AcoArt Ⅰ / SFA China

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

COMPLETED

Clinical Phase

NA

Total Enrollment

200 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-04-30

Study Completion Date

2016-09-30

Brief Summary

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The purpose of this study is to determine whether DEB is more effective than common PTA balloon in long-term vessel patency and inhibiting restenosis.

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Detailed Description

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Conditions

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Peripheral Artery Disease

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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drug eluting balloon catheter

use drug eluting balloon catheter to inflate the stenosis or occlusion in superficial femoral artery(SFA) and/or popliteal artery

Group Type EXPERIMENTAL

drug eluting balloon catheter (trade name: Orchid)

Intervention Type DEVICE

common balloon catheter(uncoated drug)

use common balloon catheter to inflate stenosis or occlusion in SFA and/or popliteal artery

Group Type ACTIVE_COMPARATOR

common percutaneous transluminal angioplasty balloon catheter (trade name: Admiral)

Intervention Type DEVICE

Interventions

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drug eluting balloon catheter (trade name: Orchid)

Intervention Type DEVICE

common percutaneous transluminal angioplasty balloon catheter (trade name: Admiral)

Intervention Type DEVICE

Other Intervention Names

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drug eluting dilation catheter common PTA catheter

Eligibility Criteria

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Inclusion Criteria

* Age between 18 and 80 years
* Patients with peripheral artery disease (PAD), with Rutherford classification between 2 and 5
* an occlusion or a minimum grade of stenosisPrimary over 70% in the superficial femoral artery an /or the popliteal artery
* Total length of treat lesion(s)is less or equal to 40cm
* signed Patient informed consent form

Exclusion Criteria

* plasma Cr level greater than 150 umol/L in patients
* patients with acute thrombosis requiring lysis or thrombectomy
* patient with a lysis or an lower limb intervention as a therapy within the last 6 weeks
* patient requiring intervention in both lower limbs at the same time
* target lesion can't be cross by the guide wire
* distal outflow through less than one lower leg vessel
* known hypersensitivity to aspirin, heparin, clopidogrel,paclitaxel, contrast medium, etc.
* patients participating in another clinical trials with interfere with this trial in the past 3 months
* pregnancy and lactating woman
* untreatable bleeding diatheses
* other diseases, such as cancer, liver disease, or cardiac insufficiency, which may lead to protocol violations or markedly shorten a patients's life expectancy(less than 2 years)
* patients unable or unwilling to participate this trial

Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No