NCT01106391已完成不适用
A Multicenter, Open Label, Prospective, Non-Randomized Study Of INCRAFT™ In Subjects With Abdominal Aortic Aneurysms
适应症
干预措施
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- Rate of Technical Success Through the One Month Follow up.
研究概览
简要总结
This study is a multi-center prospective, open label, non-randomized investigation of INCRAFT™ in subjects with abdominal aortic aneurysms.
The study will enroll up to 60 subjects in up to 7 sites in Germany and Italy.
详细描述
This study is a multi-center prospective, open label, non-randomized investigation of INCRAFT™ in subjects with abdominal aortic aneurysms. The study will enroll up to 60 subjects at 7 sites in Germany and Italy. All treated subjects will be evaluated at 1 month, 3 months (if applicable), 6 and 12 months, and annually for a total of 5 years post-procedure. An interim analysis will be conducted after the 25th enrolled subject reaches the 30-day follow up visit
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
- •Subject is a male or infertile female > 18 years of age
- •Subject understands study requirements and treatment procedures and agrees to sign an informed consent form prior to any study procedures.
- •Subject is considered an appropriate candidate for open surgical repair of an abdominal aortic aneurysm.
- •Subject has at least one of the following:
- •Abdominal aortic aneurysm ≥4.5 cm in women or ≥ 5 cm in men in diameter
- •Aneurysm, which is >4 cm and which has increased in size by 0.5 cm within 6 months
- •The maximum aortic diameter is ≥1.5 times that of the reference aortic diameter
- •Saccular aneurysm
- •Subject has access vessel size compatible with vascular access techniques and potential accessories used with delivery profile of 14Fr
- •Subject aortic aneurysm neck is ≥15 mm in length
- •Subject iliac landing zone≥10mm in length
- •Subject has distal iliac landing sites with diameter ranges of 9-18mm
- •Subject proximal aortic attachment is between 20-27 mm in diameter.
- •Subject has a minimum overall AAA treatment length (from lowest renal artery to distal landing zone) of 140 mm.
- •Subject is willing to comply with all specified follow-up evaluations.
排除标准
- •Subject has one of the following:
- •a dissecting or inflammatory aneurysm
- •acutely ruptured aneurysm
- •pararenal or leaking aneurysm
- •The supra-renal aorta at 2cm above the lowest renal aorta is not more than the nominal diameter of the aortic bifurcate prosthesis
- •Aortic length (lowest renal artery origin to the aortic bifurcation) of <8.7 cm
- •Circumferential thrombosis and/or calcification ≥50% in the aortic and iliac landing zones
- •Circumferential thrombosis and/or calcification ≥50% in the supra-renal aorta
- •Subject has aneurysm neck angulations that are >60° in the supra-renal and/or infra-renal locations
- •Aortic bifurcation ≤18mm in diameter
- •Acute vascular injury due to trauma
- •Subject has a known allergy to contrast medium
- •Subject has known allergy to nitinol, PET or PTFE
- •Subject has a need for emergent surgery
- •Subject has a contraindication to undergoing angiography
- •Subject has a thoracic aortic aneurysm that requires treatment
- •Subject has Infra-renal aortic dissection
- •Subject has an Iliac anatomy which would require occlusion of both internal iliac arteries
- •Subject has congenital abnormalities in which the placement of the stent-graft will cause occlusion of major arterial flow. Such abnormalities should be evaluated (e.g. angiography or CT) prior to treatment
- •Subject has unstable angina as defined by Braunwald angina classification
- •Subject has morbid obesity (BMI of >40.0) or other clinical conditions that severely inhibit visualization of the aorta
- •Subject has connective tissue disease (e.g., Marfan's or Ehler's-Danos syndrome)
- •Subject has known bleeding or hypercoagulable disorder
- •Subject has contraindication for anticoagulation
- •Subject with Stroke or MI or intracranial bleeding within 3 months prior to the procedure
- •Subject with renal insufficiency (creatinine > 2.0 mg/dl)
- •Subject has known or suspected active infection at the time of the index procedure (for ex. Pneumonia, acute virus infection, contaminated wounds etc)
- •Subject is currently taking systemic immunosuppressant therapy
- •Subject had a major surgical procedure within 30 days prior to procedure or planned within 30 days post procedure
- •Subject has a life expectancy less than 2 years
- •Subject is currently participating in another research study involving an investigational device or new drug
- •Other medical, social, or psychological issues that in the opinion of the investigator preclude them from receiving this treatment, and the procedures and evaluations pre- and post-treatment
- •Subject with an existing AAA surgical graft and/or a AAA stent-graft system
研究组 & 干预措施
AAA stent graft system
Experimental
Cordis AAA stent graft system "INCRAFT TM"
干预措施: Cordis AAA stent graft system "INCRAFT TM" (Device)
结局指标
主要结局
Rate of Technical Success Through the One Month Follow up.
时间窗: From procedure to one month follow up
Technical success is defined as the successful deployment of the stent-graft to the desired location in the absence of Types I, III or IV endoleaks at the conclusion of the procedure and through the one month follow up.
Rate of Primary Safety Endpoint Within 1 Month Post-procedure.
时间窗: One month follow-up
Primary safety is defined by the absence of Types I, III or IV endoleaks and device and/or procedural related major adverse events within 1 month post-procedure. Major adverse events include death, MI, stroke and renal failure.
次要结局
- The Cumulative Percentage of Participants With Major Adverse Events at Annually Through 5 Years Post - Procedure.(From day 1 through year 5 post-procedure)
- The Percentage of Participants With Stent Graft Explant at 30 Days and Annually Through 5 Years Post - Procedure.(From day 1 through year 5 post-procedure)
- The Percentage of Participants With Endoleg Patency at 30 Days and Annually Through 5 Years Post - Procedure.(From day 1 through year 5 post-procedure)
- Percentage of Participants With Incidence of Stent-graft Migration Annually Through 5 Years Post - Procedure.(Day 30 through year 5 post-procedure)
- The Percentage of Participants With Thrombosis at 30 Days and Annually Through 5 Years Post - Procedure.(From day 1 through year 5 post-procedure)
- Percentage of Participants With Incidence of Aneurysm Enlargement Annually Through 5 Years Post - Procedure.(Day 30 through year 5 post-procedure)
- The Percentage of Participants With Endoleaks at Annually Through 5 Years Post - Procedure.(From day 1 through year 5 post-procedure)
- The Percentage of Participants With Stent-graft Fractures at 30 Days and Annually Through 5 Years Post - Procedure.(From day 1 through year 5 post-procedure)
研究者
研究点 (1)
Loading locations...
相似试验
已完成
不适用
A Multicenter, Open Label, Prospective, Non-randomized Study of the InCraft® Stent Graft System in Subjects With Abdominal Aortic Aneurysms (INSPIRATION)Abdominal Aortic AneurysmNCT01664078Cordis US Corp.190
已完成
不适用
Assessment of Efficacy and Safety of the Use of Two Eye Gel Products Containing 5% Dexpanthenol in Patients With Moderate to Severe Dry Eye SyndromeDry Eye DiseaseNCT06210373Fidia Farmaceutici s.p.a.125
已完成
不适用
To Evaluate Clinical Outcome and Injection Compliance of ScilinDiabetes Mellitus, Type 2NCT01588639Bayer2,683
撤回
不适用
The Evaluation of the DIMI RRT System In-Center to Demonstrate Safety and Usability in the Home EnvironmentHemodialysisESRDNCT04868643Dialco Medical Inc.
已完成
不适用
A Prospective, Multi Centre, Interventional, Non-comparator, Open Label Study to Demonstrate the Efficacy, Performance and Safety of ConvaFoam™ Silicone, ConvaFoam™ Border and ConvaFoam™ Non-Adhesive Dressings in the Management of Surgical and Traumatic WoundsTrauma-related WoundSurgical WoundNCT05632276ConvaTec Inc.54