Results of the Treatment of Medium and Long de Novo and Restenotic Lesions in the Superficial Femoral Artery and/or Popliteal Artery With Primary or Salvage Pulsar® -18 t3 Stent
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 100
- 主要终点
- No major amputation of the treated limb
研究概览
简要总结
The purpose of this post-authorization registry is to describe the clinical outcomes of de novo and restenotic lesions in the superficial femoral and/or popliteal artery treated with the PULSAR® -18 T3 stent, implanted both primary and salvage.
详细描述
Post-authorization, prospective and multicenter registry to evaluate the clinical results of the PULSAR® -18 T3 stent, in the treatment of de novo or restenotic lesions of the superficial femoral and/or popliteal artery, primarily as salvage, in a population of patients residing in Spain and in "real life" conditions.
In this registry, data will be collected from approximately 100 consecutive patients who have been treated with the PULSAR® -18 T3 Stent.
Subjects with PAD treated with the PULSAR® -18 T3 Stent will be assessed for eligibility for the registry and will be consecutively included in the registry. Once informed consent is obtained, the required data will be collected.
研究设计
- 研究类型
- Observational
- 观察模型
- Other
- 时间视角
- Prospective
入排标准
- 年龄范围
- 55 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients with documented PAD from the AFS and/or AP, classified as having intermittent claudication or critical limb ischemia (CLI), with a Rutherford score between 3 and
- •Age ≥ 55 years. I
- •The target lesion consists of one or multiple de novo or restenotic lesions > 5 cm.
- •Adequate run-off distal circulation to the foot (at least one patent, pre-existing, or successfully restored native distal vessel before beginning treatment of the target lesion).
- •Adequate in-flow defined as, stenosis ≤ 30% of the diameter (either pre-existing or successfully reestablished before starting treatment of the target lesion).
- •CI signed and dated.
排除标准
- •Failure to successfully cross the target lesion with a guidewire (successful crossing means that the tip of the guidewire is distal to the target lesion, without dissection or perforation that limits blood flow).
- •Life expectancy < 12 months.
- •Any contraindication to the use of antiplatelet therapy and/or heparin
- •Acute or subacute thrombosis in the target vessel.
结局指标
主要结局
No major amputation of the treated limb
时间窗: Up to 24 months.
Number of amputations
Revascularization rate of the clinically indicated target lesion
时间窗: Up to 24 months.
Number of new intervention of the target lesion, indicated by symptomatology or by a decrease in ABI (Ankle Brachial Index) ≥ 20% or ≥ 0.15 compared to the ABI after the index procedure or, a PSVR (Pick Systolic Velocity Ratio) \> 2.4 measured by DUS (Doppler Ultrasound)
No device- or procedure-related mortality
时间窗: Up to 24 months.
Number of deaths
No revascularization of the target lesion
时间窗: Up to 24 months.
Number of lesions not revascularized
次要结局
- Secondary patency.(Up to 24 months.)
- Serious Adverse Event Rates(Up to 24 months.)
- Assisted primary patency.(Up to 24 months.)
- Rate of patients with major amputation of target limb(Up to 24 months.)
- Hemodynamic improvement(Up to 24 months.)
- Rate of success of the procedure(Up to 24 months.)
- Rate of Clinical improvement (based on the Rutherford and WIfI classification) or absence of critical ischemia(Up to 24 months.)
- Primary patency(Up to 24 months.)
- Mortality from any cause(Up to 24 months.)