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This study will evaluate the effectiveness and safety of directional atherectomy plus local drug delivery using balloon catheter system in the treatment of femoropopliteal occlusive disease. Patients of femoropopliteal occlusive disease will randomly receive directional atherectomy plus local drug delivery using balloon catheter system and dilation using drug-coated balloon. Their clinical outcomes (e.g. 12-month late lumen loss rate, 1-year patency rate of target vessel) in 1 year after the treatment will be compared.
Femoropopliteal occlusive disease is a common type of peripheral arterial disease. Endovascular treatment has been the first-line treatment of femoropopliteal occlusive disease. However, the in-stent re-stenosis has been a major limitation of well long-term patency rate after stent implantation. The chronic inflammation induced by stenting could be a main reason of re-stenosis. Then the concept "leave nothing behind" is proposed, and some novel treatment methods and devices, such as paclitaxel-coated balloon dilation, directional atherectomy, are developed. Directional atherectomy can effectively remove the atherosclerosis plaque but leave the inflammatory reaction along the atherectomy route. Here, we propose the hypothesis that using local drug delivery with balloon system can relieve the inflammation induced by atherectomy. Therefore, 40 patients of femoropopliteal occlusive disease will be randomly allocated into the group "directional atherectomy+local drug delivery with balloon system" or "drug-coated balloon only". The 1-year patency rate, incidence of complications, imaging parameters will be compared between groups.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| durg-coated balloon dilation | Other | The drug-coated balloon will be used to treat the femoropopliteal occlusion. |
|
| directional atherectomy and LDD | Other | The directional atherectomy and local drug delivery will be used to treat the femoropopliteal occlusion. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| directional atherectomy and locol drug delivery | Device | combined use of directional atherectomy and locol drug delivery for the treatment of femoralpopliteal disease |
|
| Measure | Description | Time Frame |
|---|---|---|
| late lumen loss rate | the rate of late lumen loss of target vessel | 12 months |
| patency rate | the rate of patency of target vessel | 6 months |
| patency rate | the rate of patency of target vessel | 12 months |
| Measure | Description | Time Frame |
|---|---|---|
| MLD | minimal lumen diameter of target vessel at 6 months | 12 months |
| clinical outcomes | rate of re-intervention of target vessel | 12 months |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Shuofei Yang, M.D., Ph.D. | Contact | +86 13764227372 | doctor_yangshuofei@163.com |
| Name | Affiliation | Role |
|---|---|---|
| Lan Zhang, M.D., Ph.D. | RenJi Hospital | Principal Investigator |
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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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only the doctor know the group the patient goes into
| drug-coated balloon dilation | Device | use of drug-coated balloon dilation for the treatment of femoralpopliteal disease |
|
| incidence of complications | incidence of treatment induced major complications | 12 months |
| re-stenosis rate | the rate of re-stenosis (≥50) | 12 months |
| adverse events | incidence of treatment related adverse events | 12 months |
| Rutherford level | change of Rutherford level | 12 months |
| ABI | change of ankle brachial index | 12 months |
| main amputation | rate of main amputation | 12 months |
| D002318 |
| Cardiovascular Diseases |
| D016491 | Peripheral Vascular Diseases |