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Peripheral Artery DiseaseNCT02137577

AcoArt Ⅱ/ BTK China: Drug-eluting Balloon for Below-The-Knee Angioplasty Evaluation in China

A study testing DEB catheter and common PTA balloon catheter in people with Peripheral Artery Disease, run by Acotec Scientific Co., Ltd at 11 sites in China.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 to 85 years
Conditions the study is for
Peripheral Artery Disease
What is being tested?
DEB catheter and common PTA balloon catheter
Type of treatment
Surgery or procedure
Could I receive a placebo?
No, everyone receives an active treatment
How many people
120 participants
Where
11 sitesChina
Study dates
May 2014to 17 Dec 2020
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 85 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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
Show all 14Show fewer
  • 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

Trial locations and contacts

11 sites in 1 country.

11 sites in 1 country

China11 sites

  • People's Liberation Army General Hospital

    Beijing, 100853

  • Peking Union Medical College Hospital

    Beijing

  • Xiyuan Hospital, China Academy of Chinese Medical Sciences

    Beijing

  • Xuanwu Hospital, Capital Medical University

    Beijing

  • The First Affiliated Hospital of Dalian Medical University

    Dalian

  • The First Affiliated Hospital, Sun Yat-sen University

    Guangzhou

  • Renji Hospital, Shanghai Jiaotong University School of Medicine

    Shanghai

  • The Ninth People's Hospital, Shanghai Jiaotong University School of Medicine

    Shanghai

  • Shengjing Hospital of China Medical University

    Shenyang

  • The Second Hospital of Hebei Medical University

    Shijiazhuang

  • Tianjin Medical University General Hospital

    Tianjin

Other trials in China

About this study

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

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.

Read the 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.

Being tested
DEB catheter, common PTA balloon catheter
Keywords
drug eluting balloon catheter
Medical subject headings
Peripheral Arterial Disease

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • DEB catheterProcedure or surgery

    DEB catheter (trade name: Litos/Tulip)

  • common PTA balloon catheterProcedure or surgery

    common PTA balloon catheter

Study groups in NCT02137577
Study groupRoleWhat they receive
DEB catheterExperimentaluse DEB catheter(trade name: Lotus/Tulip) to treat the stenosis or occlusion in below popliteal artery of experimental arm
Receives: Procedure: DEB catheter
common PTA balloon catheterActive comparatoruse common PTA balloon catheter(trade name:Amphirion Deep) to treat stenosis or occlusion in below popliteal artery of control group
Receives: Procedure: common PTA balloon catheter

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Primary Patency [Time Frame: 6 months]

    Freedom from target vessel occlusion and clinically driven target lesion reintervention

    Measured: 6 months

Secondary outcomes (10)

  1. device success rate

    DEB catheter can reach the target lesions, expand as expected(not broken), and withdraw successfully.

    Measured: during the operation(after using the DEB catheter)

  2. technical success rates

    The blood supply of the target lesion recovered after treatment, and residual stenosis less than 50%

    Measured: during the operation(after using the DEB catheter)

  3. operation success rate

    both device succeed and technical succeed, and without clinical complication

    Measured: during the operation(after using the DEB catheter)

  4. if occured clinically driven TLR( target lesion revascularization)

    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

    Measured: 6 months, 12 months,18 months, 24 months

  5. target lesion late lumen loss 6 months

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

    Measured: 6 months

  6. Ulcer healing rate

    Healed or not, if not, improving,stagnant, worsening

    Measured: 6 months, 12 months

  7. Ulcer healing time

    Healed or not

    Measured: 6 months, 12 months, 18 months, 24 months

  8. Change from baseline ankle brachial index(ABI) at 6 months

    measure ankle brachial index

    >1.3 Vascular wall calcification is severe

    0.9~1.1 Normal range

    0.5~0.8 Mild and moderate ischemia of lower limb arteries

    <0.5 severe ischemia

    Measured: 6 months

  9. change from baseline Rutherford stage at 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

    Measured: 6 months, 12 months,18 months, 24 months

  10. limb salvage in surviving subjects

    No Amputation of target limb

    Measured: 30 days, 6 months, 12 months,18 months, 24 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted14 May 2014 (estimated)
  2. Study startMay 2014
  3. Primary completionNov 2018
  4. Study completion17 Dec 2020

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Single blind
Who is masked
Outcomes assessor
Enrolment
120 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02137577
Sponsor's protocol ID
acotec-03
Status last verified
Jun 2021
First submitted
5 May 2014
Last updated
18 Jun 2021
Results posted
No
Data monitoring committee
Yes

Publications

  • Ma GW, Bernatchez J, Yarranton B, Dueck AD, Rajan DK, Forbes TL, de Mestral C, Kayssi A. Drug-eluting balloon angioplasty versus uncoated balloon angioplasty for peripheral arterial disease of the lower limbs. Cochrane Database Syst Rev. 2026 Aug 10;8:CD011319. doi: 10.1002/14651858.CD011319.pub3.

    PubMed 42573020

  • Jia X, Zhuang B, Wang F, Gu Y, Zhang J, Lu X, Dai X, Liu Z, Bi W, Liu C, Wang S, Liistro F, Guo W. Drug-Coated Balloon Angioplasty Compared With Uncoated Balloons in the Treatment of Infrapopliteal Artery Lesions (AcoArt II-BTK). J Endovasc Ther. 2021 Apr;28(2):215-221. doi: 10.1177/1526602820969681. Epub 2020 Oct 29.

    PubMed 33118432

Questions about this trial

What is this clinical trial studying?

A study testing DEB catheter and common PTA balloon catheter in people with Peripheral Artery Disease, run by Acotec Scientific Co., Ltd at 11 sites in China.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 18 Jun 2021. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 11 sites in China. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Primary Patency [Time Frame: 6 months] (time frame: 6 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02137577, which also lists 2 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Jun 2021.

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