2024年4月12日发(作者：)

分支型主动脉覆膜支架系统临床试验指导

原则

The Clinical Trial Guidelines for Branch Aortic Arch Stent

Graft System

Introduction:

引言：

In recent years, branch aortic arch stent graft systems

have emerged as a promising treatment option for patients

with aortic arch aneurysms. These innovative devices

provide an alternative to the traditional surgical approach

of open repair, offering reduced invasiveness and

potentially shorter hospital stays. As these stent graft

systems continue to evolve, it is essential to establish

clinical trial guidelines that ensure safety, effectiveness,

and reliable outcomes in their implementation. This article

aims to outline the key principles that should guide

clinical trials for branch aortic arch stent graft systems.

Background:

背景：

Branch aortic arch stent graft systems consist of a main

body and multiple branches or fenestrations that allow for

the preservation of vital branch vessels in the thoracic

aorta. Currently, there are several commercially available

branch stent graft systems with different designs and

techniques. However, due to their complexity and unique

variations among patients, clinical trials are necessary to

evaluate their efficacy and safety.

Key principles:

关键原则：

1. Patient selection criteria:

患者选择标准：

Careful patient selection is crucial for the success of

any clinical trial involving branch aortic arch stent graft

systems. Patients with suitable anatomy, favorable

operative risk profiles, and appropriate indications should

be considered. Additionally, preoperative imaging

assessments should be standardized to ensure accurate

assessment of anatomical suitability and identification of

potential contraindications.

2. Multidisciplinary collaboration:

多学科合作：

Given the complexity of branch aortic arch pathology and

the necessity for precise device placement,

multidisciplinary collaboration is imperative during both

the planning stage and actual implementation of clinical

trials. Close collaboration between cardiovascular surgeons,

interventional radiologists, anesthesiologists, and other

relevant specialists will help optimize patient selection

criteria, intraoperative decision-making, and postoperative

care protocols.

3. Standardized procedural techniques:

规范化的操作技术：

Establishing standardized procedural techniques is

essential to ensure consistent outcomes and minimize

variability between different centers participating in

clinical trials. This involves defining the optimal

approach for device deployment, cannulation of branch

vessels, and management of complications or adverse events.

The development of a detailed procedural manual that takes

into account various anatomical scenarios will provide

guidance to operators and assist in reproducibility across

centers.

4. Long-term follow-up:

长期随访：

Adequate long-term follow-up is crucial to evaluate the

durability and effectiveness of branch aortic arch stent

graft systems. Regular monitoring should include imaging

assessments, clinical evaluations, and quality-of-life

assessments to assess the device's performance over time.

The duration and frequency of follow-up visits should be

determined based on the anticipated lifespan of the stent

graft system.

Conclusion:

In conclusion, establishing clear clinical trial guidelines

for branch aortic arch stent graft systems is paramount to

ensure patient safety, optimize outcomes, and facilitate

further advancements in this field. By carefully selecting

patients, fostering multidisciplinary collaboration,

standardizing procedural techniques, and ensuring long-term

follow-up, clinical trials can provide valuable evidence on

the efficacy and safety of these innovative devices.