Distal Aortic Dissection
Conditions
Keywords
Single-Branched Stent Graft System, Aortic Dissection, Endovascular Repair
Brief summary
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: 1. efficacy: * 1 year success rate of treatment * 1 year patency rate of branch stent 2. safety: * in-hospital mortality * complication rate of neural system * 1 year dissection or stent related mortality
Interventions
DEVICECastor Stent Graft
Endovascular Repair of Aortic Dissection
Sponsors
Fudan University
The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School
Central South University
Beijing Anzhen Hospital
Peking Union Medical College Hospital
Peking University People's Hospital
Chinese PLA General Hospital
The Second Affiliated Hospital of Harbin Medical University
The First Affiliated Hospital with Nanjing Medical University
Nanjing PLA General Hospital
First Affiliated Hospital, Sun Yat-Sen University
Shandong Provincial Hospital
The First Affiliated Hospital of Zhengzhou University
Xijing Hospital
China Medical University, China
First Affiliated Hospital of Chongqing Medical University
Changhai Hospital
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| success rate of endovascular repair | during the surgery | \- 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 1 year stent related adverse event rate | 1 year | * unexpected breakage and shifting of the stent * type I or type III endoleak which needs intervention * dissection rupture around the stent |
Other
| Measure | Time frame | Description |
|---|---|---|
| in-hospital mortality | participants will be followed for the duration of hospital stay, an expected average of 1 week | mortality of patients caused by dissection related postoperative complications before discharge. |
| 1 year success rate of treatment | 1 year | * complete exclusion of the dissection * no dissection rupture * no type I or type III endoleak which needs twice intervention * false lumen of aorta around stent graft closed with thrombus |
| 1 year dissection or stent related mortality | 1 year | 1 year dissection or stent related mortality |
| complication rate of neural system | 2 years | complication rate of neural system related to the stent graft |
| 1 year patency rate of branch stent | 1 year | The incidence of more than 50% branch stent patency |
Countries
China
Contacts
Primary ContactZaiping JING, MD
Outcome results
None listed