Status:
COMPLETED
AcoArt Ⅰ / SFA China
Lead Sponsor:
Acotec Scientific Co., Ltd
Conditions:
Peripheral Artery Disease
Eligibility:
All Genders
18-80 years
Phase:
NA
Brief Summary
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.
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
April 1 2013
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 1 2016
Estimated Enrollment :
200 Patients enrolled
Trial Details
Trial ID
NCT01850056
Start Date
April 1 2013
End Date
September 1 2016
Last Update
July 12 2018
Active Locations (10)
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1
Xiyuan Hospital CACMS
Beijing, Beijing Municipality, China, 100091
2
Chinese PLA General Hospital
Beijing, Beijing Municipality, China, 100853
3
The First Affiliated Hospital of Chongqing Medical University
Chongqing, Chongqing Municipality, China
4
The First Affiliated Hospital of Fujian Medical University
Fuzhou, Fujian, China