AcoArt Ⅰ / SFA China
- Conditions
- Peripheral Artery Disease
- Registration Number
- NCT01850056
- Lead Sponsor
- Acotec Scientific Co., Ltd
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 200
- 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
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Primary Outcome Measures
Name Time Method Late Lumen Loss 6 months measure difference of the MLD(minimal lumen diameter) at 0 time and 6 months
- Secondary Outcome Measures
Name Time Method change in Rutherford stage 6 months, 12 months, 18 months, 24 months based the following definition of Rutherford stage, evaluate the stage of patient. Then compare the stage of patient just after procedure and 6 months after treatment
Stage clinical symptom
0 asymptomatic
1. mild claudication
2. moderate claudication
3. severe claudication
4. ischemic rest pain
5. minor tissue loss
6. ulceration or gangreneRestenosis rate of target vessel 6 months, 12 months, 18 months, 24months stenosis over 50% is defined as restenosis
target lesion revascularization 6 months, 12 months, 18 months, 24 months target lesion revascularization is defined as any reintervention of artery bypass graft surgery involving the target lesion
Death 12 months, 18 months, 24 months death of any cause
major amputation 6 months, 12 months, 18 months, 24 months major amputation at the index limb(major amputation is defined as an amputation above the foot)
Minimal lumen diameter (MLD) 6 months measure minimal lumen diameter (MLD) of target lesion
change in ankle brachial index(ABI) 6 months change in ankle brachial index(ABI) compared to pretreatment
Trial Locations
- Locations (10)
Chinese PLA General Hospital
🇨🇳Beijing, Beijing, China
Renji Hospital ShangHai Jiaotong University School Of Medicine
🇨🇳Shanghai, Shanghai, China
The First Affiliated Hospital, Dalian Medical University
🇨🇳Dalian, Liaoning, China
Zhongshan Hospital Fudan University
🇨🇳Shanghai, Shanghai, China
The First Affiliated Hospital of Chongqing Medical University
🇨🇳Chongqing, Chongqing, China
The First Affiliated Hospital of Fujian Medical University
🇨🇳Fuzhou, Fujian, China
Xiyuan Hospital CACMS
🇨🇳Beijing, Beijing, China
The First Affiliated Hospital, Sun Yat-sen University
🇨🇳Guangzhou, Guangdong, China
The second Hospital Of Hebei University
🇨🇳Shijiazhuang, Hebei, China
The People's Hospital of Liaoning Province
🇨🇳Shenyang, Liaoning, China