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| ID | Type | Description | Link |
|---|---|---|---|
| 82460098 | Other Grant/Funding Number | National Natural Science Foundation of China |
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The primary objective of this study is to evaluate the safety and efficacy of the TEVAR combined with extended bare-metal stenting (distal landing zone ≥2 cm below renal arteries) in patients with acute complicated type B aortic dissection (ATBAD).
Additionally, to prevent postoperative true lumen hypoperfusion in residual thoracoabdominal aortic dissection (visceral zone, infrarenal aorta, and iliac arteries) and persistent ischemic manifestations in visceral and lower extremity arteries post-endovascular repair, extended bare-metal stents are deployed to maintain adequate distal true lumen patency. This strategy ensures perfusion to visceral branches and lower limbs while preparing for future complete endovascular aortic repair.
Stanford type B aortic dissection (TBAD) accounts for 25-40% of all aortic dissections, characterized by acute onset, rapid progression, and high mortality, representing a critical cardiovascular emergency. While thoracic endovascular aortic repair (TEVAR) remains the standard intervention for TBAD, its benefits on true lumen remodeling and false lumen thrombosis are primarily limited to the stent-graft covered segment. Distal to the stent-graft, persistent re-entry tears in thoracoabdominal arteries convert preoperative exit sites into new entry points. Although TEVAR improves true lumen perfusion distal to the stent-graft, remodeling efficacy remains suboptimal, particularly in cases with preoperative true lumen collapse where post-TEVAR true lumen dimensions remain critically compressed by large false lumen volumes. Currently deployed stent-grafts typically measure 15-20 cm in length. Conventional TEVAR requires ≥1.5 cm proximal healthy aortic segment as landing zone to prevent retrograde type A dissection (RTAD) and ensure stability. For patients with inadequate proximal landing zones (<1.5 cm), advanced techniques including branched stent-grafts, fenestrations, and parallel grafting have enabled TEVAR implementation even with ≤0.5 cm landing zones, facilitated by evolving device technologies and operator expertise. The "TEVAR+bare-stent" hybrid approach theoretically enhances aortic remodeling through reduced radial force. However, standard TEVAR typically deploys single stent-grafts at the proximal descending aortic tear. Extended stent-graft coverage beyond celiac axis level risks visceral artery occlusion, making maintenance of distal organ and limb perfusion an enduring challenge. Moreover, residual distal thoracoabdominal dissection carries risks of false lumen aneurysmal degeneration and rupture, particularly >5 years post-TEVAR. Secondary interventions for chronic residual dissections are complicated by intimal calcification from prolonged false lumen hypertension, combined with chronic hypoxia and inflammation that compromise aortic wall integrity. Persistent false lumen expansion and rupture in residual thoracoabdominal dissection are observed in 23-35% of conventional TEVAR cases, particularly affecting young-to-middle-aged patients with suboptimal blood pressure control beyond 5-year follow-up. Technical challenges in secondary visceral branch reconstruction further compromise long-term quality of life. Therefore, post-endovascular true lumen remodeling in thoracoabdominal segments warrants particular attention, as aortic remodeling constitutes a crucial determinant of therapeutic success beyond procedural technique alone.
This study aims to validate the feasibility and safety of proximal stent-graft plus extended distal bare-metal stenting in thoracoabdominal aorta, compare its efficacy with conventional TEVAR, and characterize its impacts on aortic remodeling and subsequent visceral/distal arterial reconstruction. We anticipate this research will provide critical clinical evidence for managing residual thoracoabdominal dissection after acute TBAD repair.
Using imaging-based analysis and clinical follow-up, this study will compare: (1) conventional TEVAR vs. (2) hybrid proximal stent-graft + extended distal bare-stent strategies in terms of morphological remodeling, adverse events, and long-term outcomes. The findings may elucidate differential impacts on aortic reconstruction and visceral/iliac revascularization, offering evidence-based guidance for managing distal dissection in acute TBAD.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Carstor® 70-240mm, AnkuraTMⅡ60-200mm, WeFlow-TbranchTM and Fabulous® Device Surgical Implant | Experimental | Subjects with acute type B aortic dissection were treated with an endovascular procedure using the Carstor® 70-240mm, AnkuraTMⅡ60-200mm, WeFlow-TbranchTM 160-240mm Thoracic Aortic Endoprosthesis and the Fabulous® 45-150mm long big bare stent via femoral artery access. (Permanent implant) |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Hybrid TEVAR combined with long bare-metal stent intervention | Device | - Primary TEVAR: Primary TEVAR: Employ Carstor® 70-240mm, AnkuraTMⅡ60-200mm, WeFlow-TbranchTM 160-240mm endograft deployed with ≥2cm proximal landing zone coverage. Concurrent bare-stenting: Post-TEVAR femoral access deployment of Fabulous® (45-150mm) long bare-metal stent with: Proximal overlap ≥3cm with TEVAR graft. Distal extension 2-6cm below renal artery plane. Maximum distal limit: above iliac bifurcation. - Intraprocedural angiography with spinal reference mapping guides precise stent positioning relative to visceral arteries and infrarenal aorta. |
| Measure | Description | Time Frame |
|---|---|---|
| 30-day all-cause mortality | 30-day all-cause mortality | 30 days post-intervention |
| Ratio of increase in aortic true lumen (%) | Ratio of increase in aortic true lumen(%) including three parameters:
Definition: Postoperative true lumen diameter increase ratio: (postoperative - preoperative) / preoperative*100% True lumen diameter increase ratio after follow-up: (current follow-up - last follow-up) / last follow-up*100% Postoperative true lumen area increase ratio: (postoperative - preoperative) / preoperative*100% True lumen area increase ratio after follow-up: (current follow-up - last follow-up) / last follow-up area*100% | 1 month, 6 months, 12 months after surgery |
| Measure | Description | Time Frame |
|---|---|---|
| Aortic rupture incidence | Aortic rupture incidence | 1 month, 6 months, 12 months after surgery |
| Device-related complications |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Xunqiang Prof. Liu, M.D. | Contact | +8613888390126 | liuxunqiang1001@163.com | |
| Zheng Dr. Jia, Ph.D. | Contact | +8613669776843 | jiazhenghappy@163.com |
| Name | Affiliation | Role |
|---|---|---|
| Xunqiang Prof. Liu, M.D. | Yan'an Affiliated Hospital of Kunming Medical University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Yan'an Affiliated Hospital of Kunming Medical University | Kunming | Yunnan | 650051 | China |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 31684692 | Result | Rong D, Ge Y, Liu J, Liu X, Guo W. Combined proximal descending aortic endografting plus distal bare metal stenting (PETTICOAT technique) versus conventional proximal descending aortic stent graft repair for complicated type B aortic dissections. Cochrane Database Syst Rev. 2019 Oct 30;2019(10):CD013149. doi: 10.1002/14651858.CD013149.pub2. | |
| 23968705 |
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Single Group Assignment: All enrolled subjects receive uniform intervention protocol (TEVAR combined with long bare-metal stent intervention)
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Open-label design: Participants, operators and assessors are unblinded
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| 1 month, 6 months, 12 months after surgery |
| False lumen thrombosis grading |
| 1 month, 6 months, 12 months after surgery |
| Fattori R, Montgomery D, Lovato L, Kische S, Di Eusanio M, Ince H, Eagle KA, Isselbacher EM, Nienaber CA. Survival after endovascular therapy in patients with type B aortic dissection: a report from the International Registry of Acute Aortic Dissection (IRAD). JACC Cardiovasc Interv. 2013 Aug;6(8):876-82. doi: 10.1016/j.jcin.2013.05.003. |
| 17154712 | Result | Nienaber CA, Kische S, Zeller T, Rehders TC, Schneider H, Lorenzen B, Bunger C, Ince H. Provisional extension to induce complete attachment after stent-graft placement in type B aortic dissection: the PETTICOAT concept. J Endovasc Ther. 2006 Dec;13(6):738-46. doi: 10.1583/06-1923.1. |