This study is the feasible study on a new technique of ZIPPER aortic arch stentgraft system
The study of ZIPPER aortic arch stentgraft system is a prospective, multicenter, single arm trial, which will enroll a total of 127 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 dissections, residual dissection following ascending aorta surgical operation.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
127
The ZIPPER aortic arch stentgraft system consists of the arch mainbody stentgraft system, the branch artery stentgraft system and the thoracic extension stentgraft system.
30-day major adverse event (MAE)-free rate
Absence of the following events within 30 days post-procedure: All-cause mortality Ischemic stroke Myocardial infarction Renal failure: Defined as requiring persistent dialysis, renal transplantation, or leading to fatal outcomes Respiratory failure: Defined as requiring prolonged intubation (\>72 hours), tracheostomy, pulmonary function deterioration, or leading to fatal outcomes Permanent paraplegia Bowel necrosis: Defined as requiring bowel resection or leading to fatal outcomes Intraoperative blood loss \>1000 mL
Time frame: 30 days after intervention
12-month Clinical Treatment Success Rate
Immediate technical success (intraoperative) Freedom from the following at 12 months post-procedure All-cause mortality. Stent graft migration (confirmed by CTA). Type I or III endoleaks (confirmed by CTA). Loss of branch stent patency (confirmed by imaging or clinical symptoms). Secondary surgical intervention
Time frame: 12 months post-intervention
All-cause mortality rate
Time frame: Prior to discharge, 30 days, 6 months,12 months, 24-60 months post-procedure
Severe stroke rate (defined as modified Rankin Scale [mRS] score ≥2 at 90 days post-stroke)
Time frame: Prior to discharge, 30 days, 6 months,12 months, 24-60 months post-procedure
Aortic dissection-related mortality rate
Time frame: Prior to discharge, 30 days, 6 months,12 months, 24-60 months post-procedure
Major adverse event (MAE) rate
Time frame: Prior to discharge, 30 days, 6 months,12 months, 24-60 months post-procedure
Device-related adverse event rate
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Time frame: Prior to discharge, 30 days, 6 months,12 months, 24-60 months post-procedure
Aortic dissection vascular remodeling success rate. Evaluation: Assessed via CT angiography (CTA), defined as: True lumen expansion in the stented aortic segment; False lumen reduction or obliteration; False lumen thrombosis formation.
Time frame: Prior to discharge, 30 days, 6 months,12 months, 24-60 months post-procedure
Type I or III endoleak incidence rate
Time frame: Prior to discharge, 30 days, 6 months,12 months, 24-60 months post-procedure
Aortic and branch stent graft migration rate
Time frame: Prior to discharge, 30 days, 6 months,12 months, 24-60 months post-procedure
Postoperative branch vessel occlusion rate
Time frame: Prior to discharge, 30 days, 6 months,12 months, 24-60 months post-procedure
Secondary surgical intervention rate
Time frame: Prior to discharge, 30 days, 6 months,12 months, 24-60 months post-procedure