National Observational Study of the Thoraflex™ Hybrid Vascular Prosthesis in the Replacement of the Aortic Arch and the Treatment of Aneurysm/dissection of the Descending Thoracic Aorta
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 351
- 试验地点
- 37
- 主要终点
- Patients who did not die, nor suffered paraplegia due to the prosthesis, nor had complications linked to the procedure and surgical conversion
研究概览
简要总结
The purpose of this national observational study is to evaluate the Thoraflex™ Hybrid vascular prosthesis in the replacement of the aortic arch and the treatment of aneurysm/dissection of the descending thoracic aorta in relation to morbidity-mortality, visceral malperfusions, neurological and renal complications, endoleak and evolution of the aortic thoracic stent over time.
详细描述
Quality control will be performed continuously at various stages of the error correction process, according to the sponsor's Standard Operating Procedures.
Systematic coherence control procedures will be implemented and documented. The correction procedures will be tracked. For the study data, requests (Queries) will be issued and transmitted to the various centres for resolution.
To ensure data quality, a Monitoring Plan will be implemented. This plan will detail the frequency of visits or check-ups and the proportion of the data verified. It is expected that at least 10% of the data will be verified.
The monitoring factors in relation to the quality of electronic case report form completion will be performed by one of the Clinical Research Associates.
The participating physicians will be automatically contacted in the event of the absence of data entry after inclusion of patients and/or dates of scheduled visits and planned controls.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patient presenting an aneurysm/dissection of the thoracic aorta of the aortic arch and/or the descending thoracic aorta, and necessitating a procedure of the "Elephant Trunk" type, with the Thoraflex™ Hybrid hybrid vascular prosthesis.
排除标准
- •Patient having refused to sign the Consent form to the use of his/her data.
- •Patient residing abroad, for whom follow-up is not possible.
- •Patient with active endocarditis
- •Patient who has received a post-infarction septal repair.
- •A list of all of the patients who have received the Thoraflex™ Hybrid hybrid vascular prosthesis but not participating in the observational study will be documented, as well as the reasons for non-inclusion
结局指标
主要结局
Patients who did not die, nor suffered paraplegia due to the prosthesis, nor had complications linked to the procedure and surgical conversion
时间窗: 30 days post-operative
Percentage of patients who did not die, nor suffered paraplegia due to the prosthesis, nor had complications linked to the procedure and surgical conversion for 30 days post-operative
次要结局
- Complications linked to the device(Within 30 days of intervention; Between 3 and 6 months; then documented by the patient's clinical course up to 3 years.)
- Technical success(Within 30 days of intervention; Between 3 and 6 months; then documented by the patient's clinical course up to 3 years.)
- Follow-up surgery(Within 30 days of intervention; Between 3 and 6 months; then documented by the patient's clinical course up to 3 years.)
- Rates of visceral malperfusion, neurological, renal, cardiac, respiratory and Haemorrhagic complications(Within 30 days of intervention; Between 3 and 6 months; then documented by the patient's clinical course up to 3 years.)
- Death(Within 30 days of intervention; Between 3 and 6 months; then documented by the patient's clinical course up to 3 years.)
- Transitory paraplegia/Para-paresis(Within 30 days of intervention; Between 3 and 6 months; then documented by the patient's clinical course up to 3 years.)