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Background: Aortic dissection (AD) is a common emergency in vascular surgery, which seriously threatens human life and health. The rupture of Stanford type B dissection is located in aortic arch and the dissection range is from the descending aorta or involves the abdominal aorta. At present, the endovascular repair of the thoracic aorta (TEVAR) for AD has been widely deployed worldwide and has become the standard surgical procedure for the treatment of AD. However, there is still controversy regarding the Stanford B aortic dissection that involves the left subclavian artery or the stent landing area less than 1.5 cm.
Study objective: To evaluate the effectiveness and safety of endovascular repair with in situ needle fenestration of left subclavian artery.
Methods: This study intends to enroll 217 patients with Stanford type B aortic dissection who meet the enrollment criteria. The patients will be followed up at 1, 6, 12, and 24 months after endovascular repair, and the CTA images of the thoracic aorta were collected.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| group RISEN STAR | Patients with Stanford B-type aortic dissection will be treated with endovascular repair with in situ needle fenestration of left subclavian artery. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| In situ fenestration | Behavioral | Interventional therapy of aortic dissection. In situ needle fenestration of left subclavian artery. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Patency rate of main and branch stent. | Patency of main and branch stent will be evaluated by Computed Tomography Angiography. | 1 month after interventional therapy. |
| Patency rate of main and branch stent. | Patency of main and branch stent will be evaluated by Computed Tomography Angiography. | 6 months after interventional therapy. |
| Patency rate of main and branch stent. | Patency of main and branch stent will be evaluated by Computed Tomography Angiography. | 12 months after interventional therapy |
| Patency rate of main and branch stent. | Patency of main and branch stent will be evaluated by Computed Tomography Angiography. | 24 months after interventional therapy |
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Inclusion Criteria:
Exclusion Criteria:
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Patients diagnosed with Stanford B-type aortic dissection, the proximal landing area is less than 15mm, and the left subclavian artery needs to be reconstructed.
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Hongkun Zhang, Doctor | Contact | +8687236745 | 1198050@zju.edu.cn | |
| Donglin Li, Doctor | Contact | +8687236745 | lidonglin@zju.edu.cn |
| Name | Affiliation | Role |
|---|---|---|
| Hongkun Zhang, Doctor | Zhejiang University | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The First Affiliated Hospital, Zhejiang University School of Medicine | Recruiting | Hangzhou | Zhejiang | 310003 | China |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 19539264 | Background | Eggebrecht H, Mehta RH, Dechene A, Tsagakis K, Kuhl H, Huptas S, Gerken G, Jakob HG, Erbel R. Aortoesophageal fistula after thoracic aortic stent-graft placement: a rare but catastrophic complication of a novel emerging technique. JACC Cardiovasc Interv. 2009 Jun;2(6):570-6. doi: 10.1016/j.jcin.2009.03.010. | |
| 10332016 | Result |
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| Dake MD, Kato N, Mitchell RS, Semba CP, Razavi MK, Shimono T, Hirano T, Takeda K, Yada I, Miller DC. Endovascular stent-graft placement for the treatment of acute aortic dissection. N Engl J Med. 1999 May 20;340(20):1546-52. doi: 10.1056/NEJM199905203402004. |
| 26211376 | Result | Cambria RP, Conrad MF, Matsumoto AH, Fillinger M, Pochettino A, Carvalho S, Patel V, Matsumura J. Multicenter clinical trial of the conformable stent graft for the treatment of acute, complicated type B dissection. J Vasc Surg. 2015 Aug;62(2):271-8. doi: 10.1016/j.jvs.2015.03.026. |
| 28867380 | Result | Canaud L, Morishita K, Gandet T, Sfeir J, Bommart S, Alric P, Mandelli M. Homemade fenestrated stent-graft for thoracic endovascular aortic repair of zone 2 aortic lesions. J Thorac Cardiovasc Surg. 2018 Feb;155(2):488-493. doi: 10.1016/j.jtcvs.2017.07.045. Epub 2017 Aug 5. |
| 31200061 | Result | Xiang Y, Qiu C, He Y, Li D, Shang T, Wu Z, Zhang H. A Single Center Experience of In Situ Needle Fenestration of Supra-aortic Branches During Thoracic Endovascular Aortic Repair. Ann Vasc Surg. 2019 Nov;61:107-115. doi: 10.1016/j.avsg.2019.03.016. Epub 2019 Jun 11. |
| ID | Term |
|---|---|
| D000784 | Aortic Dissection |
| D014652 | Vascular Diseases |
| ID | Term |
|---|---|
| D000094665 | Dissection, Blood Vessel |
| D000783 | Aneurysm |
| D002318 | Cardiovascular Diseases |
| D000094683 | Acute Aortic Syndrome |
| D001018 | Aortic Diseases |
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