Evaluation of the Safety and Performance of the Multilayer Flow Modulator (MFM) for the Treatment of Chronic Type B Aortic Dissection
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 27
- 试验地点
- 5
- 主要终点
- Re-establishment of the flow inside the true lumen
研究概览
简要总结
Dragon Study Europe is an international, multicenter, prospective, non-randomized study. It is designed to evaluate safety and performance of the MFM for the treatment of chronic type B aortic dissection. About 35 patients in up to 11 countries will be enrolled and screened per the protocol-required inclusion, exclusion criteria, in order to obtain 30 completed patients. For early demonstration of safety and performance, an interim analysis report will be performed after all patients included will complete their 6-month follow-up.
The study purpose is to determine the safety and performance of the MFM for the endovascular treatment of chronic type B aortic dissection. It should be noted that the MFM has CE mark approval for aortic and peripheral artery aneurysms treatment.
详细描述
Aortic dissection (AD) is the surging of blood through a tear in the aortic intima with separation of the intima and media and creation of a false lumen.
The dissection may occur anywhere along the aorta and extend proximally or distally into other arteries. It occurs most commonly at the proximal ascending aorta (within 5 cm of the aortic valve) or the descending thoracic aorta (just beyond the origin of the left subclavian artery).
The passage of blood through the false channel can lead to complications such as spinal cord injury (paraplegia), lack of blood supply to the intestines (mesenteric ischemia) or lower extremities. The flow of blood in the false channel can cause these complications by pinching/narrowing off the flow of blood into the branches off the aorta. Aortic dissection always occurs in the setting of pre-existing degeneration of the aortic media. Causes include connective tissue disorders and injury. Atherosclerotic risk factors, notably hypertension, contribute in more than two thirds of patients.
Evidence of dissection is found in 1 to 3% of all autopsies. Population-based studies suggest that the incidence of AD is approximately 5-30 cases per million people per year. The diagnosis of AD is missed in 40% of cases on initial presentation, and 30% of AD are first diagnosed on post mortem exams.
African-Americans, men, the elderly, and people with hypertension are especially at risk. Peak incidence occurs at age 50 to 65 or, for patients with congenital connective tissue disorders (eg, Marfan syndrome, Ehlers-Danlos syndrome), at age 20 to 40.
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
- •Age over 18
- •Life expectancy > 12 months
- •Informed consent understood, signed and patient agrees to all follow-up visits
- •Chronic type B aortic dissection must be presenting with at least one of the following factors:
- •Uncontrollable hypertension
- •Persistent back/chest pain despite medical treatment
- •Expansion of aortic diameter (false lumen and total diameter)
- •With risk of progression, i.e. partial thrombosis of the false lumen
- •Healthy proximal and distal landing zone
- •Adequate arterial anatomy to perform EVAR by MFM
- •Healthy branches and collaterals (no stenosis or previously treated by angioplasty)
- •The patient must be available for the appropriate follow-up visits for the study duration
排除标准
- •Stage 4 or 5 Renal Insufficiency as per K/DOQI clinical practice guidelines for chronic kidney disease (GFR < 29ml/min/1.73m²)
- •Dissection or aneurysm rupture, impending or contained rupture
- •Aortic root aneurysm
- •Pleural effusion untreated at the procedure time
- •Prior all surgical procedure within 30 days unless procedure is in preparation for device implantation or planned within 30 days post stent deployment
- •Myocardial infarction or cerebral vascular accident within 6 weeks of treatment
- •Presence/suspicion of connective tissue disorders, for example, Marfan or Ehlers-Danlos etc.
- •Contraindications to the anticoagulant or/ and antiplatelet medications
- •Thrombocytopenia
- •Allergic reaction to a contrast agent
- •Patient with undergoing or planned chemotherapy
- •History of bleeding disorder (coagulopathy) or thrombophilia
- •Patient with atrial fibrillation who are under anticoagulation therapy
- •Presence/suspicion of infection (for example: mycotic aorta)
- •The use of the MFM with stent-grafts or previously implanted stent-grafts
- •Pregnant or breastfeeding woman
- •Patients included in another clinical study
- •Severe left ventricular dysfunction
- •Significant arrhythmias
- •Severe valvular disease
结局指标
主要结局
Re-establishment of the flow inside the true lumen
时间窗: 12 months
the re-establishment of the flow inside the true lumen will be evaluated using medical imagery. Data will be compared to pre-op imaregy, and will be presented as a percentage of patient with true lumen repressurization compared to baseline.
Keeping all branches patent
时间窗: 12 months
the re-establishment of the flow inside the true lumen will be evaluated using medical imagery. Data will be compaired to pre-op imaregy, and will be presented as a percentage of patient with true lumen repressurization compared to baseline.
次要结局
- Number of Serious Adverse Events(30 days, 12 months, 24 months and 36 months)
- Procedural/in-hospital evaluations (Estimated Blood loss)(The Procedural/in-hospital evaluation are recorded during hospital stay and collected data is presented in the 12 months report.)
- Procedural/in-hospital evaluations (time to hospital discharge)(The Procedural/in-hospital evaluation are recorded during hospital stay and collected data is presented in the 12 months report.)
- Procedural/in-hospital evaluations (Fluoroscopy time)(The Procedural/in-hospital evaluation are recorded during hospital stay and collected data is presented in the 12 months report.)
- Procedural/in-hospital evaluations (procedure time)(The Procedural/in-hospital evaluation are recorded during hospital stay and collected data is presented in the 12 months report.)
- Mortality at 30 days(30 days)
- Technical Success(The technical success is evaluated/recorded post-procedure and presented in the 12 months report)
- Procedural/in-hospital evaluations (Anesthesia time)(The Procedural/in-hospital evaluation are recorded during hospital stay and collected data is presented in the 12 months report.)
- Procedural/in-hospital evaluations (Contrast Volume)(The Procedural/in-hospital evaluation are recorded during hospital stay and collected data is presented in the 12 months report)