural)
- Healthcare Economics(30 days)