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| Name | Class |
|---|---|
| Fudan University | OTHER |
| The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School | OTHER |
| Central South University | OTHER |
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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:
safety:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Castor Stent Graft | Experimental | To study the safety and efficacy of Castor single-branched stent graft system in endovascular repair of aortic dissection. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Castor Stent Graft | Device | Endovascular Repair of Aortic Dissection |
|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 1 year stent related adverse event rate |
| 1 year |
| Measure | Description | Time Frame |
|---|---|---|
| 1 year success rate of treatment |
| 1 year |
| 1 year patency rate of branch stent |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Zaiping JING, MD | Contact | 86-21-31166666 | jingzp@xueguan.net |
| Name | Affiliation | Role |
|---|---|---|
| Zaiping JING, MD | Department of Vascular Surgery, Changhai Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Department of Vascular Surgery, Changhai Hospital | Recruiting | Shanghai | Shanghai Municipality | 200433 | China |
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| ID | Term |
|---|---|
| D000784 | Aortic Dissection |
| ID | Term |
|---|---|
| D000094665 | Dissection, Blood Vessel |
| D000783 | Aneurysm |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
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| Beijing Anzhen Hospital |
| OTHER |
| Peking Union Medical College Hospital | OTHER |
| Peking University People's Hospital | OTHER |
| Chinese PLA General Hospital | OTHER |
| The Second Affiliated Hospital of Harbin Medical University | OTHER |
| The First Affiliated Hospital with Nanjing Medical University | OTHER |
| Nanjing PLA General Hospital | OTHER |
| First Affiliated Hospital, Sun Yat-Sen University | OTHER |
| Shandong Provincial Hospital | OTHER_GOV |
| The First Affiliated Hospital of Zhengzhou University | OTHER |
| Xijing Hospital | OTHER |
| China Medical University, China | OTHER |
| First Affiliated Hospital of Chongqing Medical University | OTHER |
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The incidence of more than 50% branch stent patency |
| 1 year |
| in-hospital mortality | mortality of patients caused by dissection related postoperative complications before discharge. | participants will be followed for the duration of hospital stay, an expected average of 1 week |
| complication rate of neural system | complication rate of neural system related to the stent graft | 2 years |
| 1 year dissection or stent related mortality | 1 year dissection or stent related mortality | 1 year |
| D000094683 |
| Acute Aortic Syndrome |
| D001018 | Aortic Diseases |