Effectiveness and safety study of fenestrated/branched stent graft for thoraco-abdominal aortic disease

JRCT ID: jRCTs052180100

Registered date:07/03/2019

Basic Information

• Recruitment status: Complete
• Health condition(s) or Problem(s) studied: thoraco-abdominal aortic disease
• Date of first enrollment: 12/11/2015
• Target sample size: 20
• Study type: Interventional
• Intervention(s): Endovascular aortic repair using fenestrated/branched stent graft

Outcome(s)

• Primary Outcome: Freedom from aortic rupture and enlargement 6 months after procedure

Secondary Outcome

1. Freedom rate from endoleak at discharge and 6 months after procedure
2. Incidence of major adverse cerebral and cardiovascular events (MACCE) at 30 days and 6 months postoperatively
3. Device success
4. Technical success
5. Aorta-related death at 30 days and 6 months postoperatively
6. All other adverse events at 30 days and 6 months postoperatively

Key inclusion & exclusion criteria

• Age minimum: >= 20age old
• Age maximum: Not applicable
• Gender: Both

Include criteria

1. Thoraco-abdominal aortic aneurysm with following characteristics
1-a) Fusiform aneurysm with maximum diameter more than 50mm
1-b) Saccular aneurysm
1-c) Rapid enlargement (5mm/year)
1-d) Symptomatic
1-e) Surgical treatment is deemed necessary due to risk of rupture or malperfusion
2. Anatomical requirement dose not meet instructions for use of commercially available stent-graft systems
3. High-risk patients for conventional open aortic repair
4. Sufficient vascular access for insertion of the delivery system (Maximum OD 22Fr (8.5mm))
5. Subjects must receive explanation about contents of this research and informed consent in writing must be obtained
6. Subjects and doctors conducting this study agree that subjects will come to the hospital on all required follow-up days after the procedure

Exclude criteria

1. Untreated coronary artery disease requiring revascularization
2. Severe cardiac dysfunction with reduced left ventricular ejection fraction (LVEF) less than 20% by echocardiography
3. Pregnant patients
4. Patients with one of the following blood diseases
4-1) Leukopenia (< 1,000/mm3)
4-2) Thrombocytopenia (< 50,000/mm3)
4-3) Hemorrhagic diathesis or abnormal blood coagulation
5. Morbidly obese patients
6. Chronic Obstructive Pulmonary Disease (COPD) requiring home oxygen therapy
7. Patients with contraindication to one of the followings
7-1) Contrast agent
7-2) Stainless, gold, polyester
7-3) Heparin
8. Patients with active systemic infection and/or infective aortic aneurysm
9. History of cerebrovascular accident (CVA) or transient ischemic attack (TIA) within one month from scheduled surgical day
10. Active gastrointestinal bleeding
11. Patients with life expectancy less than one year
12. Patients participating in other clinical trials
13. Patients refusing blood transfusion
14. Severe dementia
15. Patients judged by the attending physician that it is difficult to participate in this study medically, socially, or psychologically
16.infant

Related Information

• Primary Sponsor: shimamura kazuo
• Secondary ID(s): UMIN000019661