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Arteriovenous Fistula StenosisNCT03366727

AcoArt III / Arterio-venous Fistula in China

A study testing drug-coated balloon catheter （Orchid, Acotec） and plain balloon catheter (Admiral, medtronic) in people with Arteriovenous Fistula Stenosis, run by Acotec Scientific Co., Ltd at 13 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

This trial is aimed to evaluate the safety and efficacy of DCB in treating AVF stenosis in chinese population. Read more about this study

Who is it for?
Ages 18 to 85 years
Conditions the study is for
Arteriovenous Fistula Stenosis
What is being tested?
drug-coated balloon catheter （Orchid, Acotec） and plain balloon catheter (Admiral, medtronic)
Type of treatment
Medical device
Could I receive a placebo?
No, everyone receives an active treatment
How many people
244 participants
Where
13 sitesChina
Study dates
1 May 2018to 7 Jul 2022
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 during 18-85 years old
  • Arteriovenous fistula is matured and has undergone one or more hemodialysis sessions
  • Venous stenosis of the AV fistula
  • target lesion has stenosis ≥50% evidenced by angiography. and have at least one symptom of these：1,the venous pressure increased significantly during dialysis. 2,abnormal physical examination. 3,Decrease in blood flow
  • the length of target lesion ≤100mm
  • Patient able to give informed consent
  • residual stenosis ≤30% after predilation

Who cannot join

  • Women who are breastfeeding, pregnant or are intending to become pregnant
  • AVF located at lower limbs
  • two or more than two stenosis at the target vessel.
  • Obstruction of central venous return
  • ISR
  • AVF with acute thrombosis requiring lysis or thrombectomy in 30 days
Show all 15Show fewer
  • vascular access has surgery in 30 days or intending to undergo a surgery
  • known hypersensitivity to aspirin, heparin, clopidogrel,paclitaxel, contrast medium, etc.
  • Patients undergoing immunotherapy or suspected / confirmed vasculitis
  • Patients with history of blood coagulation dysfunction and history of thrombocytopenic purpura
  • Vascular access infection or systemic active infection
  • patients's life expectancy is less than 12 months
  • Renal transplantation has been planned or converted to peritoneal dialysis
  • Other medical conditions that lead to researchers who believe that patients may not be able to follow the trial program
  • involved in other drugs, biology, medical device research, or has been involved in other similar products clinical Test

Trial locations and contacts

13 sites in 1 country.

13 sites in 1 country

China13 sites

  • Chinese PLA General Hospital

    Beijing, Beijing Municipality

  • Tongren hospital, Capital medical university

    Beijing, Beijing Municipality

  • Beijing Friendship Hospital,Capital Medical University

    Beijing

  • The first hospital of Jilin medical university

    Changchun, Jilin

  • The First Affiliated Hospital of Chongqing Medical University

    Chongqing, Chongqing Municipality

  • Guangdong provincial people's hospital

    Guangzhou, Guangdong

  • Nanfang hospital

    Guangzhou, Guangzhou

  • Shaoyifu hospital, zhejiang medical universiyt

    Hangzhou, Zhejiang

  • Zhejiang provincial people's hospital

    Hangzhou, Zhejiang

  • The first hospital of Chinese medical university

    Harbin, Heilongjiang

  • Renji Hospital ShangHai Jiaotong University School Of Medicine

    Shanghai, Shanghai Municipality

  • The first hospital of Hebei medical university

    Shijiangzhuang, Hebei

  • The First Affiliated Hospital of Zhengzhou University

    Zhengzhou, Henan

Other trials in China

About this study

Official title: Drug-eluting Balloon for Arteriovenous Fistula in China

This trial is aimed to evaluate the safety and efficacy of DCB in treating AVF stenosis in chinese population.

Read the detailed description

For years, first-line treatment of AVFs stenoses has been percutaneous transluminal angioplasty. However, restenosis and reintervention rates remain incredibly high and occur, according to recent studies, in up to 60% and 70% of patients at 6 and 12 months, respectively. Drug-coated balloons delivering paclitaxel at the angioplasty site have proved their superiority in the treatment of coronary and peripheral arterial stenoses. Paclitaxel reduces neointimal hyperplasia and drug-coated balloons,therefore, it represents an attractive option for AVF stenoses.

Being tested
drug-coated balloon catheter （Orchid, Acotec）, plain balloon catheter (Admiral, medtronic)
Keywords
drug eluting balloon

What participants receive

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

  • drug-coated balloon catheter （Orchid, Acotec）Device

    After predilation, using drug-coated balloon catheter to cover the whole treated segment

  • plain balloon catheter (Admiral, medtronic)Device

    After predilation, using plain balloon catheter to cover the whole treated segment

Study groups in NCT03366727
Study groupRoleWhat they receive
DCB groupExperimentalthis group treated with drug coated balloon catheter, Orchid
Receives: Device: drug-coated balloon catheter （Orchid, Acotec）
PTA groupExperimentalthis group treated with plain balloon catheter, Admiral Xtreme
Receives: Device: plain balloon catheter (Admiral, medtronic)

What is being measured

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

  1. primary patency of target lesion in 6 months

    Primary Patency is defined as the freedom of reintervention for the target lesion,including: 1)clinical driven target lesion reintervention;2)thrombus formation in target lesion; 3) surgical removal of target lesion;4) AVF was abandoned because of the target lesion could not be retreated

    Measured: 6 months

Secondary outcomes (5)

  1. primary patency of target lesion in 12 months

    Primary Patency is defined as the freedom of reintervention for the target lesion,including: 1)clinical driven target lesion reintervention;2)thrombus formation in target lesion; 3) surgical removal of target lesion;4) AVF was abandoned because of the target lesion could not be retreated

    Measured: 12 months

  2. number of reinterventions

    number of reinterventions in 12 months

    Measured: 12 months

  3. device success

    Successful delivery to the target lesion, deployment, and retrieval at index procedure

    Measured: during the procedure

  4. clinical success

    The resumption of dialysis for at least one session after the index procedure

    Measured: 5 days

  5. Procedural Success

    residual stenosis≤30% and absence of SAE during perioperative period

    Measured: 2 weeks

Timeline

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

  1. First posted8 Dec 2017
  2. Study start1 May 2018
  3. Primary completion1 Jun 2021
  4. Study completion7 Jul 2022

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
Model description
one arm treated with drug-coated balloon catheter, the other arm treated with plain balloon catheter
Masking
Single blind
Who is masked
Outcomes assessor
Enrolment
244 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03366727
Sponsor's protocol ID
Acotec-05
Status last verified
Jul 2022
First submitted
27 Oct 2017
Last updated
27 Jul 2022
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No

Publications

  • Zhao Y, Wang P, Wang Y, Zhang L, Zhao Y, Li H, He Q, Liu H, Luo J, Jia X, Yu Z, Guo W, Zhang L. Drug-Coated Balloon Angioplasty for Dysfunctional Arteriovenous Hemodialysis Fistulae: A Randomized Controlled Trial. Clin J Am Soc Nephrol. 2024 Mar 1;19(3):336-344. doi: 10.2215/CJN.0000000000000359. Epub 2023 Dec 18.

    PubMed 38191561

Questions about this trial

What is this clinical trial studying?

A study testing drug-coated balloon catheter （Orchid, Acotec） and plain balloon catheter (Admiral, medtronic) in people with Arteriovenous Fistula Stenosis, run by Acotec Scientific Co., Ltd at 13 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 7 inclusion and 15 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 27 Jul 2022. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 13 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 of target lesion in 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 NCT03366727, which also lists 1 linked publication.

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 27 Jul 2022.

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