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The objective of this prospective, multi-center, single arm study is to obtain further data on the safety and performance of the Drug-coated Balloon catheters in the treatment of the Superficial Femoral Artery (SFA) and Popliteal Arteries (PA).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| drug eluting balloon catheter | Experimental | use drug eluting balloon catheter to treat the stenosis or occlusion in superficial femoral artery(SFA) and/or popliteal artery |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Drug eluting Balloon | Device | Drug eluting Balloon is a kind of the product that has been used for many years. By filling the micropores on the surface of the balloon with anti-proliferative drugs like immunosuppressive agents, the balloon is expanded and contacted with the lesion to rapidly release the drug to the local arterial wall. |
| Measure | Description | Time Frame |
|---|---|---|
| rate of device success | intraoperative | |
| rate of procedural success | intraoperative | |
| rate of technical success | intraoperative | |
| rate of primary patency of target lesion | 12 months | |
| rate of primary patency of target lesion | 24 months | |
| rate of Clinically-driven TLR | 12 months | |
| rate of Clinically-driven TLR | 24 months | |
| rate of TLR | 1 month | |
| rate of TLR | 12 months | |
| rate of TLR | 24 months | |
| rate of Clinically-driven TVR | 12 months | |
| rate of Clinically-driven TVR | 24 months |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Jie Liang | Contact | 13819565660 | jie.liang@zyloxmedical.com |
| Name | Affiliation | Role |
|---|---|---|
| Weiguo Fu | Shanghai Zhongshan Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Xuanwu hospital | Recruiting | Beijing | China |
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|
| rate of TVR | 1 month |
| rate of TVR | 12 months |
| rate of TVR | 24 months |
| change in Rutherford clinical category (target limb) | 12 months |
| change in Rutherford clinical category (target limb) | 24 months |
| change in ankle brachial index(ABI) | 12 months |
| change in ankle brachial index(ABI) | 24 months |
| rate of SAE | 12 months |
| rate of SAE | 24 months |
| rate of All-cause mortality | 1 month |
| rate of All-cause mortality | 12 months |
| rate of All-cause mortality | 24 months |
| rate of Major amputation | 1 month |
| rate of Major amputation | 12 months |
| rate of Major amputation | 24 months |
| rate of target lesion thrombosis | 12 months |
| rate of target lesion thrombosis | 24 months |
| Rate of adverse events | intraoperative |
| Rate of adverse events | 1 month |
| Rate of adverse events | 12 months |
| Rate of adverse events | 24 months |
| Affiliated Hospital of Chengde Medical College | Recruiting | Chengde | China |
|
| The Third People's Hospital of Chengdu | Recruiting | Chengdu | China |
|
| The First Affiliated Hospital of Dalian Medical University | Recruiting | Dalian | China |
|
| The Second Affiliated Hospital of Dalian Medical University | Recruiting | Dalian | China |
|
| Guangzhou Huaqiao hospital | Recruiting | Guangzhou | China |
|
| Hospital of Traditional Chinese Medicine affiliated to Guangzhou Medical University | Recruiting | Guangzhou | China |
|
| The Third Affiliated Hospital of Guangzhou Medical University | Recruiting | Guangzhou | China |
|
| Hangzhou First People's Hospital | Recruiting | Hangzhou | China |
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| The First Affiliated Hospital of Harbin Medical University | Recruiting | Ha’erbin | China |
|
| First Hospital of Lanzhou University | Recruiting | Lanzhou | China |
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| Ningbo huamei hospital | Recruiting | Ningbo | China |
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| Qingdao Municipal Hospital | Recruiting | Qingdao | China |
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| Ruian People's Hospital | Recruiting | Rui’an | China |
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| Shanghai Ninth People'S Hospital | Recruiting | Shanghai | China |
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| Zhongshan Hospital | Recruiting | Shanghai | China |
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| Northern Theatre General Hospital | Recruiting | Shenyang | China |
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| Tianjin Medical University General Hospital | Recruiting | Tianjin | China |
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| Tianjin People's Hospital | Recruiting | Tianjin | China |
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| Weifang People's Hospital | Recruiting | Weifang | China |
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| The First Affiliated Hospital of Wenzhou Medical University | Recruiting | Wenzhou | China |
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| The Second Affiliated Hospital of Wenzhou Medical University | Recruiting | Wenzhou | China |
|
| The First Affiliated Hospital of Xi 'an Jiaotong University School of Medicine | Recruiting | Xi'an | China |
|
| People's Hospital of Xinjiang Uygur Autonomous Region | Recruiting | Xinjiang | China |
|
| ID | Term |
|---|---|
| D058729 | Peripheral Arterial Disease |
| ID | Term |
|---|---|
| D050197 | Atherosclerosis |
| D001161 | Arteriosclerosis |
| D001157 | Arterial Occlusive Diseases |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| D016491 | Peripheral Vascular Diseases |
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