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AcoArt Ⅰ / SFA China

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01850056
Recruitment Status : Completed
First Posted : May 9, 2013
Last Update Posted : July 12, 2018
Information provided by (Responsible Party):
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.

Condition or disease Intervention/treatment Phase
Peripheral Artery Disease Device: drug eluting balloon catheter (trade name: Orchid) Device: common percutaneous transluminal angioplasty balloon catheter (trade name: Admiral) Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 200 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
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)
Actual Study Start Date : April 2013
Actual Primary Completion Date : August 2016
Actual Study Completion Date : September 2016

Arm Intervention/treatment
Experimental: drug eluting balloon catheter
use drug eluting balloon catheter to inflate the stenosis or occlusion in superficial femoral artery(SFA) and/or popliteal artery
Device: drug eluting balloon catheter (trade name: Orchid)
Other Name: drug eluting dilation catheter

Active Comparator: common balloon catheter(uncoated drug)
use common balloon catheter to inflate stenosis or occlusion in SFA and/or popliteal artery
Device: common percutaneous transluminal angioplasty balloon catheter (trade name: Admiral)
Other Name: common PTA catheter

Primary Outcome Measures :
  1. Late Lumen Loss [ Time Frame: 6 months ]
    measure difference of the MLD(minimal lumen diameter) at 0 time and 6 months

Secondary Outcome Measures :
  1. Minimal lumen diameter (MLD) [ Time Frame: 6 months ]
    measure minimal lumen diameter (MLD) of target lesion

  2. Restenosis rate of target vessel [ Time Frame: 6 months, 12 months, 18 months, 24months ]
    stenosis over 50% is defined as restenosis

  3. target lesion revascularization [ Time Frame: 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

  4. change in Rutherford stage [ Time Frame: 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

  5. change in ankle brachial index(ABI) [ Time Frame: 6 months ]
    change in ankle brachial index(ABI) compared to pretreatment

  6. major amputation [ Time Frame: 6 months, 12 months, 18 months, 24 months ]
    major amputation at the index limb(major amputation is defined as an amputation above the foot)

  7. Death [ Time Frame: 12 months, 18 months, 24 months ]
    death of any cause

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01850056

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China, Beijing
Xiyuan Hospital CACMS
Beijing, Beijing, China, 100091
Chinese PLA General Hospital
Beijing, Beijing, China, 100853
China, Chongqing
The First Affiliated Hospital of Chongqing Medical University
Chongqing, Chongqing, China
China, Fujian
The First Affiliated Hospital of Fujian Medical University
Fuzhou, Fujian, China
China, Guangdong
The First Affiliated Hospital, Sun Yat-sen University
Guangzhou, Guangdong, China
China, Hebei
The second Hospital Of Hebei University
Shijiazhuang, Hebei, China, 050000
China, Liaoning
The First Affiliated Hospital, Dalian Medical University
Dalian, Liaoning, China
The People's Hospital of Liaoning Province
Shenyang, Liaoning, China
China, Shanghai
Zhongshan Hospital Fudan University
Shanghai, Shanghai, China, 200032
Renji Hospital ShangHai Jiaotong University School Of Medicine
Shanghai, Shanghai, China
Sponsors and Collaborators
Acotec Scientific Co., Ltd
Publications automatically indexed to this study by Identifier (NCT Number):
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Responsible Party: Acotec Scientific Co., Ltd Identifier: NCT01850056    
Other Study ID Numbers: acotec-02
First Posted: May 9, 2013    Key Record Dates
Last Update Posted: July 12, 2018
Last Verified: December 2015
Keywords provided by Acotec Scientific Co., Ltd:
drug eluting balloon catheter
Additional relevant MeSH terms:
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Peripheral Arterial Disease
Arterial Occlusive Diseases
Vascular Diseases
Cardiovascular Diseases
Peripheral Vascular Diseases