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This study will evaluate the effectiveness and safety of local drug delivery using TAPAS balloon catheter system in the treatment of femoropopliteal in-stent restenosis. Patients with femoropopliteal in-stent restenosis will randomly receive balloon dilation or balloon dilation plus local drug delivery using balloon catheter system. Their clinical outcomes (e.g. 12-month late lumen loss or late lumen loss at secondary intervention within 12 months, 6-month and 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 after stent implantation. The chronic inflammation induced by stenting could be a main reason of restenosis. Then the concept "leave nothing behind" is proposed, and some novel treatment methods and devices are developed. Here, the investigators propose the hypothesis that using local drug delivery with TAPAS balloon system can relieve the inflammation induced by the stent implantation and balloon dilation. Therefore, 40 patients of femoropopliteal in-stent restenosis will be randomly allocated into the group "balloon dilation+local drug delivery with balloon system" or "balloon dilation only". The 1-year patency rate,12-month late lumen loss, incidence of complications, imaging parameters will be compared between two groups.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| balloon dilation only | Experimental | The balloon dilation only will be used to treat the femoropopliteal in-stent restenosis. |
|
| balloon dilation+local drug delivery | Experimental | The balloon dilation and local drug delivery will be used to treat the femoropopliteal in-stent restenosis. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| balloon dilation only | Device | The balloon dilation only will be used to treat the femoropopliteal in-stent restenosis. |
|
| Measure | Description | Time Frame |
|---|---|---|
| target lesion revascularization | the revascularization rate of target lesion | 12 months |
| Measure | Description | Time Frame |
|---|---|---|
| MLD | minimal lumen diameter of target vessel at 6 months | 6 months |
| restenosis rate | the rate of re-stenosis (≥50) of target vessel at 6 months |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Meng Ye, M.D., Ph.D. | Contact | +86 13817145123 | 13817145123@163.com | |
| Shuofei Yang, M.D., Ph.D. | Contact | +8613764227372 | doctor_yangshofei@163.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Renji Hospital | Recruiting | Shanghai | Shanghai Municipality | 200127 | China |
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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 doctors know the group the patient goes into
| balloon dilation+local drug delivery | Device | The balloon dilation and local drug delivery will be used to treat the femoropopliteal in-stent restenosis. |
|
| 6 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 |
| 12-month patency rate | the 12-month patency rate of target vessel | 12 months |
| 6-month patency rate | the 6-month patency rate of target vessel | 6 months |
| late lumen loss rate at secondary intervention | the rate of late lumen loss of target vessel at secondary intervention within 12 months | 12 months |
| D002318 |
| Cardiovascular Diseases |
| D016491 | Peripheral Vascular Diseases |