NCT00706394已完成不适用
Prospective, Multicenter, Single Arm Phase II Study of the Powerlink 34mm Cuff for the Endovascular Repair of Abdominal Aortic Aneurysms
适应症
干预措施
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- Endologix
- 入组人数
- 19
- 试验地点
- 10
- 主要终点
- Number of Participants With Proximal Type I Endoleak at Each Timepoint
研究概览
简要总结
Study of anatomical fixation with a 34mm proximal extension
详细描述
The 34mm proximal extension stent graft is intended to augment the primary 28mm infrarenal bifurcated stent graft to accommodate patient anatomy (neck diameters up to 32mm) and provide an effective seal to prevent/repair proximal Type I endoleaks.
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
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •18 years old or older
- •Informed consent understood and signed
- •Will comply with protocol follow-up requirements
- •Candidate for conventional open surgical repair
- •Aneurysm outer diameter is one or more of the following:
- •greater than or equal to 4.0cm
- •greater than or equal to 3.0cm (saccular aneurysm)
- •greater than or equal to twice the normal aortic outer diameter
- •rapidly growing (greater than or equal to 5mm over 6 months)
- •Proximal non-aneurysmal aortic neck fixation length greater than or equal to 1.5cm between the renal arteries and the aneurysm
- •Non-aneurysmal proximal aortic neck inner diameter between 23 and 32mm
- •Iliac artery internal diameter greater than or equal to 8 mm
排除标准
- •Life expectancy <2 years
- •Participating in another clinical study
- •Pregnant or lactating women
- •Acutely ruptured/leaking aneurysm
- •Traumatic vascular injury
- •Other medical or psychiatric problems
- •Contraindication to non-ionic contrast media or anticoagulants
- •Coagulopathy or bleeding disorder
- •Active systemic or localized groin infection
- •Indispensable inferior mesenteric artery
- •Connective tissue disease (e.g., Marfan's Syndrome)
- •Creatinine level >1.7 mg/dl
- •Renal transplant patient
- •Proximal attachment site >60º angle to the aneurysm body
- •Iliac arteries >90º angle
- •<1.5 cm of non-aneurysmal common iliac artery above the iliac bifurcation on both sides [One internal iliac artery is required to remain patent]
- •Thrombus >30% at implantation site
研究组 & 干预措施
A
Experimental
Powerlink 34mm cuff stent graft
干预措施: Endologix Powerlink 34 mm stent graft cuff (Device)
结局指标
主要结局
Number of Participants With Proximal Type I Endoleak at Each Timepoint
时间窗: Five years
Percentage of patients with Type Ia endoleaks at each timepoint (discharge, 1, 6, 12, 24, 36, 48 and 60 months).
次要结局
- Number of Participants With Type III Endoleaks at Each Timepoint(5 Years)
- Maximum Diameter Measurements(5 Years)
- Number of Participants With Aneurysm Diameter Change at Each Timepoint(5 Years)
- Number of Participants With Migration at Each Timepoint(5 Years)
- Aneurysm Volume Measurements(5 Years)
- Number of Participants With Stent Fracture at Each Timepoint(5 Years)
- Number of Participants With Stent Graft Obstruction at Each Timepoint(5 Years)
- Number of Participants With Type II Endoleaks at Each Timepoint(5 Years)
- Number of Participants With Successful Delivery and Deployment of the Device(1 Month)
研究者
研究点 (10)
Loading locations...
相似试验
已完成
不适用
Symmcora® Long-term Bidirectional Barbed Suture for Anastomosis in Patients Undergoing Robot Assisted Radical ProstatectomyProstate CancerNCT06055946Aesculap AG70
已完成
不适用
Assessment of Implant Fixation and SF-36 for Short Hip-Stems - A Prospective Clinical StudyPrimary and Secondary CoxarthrosisDysplasia CoxarthrosisPost-traumatic Necrosis of the Femoral HeadNCT04172129Smith & Nephew Orthopaedics AG60
终止
不适用
Curvafix® Intramedullary System for Fixation of Pelvic and Acetabular Fractures, A Post Market EvaluationPelvic Ring FracturePelvic Fracture AcetabulumAcetabular FracturePelvic FractureNCT05606042CurvaFix, Inc.53
Unknown
4 期
A Safety Study of Hylan GF-20 to Treat Shoulder OsteoarthritisPainful Shoulder OsteoarthritisNCT00253799Northwestern Ophthalmic Institute S.C.35
Unknown
不适用
Evaluation of Adjunctive EndoAnchors for EVAR and TEVARAortic AneurysmThoracic Aortic AneurysmNCT04100499Hospital Universitario Ramon y Cajal300