A Prospective Physician-Initiated PMCF Study Investigating the Safety and Clinical Performance of the Lokum L-Quest Guidewire, the Lokum Amplatz Guidewire, the Slider Hydrophilic Nitinol Guidewire, the AltoSa-XL PTA Balloon, the AltoSa-XL Gemini Balloon Catheter, the Optimus XL CoCr Stent and the Optimus CVS PTFE Covered XL Stent for the Endovascular Intervention
试验速览
- 阶段
- 不适用
- 状态
- 撤回
- 发起方
- 主要终点
- Freedom from MACE (Major Adverse Clinical Events) and/or Device related events during the procedure
研究概览
简要总结
This PMCF study is designed as prospective, multi-center study to collect real-life data.
The rationale of this study is to confirm and support the clinical safety and performance of the aforementioned products in 200 patients who will undergo an endovascular intervention within standard-of-care (SOC) where at least 1 of the following devices from AndraTec were used:
The LOKUM-Quest guidewire, The LOKUM AMPLATZ guidewire, the Slider Hydrophilic Nitinol Guidewire, the AltoSa-XL PTA balloon, the AltoSa-XL GEMINI PTA Balloon, the OPTIMUS CoCr Stent , the OPTIMUS-CVS PTFE-Covered stent.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
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
- •Corresponding to the CE-mark indications/contra-indications and according to the current medical guidelines for minimally invasive peripheral interventions.
- •Patient is willing to comply with specified follow-up evaluations at the specified times for the duration of the study (depending on the used device during the procedure) Patient is >18 years old Patient understands the nature of the procedure and provides written informed consent, prior to enrolment in the study Patient is eligible for treatment with
- •the Lokum L-Quest guidewire
- •and/or the Lokum Amplatz guidewire
- •and/or the Slider Hydrophilic Nitinol Guidewire
- •and/or the AltoSa-XL PTA balloon
- •and/or the AltoSa-XL Gemini balloon catheter
- •and/or the Optimus-XL CoCr Bare Metal Stent
- •and/or the Optimus-XL CVS PTFE Covered Stent, as described in the IFU for each device.
排除标准
- •Application in coronary, cerebral arteries and central circulatory system
- •Known contraindication to peripheral arterial and visceral vasculature treatment - Anatomy or size of vessels that will not allow appropriate usage of the investigational devices, following IFU of the investigational devices.
- •Known contraindication and/or allergy to (a component of) an investigational device
- •Pregnant women and women with childbearing potential not taking adequate contraceptives or currently breastfeeding
- •Life expectancy of less than twelve months
- •Any planned surgical intervention/procedure within 30 days of the study procedure
- •Any patient considered to be hemodynamically unstable at onset of procedure
- •Patient is currently participating in another investigational drug or device study that has not completed the entire follow-up period.
- •Device-related exclusion criteria (not applicable for guidewire):
- •Known contraindications given in the IFU of Optimus CoCr and Optimus-CVS PTFE- Covered Balloon-Expandable Stent which includes treatment of renal arteries, aneurysms adjacent to site of stent implantation and neurovascular treatment
- •Known contraindications given in the IFU of AltoSa-XL-PTA and AltoSa-XL-Gemini Balloon catheter:
- •patients with a contraindication for anti-platelet/anti-coagulant therapy
- •patients with excessive vessel tortuosity
- •dilatation of in-stent restenosis and highly calcified stenosis
- •patients with perforated vessels evidenced by extravasation of contrast media
- •patients with a known hypersensitivity to nylon
结局指标
主要结局
Freedom from MACE (Major Adverse Clinical Events) and/or Device related events during the procedure
时间窗: during procedure
MACE defined as: Death, Myocardial Infarction, Stroke, Emergent surgical revascularization of the target vessel, repeat vascularization of the target vessel, bleeding complication requiring transfusion)
Technical success rate
时间窗: during procedure
defined as successfully introduction and deployment of the Lokum L-Quest, and/or the Lokum Amplatz, and/or the Slider Hydrophilic Nitinol Guidewire, and/or the Optimus CoCr Stent, and/or the Optimus PFTE covered BE Stent, and/or the AltoSa-XL-PTA, and/or the AltoSa-XL-Gemini Balloon Catheter according to the respective IFU and without device related deficiencies.
次要结局
- For the Optimus CoCr and Optimus-CVS PTFE-covered stent: Freedom from MACE post-procedure, after 6- and 12-months.(Through study completion, an average of 1 year)
- For the Optimus CoCr and Optimus-CVS PTFE-covered stent: Freedom from Device-related serious adverse events (SAE's) post-procedure, after 6- and 12-months(Through study completion, an average of 1 year)
- Freedom from Target Lesion Revascularization post-procedure, at 6- and 12-months(Through study completion, an average of 1 year)
研究者
Dr. Sabrina Overhagen
Study Director
FCRE (Foundation for Cardiovascular Research and Education)