Assessment of the GORE® EXCLUDER® Conformable AAA Endoprosthesis in the Treatment of Abdominal Aortic Aneurysms
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 156
- 试验地点
- 8
- 主要终点
- Primary safety success defined by the absence of major adverse events
研究概览
简要总结
EVAR continues to evolve as a treatment option for AAA. New devices which are specifically designed to perform adequately across the spectrum of potential anatomic presentations for infrarenal EVAR are needed. The Department of Vascular Surgery at Catharina Hospital Eindhoven, The Netherlands initiates the EXCeL Registry.
This study will assess the safety and effectiveness of the GORE® EXCLUDER® Conformable AAA Endoprosthesis (CEXC Device) in patients who meet the IFU anatomic criteria (≥15mm proximal neck length and ≤90˚ proximal neck angulation; and ≥10mm proximal neck length and ≤60˚ proximal neck angulation) and in patients with challenging anatomic presentation that may present outside the IFU anatomic criteria. Successful outcomes from this study will provide evidence to support the CEXC Device as an option for expanding EVAR to a broader patient population with more challenging anatomic presentations.
详细描述
EXCeL Registry is a multi-center, post-market, non-interventional, non-randomized, single-arm, prospective observational study, initiated by the Department of Vascular Surgery at Catharina Hospital Eindhoven, The Netherlands. The study has a single-arm without controls, as it is descriptive in nature, 150 consented subjects from up to 10 high-volume sites across Europe will be included into this registry.
Study enrollment is open to consecutively enrolled subjects who in the opinion of the investigator and according to Table A (p.9) -Anatomic measurement table and group specific- are suitable for being treated. An independent core lab will validate pre-requisite anatomy measurement to evaluate candidates for endovascular AAA repair with the GORE® EXCLUDER® Conformable AAA Endoprosthesis.
EXCeL Registry does not intervene with the physician's decision to choose for endovascular treatment with a GORE® EXCLUDER® Conformable AAA Endoprosthesis. Follow-up measurements are requested at 1 month, 12 months, and yearly thereafter, as minimally required by the reporting standards for endovascular aortic aneurysm repair. Beyond this, sites can schedule the subject's follow-up visits as usual in their clinical practice, as this study does not intervene in or influence the follow-up regimen. For data completion it is, however, possible that a telephone-contact with subjects will be requested.
This study will assess the safety and effectiveness of the GORE® EXCLUDER® Conformable AAA Endoprosthesis in patients who meet the IFU anatomic criteria and in patients with challenging anatomic presentation that may fall outside the IFU anatomic criteria and identified in the protocol as challenging anatomy treatment cohort. Consented subjects placed in the challenging anatomy cohort will be followed per the protocol and any data analysis on this cohort will be descriptive in nature only.
Up to 11 clinical investigative Sites will enroll a total of 150 subjects to allow for the broad range of aortic necks lengths and aortic neck angulations to be in the study. Consecutive consented subjects meeting protocol criteria will be part of the enrollment strategy:
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
- •AAA meeting any of the following criteria:
- •Maximum diameter ≥50 mm
- •Rapid growth (>5 mm in a 6 month period)
- •Non-ruptured AAA presenting with clinical symptoms 2 Adequate anatomy to receive the CEXC Device, including:
- •Adequate iliac / femoral access
- •Infrarenal aortic neck diameter 16-32 mm
- •Distal iliac artery seal zone ≥10 mm
- •Iliac artery diameter 8-25 mm
- •An Informed Consent Form (ICF) dated and signed by subject
- •Male or infertile female*
- •Able to comply with protocol requirements including following-up
- •Life expectancy >2 years
- •Age ≥18 years * Infertile female - condition which prevents pregnancy, e.g., hysterectomy, tubal ligation or post-menopausal for greater than 1 year
排除标准
- •Mycotic or ruptured aneurysm
- •Saccular aneurysm, unless it meets inclusion criteria of rapid growth (>5 mm in a 6 month period) or maximum diameter of (≥50 mm)
- •Known concomitant thoracic aortic aneurysm which requires surgical intervention
- •Renal insufficiency defined as creatinine >2.5 mg/dL or GFR <30 mL/min/1.73 m2
- •Patient has body habitus or other medical condition which prevents adequate delineation of the aorta
- •Participating in another investigational device study within 1 year of treatment
- •Systemic infection which may increase the risk of endovascular graft infection
- •Known degenerative connective tissue disease, e.g. Marfan or Ehler-Danlos Syndrome
- •Planned concomitant surgical procedure or major surgery within 30 days of treatment date, including planned branched, snorkel or chimney procedures
- •Known sensitivities or allergies to the device materials
- •Use of non-Gore stent grafts in initial procedure
结局指标
主要结局
Primary safety success defined by the absence of major adverse events
时间窗: up to 30 days after index procedure
These major adverse events are defined as all-cause mortality, stroke, mycardial infarction, bowel ischemia, paraplegia, respiratory failure, renal failure and thromboembolic events (including limb occlusion and distal embolic events).
Technical treatment success
时间窗: At the primary procedure
Proportion of subjects who experience successful, delivery and deployment of all required EXCC Device components annd successful removal of EXCC device delivery catheter(s)
Clinical effectiveness success
时间窗: From the day after the initial procedure up to 3 years after the initial procedure (which is the end of the follow up period for this registry
Effectiveness defined as absence of type I endoleak at each visit, Type III endoleak at the 12 month visit, migration (10 mm or more) between the one month and the 12 month visit, AAA enlargement \>5 mm with or without intervention between the one month and the 12 month visit, AAA rupture through the 12 month visit, conversion to open repair through the 12 month visit, limb occlusion
次要结局
- Incidence of treatment-emerged adverse events (safety)(From hospital admission before index procedure up to study completion after the 3 years follow up)
研究者
Marc van Sambeek
prof. dr. M.R.H.M. van Sambeek, vascular surgeon
Catharina Ziekenhuis Eindhoven