Peripheral Artery Disease Clinical Trial
Official title:
Prospective, Multi-center and Randomized Controlled Clinical Study to Verify Effectiveness and Safety of Drug-eluting Balloon in PTA Procedure (AcoArt I Study)
NCT number | NCT01850056 |
Other study ID # | acotec-02 |
Secondary ID | |
Status | Completed |
Phase | N/A |
First received | |
Last updated | |
Start date | April 2013 |
Est. completion date | September 2016 |
Verified date | December 2015 |
Source | Acotec Scientific Co., Ltd |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 200 |
Est. completion date | September 2016 |
Est. primary completion date | August 2016 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years to 80 Years |
Eligibility |
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 |
Country | Name | City | State |
---|---|---|---|
China | Chinese PLA General Hospital | Beijing | Beijing |
China | Xiyuan Hospital CACMS | Beijing | Beijing |
China | The First Affiliated Hospital of Chongqing Medical University | Chongqing | Chongqing |
China | The First Affiliated Hospital, Dalian Medical University | Dalian | Liaoning |
China | The First Affiliated Hospital of Fujian Medical University | Fuzhou | Fujian |
China | The First Affiliated Hospital, Sun Yat-sen University | Guangzhou | Guangdong |
China | Renji Hospital ShangHai Jiaotong University School Of Medicine | Shanghai | Shanghai |
China | Zhongshan Hospital Fudan University | Shanghai | Shanghai |
China | The People's Hospital of Liaoning Province | Shenyang | Liaoning |
China | The second Hospital Of Hebei University | Shijiazhuang | Hebei |
Lead Sponsor | Collaborator |
---|---|
Acotec Scientific Co., Ltd |
China,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Late Lumen Loss | measure difference of the MLD(minimal lumen diameter) at 0 time and 6 months | 6 months | |
Secondary | Minimal lumen diameter (MLD) | measure minimal lumen diameter (MLD) of target lesion | 6 months | |
Secondary | Restenosis rate of target vessel | stenosis over 50% is defined as restenosis | 6 months, 12 months, 18 months, 24months | |
Secondary | target lesion revascularization | target lesion revascularization is defined as any reintervention of artery bypass graft surgery involving the target lesion | 6 months, 12 months, 18 months, 24 months | |
Secondary | change in Rutherford stage | 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 mild claudication moderate claudication severe claudication ischemic rest pain minor tissue loss ulceration or gangrene |
6 months, 12 months, 18 months, 24 months | |
Secondary | change in ankle brachial index(ABI) | change in ankle brachial index(ABI) compared to pretreatment | 6 months | |
Secondary | major amputation | major amputation at the index limb(major amputation is defined as an amputation above the foot) | 6 months, 12 months, 18 months, 24 months | |
Secondary | Death | death of any cause | 12 months, 18 months, 24 months |
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