Objectives To evaluate the safety and feasibility of thoracic endovascular repair (TEVAR) of type B aortic dissection (TBAD) with Cratos branched stent-graft. Materials and methods A prospective, multicenter study consisting of consecutive TBAD patients across 12 centers in China who were treated with the Cratos branched stent-graft was conducted. Outcomes were reported using descriptive statistics. Overall survival, freedom from reintervention, and branch artery patency were estimated using Kaplan-Meier estimates. Results The first enrollment started from January 2022 and ended in July 2023, with a total of 89 patients finally enrolled. All patients were diagnosed with TBAD and underwent TEVAR using the Cratos branched stent-graft. Technical success was achieved in all patients. One patient (1.1%) died of respiratory failure within the first 30 days after the operation. The rate was 1.1% for both stroke and spinal cord ischemia. The median follow-up was 369 days. Two patients (2.2%) died during follow-up, and neither death was related to the aorta. One patient had reintervention because of retrograde type A aortic dissection (RTAD). Two cases of endoleak resolved spontaneously but the one with RTAD and type Ia endoleak. Eighty-one patients completed a 12-month computed tomography angiography. The patency rate for the branch section was 95.06%. At the segment covered by the stent-graft, the complete thrombosis rate was 92.59% (75/81) at 12 months. Conclusions Cratos branched stent-graft was a safe and feasible device for TEVAR of TBAD. The updated device exhibited easy, safe, and accurate deployment. (Chinese Clinical Trial Register identifier: ChiCTR2200064412: ChiCTR2200064412). Key Points <Emphasis Type="BoldItalic">Question</Emphasis> How can thoracic endovascular aortic repair (TEVAR) for type B aortic dissection (TBAD) safely provide sufficient proximal landing while maintaining left subclavian artery perfusion? <Emphasis Type="BoldItalic">Findings</Emphasis> The Cratos unibody single-branched stent-graft achieved high technical success, low complication rates, and excellent branch patency in treating TBAD while revascularizing the left subclavian artery. <Emphasis Type="BoldItalic">Clinical relevance</Emphasis> The Cratos stent-graft enables one-stage, minimally invasive TEVAR for TBAD, addressing the need for safe left subclavian artery coverage and revascularization, thereby improving sealing, reducing complications, and enhancing clinical outcomes. Graphical Abstract

Second-generation unibody single-branched stent-graft for thoracic endovascular aortic repair of type B aortic dissection

期刊论文
发表日期：

2025年10月17日

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Xiaoye Li,
Xunqiang Liu,
Dongjin Wang,
Minxin Wei,
Zhixiong Zhong,
Jinping Liu,
Xinyan Pang,
Chao Song,
Qingsheng Lu

摘要

Objectives

To evaluate the safety and feasibility of thoracic endovascular repair (TEVAR) of type B aortic dissection (TBAD) with Cratos branched stent-graft.

Materials and methods

A prospective, multicenter study consisting of consecutive TBAD patients across 12 centers in China who were treated with the Cratos branched stent-graft was conducted. Outcomes were reported using descriptive statistics. Overall survival, freedom from reintervention, and branch artery patency were estimated using Kaplan-Meier estimates.

Results

The first enrollment started from January 2022 and ended in July 2023, with a total of 89 patients finally enrolled. All patients were diagnosed with TBAD and underwent TEVAR using the Cratos branched stent-graft. Technical success was achieved in all patients. One patient (1.1%) died of respiratory failure within the first 30 days after the operation. The rate was 1.1% for both stroke and spinal cord ischemia. The median follow-up was 369 days. Two patients (2.2%) died during follow-up, and neither death was related to the aorta. One patient had reintervention because of retrograde type A aortic dissection (RTAD). Two cases of endoleak resolved spontaneously but the one with RTAD and type Ia endoleak. Eighty-one patients completed a 12-month computed tomography angiography. The patency rate for the branch section was 95.06%. At the segment covered by the stent-graft, the complete thrombosis rate was 92.59% (75/81) at 12 months.

Conclusions

Cratos branched stent-graft was a safe and feasible device for TEVAR of TBAD. The updated device exhibited easy, safe, and accurate deployment. (Chinese Clinical Trial Register identifier: ChiCTR2200064412: ChiCTR2200064412).

Key Points

Question How can thoracic endovascular aortic repair (TEVAR) for type B aortic dissection (TBAD) safely provide sufficient proximal landing while maintaining left subclavian artery perfusion?

Findings The Cratos unibody single-branched stent-graft achieved high technical success, low complication rates, and excellent branch patency in treating TBAD while revascularizing the left subclavian artery.

Clinical relevance The Cratos stent-graft enables one-stage, minimally invasive TEVAR for TBAD, addressing the need for safe left subclavian artery coverage and revascularization, thereby improving sealing, reducing complications, and enhancing clinical outcomes.

Graphical Abstract