Suture-Tight™ First-in-Human Safety and Performance Study (CLP-05)
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 6
- 试验地点
- 2
- 主要终点
- Serious Adverse Events related to the Suture-Tight Suture Delivery System
研究概览
简要总结
Single center, open label, prospective, single-arm, first-in-human (FIH), pre-market clinical study with the objective of validating the safety and performance of the Suture-Tight™ Suture Delivery System in an EVAR procedure.
详细描述
Single center, study conducted at the Prince of Wales Private Hospital in Randwick, Australia. Up to 6 subjects may be enrolled. 1 to 3 subjects will complete initial enrollment and be followed for 30-days evaluating procedure and device safety. Additional subjects may be enrolled following the safety review to complete the 6-subject study. All subjects will be followed for six (6) months.
Subjects meeting all inclusion and exclusion criteria will be consented to receive an elective endovascular aortic aneurysm repair (EVAR) with graft anchoring utilizing the Suture-Tight device. Procedure and device safety and performance will be evaluated at 1- and 6-months by completing CT scans and KUB x-rays.
Data may be used to support a pivotal study of the investigational device and future global regulatory submissions.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 21 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Currently scheduled for an elective endovascular repair of an abdominal aortic aneurysm (AAA) by EVAR with CT scan from within last 4 months. Acceptable AAA parameters include: AAA ≥ 5.0 cm in diameter OR AAA ≥ 4.5 cm in diameter with an increase of ≥ 0.5 cm within the past 6-months or ≥ 1.0 cm over the past 12-months
- •Neck diameter, length and angulation that meets labeling requirements for the endograft used
- •Successful EVAR graft placement with no evidence of EVAR-associated serious adverse event.
排除标准
- •Mycotic or inflammatory AAA
- •Prior surgical repair of an AAA
- •Renal dialysis or significant chronic renal failure
- •Evidence of recent acute coronary disease, thrombotic disease, or cerebral infarct
- •Pregnancy
研究组 & 干预措施
Suture-Tight
Subjects meeting all inclusion and exclusion criteria will receive graft anchoring utilizing the Suture-Tight Suture Delivery System.
干预措施: Suture-Tight Suture Delivery System (Device)
结局指标
主要结局
Serious Adverse Events related to the Suture-Tight Suture Delivery System
时间窗: 30-days
Recording of all Serious Adverse Event (SAE) related to the Suture-Tight™ Suture Delivery System procedure or device
Analysis of the Suture-Tight endoanchor effectiveness
时间窗: 30-days
1. Documentation of Procedural success defined as: * Successful delivery of the Suture-Tight™ Delivery Catheter to the site of intended treatment * Successful removal of Suture-Tight™ Delivery Catheter * Absence of evidence of acute endograft migration or dysfunction at the conclusion of the procedure 2. Absence of a Type 1a Endo Leak 3. Absence of a stent graft migration
次要结局
- All cause safety events recorded during the study(6-months)
- Clinical Performance of the Suture-Tight following implant(6-months)
- Clinical Performance of the Stent Graft following Suture-Tight implant(6-months)