A Multi-center Trial of Single-Branched Stent Graft System to Treat Aortic Dissection

Study Overview
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Brief Summary
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Aim:Castor is a novel single-branched stent graft system for endovascular repair of aortic arch dissection. This is a prospective, one-arm, open, multi-center, pre-market study of Castor stent to evaluate its efficacy and safety in treatment of aortic dissection. Number of patients: 70 patients will be included and undertaken endovascular repair with Castor stent. Follow-up: 1.aortic computed tomographic angiography (CTA) examination 6 and 12 months after the surgery 2.telephone or clinical follow-up 30 days and 2-5 years after the surgery Primary Outcome Measure: success rate of endovascular repair for efficacy measurement. Secondary Outcome Measure: 1 year stent related adverse event rate for safety measurement. Other Outcome Measures: efficacy: 1 year success rate of treatment 1 year patency rate of branch stent safety: in-hospital mortality complication rate of neural system 1 year dissection or stent related mortality

Official Title
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A Multi-center Trial of Castor Single-Branched Stent Graft System for Endovascular Repair of Aortic Dissection.

Conditions
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Distal Aortic Dissection

Intervention / Treatment
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* Device: Castor Stent Graft


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: age from 18 to 80, male or unpregnant female diagnosed as aortic dissection proximal tear of the dissection locates between 15mm to the distal end of left common carotid artery and 20mm to the distal end of left subclavian artery (LSA) or inverse tear to LSA good compliance with the instructions and cooperate with follow-up voluntarily signed the informed consent form Exclusion Criteria: Pregnant female no appropriate vessel approaches patients with connective tissue diseases (such as Marfan syndrome) allergic to nitinol or contrast medium bad compliance with the instructions and follow-up estimated remaining life is less than 12 months

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Castor Stent Graft<br>To study the safety and efficacy of Castor single-branched stent graft system in endovascular repair of aortic dissection. | Device: Castor Stent Graft<br>* Endovascular Repair of Aortic Dissection<br>* Other names: Castor Single-Branched Stent Graft System;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| success rate of endovascular repair | - during the surgery: successful conduction, accurate positioning and release, and no warping, folding, narrowing or blocking of the stent graft system. Immediately after the stent release, angiography shows both main stent and side arm stent patency, successful exclusion of dissection and no arteriorrhexis or dissection rupture. | during the surgery | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 1 year stent related adverse event rate | unexpected breakage and shifting of the stent type I or type III endoleak which needs intervention dissection rupture around the stent | 1 year | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Single-Branched Stent Graft System, Aortic Dissection, Endovascular Repair