LDD in Treatment of Femoropopliteal ISR

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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Study of Local Drug Delivery in the Treatment of Femoropopliteal In-stent Restenosis

Conditions
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Peripheral Artery Disease, In-stent Restenosis

Intervention / Treatment
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* Device: balloon dilation only
* Device: balloon dilation+local drug delivery


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: have signed the informed consent age of 18-80 years old femoropopliteal artery disease (Rutherford 2-4) femoropopliteal in-stent restenosis (≥70%) length of lesion ≤ 20cm at least one infrapopliteal run-off vessel Exclusion Criteria: serum Cr > 150 umol/L patients with acute thrombosis stent fracture within femoropopliteal artery allergic to aspirin, heparin, clopidogrel, paclitaxel, contrast medium already recruited into other clinical trials that could influence the outcome of this study pregnancy and lactation relatively easy bleeding malignancy or irreversible organ failure

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: balloon dilation only<br>The balloon dilation only will be used to treat the femoropopliteal in-stent restenosis. | Device: balloon dilation only<br>* The balloon dilation only will be used to treat the femoropopliteal in-stent restenosis.<br>|
| Experimental: balloon dilation+local drug delivery<br>The balloon dilation and local drug delivery will be used to treat the femoropopliteal in-stent restenosis. | Device: balloon dilation+local drug delivery<br>* The balloon dilation and local drug delivery will be used to treat the femoropopliteal in-stent restenosis.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| target lesion revascularization | the revascularization rate of target lesion | 12 months | 

Secondary Outcome Measures

| Outcome Measure | 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 | 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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femoropopliteal occlusive disease, local drug delivery, endovascular treatment