Peripheral Artery DiseaseNCT01850056
AcoArt Ⅰ / SFA China
A study testing drug eluting balloon catheter (trade name: Orchid) and common percutaneous transluminal angioplasty balloon catheter (trade name: Admiral) in people with Peripheral Artery Disease, run by Acotec Scientific Co., Ltd at 10 sites in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Peripheral Artery Disease
- What is being tested?
- drug eluting balloon catheter (trade name: Orchid) and common percutaneous transluminal angioplasty balloon catheter (trade name: Admiral)
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 200 participants
- Where
- 10 sitesChina
- Study dates
- Apr 2013to Sep 2016
- 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 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 12Show fewer
- 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
Trial locations and contacts
10 sites in 1 country.
10 sites in 1 country
China10 sites
Xiyuan Hospital CACMS
Beijing, Beijing Municipality, 100091
Chinese PLA General Hospital
Beijing, Beijing Municipality, 100853
The First Affiliated Hospital of Chongqing Medical University
Chongqing, Chongqing Municipality
The First Affiliated Hospital, Dalian Medical University
Dalian, Liaoning
The First Affiliated Hospital of Fujian Medical University
Fuzhou, Fujian
The First Affiliated Hospital, Sun Yat-sen University
Guangzhou, Guangdong
Zhongshan Hospital Fudan University
Shanghai, Shanghai Municipality, 200032
Renji Hospital ShangHai Jiaotong University School Of Medicine
Shanghai, Shanghai Municipality
The People's Hospital of Liaoning Province
Shenyang, Liaoning
The second Hospital Of Hebei University
Shijiazhuang, Hebei, 050000
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 (AcoArt I Study)
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.
- Conditions
- Peripheral Artery Disease
- Being tested
- drug eluting balloon catheter (trade name: Orchid), common percutaneous transluminal angioplasty balloon catheter (trade name: Admiral)
- 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.
drug eluting balloon catheter (trade name: Orchid)Device
Also called drug eluting dilation catheter
common percutaneous transluminal angioplasty balloon catheter (trade name: Admiral)Device
Also called common PTA catheter
| Study group | Role | What they receive |
|---|---|---|
| drug eluting balloon catheter | Experimental | use drug eluting balloon catheter to inflate the stenosis or occlusion in superficial femoral artery(SFA) and/or popliteal artery Receives: Device: drug eluting balloon catheter (trade name: Orchid) |
| common balloon catheter(uncoated drug) | Active comparator | use common balloon catheter to inflate stenosis or occlusion in SFA and/or popliteal artery Receives: Device: common percutaneous transluminal angioplasty balloon catheter (trade name: Admiral) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Late Lumen Loss
measure difference of the MLD(minimal lumen diameter) at 0 time and 6 months
Measured: 6 months
Secondary outcomes (7)
Minimal lumen diameter (MLD)
measure minimal lumen diameter (MLD) of target lesion
Measured: 6 months
Restenosis rate of target vessel
stenosis over 50% is defined as restenosis
Measured: 6 months, 12 months, 18 months, 24months
target lesion revascularization
target lesion revascularization is defined as any reintervention of artery bypass graft surgery involving the target lesion
Measured: 6 months, 12 months, 18 months, 24 months
change in Rutherford stage
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
Measured: 6 months, 12 months, 18 months, 24 months
change in ankle brachial index(ABI)
change in ankle brachial index(ABI) compared to pretreatment
Measured: 6 months
major amputation
major amputation at the index limb(major amputation is defined as an amputation above the foot)
Measured: 6 months, 12 months, 18 months, 24 months
Death
death of any cause
Measured: 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.
- First posted9 May 2013 (estimated)
- Study startApr 2013
- Primary completionAug 2016
- Study completionSep 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Peripheral Artery DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- 200 participants (actual)
Sponsor and investigators
- Lead sponsor
- Acotec Scientific Co., Ltd
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01850056
- Sponsor's protocol ID
- acotec-02
- Status last verified
- Dec 2015
- First submitted
- 27 Apr 2013
- Last updated
- 12 Jul 2018
- 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 42573020Ren H, Liu J, Zhang J, Zhuang B, Fu W, Wu D, Wang F, Zhao Y, Guo P, Bi W, Wang S, Guo W. Five-Year Outcomes of Post-Drug-Coated Balloon Angioplasty Dissection in Complex Femoropopliteal Artery Disease. Int J Gen Med. 2021 Aug 5;14:4197-4207. doi: 10.2147/IJGM.S316916. eCollection 2021.
PubMed 34385840Sun 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. 2021 Jun;29(3):340-349. doi: 10.1177/1708538120953663. Epub 2020 Sep 9.
PubMed 32903168
Study at a glance
From the registry record, last updated by the sponsor on 12 Jul 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective, Multi-center and Randomized Controlled Clinical Study to Verify Effectiveness and Safety of Drug-eluting Balloon in PTA Procedure (AcoArt I Study)
- ClinicalTrials.gov ID
- NCT01850056
- Acronym / sponsor ID
- acotec-02
- Conditions
- Peripheral Artery Disease
- Keywords
- drug eluting balloon catheter
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 200 participants (actual)
- Lead sponsor
- Acotec Scientific Co., LtdIndustry (pharma, biotech, devices)
- Study start
- Apr 2013 (actual)
- Primary completion
- Aug 2016 (actual)
- Study completion
- Sep 2016 (actual)
- First posted
- 9 May 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| drug eluting balloon catheter | Experimental | Device: drug eluting balloon catheter (trade name: Orchid)use drug eluting balloon catheter to inflate the stenosis or occlusion in superficial femoral artery(SFA) and/or popliteal artery |
| common balloon catheter(uncoated drug) | Active comparator | Device: common percutaneous transluminal angioplasty balloon catheter (trade name: Admiral)use common balloon catheter to inflate stenosis or occlusion in SFA and/or popliteal artery |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (12 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| drug eluting balloon catheter (trade name: Orchid)Also: drug eluting dilation catheter | Device | drug eluting balloon catheter |
| common percutaneous transluminal angioplasty balloon catheter (trade name: Admiral)Also: common PTA catheter | Device | common balloon catheter(uncoated drug) |
Primary outcome
Late Lumen Loss
Time frame: 6 months
measure difference of the MLD(minimal lumen diameter) at 0 time and 6 months
7 secondary outcomes
Minimal lumen diameter (MLD)
Time frame: 6 months
Restenosis rate of target vessel
Time frame: 6 months, 12 months, 18 months, 24months
target lesion revascularization
Time frame: 6 months, 12 months, 18 months, 24 months
change in Rutherford stage
Time frame: 6 months, 12 months, 18 months, 24 months
change in ankle brachial index(ABI)
Time frame: 6 months
major amputation
Time frame: 6 months, 12 months, 18 months, 24 months
Death
Time frame: 12 months, 18 months, 24 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Jul 2018.
- Derived from this study: PubMed 42573020Ma 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.
- Derived from this study: PubMed 34385840Ren H, Liu J, Zhang J, Zhuang B, Fu W, Wu D, Wang F, Zhao Y, Guo P, Bi W, Wang S, Guo W. Five-Year Outcomes of Post-Drug-Coated Balloon Angioplasty Dissection in Complex Femoropopliteal Artery Disease. Int J Gen Med. 2021 Aug 5;14:4197-4207. doi: 10.2147/IJGM.S316916. eCollection 2021.
- Derived from this study: PubMed 32903168Sun 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. 2021 Jun;29(3):340-349. doi: 10.1177/1708538120953663. Epub 2020 Sep 9.
Related trials for Peripheral Artery Disease
RecruitingPhase 4
Inclisiran Versus Placebo for the Prevention of Major Adverse Cardiovascular and Limb Events in Patients Undergoing Percutaneous Coronary Intervention or Peripheral Endovascular Intervention
Percutaneous Coronary Intervention, Peripheral Endovascular Intervention
Active, not recruitingObservational study
Laser Atherectomy and Sirolimus-eluting Balloon Angioplasty for CLTI
Chronic Limb Threatening Ischemia
Not yet recruitingPhase 1
A Bioequivalence and Safety Study of AJU-B718 and B718R in Healthy Adult Volunteers Under Fasting Conditions
Peripheral Arterial Disease
RecruitingObservational study
Rare Disease Patient Registry & Natural History Study - Coordination of Rare Diseases at Sanford
Rare Disorders, Undiagnosed Disorders
Active, not recruitingPhase 4
Ramipril Treatment of Claudication: Oxidative Damage and Muscle Fibrosis
Peripheral Arterial Disease
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
10 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing drug eluting balloon catheter (trade name: Orchid) and common percutaneous transluminal angioplasty balloon catheter (trade name: Admiral) in people with Peripheral Artery Disease, run by Acotec Scientific Co., Ltd at 10 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 12 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 12 Jul 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 10 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?
Late Lumen Loss (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 NCT01850056, which also lists 3 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 12 Jul 2018.