LDD in Treatment of Femoropopliteal ISR

Shanghai Jiao Tong University

Status: Unknown

Conditions: Peripheral Artery Disease; In-stent Restenosis

Treatments: Device: balloon dilation+local drug delivery; Device: balloon dilation only

Study type: Interventional

Funder types: Other

Identifiers

NCT03521843

12345678

Details and patient eligibility

About

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.

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 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.

Enrollment: 40 estimated patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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40 participants in 2 patient groups

balloon dilation only

Experimental group

Description:

The balloon dilation only will be used to treat the femoropopliteal in-stent restenosis.

Treatment:

Device: balloon dilation only

balloon dilation+local drug delivery

Experimental group

Description:

The balloon dilation and local drug delivery will be used to treat the femoropopliteal in-stent restenosis.

Treatment:

Device: balloon dilation+local drug delivery