NCT05372952已完成不适用
An Investigator Initiated Trial to Evaluate the Safety and Feasibility of the DyNETIC-35 Cobalt Chromium Balloon-expandable Stent for the Treatment of Atherosclerotic Iliac Lesions Via a Trans-radial Approach - Bionetic-TRA
Klinikum Arnsberg1 个研究点 分布在 1 个国家目标入组 25 人开始时间: 2022年7月25日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 25
- 试验地点
- 1
- 主要终点
- Death
研究概览
简要总结
This feasibility study with a 30 day follow up period will assess the safety and feasibility of the Dynetic-35 stent for the treatment of peripheral iliac artery lesions via a trans-radial approach.
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
- •Subject is ≥ 18 years
- •Subject is capable (no legally authorized representative allowed) to provide written informed consent as approved by the Institutional Review Board (IRB)/Ethics Committee (EC) of the respective clinical site prior to any study related procedure
- •Subject has provided written informed consent before any study specific test or procedure and is willing to comply with all protocol and follow-up requirements
- •Subjects have a target lesion(s) with ≥ 70% stenosis (visual estimate) located in the iliac arteries
- •Target lesion is a de novo, restenotic or occluded lesion
- •Reference lumen (vessel) diameter between 5mm and 10 mm
- •The target lesion can be successfully crossed with a guide wire
- •Patient is eligible for transradial access
- •Subject has symptomatic iliac artery disease defined as Rutherford category 2 or higher
排除标准
- •Subject is pregnant and/or breastfeeding or planning to become pregnant during the course of the study.
- •Subject is with a current medical condition with a life expectancy of less than one year.
- •Pre-existing target iliac artery aneurysm or perforation or dissection
- •Any medical condition that in the opinion of the investigator poses an unacceptable risk for implant of a stent according to the study indications like, sensitivity to metal ions, intolerance to contrast or antiplatelet, anticoagulant or thrombolytic medications required per the protocol
- •Abdominal aortic aneurysm (AAA) contiguous to the iliac artery target lesion requiring treatment
- •The subject is currently participating in an investigational drug, biologic, or another device study and has not reached their primary endpoint yet
- •Subjects with small diameter upper extremity arteries that posed a contraindication to the use of 6F sheath
- •Severe stenosis or calcification of upper extremity arteries
- •Patient height precluding transradial access with a 170 cm long catheter shaft
- •Patient with a history of aortic arch atheroembolism
- •Infrainguinal outflow lesions that need to be treated during the same index procedure
- •Patients with negative bilateral Allen or barbeau tests (Note: vascular access should be done via the left hand where possible)
- •Subject has IFU listed contraindication(s)
- •Subject has in-stent restenosis
结局指标
主要结局
Death
时间窗: 30 days
Number of patients converting to femoral artery access
时间窗: 1 hour post procedure
Transradial access feasibility is assessed as number of patients in whom access is converted to femoral artery access due to failure to access the lesion via the radial artery
Access site complications
时间窗: 1 hour post procedure
bleeding, , pseudoaneurysm, arteriovenous fistula (AVF), radial artery rupture or occlusion
Transradial technical success
时间窗: Immediately after stent placement via radial access
Successful delivery of the Dynetic-35 stent at the lesion site with residual stenosis of ≤ 30%
Stroke
时间窗: 30 days
次要结局
- Procedure time [min](Intraoperative)
- Patient satisfaction regarding access site(24 hours post procedure)
- Procedure cost(1 hour post procedure)
- Length of hospital stay [hours](up to 30 days)
- Time to ambulation(up to 30 days)
研究者
研究点 (1)
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