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The purpose of this study is to determine whether DEB is more effective than common PTA balloon in long-term vessel patency and inhibiting restenosis.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| drug eluting balloon catheter | Experimental | use drug eluting balloon catheter to inflate the stenosis or occlusion in superficial femoral artery(SFA) and/or popliteal artery |
|
| common balloon catheter(uncoated drug) | Active Comparator | use common balloon catheter to inflate stenosis or occlusion in SFA and/or popliteal artery |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| drug eluting balloon catheter (trade name: Orchid) | Device |
|
|
| Measure | Description | Time Frame |
|---|---|---|
| Late Lumen Loss | measure difference of the MLD(minimal lumen diameter) at 0 time and 6 months | 6 months |
| Measure | Description | Time Frame |
|---|---|---|
| Minimal lumen diameter (MLD) | measure minimal lumen diameter (MLD) of target lesion | 6 months |
| Restenosis rate of target vessel | stenosis over 50% is defined as restenosis |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Xiyuan Hospital CACMS | Beijing | Beijing Municipality | 100091 | China | ||
| Chinese PLA General Hospital |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 34385840 | Derived | Ren H, Liu J, Zhang J, Zhuang B, Fu W, Wu D, Wang F, Zhao Y, Guo P, Bi W, Wang S, Guo W. Five-Year Outcomes of Post-Drug-Coated Balloon Angioplasty Dissection in Complex Femoropopliteal Artery Disease. Int J Gen Med. 2021 Aug 5;14:4197-4207. doi: 10.2147/IJGM.S316916. eCollection 2021. | |
| 32903168 | Derived | Sun G, Liu J, Jia S, Zhang J, Zhuang B, Jia X, Fu W, Wu D, Wang F, Zhao Y, Guo P, Bi W, Wang S, Guo W; AcoArt I Trial Investigators. Comparison of drug-coated balloon angioplasty versus uncoated balloon angioplasty in treatment of total occlusions with severe femoropopliteal lesions: An additional analysis from the AcoArt I study. Vascular. 2021 Jun;29(3):340-349. doi: 10.1177/1708538120953663. Epub 2020 Sep 9. |
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| ID | Term |
|---|---|
| D058729 | Peripheral Arterial Disease |
| ID | Term |
|---|---|
| D050197 | Atherosclerosis |
| D001161 | Arteriosclerosis |
| D001157 | Arterial Occlusive Diseases |
| D014652 | Vascular Diseases |
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| common percutaneous transluminal angioplasty balloon catheter (trade name: Admiral) | Device |
|
|
| 6 months, 12 months, 18 months, 24months |
| target lesion revascularization | target lesion revascularization is defined as any reintervention of artery bypass graft surgery involving the target lesion | 6 months, 12 months, 18 months, 24 months |
| change in Rutherford stage | based the following definition of Rutherford stage, evaluate the stage of patient. Then compare the stage of patient just after procedure and 6 months after treatment Stage clinical symptom 0 asymptomatic
| 6 months, 12 months, 18 months, 24 months |
| change in ankle brachial index(ABI) | change in ankle brachial index(ABI) compared to pretreatment | 6 months |
| major amputation | major amputation at the index limb(major amputation is defined as an amputation above the foot) | 6 months, 12 months, 18 months, 24 months |
| Death | death of any cause | 12 months, 18 months, 24 months |
| Beijing |
| Beijing Municipality |
| 100853 |
| China |
| The First Affiliated Hospital of Chongqing Medical University | Chongqing | Chongqing Municipality | China |
| The First Affiliated Hospital of Fujian Medical University | Fuzhou | Fujian | China |
| The First Affiliated Hospital, Sun Yat-sen University | Guangzhou | Guangdong | China |
| The second Hospital Of Hebei University | Shijiazhuang | Hebei | 050000 | China |
| The First Affiliated Hospital, Dalian Medical University | Dalian | Liaoning | China |
| The People's Hospital of Liaoning Province | Shenyang | Liaoning | China |
| Zhongshan Hospital Fudan University | Shanghai | Shanghai Municipality | 200032 | China |
| Renji Hospital ShangHai Jiaotong University School Of Medicine | Shanghai | Shanghai Municipality | China |
| D002318 |
| Cardiovascular Diseases |
| D016491 | Peripheral Vascular Diseases |