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AcoArt Ⅰ / SFA China

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ClinicalTrials.gov Identifier: NCT01850056
Recruitment Status : Completed
First Posted : May 9, 2013
Last Update Posted : July 12, 2018
Sponsor:
Information provided by (Responsible Party):
Acotec Scientific Co., Ltd

Tracking Information
First Submitted Date  ICMJE April 27, 2013
First Posted Date  ICMJE May 9, 2013
Last Update Posted Date July 12, 2018
Actual Study Start Date  ICMJE April 2013
Actual Primary Completion Date August 2016   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: May 7, 2013)
Late Lumen Loss [ Time Frame: 6 months ]
measure difference of the MLD(minimal lumen diameter) at 0 time and 6 months
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: May 5, 2014)
  • Minimal lumen diameter (MLD) [ Time Frame: 6 months ]
    measure minimal lumen diameter (MLD) of target lesion
  • Restenosis rate of target vessel [ Time Frame: 6 months, 12 months, 18 months, 24months ]
    stenosis over 50% is defined as restenosis
  • 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
  • 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
  • change in ankle brachial index(ABI) [ Time Frame: 6 months ]
    change in ankle brachial index(ABI) compared to pretreatment
  • 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)
  • Death [ Time Frame: 12 months, 18 months, 24 months ]
    death of any cause
Original Secondary Outcome Measures  ICMJE
 (submitted: May 7, 2013)
  • Minimal lumen diameter (MLD) [ Time Frame: 6 months ]
    measure minimal lumen diameter (MLD) of target lesion
  • Restenosis rate of target vessel [ Time Frame: 6 months ]
    Restenosis rate of target vessel 6 months later (stenosis over 50% is defined as restenosis)
  • target lesion revascularization [ Time Frame: 6 months ]
    target lesion revascularization is defined as any reintervention of artery bypass graft surgery involving the target lesion
  • change in Rutherford stage [ Time Frame: 6 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
    0
  • change in ankle brachial index(ABI) [ Time Frame: 6 months ]
    change in ankle brachial index(ABI) compared to pretreatment
  • major amputation [ Time Frame: 6 months ]
    major amputation at the index limb(major amputation is defined as an amputation above the foot)
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE AcoArt Ⅰ / SFA China
Official Title  ICMJE Prospective, Multi-center and Randomized Controlled Clinical Study to Verify Effectiveness and Safety of Drug-eluting Balloon in PTA Procedure (AcoArt I Study)
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 Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE Peripheral Artery Disease
Intervention  ICMJE
  • Device: drug eluting balloon catheter (trade name: Orchid)
    Other Name: drug eluting dilation catheter
  • Device: common percutaneous transluminal angioplasty balloon catheter (trade name: Admiral)
    Other Name: common PTA catheter
Study Arms  ICMJE
  • 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
    Intervention: Device: drug eluting balloon catheter (trade name: Orchid)
  • Active Comparator: common balloon catheter(uncoated drug)
    use common balloon catheter to inflate stenosis or occlusion in SFA and/or popliteal artery
    Intervention: Device: common percutaneous transluminal angioplasty balloon catheter (trade name: Admiral)
Publications * Sun G, Liu J, Jia S, Zhang J, Zhuang B, Jia X, Fu W, Wu D, Wang F, Zhao Y, Guo P, Bi W, Wang S, Guo W; AcoArt I Trial Investigators. Comparison of drug-coated balloon angioplasty versus uncoated balloon angioplasty in treatment of total occlusions with severe femoropopliteal lesions: An additional analysis from the AcoArt I study. Vascular. 2020 Sep 9:1708538120953663. doi: 10.1177/1708538120953663. [Epub ahead of print]

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: May 7, 2013)
200
Original Estimated Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE September 2016
Actual Primary Completion Date August 2016   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 80 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE China
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01850056
Other Study ID Numbers  ICMJE acotec-02
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Acotec Scientific Co., Ltd
Study Sponsor  ICMJE Acotec Scientific Co., Ltd
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account Acotec Scientific Co., Ltd
Verification Date December 2015

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP