Study of DA+LDD in the Treatment of Femoropopliteal Occlusive Disease

Study Overview
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Brief Summary
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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.

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 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.

Official Title
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Study of Combined Use of Directional Atherectomy and Local Drug Delivery With Balloon Catheter System in the Treatment of Femoropopliteal Occlusive Disease

Conditions
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Peripheral Artery Disease, Endovascular Treatment

Intervention / Treatment
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* Device: directional atherectomy and locol drug delivery
* Device: drug-coated balloon dilation


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: age of 18-80 years old patients of femoropopliteal occlusive disease (Rutherford 2-4) length of lesion ≤ 20cm have signed the informed consent Exclusion Criteria: serum Cr > 150 umol/L patients with acute thrombosis received endovascular treatment for femoropopliteal disease in recent 6 months less than 1 run-off vessel allergic to aspirin, heparin, clopidogrel, paclitaxel, contrast medium 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 |
| --- | --- |
| Other: durg-coated balloon dilation<br>The drug-coated balloon will be used to treat the femoropopliteal occlusion. | Device: drug-coated balloon dilation<br>* use of drug-coated balloon dilation for the treatment of femoralpopliteal disease<br>|
| Other: directional atherectomy and LDD<br>The directional atherectomy and local drug delivery will be used to treat the femoropopliteal occlusion. | Device: directional atherectomy and locol drug delivery<br>* combined use of directional atherectomy and locol drug delivery for the treatment of femoralpopliteal disease<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 | 

Secondary Outcome Measures

| Outcome Measure | 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 | 
| 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 | 

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