AcoArt Ⅰ / SFA China

Acotec Scientific

Status: Completed

Conditions: Peripheral Artery Disease

Treatments: Device: common percutaneous transluminal angioplasty balloon catheter (trade name: Admiral); Device: drug eluting balloon catheter (trade name: Orchid)

Study type: Interventional

Funder types: Industry

Identifiers

NCT01850056

acotec-02

Details and patient eligibility

About

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.

Enrollment: 200 patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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200 participants in 2 patient groups

drug eluting balloon catheter

Experimental group

Description:

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

Treatment:

Device: drug eluting balloon catheter (trade name: Orchid)

common balloon catheter(uncoated drug)

Active Comparator group

Description:

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

Treatment:

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