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This study is the first in man study of WeFlow-Arch Module Embedded Aorta Arch Stent Graft System
The WeFlow-Arch Moduler Embedded Aorta Arch Stent Graft System first in man study is a prospective, single center, single arm trial, which will enroll a total of 20 patients. The goal of this study is to evaluate the safety and efficacy of WeFlow-Arch Moduler Embedded Aorta Arch Stent Graft System in the treatment of patients with lesions of the aortic arch.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| WeFlow-Arch Moduler Embedded Branch Stent Graft System | Experimental |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| WeFlow-Ach Moduler Embedded Branch Stent Graft System | Device | The modular embedded aortic arch stent graft system consists of the embedded ascending aorta stent graft system, the arch aorta stent graft system and the branch stent system. |
| Measure | Description | Time Frame |
|---|---|---|
| Rate of no major adverse events related to device or surgery | Major adverse events related to device or surgery include: stroke, respiratory failure, pericardial tamponade, dissection or aneurysm rupture, paraplegia, stent occlusion, stent bend, stent displacement, thrombosis or rupture of the approach vessel, switch to open surgery, death, etc. | 30 days after surgery |
| Measure | Description | Time Frame |
|---|---|---|
| Technical success rate | Successful delivery of the stent graft conveyors to their predetermined positions, accurate positioning and successful deployment of the stent, safe removal of the delivery device outside the body. | immediately after the surgery |
| Immediate surgery success rate |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Chinese PLA General Hospital | Beijing | China |
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| ID | Term |
|---|---|
| D000783 | Aneurysm |
| D014456 | Ulcer |
| ID | Term |
|---|---|
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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Successful delivery of the stent graft, no major adverse events related to devices or surgery. |
| immediately after the surgery |
| The clinical success rate | Clinical success rateļ¼12 months after the operation, there was no displacement of the stent, I and III endoleak requiring treatment, aneurysm enlargement or rupture, and branch stent occlusion. | 12 months after the surgery |
| The incidence rate of secondary operations within 12 months after surgery | The incidence rate of secondary operations within 12 months after surgery. | 12 months after surgery |
| Adverse event rate within 12 months after surgery | Adverse event rate within 12 months after surgery. | 12 months after surgery |