A Cobalt Chromium Stent With a Bio Inducer Surface for the Treatment of Peripheral Iliac Artery Disease: Evaluation of Safety and Performance in Everyday Clinical Practice. The Isthmus Logic Post Market Clinical Follow-up Study.
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 80
- 试验地点
- 1
- 主要终点
- Rate of Major Adverse Events (MAE)
研究概览
简要总结
Isthmus Logic Carbostent™ is a CE-marked cobalt chromium stent with a bio inducer surface for the treatment of peripheral iliac artery disease.
The aim of this post-market retrospective study protocl P22202 is to collect clinical data of patients treated with Isthmus Logic for the treatment of peripheral iliac artery disease in routine clinical practice.
In order to obtain long-term follow-up data, the data collection will be limited to patients that have been treated with these devices at least 12 months prior to the study start.
详细描述
The objective of this post-market study is to systematically collect retrospective clinical data on the implantable medical device Isthmus Logic in the daily clinical practice in an unselected population treated within the intended use. Data will be collected via medical chart review in anonymous form to assess the safety and efficacy of Isthmus Logic. The Isthmus Logic Carbostent™ stent is made of cobalt chromium alloy and is coated with iCarbofilm™, a thin carbon film with a high-density turbostratic structure substantially identical with that of the pyrolitic carbon used for mechanical cardiac valve discs. Coating the substrate provides it with the bio- and haemocompatible characteristics of pyrolitic carbon, without affecting the physical and structural properties of the substrate itself.
Two radio-opaque platinum markers at either end of the stent allow for accurate positioning over the lesion to be treated.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Retrospective
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
- •Patient has been implanted with at least one Isthmus Logic stent according to the indications described in the Instructions for Use (IFU).
- •Study device implantation date is at least one year (12 months) prior to the starting date of the retrospective anonymous data collection.
排除标准
- •Patients treated less than 12 months prior to study start
结局指标
主要结局
Rate of Major Adverse Events (MAE)
时间窗: 12 months
Composite endpoint of all causes of death, unplanned target limb major amputation and/or clinically indicated target lesion revascularization (TLR)
次要结局
- Primary patency(6 months and 12 months)
- Limb-salvage rate (LSR)(6 months and 12 months)
- Secondary patency(6 months and 12 months or latest patency data available)
- Death(30 days)
- Clinically driven Target Lesion Revascularization(6 months and 12 months)
- Target limb ischemia(6 months and 12 months)
- Rutherford category measurement(pretreatment, 6 months and 12 months)
- Evaluation of Serious Adverse Events (SAEs)(6 months and 12 months)
- Acute success (device and procedural) within discharge(24/72 hours)