Peripheral Artery DiseaseNCT03267056
AcoArt IV / SFA in China:Drug-eluting Balloon for SFA Angioplasty Evaluation in China
An observational study of Peripheral Artery Disease, run by Acotec Scientific Co., Ltd at 10 sites in China.
Trial summary
The registry is a prospective, multicenter, single arm post-market real-world registry in China assessing the clinical use, safety and outcomes of the Orchid 035 DCB Catheter in the Superficial Femoral Artery (SFA) and Popliteal Arteries (PA). 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)
- Type of treatment
- Medical device
- How many people
- 120 participants
- Where
- 10 sitesChina
- Study dates
- 19 Jan 2018to 1 Jun 2020
- How long will I take part?
- 1 Year
- Phase
- Observational
- 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
Study population: patients with a more than 70% stenosis at femoral and/or popliteal artery meet all the inclusion and excluison criteria
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 20cm
- 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
- 2 or more than 2 stenosis lesions in traget vessel
- 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
- have >30% residual stenosis or blood-limited dissection after predilation
Show all 13Show fewer
- 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 1 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
Chinese PLA General Hospital
Beijing, Beijing Municipality, 100853
Peking University First Hospital
Beijing, Beijing Municipality
The First Affiliated Hospital of Dalian Medical University
Dalian, Liaoning
The second affiliated hospital of Harbin medical university
Harbin, Heilongjiang
Jiangsu Province Hospital
Nanjing, Jiangsu
The First Affiliated Hospital of Zhejiang University
Nanjing, Zhejiang
Shengjing Hospital of China Medical University
Shenyang, Liaoning
The second hospital of hebei medical university
Shijiazhuang, Hebei
Tianjin First Center Hospital
Tianjin, Tianjin Municipality
Wuhan central hospital
Wuhan, Hubei
About this study
Official title: Real-World Registry Assessing the Clinical Use of the Orchid Drug Coated Balloon Catheter
The registry is a prospective, multicenter, single arm post-market real-world registry in China assessing the clinical use, safety and outcomes of the Orchid 035 DCB Catheter in the Superficial Femoral Artery (SFA) and Popliteal Arteries (PA).
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.
- Conditions
- Peripheral Artery Disease
- Being tested
- drug eluting balloon catheter (trade name: Orchid)
- Keywords
- drug-coated balloon
- 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
use drug eluting balloon catheter(trade name: Orchid) to inflate the stenosis or occlusion in superficial femoral artery(SFA) and/or popliteal artery
| Study group | Role | What they receive |
|---|---|---|
| DCB arm | drug eluting balloon catheter Receives: Device: drug eluting balloon catheter (trade name: Orchid) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Primary patency of target lesion.
The primary efficacy end point was primary patency at 12 months following the index procedure, defined as freedom from clinically driven target lesion revascularization and restenosis as determined by a duplex ultrasonography-derived peak systolic velocity ratio of
≤2.4
Measured: 12 months
Secondary outcomes (4)
target lesion revascularization,target lesion revascularization is defined as any reintervention of artery bypass graft surgery involving the target lesion
target lesion revascularization is defined as any reintervention of artery bypass graft surgery involving the target lesion
Measured: 6 months, 12 months
improvment in Rutherford stage
improvementin Rutherford stage is defined as an upward shift of at least 1 category on Rutherford classification as compared to baseline
Measured: 6 months, 12 months
change in ankle brachial index(ABI)
change in ankle brachial index(ABI) compared to baseline
Measured: 12 months
Device success during the operation
Device success is defined as successful delivery, balloon inflation, deflation and retrieval of the intact study device without burst below the rated burst pressure (RBP).
Measured: during the operation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Aug 2017
- Study start19 Jan 2018
- Primary completion30 Apr 2020
- Study completion1 Jun 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 120 participants (actual)
- Target duration
- 1 Year
Sponsor and investigators
- Lead sponsor
- Acotec Scientific Co., Ltd
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Wei Guo, Principal investigator, Chinese PLA General HospitalYinghua Zou, Principal investigator, Peking University First Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03267056
- Sponsor's protocol ID
- Acotec-04
- Status last verified
- Apr 2020
- First submitted
- 24 Aug 2017
- Last updated
- 19 Aug 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Aug 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Real-World Registry Assessing the Clinical Use of the Orchid Drug Coated Balloon Catheter
- ClinicalTrials.gov ID
- NCT03267056
- Acronym / sponsor ID
- Acotec-04
- Conditions
- Peripheral Artery Disease
- Keywords
- drug-coated balloon
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 120 participants (actual)
- Lead sponsor
- Acotec Scientific Co., LtdIndustry (pharma, biotech, devices)
- Study start
- 19 Jan 2018 (actual)
- Primary completion
- 30 Apr 2020 (actual)
- Study completion
- 1 Jun 2020 (actual)
- First posted
- 30 Aug 2017 (actual)
- 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 registry is a prospective, multicenter, single arm post-market real-world registry in China assessing the clinical use, safety and outcomes of the Orchid 035 DCB Catheter in the Superficial Femoral Artery (SFA) and Popliteal Arteries (PA).
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 1 Year
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| DCB arm | – | Device: drug eluting balloon catheter (trade name: Orchid)drug eluting balloon catheter |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- patients with a more than 70% stenosis at femoral and/or popliteal artery meet all the inclusion and excluison criteria
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 20cm
- signed Patient informed consent form
Key exclusion criteria (13 listed)
- plasma Cr level greater than 150 umol/L in patients
- patients with acute thrombosis requiring lysis or thrombectomy
- 2 or more than 2 stenosis lesions in traget vessel
- 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
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)use drug eluting balloon catheter(trade name: Orchid) to inflate the stenosis or occlusion in superficial femoral artery(SFA) and/or popliteal artery | Device | DCB arm |
Primary outcome
Primary patency of target lesion.
Time frame: 12 months
The primary efficacy end point was primary patency at 12 months following the index procedure, defined as freedom from clinically driven target lesion revascularization and restenosis as determined by a duplex ultrasonography-derived peak systolic velocity ratio of ≤2.4
4 secondary outcomes
target lesion revascularization,target lesion revascularization is defined as any reintervention of artery bypass graft surgery involving the target lesion
Time frame: 6 months, 12 months
improvment in Rutherford stage
Time frame: 6 months, 12 months
change in ankle brachial index(ABI)
Time frame: 12 months
Device success during the operation
Time frame: during the operation
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 19 Aug 2020.
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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.
Wei Guo principal investigator
Chinese PLA General Hospital
Yinghua Zou principal investigator
Peking University First Hospital
10 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of 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 13 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 19 Aug 2020. 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?
Primary patency of target lesion. (time frame: 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 19 Aug 2020.