A Real-World Study on Distal Aortic Remodeling for Stanford Type B Aortic Dissection With Fabulous Thoracic Aortic Stent System
Study Details
Study Description
Brief Summary
To evaluate aortic remodeling of Fabulous thoracic aortic stent system in the treatment of acute and subacute Stanford type B aortic dissection (the changes of aortic diameter, cross-sectional area,and volume of true lumen, false lumen and total aorta in different aoritc levels, and false lumen thrombosis in different aoritc levels), and splanchnic artery perfusion.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
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Detailed Description
Fabulous Thoracic Aortic Stent System is specially designed for aortic dissection based on PETTICOAT technique.
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Fabulous Thoracic Aortic Stent System
|
Device: Fabulous Thoracic Aortic Stent System
Endovascular treament in patients with aortic dissection with Fabulous Thoracic Aortic Stent System
|
Outcome Measures
Primary Outcome Measures
- Change of diameter [3 months, 6 months,12 months after operation]
The changes of true lumen, false lumen and total aortic diameter before and after surgery in the level of pulmonary artery bifurcation/left atrial (L1), the distal end of covered stent (L2), superior mesenteric artery (L3) and abdominal aortic bifurcation (L4) were recorded.
- Changes of cross-sectional area [3 months, 6 months,12 months after operation]
The changes of true lumen, false lumen and total aortic cross-sectional area before and after surgery in the level of pulmonary artery bifurcation/left atrial (L1), the distal end of covered stent (L2), superior mesenteric artery (L3) and abdominal aortic bifurcation (L4) were recorded.
- Volumetric change [3 months, 6 months,12 months after operation]
The volumes of the true lumen and false lumen of the aorta before and after surgery were measured from the covered stent placement segment, the proximal end of the bare stent to the level of celiac trunk, from the level of celiac trunk to the level of low kidney, and from the level of low kidney to the abdominal aorta bifurcation.
Secondary Outcome Measures
- Splanchnic arteries perfusion [3 months, 6 months,12 months after operation]
The change rate of postoperative true lumen diameter of branch artery = (postoperative true lumen diameter - preoperative true lumen diameter)/preoperative true lumen diameter ×100%
- Incidence of distal new entry [3 months, 6 months,12 months after operation]
The number of visceral artery segment tears and infrarenal abdominal aorta segment tears were evaluated.
- Tortuosity of the descending thoracic aorta [3 months, 6 months,12 months after operation]
Tortuosity of the descending thoracic aorta = the length of left subclavian artery to descending aorta of coeliac trunk along the center lumen line/the outer curvature length of left subclavian artery to coeliac trunk
- Immediate technical success [Immediate during surgery]
Immediate technical success was defined as the stent was successfully delivered to the intended site and released.
- Incidence of type I and III endoleak [Immediate during surgery,3 months, 6 months,12 months after operation]
- Major adverse events occurring within 30 days after surgery [within 30 days after operation]
Refers to all-cause mortality, myocardial infarction, ischemic stroke or respiratory failure occurring within 30 days after surgery. More specifically, myocardial infarction refers to a drastic reduction or complete interruption of the coronary blood supply due to coronary artery disease, resulting in severe and prolonged acute ischemia of the corresponding myocardium, leading to necrosis of cardiomyocytes. Ischemic stroke refers to the end result of necrosis of brain tissue caused by narrowing or occlusion of the arteries supplying blood to the brain or insufficient blood supply to the brain. Respiratory failure is defined as a state resulting in significantly prolonged intubation, tracheotomy, deterioration of lung function, or other fatal outcomes.
- Incidence of severe adverse events [3 months, 6 months,12 months after operation]
Refers to an event that occurs during the clinical trial that results in mortality or serious deterioration in patient health, including a fatal illness or injury, a permanent defect in body structure or body function, or an event that requires medical or surgical intervention to avoid one or more permanent defects in body structure or body function.
Eligibility Criteria
Criteria
Inclusion Criteria:
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≥18 years old, regardless of gender;
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Fabulous thoracic aortic stent System is suitable for the treatment of acute or subacute Stanford type B dissection, and the lesions meet one of the following criteria:
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It is necessary to treat distal lesions due to the presence of distal tears;
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The dissection involved a wide range, and there was collapse of the distal true cavity;
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Dissection combined with poor perfusion of distal branch vessels.
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With appropriate arterial access and suitable for endovascular aortic repair;
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Subjects could understand the purpose of the trial, volunteered to participate in the study, signed the informed consent form by themselves or their legal representatives, and were willing to complete the follow-up as required by the protocol.
Exclusion Criteria:
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Patients have participated in clinical trials of other drugs or medical devices related to target lesion treatment or have participated in clinical trials of other drugs or medical devices and have not reached the primary endpoint;
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Patients were unable or unwilling to participate in the study;
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Patients were judged by the investigator to be ineligible for participation in the trial.
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Beijing Anzhen Hospital, Capital Medical University | Beijing | Beijing | China | |
| 2 | Beijing Friendship Hospital, Capital Medical University | Beijing | China |
Sponsors and Collaborators
- Hangzhou Endonom Medtech Co., Ltd.
Investigators
None specified.Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- Fabulous WQ-F01