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Completed

NCT Number: NCT01850056

AcoArt Ⅰ / SFA China

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.

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Key information

Conditions

Peripheral Artery Disease Arterial Occlusive Diseases Arteriosclerosis Atherosclerosis Cardiovascular Diseases Peripheral Arterial Disease Peripheral Vascular Diseases Vascular Diseases

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Chinese PLA General Hospital, Beijing, Beijing Municipality, China

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

drug eluting balloon catheter (trade name: Orchid)

Device

Other names: drug eluting dilation catheter

common percutaneous transluminal angioplasty balloon catheter (trade name: Admiral)

Device

Other names: common PTA catheter

Primary outcomes

  1. Late Lumen Loss

    Time frame: 6 months

    measure difference of the MLD(minimal lumen diameter) at 0 time and 6 months

Secondary outcomes

  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

    • mild claudication
    • moderate claudication
    • severe claudication
    • ischemic rest pain
    • minor tissue loss
    • 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

Sponsors and collaborators

Lead sponsor

Acotec Scientific Co., Ltd

Industry

Registry information

Official study title

Prospective, Multi-center and Randomized Controlled Clinical Study to Verify Effectiveness and Safety of Drug-eluting Balloon in PTA Procedure (AcoArt I Study)

Important dates

Study start
2013
Primary completion
2016
Study completion
2016
First posted
May 9, 2013
Registry last updated
Jul 12, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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