Endovascular Treatment, Peripheral Artery Disease
Conditions
Keywords
femoropopliteal occlusive disease, directional atherectomy, local drug delivery, endovascular treatment
Brief summary
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
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.
Interventions
DEVICEdirectional atherectomy and locol drug delivery
combined use of directional atherectomy and locol drug delivery for the treatment of femoralpopliteal disease
DEVICEdrug-coated balloon dilation
use of drug-coated balloon dilation for the treatment of femoralpopliteal disease
Sponsors
RenJi Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)
Masking description
only the doctor know the group the patient goes into
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| late lumen loss rate | 12 months | the rate of late lumen loss of target vessel |
| patency rate | 6 months | the rate of patency of target vessel |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| MLD | 12 months | minimal lumen diameter of target vessel at 6 months |
| clinical outcomes | 12 months | rate of re-intervention of target vessel |
| incidence of complications | 12 months | incidence of treatment induced major complications |
| re-stenosis rate | 12 months | the rate of re-stenosis (≥50) |
| adverse events | 12 months | incidence of treatment related adverse events |
| Rutherford level | 12 months | change of Rutherford level |
| ABI | 12 months | change of ankle brachial index |
| main amputation | 12 months | rate of main amputation |
Contacts
Primary ContactShuofei Yang, M.D., Ph.D.
Outcome results
None listed