Sirolimus Drug-eluting Stent for the Treatment of Infrapopliteal Peripheral Artery Disease: Evaluation of Safety and Performance in Everyday Clinical Practice. The Cre8™ BTK 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
- 50
- 试验地点
- 2
- 主要终点
- Rate of Major Adverse Events (MAE)
研究概览
简要总结
Cre8™ BTK is a CE marked drug eluting stent, integrally coated with i-Carbofilm, loaded with formulated Sirolimus for the treatment of infrapopliteal peripheral artery disease.
The aim of this post-market retrospective study protocol P32102 is to collect clinical data of patient treated with Cre8™ BTK stent 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 the Cre8™ BTK stent at least 12 months prior to the study start.
详细描述
The objective of this post-market observational study is to collect retrospective clinical data on the implantable medical device Cre8™ BTK in an unselected population, in the current clinical practice treated within the intended use. Data will be collected via medical chart review in anonymous form to assess the safety and efficacy of the device.
The Cre8™ BTK stent is made of cobalt-chromium alloy (L605) and it is coated with iCarbofilm™, a thin carbon film with a high density turbostratic structure substantially identical with that of the pyrolytic carbon used for mechanical cardiac valve discs. Coating the substrate with iCarbofilm™ provides it with the bio- and haemocompatible characteristics of pyrolytic carbon, without affecting the physical and structural properties of the substrate itself. The outer surface of the stent has dedicated grooves, fully coated with iCarbofilm™, for containing the pharmaceutical formulation Amphilimus™, which is composed of the drug sirolimus and a mixture of long-chain fatty acid.
The specific drug dosage is 0.9 μg/mm2 corresponding to a minimum dose of 50 μg on the smaller stent (2.25x8mm) and a maximum dose of 395 μg on the larger stents (4.0x38mm and 3.5x46mm). Two radiopaque platinum markers, positioned at each end of the stent, allow to correctly position it 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 Cre8™ BTK device 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)