An Efficacy and Safety Study to Evaluate Ranger Drug-eluting Balloon for Below the Knee Angioplasty in Patients With Critical Limb Ischemia
试验速览
- 阶段
- 2 期
- 入组人数
- 30
- 试验地点
- 2
- 主要终点
- Efficacy: Primary patency (no stenosis >50%) of the Target Lesion measured by Quantitative Vascular Angiography (QVA)
研究概览
简要总结
Endovascular treatment of below the knee disease is a well-established therapy to improve outcomes in patients with critical limb ischemia. Several large cohort studies demonstrated the safety and the efficacy of percutaneous recanalization and angioplasty for distal vessel disease. A successful recanalization of foot artery was related to a higher ulcer healing and a reduction of major amputation. Moreover absence of revascularization in a patient with critical limb ischemia is an independent risk factor for mortality. Despite the introduction of new devices dedicated to below the knee vessel disease treatment, with the development of guides and conical balloons, long term patency outcomes are still poor. Restenosis was observed in more than two thirds of patients within 3 months after angioplasty of tibial arteries with a high target lesions revascularization. These re-interventions are characterized by a higher morbidity and mortality due to several comorbidities associated to these patients. These data confirm the need to obtain more lasting results in order to improve long-term outcomes of these patients.
Recently, the use of drug-eluting balloons (DEB) has revealed an increase in patency after angioplasty of the femoral artery. On the contrary, results for BTK arteries angioplasty have shown controversial results.
The purpose of this study is to evaluate the safety and the efficacy of the Ranger™ SL paclitaxel coated balloon a model of drug eluting balloon in patients with critical limb ischemia.
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 85 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •General Inclusion Criteria :
- •Age ≥18 years and ≤85 years
- •Patient signed an approved consent form
- •Patient has documented chronic Critical Limb Ischemia (CLI) in the target limb prior to the study procedure with Rutherford Category 4, 5 or 6
- •Menopausal or under contraception for women
- •Negative serum β-HCG for women of childbearing age
- •Angiographic Inclusion Criteria :
- •Single or multiple lesions with ≥70% diameter stenosis (DS) of different lengths in one or more main below the knee vessels
- •Intraluminal recanalization of the target lesion with successful traversal of the target lesion and placement of the guidewire into the distal true lumen
- •Reference vessel reference diameter comprised between 2 and 4 mm
排除标准
- •General non-inclusion criteria:
- •Patient with known hypersensitivity to paclitaxel
- •Patient unwilling or unlikely to comply with Follow-Up schedule
- •Life expectancy <1 year (investigator's appreciation)
- •Planned major index limb amputation
- •Pregnant or breast feeding women
- •Angiographic exclusion criteria:
- •Significant (≥50% DS) inflow lesion or occlusion in the ipsilateral iliac, superficial femoral or popliteal artery that cannot be treated successfully in the same session
- •Previously implanted stent in the target lesions(s)
- •Aneurysm in the target vessel
- •Acute thrombus in the target limb
- •Failure to cross the target lesion
研究组 & 干预措施
Ranger SL DEB angioplasty
patients filling general and angiographic inclusion/exclusion criteria will have an BTK angioplasty using one or several Ranger SL drug-eluting balloons
干预措施: Ranger SL DEB (Device)
结局指标
主要结局
Efficacy: Primary patency (no stenosis >50%) of the Target Lesion measured by Quantitative Vascular Angiography (QVA)
时间窗: 6 months
Primary patency (no stenosis \>50%) of the Target Lesion measured by Quantitative Vascular Angiography (QVA)
Safety: Number of deaths and major amputations
时间窗: 6 months
Number of deaths and major amputations (any amputation above the knee) at 6 months after procedure
次要结局
- Composite of all death and major amputation(12 months)
- Rate of Wound Healing(6 and 12 months)
- Toe pressure(1, 6 and 12 months)
- ABI (Ankle-Brachial Index)(1, 6 and 12 months)
- Technical success rates(Through angioplasty completion)
- Number of AEs(12 months)
- Late Lumen Loss (LLL)(6 months)
- Clinically driven Target Lesion Revascularization (TLR)(6 and 12 months)
- Ulcer diameter(1, 6 and 12 months)
- Device success rates(Through angioplasty completion)
- Number of SAEs(12 months)
- Amputation Free Survival(6 and 12 months)
- Quality of Life(6 and 12 months)