Thoracic Aortic Stent-graft Study for the Treatment of Thoracic Aortic Pathologies - Assessment of the Relay Plus and Relay NBS Plus Stent-graft
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 170
- 试验地点
- 10
- 主要终点
- Long-term all-cause mortality
研究概览
简要总结
Stent treatment of thoracic aortic pathologies, including aneurysms, pseudo-aneurysms, dissections, intramural hematomas, penetrating ulcers and ruptures of the isthmus, seems to provide a likely benefit compared to surgery in terms of surgical mortality and severe morbidity. However, the data concerning the long-term fate of these stents are insufficient. For this reason, the French National Health Authority (HAS) requests a 5-year follow-up in relation to the renewal of insurance reimbursement for these stent-grafts. Therefore, this long-term observational study has been set up.
详细描述
Study outline:
French observational, prospective, multi-center, non-randomized, single arm and open-label study.
Study device:
RELAY PLUS and RELAY NBS PLUS thoracic aortic stent or future range extension models, excluding custom-made devices.
A total of 160 patients will be included in France consecutively from all participating centers and among users of the studied stent-graft (all of the centers) or any new center during the inclusion period. The patient will be considered as included in the study when the RELAY PLUS or RELAY NBS PLUS stent-graft is introduced via the surgical or percutaneous approach and provided that the patient meets all of the study eligibility criteria.
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
- — 至 80 Years（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patient requiring the placement of the RELAY PLUS or RELAY NBS PLUS thoracic aortic stent-graft for the treatment of a pathology of their descending thoracic aorta.
- •Patient (or legal representative for minor patients) who does not object (in writing or verbally) to the collection and transmission of their data.
排除标准
- •Patients for whom clinical follow-up is not possible, i.e. patients who are unable to return for follow-up visits (for example patients living abroad).
- •Patient who earlier benefited from one or more thoracic stent-grafts and for whom a specific follow-up of the RELAY PLUS or RELAY NBS PLUS stent-graft would not be possible depending on the nature of their treatment (e.g. patient already treated with stent-graft in the descending and/or thoraco-abdominal aorta with several extensions) .
结局指标
主要结局
Long-term all-cause mortality
时间窗: Any death occurring between the surgery when the stent-graft is introduced through the arterial access and the last follow-up at 5 years
次要结局
- Rate of device-related complications(Postoperatively or in the month following the intervention, 1 year, 2 years, 3 years, 4 years, 5 years)
- Rate of neurological complications(Postoperatively or in the month following the intervention, 1 year, 2 years, 3 years, 4 years, 5 years)
- Secondary procedure rate(Postoperatively, 1 year, 2 years, 3 years, 4 years, 5 years)
- Rate of exclusion of the aneurysm, penetrating aortic ulcer, false channel or rupture site, with no endoleak of any type(Postoperatively or in the month following the intervention, 1 year, 2 years, 3 years, 4 years, 5 years)
- Rate of cardiac, renal and pulmonary complications(Postoperatively or in the month following the intervention, 1 year, 2 years, 3 years, 4 years, 5 years)
- Surgical conversion rate(Postoperatively or in the month following the intervention, 1 year, 2 years, 3 years, 4 years, 5 years)
- Pathology-related mortality rate(Postoperatively or in the month following the intervention, 1 year, 2 years, 3 years, 4 years, 5 years)