This study is the feasible study on a new technique of ZIPPER aortic arch stentgraft system
The feasible study of ZIPPER aortic arch stentgraft system is a prospective, multicenter, single arm trial, which will enroll a total of 24 patients. The goal of this study is to evaluate the safety and efficacy of ZIPPER aortic arch stentgraft system in the treatment of patients with aortic arch disease, included aortic arch dissections, aneurysms, residual dissection following ascending aorta surgical operation.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
24
The ZIPPER aortic arch stentgraft system consists of the arch mainbody stentgraft system, the branch artery stentgraft system and the thoracic extension stentgraft system.
Jia Hu
Chengdu, China
NOT_YET_RECRUITINGWeiguo Fu
Shanghai, China
RECRUITINGHonglin Dong
Taiyuan, China
RECRUITINGFreedom from major device/procedure-related adverse events within 30 days post-operation.
Device or procedure related major adverse events included: stroke, respiratory failure, pericardial tamponade, dissection or aneurysm rupture, paraplegia, stent occlusion, fracture, migration, access vessel thrombosis or rupture, conversion to open surgery, death.
Time frame: 30 days after intervention
Immediate postoperative technical success.
Immediate technical success is defined as successful delivery of the aortic and branching stent graft conveyors to their predetermined positions, accurate positioning and successful deployment of the stent, safe removal of the delivery device outside the body, absence of Type I and III endoleaks on angiography at the end of the procedure , and patent branch stents.
Time frame: immediately after intervention
Incidence of Type I or Type III endoleaks.
Endoleak evaluated by DSA or CTA during operation and at 1 month, 6 months and 12 months after operation. Intraoperative endoleaks that were treated with adjuvant therapy were not documented. Endoleaks occurring in the same subject after completion of the procedure, and that were not treated at different visits, are counted as once.
Time frame: 1 month, 6 months and 12 months post-intervention
Incidence of aortic arch stent graft migration.
CTA will be performed at 1, 6, and 12 months after operation to determine if the stent has migrated, and evaluations will be recorded for both the main and branch stents. Migration is defined as the main and branched stents migrate more than 10 mm at postoperative follow-up compared with that 1 month post-intervention.
Time frame: 1 month, 6 months and 12 months post-intervention
Postoperative branch vessel patency rate.
CTA examinations will be performed at 1, 6, and 12 months post-operation to evaluate branch vessel revascularization and whether there is occlusion, stenosis, or stent thrombosis.
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Time frame: 1 month, 6 months and 12 months post-intervention
Results of aortic remodeling after aortic dissection surgery
CTA examinations will be performed at 1, 6, and 12 months post-operation to evaluate results of aortic remodeling, including the expansion of the true lumen and the thrombosis of the false lumen at the coverage of the aortic dissection vascular stent to determine whether the blood vessel is successfully remodeled.
Time frame: 1 month, 6 months and 12 months post-intervention
Progression control of aortic aneurysm
CTA examinations will be performed at 1, 6, and 12 months post-operation to evaluate results of progression control of aortic aneurysm. The maximum diameter of aortic aneurysm increases by ≤ 5 mm after 12 months of CTA examination compared with that before surgery.
Time frame: 1 month, 6 months and 12 months post-intervention
Incidence of surgically induced de novo aortic dissection converted to open-heart surgery or secondary intervention.
Whether or not the patient experienced surgically induced de novo aortic dissection converted to open-heart surgery or secondary intervention will be determined.
Time frame: within 12 months post-intervention
Aortic-related mortality at 12 months post operation.
Refers to death caused by aortic rupture or endovascular treatment.
Time frame: within 12 months post-intervention
All-cause mortality and major stroke within 12 months post-procedure.
All-cause mortality includes cardiac death, non-cardiac death, and unexpected death. Major stroke is defined as a modified Rankin score (mRS) ≥ 2 at 90 days after stroke onset.
Time frame: within 12 months post-intervention
Incidence of severe adverse events.
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.
Time frame: within 12 months post-intervention
Incidence of device-related adverse events.
Device-related adverse event refers to an adverse medical event related to the use of test device during the clinical trial. However, a distinction should be made with respect to normal postoperative stress response, such as fever and chest and back discomfort, which, in the judgment of the investigator, need not be recorded as an adverse event.
Time frame: within 12 months post-intervention