LDD in Treatment of Femoropopliteal ISR

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

40 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-01-01

Study Completion Date

2019-10-31

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.

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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.

Conditions

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Peripheral Artery Disease In-stent Restenosis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Participants

only the doctors know the group the patient goes into

Study Groups

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balloon dilation only

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

Group Type EXPERIMENTAL

balloon dilation only

Intervention Type DEVICE

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

balloon dilation+local drug delivery

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

Group Type EXPERIMENTAL

balloon dilation+local drug delivery

Intervention Type DEVICE

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

Interventions

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balloon dilation only

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

Intervention Type DEVICE

balloon dilation+local drug delivery

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

Intervention Type DEVICE

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

Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No