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The registry is a prospective, multicenter, single arm post-market real-world registry in China assessing the clinical use, safety and outcomes of the Orchid 035 DCB Catheter in the Superficial Femoral Artery (SFA) and Popliteal Arteries (PA).
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 |
|---|---|---|---|
| DCB arm | drug eluting balloon catheter |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| drug eluting balloon catheter (trade name: Orchid) | Device | use drug eluting balloon catheter(trade name: Orchid) to inflate the stenosis or occlusion in superficial femoral artery(SFA) and/or popliteal artery |
| Measure | Description | Time Frame |
|---|---|---|
| Primary patency of target lesion. | The primary efficacy end point was primary patency at 12 months following the index procedure, defined as freedom from clinically driven target lesion revascularization and restenosis as determined by a duplex ultrasonography-derived peak systolic velocity ratio of ≤2.4 | 12 months |
| Measure | Description | Time Frame |
|---|---|---|
| target lesion revascularization,target lesion revascularization is defined as any reintervention of artery bypass graft surgery involving the target lesion | target lesion revascularization is defined as any reintervention of artery bypass graft surgery involving the target lesion | 6 months, 12 months |
| improvment in Rutherford stage |
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Inclusion Criteria:
Exclusion Criteria:
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patients with a more than 70% stenosis at femoral and/or popliteal artery meet all the inclusion and excluison criteria
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| Name | Affiliation | Role |
|---|---|---|
| Wei Guo | Chinese PLA General Hospital | Principal Investigator |
| Yinghua Zou | Peking University First Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Chinese PLA General Hospital | Beijing | Beijing Municipality | 100853 | China | ||
| Peking University First Hospital |
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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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improvementin Rutherford stage is defined as an upward shift of at least 1 category on Rutherford classification as compared to baseline |
| 6 months, 12 months |
| change in ankle brachial index(ABI) | change in ankle brachial index(ABI) compared to baseline | 12 months |
| Device success during the operation | Device success is defined as successful delivery, balloon inflation, deflation and retrieval of the intact study device without burst below the rated burst pressure (RBP). | during the operation |
| Beijing |
| Beijing Municipality |
| China |
| The second hospital of hebei medical university | Shijiazhuang | Hebei | China |
| The second affiliated hospital of Harbin medical university | Harbin | Heilongjiang | China |
| Wuhan central hospital | Wuhan | Hubei | China |
| Jiangsu Province Hospital | Nanjing | Jiangsu | China |
| The First Affiliated Hospital of Dalian Medical University | Dalian | Liaoning | China |
| Shengjing Hospital of China Medical University | Shenyang | Liaoning | China |
| Tianjin First Center Hospital | Tianjin | Tianjin Municipality | China |
| The First Affiliated Hospital of Zhejiang University | Nanjing | Zhejiang | China |
| D002318 |
| Cardiovascular Diseases |
| D016491 | Peripheral Vascular Diseases |