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The purpose of this study is to determine whether DEB is more effective than common PTA balloon using under in long-term vessel patency and inhibiting restenosis in the infrapopliteal artery.
PTA is an established alternative to open surgical bypass for the treatment of infrainginual disease of critical limb ischemia.
DEBs are designed to promote arterial patency by reducing neointimal proliferation.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| DEB catheter | Experimental | use DEB catheter(trade name: Lotus/Tulip) to treat the stenosis or occlusion in below popliteal artery of experimental arm |
|
| common PTA balloon catheter | Active Comparator | use common PTA balloon catheter(trade name:Amphirion Deep) to treat stenosis or occlusion in below popliteal artery of control group |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| DEB catheter | Procedure | DEB catheter (trade name: Litos/Tulip) |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Primary Patency [Time Frame: 6 months] | Freedom from target vessel occlusion and clinically driven target lesion reintervention | 6 months |
| Measure | Description | Time Frame |
|---|---|---|
| device success rate | DEB catheter can reach the target lesions, expand as expected(not broken), and withdraw successfully. | during the operation(after using the DEB catheter) |
| technical success rates |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Wei Guo | Chinese PLA General Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| People's Liberation Army General Hospital | Beijing | 100853 | China | |||
| Peking Union Medical College Hospital |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 33118432 | Derived | Jia X, Zhuang B, Wang F, Gu Y, Zhang J, Lu X, Dai X, Liu Z, Bi W, Liu C, Wang S, Liistro F, Guo W. Drug-Coated Balloon Angioplasty Compared With Uncoated Balloons in the Treatment of Infrapopliteal Artery Lesions (AcoArt II-BTK). J Endovasc Ther. 2021 Apr;28(2):215-221. doi: 10.1177/1526602820969681. Epub 2020 Oct 29. |
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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 PTA balloon catheter |
| Procedure |
common PTA balloon catheter |
|
The blood supply of the target lesion recovered after treatment, and residual stenosis less than 50%
| during the operation(after using the DEB catheter) |
| operation success rate | both device succeed and technical succeed, and without clinical complication | during the operation(after using the DEB catheter) |
| if occured clinically driven TLR( target lesion revascularization) | Clinically driven TLR is defined as revascularization performed on a patient who returns with clinical symptoms such as: resting pain occur again, ulcer deterioration, new foot ulcers | 6 months, 12 months,18 months, 24 months |
| target lesion late lumen loss 6 months | measure difference of the MLD(minimal lumen diameter) at 0 time and 6 months | 6 months |
| Ulcer healing rate | Healed or not, if not, improving,stagnant, worsening | 6 months, 12 months |
| Ulcer healing time | Healed or not | 6 months, 12 months, 18 months, 24 months |
| Change from baseline ankle brachial index(ABI) at 6 months | measure ankle brachial index >1.3 Vascular wall calcification is severe 0.9~1.1 Normal range 0.5~0.8 Mild and moderate ischemia of lower limb arteries <0.5 severe ischemia | 6 months |
| change from baseline Rutherford stage at 6 months | 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 |
| limb salvage in surviving subjects | No Amputation of target limb | 30 days, 6 months, 12 months,18 months, 24 months |
| Beijing |
| China |
| Xiyuan Hospital, China Academy of Chinese Medical Sciences | Beijing | China |
| Xuanwu Hospital, Capital Medical University | Beijing | China |
| The First Affiliated Hospital of Dalian Medical University | Dalian | China |
| The First Affiliated Hospital, Sun Yat-sen University | Guangzhou | China |
| Renji Hospital, Shanghai Jiaotong University School of Medicine | Shanghai | China |
| The Ninth People's Hospital, Shanghai Jiaotong University School of Medicine | Shanghai | China |
| Shengjing Hospital of China Medical University | Shenyang | China |
| The Second Hospital of Hebei Medical University | Shijiazhuang | China |
| Tianjin Medical University General Hospital | Tianjin | China |
| D002318 |
| Cardiovascular Diseases |
| D016491 | Peripheral Vascular Diseases |