AcoArt Ⅱ/ BTK China: Drug-eluting Balloon for Below-The-Knee Angioplasty Evaluation in 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: NCT02137577
Recruitment Status : Unknown
Verified December 2015 by Acotec Scientific Co., Ltd.
Recruitment status was:  Recruiting
First Posted : May 14, 2014
Last Update Posted : June 6, 2016
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 using under in long-term vessel patency and inhibiting restenosis in the infrapopliteal artery.

Condition or disease Intervention/treatment Phase
Peripheral Artery Disease Procedure: DEB catheter Procedure: common PTA balloon catheter Not Applicable

Detailed Description:

PTA is an established alternative to open surgical bypass for the treatment of infrainginual disease of critical limb ischemia.

DEBs are designed to promote arterial patency by reducing neointimal proliferation.

Study Type : Interventional  (Clinical Trial)
Estimated 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 of the Infrapopliteal Artery
Study Start Date : May 2014
Estimated Primary Completion Date : August 2016
Estimated Study Completion Date : November 2016

Arm Intervention/treatment
Experimental: DEB catheter
use DEB catheter(trade name: Lotus/Tulip) to treat the stenosis or occlusion in below popliteal artery of experimental arm
Procedure: DEB catheter
DEB catheter (trade name: Litos/Tulip)

Active Comparator: common PTA balloon catheter
use common PTA balloon catheter(trade name:Amphirion Deep) to treat stenosis or occlusion in below popliteal artery of control group
Procedure: common PTA balloon catheter
common PTA balloon catheter

Primary Outcome Measures :
  1. LLL (late lumen loss) of target vessel at 6 months [ Time Frame: 6 months ]

Secondary Outcome Measures :
  1. device success rate [ Time Frame: during the operation(after using the DEB catheter) ]
    DEB catheter can reach the target lesions, expand as expected(not broken), and withdraw successfully.

  2. technical success rates [ Time Frame: during the operation(after using the DEB catheter) ]
    The blood supply of the target lesion recovered after treatment, and residual stenosis less than 50%

  3. operation success rate [ Time Frame: during the operation(after using the DEB catheter) ]
    both device succeed and technical succeed, and without clinical complication

  4. if occured clinically driven TLR( target lesion revascularization) at 6 months, 12 months, 18 months, 24 months [ Time Frame: 6 months, 12 months, 18 months, 24 months ]
    Clinically driven TLR is defined as revascularization performed on a patient who returns with clinical symptoms such as: resting pain occur again, ulcer deterioration, new foot ulcers

  5. if occured major amputation at 6 months, 12 months, 18 months, 24 months [ 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)

  6. Ulcer healing rate [ Time Frame: 6 months ]
  7. Change from baseline ABI(ankle brachial index) at 6 months, 12 months, 18 months, 24 months [ Time Frame: 6 months, 12 months, 18 months, 24 months ]
    measure ankle brachial index

  8. change from baseline Rutherford stage at 6 months, 12 months, 18 months, 24 months [ 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

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 85 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • Age between 18 and 85 years
  • Patients with peripheral artery disease (PAD), with Rutherford classification between 4 and 6
  • an occlusion or a minimum grade of stenosis Primary over 70% in the below popliteal artery
  • The expected survival time is more than 1 year
  • signed Patient informed consent form

Exclusion Criteria:

  • Serum creatinine clearance rate less than 30ml/min 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
  • In-stent restenosis in the blow-knee popliteal artery
  • target lesion can't be cross by the guide wire
  • the stenosis rate of proximal outflow more than 30% with or without intervention
  • the length of the stenosis or occlusion in proximal outflow(including the Iliac artery, the superficial femoral artery, the Popliteal artery) more than 150mm before intervention
  • stenosis or occlusion of distal outflow for below-the-ankle artery.
  • expected major amputations at the index limb before intervention
  • known hypersensitivity to aspirin, heparin, clopidogrel,paclitaxel, contrast medium, etc.
  • patients participating in another clinical trials with interfere with this trial in the same time
  • pregnancy and lactating woman
  • untreatable bleeding diatheses

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): NCT02137577

Contact: Qianqian Wei

People's Liberation Army General Hospital Recruiting
BeiJing, China, 100853
Contact: Wei Guo    +10 86 66936336   
Sponsors and Collaborators
Acotec Scientific Co., Ltd

Responsible Party: Acotec Scientific Co., Ltd Identifier: NCT02137577     History of Changes
Other Study ID Numbers: acotec-03
First Posted: May 14, 2014    Key Record Dates
Last Update Posted: June 6, 2016
Last Verified: December 2015

Keywords provided by Acotec Scientific Co., Ltd:
drug eluting balloon catheter

Additional relevant MeSH terms:
Peripheral Arterial Disease
Arterial Occlusive Diseases
Vascular Diseases
Cardiovascular Diseases
Peripheral Vascular Diseases