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

Shanghai Jiao Tong University

Status: Unknown

Conditions: Endovascular Treatment; Peripheral Artery Disease

Treatments: Device: directional atherectomy and locol drug delivery; Device: drug-coated balloon dilation

Study type: Interventional

Funder types: Other

Identifiers

NCT03380650

2017-092

Details and patient eligibility

About

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.

Full 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.

Enrollment: 40 estimated patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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40 participants in 2 patient groups

durg-coated balloon dilation

Other group

Description:

The drug-coated balloon will be used to treat the femoropopliteal occlusion.

Treatment:

Device: drug-coated balloon dilation

directional atherectomy and LDD

Other group

Description:

The directional atherectomy and local drug delivery will be used to treat the femoropopliteal occlusion.

Treatment:

Device: directional atherectomy and locol drug delivery