Peripheral Artery Disease
Conditions
Keywords
drug eluting balloon catheter
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.
Interventions
DEVICEcommon percutaneous transluminal angioplasty balloon catheter (trade name: Admiral)
Sponsors
Acotec Scientific Co., Ltd
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Late Lumen Loss | 6 months | measure difference of the MLD(minimal lumen diameter) at 0 time and 6 months |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Minimal lumen diameter (MLD) | 6 months | measure minimal lumen diameter (MLD) of target lesion |
| Restenosis 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 |
| change in ankle brachial index(ABI) | 6 months | change in ankle brachial index(ABI) compared to pretreatment |
| 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) |
| Death | 12 months, 18 months, 24 months | death of any cause |
| 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 gangrene |
Countries
China
Outcome results
None listed