Peripheral Artery DiseaseNCT04982367
Acoart SCB SFA: Sirolimus Coated Balloon Catheter in the Treatment of Femoropopliteal Artery Stenosis
A study testing Sirolimus-eluting balloon catheter and Paclitaxel-eluting balloon catheter in people with Peripheral Artery Disease, run by Acotec Scientific Co., Ltd at 1 site in China.
Trial summary
A prospective randomized trial designed to compare the efficacy and safety of Sirolimus coated balloon (SCB) versus paclitaxel coated balloon (DCB) in the treatment of femoropopliteal artery stenosis 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?
- Sirolimus-eluting balloon catheter and Paclitaxel-eluting balloon catheter
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 166 participants
- Where
- 1 siteChina
- Study dates
- 8 Dec 2021to Jul 2024
- 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 ≥18 years old and ≤80 years old
- Had lower extremity arterial occlusive diseases, and Rutherford classification is 2-5
- SFA and/or popliteal artery had severe stenosis (stenosis degree ≥70%) or occlusion.
- The length of target lesion less than 20 cm
- Subject (or legal guardian) understands the study requirements and procedures and provides written Informed Consent before any study tests or procedures are performed
Who cannot join
- The plasma creatinine level is higher than 150 umol/L
- Thrombolysis or thrombectomy is required
- There are more than 2 lesion need to treat in the target vessel.
- The patient had underwent lower-limb arterial surgery or thrombolysis on the target limb within 6 weeks.
- The target lesion had residual stenosis>30% or flow-limit dissection after pre-dilatation.
- The patient had outflow less than 1 vessel
Show all 12Show fewer
- The lesion located in a stent.
- Patient has a known allergy to aspirin, clopidogrel, heparin, paclitaxel, sirolimus or contrast medium that cannot be adequately pre-medicated.
- Women who are pregnant or breast-feeding.
- The subjects have participated in other drug property studies or device studies that have not yet completed the main end point.
- Patient has life expectancy of less than 12 months.
- The investigator think the patient is not suitable for participation in the clinical trial.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Chinese PLA General Hospital
Beijing, Beijing Municipality, 100039
Wei Guo, MD, 010-66887329, pla301dml@vip.sina.com
About this study
Official title: A Prospective, Multicenter, Randomized Controlled Trial Comparing the Efficacy and Safety Between Sirolimus Coated Balloon Catheter and Paclitaxel Coated Balloon Catheter in the Treatment of Femoropopliteal Artery Stenosis.
A prospective randomized trial designed to compare the efficacy and safety of Sirolimus coated balloon (SCB) versus paclitaxel coated balloon (DCB) in the treatment of femoropopliteal artery stenosis
- Conditions
- Peripheral Artery Disease
- Being tested
- Sirolimus-eluting balloon catheter, Paclitaxel-eluting balloon catheter
- Keywords
- Drug eluting balloon catheter, Peripheral Artery Disease
- 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.
Sirolimus-eluting balloon catheterDevice
Also called Sirolimus coated balloon catheter
Sirolimus-eluting balloon catheter designed and produced by Acotec
Paclitaxel-eluting balloon catheterDevice
Also called Paclitaxel coated balloon catheter
Paclitaxel-eluting balloon catheter (trade name:DHALIA)
| Study group | Role | What they receive |
|---|---|---|
| Sirolimus-eluting balloon angioplasty | Experimental | Using Sirolimus Coated Balloon Catheter in the treatment of stenosis or occlusion in superficial femoral artery(SFA) and/or popliteal artery Receives: Device: Sirolimus-eluting balloon catheter |
| Paclitaxel-eluting balloon angioplasty | Active comparator | Using Paclitaxel Coated Balloon Catheter in the treatment of stenosis or occlusion in superficial femoral artery(SFA) and/or popliteal artery Receives: Device: Paclitaxel-eluting balloon catheter |
What is being measured
The primary outcome is the main question the study is designed to answer.
The primary patency rate of target lesion at 12 months post-procedure
Defined as freedom from clinically driven target lesion revascularization (CD-TLR) and binary restenosis (restenosis defined as duplex ultrasound (DUS) peak systolic velocity ratio (PSVR) ≥2.4)
Measured: 12 months post-procedure
Secondary outcomes (5)
Rate of device success
Defined as successful delivery, balloon inflation, deflation and retrieval of the intact study device without burst below the rated burst pressure (RBP)
Measured: immediate post-procedure
Rate of clinically driven target lesion revascularization (CD-TLR) at 12 months post-procedure
Defined as any reintervention at the target lesion due to symptoms or the following index: drop of ABI >20% or ABI >0.15 compared to the post-procedure ABI during 12 months post-procedure
Measured: 12 months post-procedure
The change of Rutherford class from baseline
Defined as change in target limb Rutherford class from baseline to 12 months
Measured: 12 months post-procedure
The change of ankle-brachial index (ABI) from baseline
Defined as change of target limb ABI from baseline to 12 months
Measured: 12 months post-procedure
Rate of composite safety endpoint
Defined a composite rate of device-related or procedure-related death, major target limb amputation (above-the-ankle amputation), clinically driven target lesion revascularization (CD-TLR) or target lesion thrombotic events through 30 days post- procedure
Measured: 30 days post-procedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Jul 2021
- Study start8 Dec 2021
- Primary completionJul 2024 (estimated)
- Study completionJul 2024 (estimated)
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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 166 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Acotec Scientific Co., Ltd
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Guo Wei, MD, Principal investigator, Chinese PLA General Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04982367
- Sponsor's protocol ID
- Acoart SCB SFA
- Status last verified
- Oct 2023
- First submitted
- 21 Jul 2021
- Last updated
- 18 Oct 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Oct 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective, Multicenter, Randomized Controlled Trial Comparing the Efficacy and Safety Between Sirolimus Coated Balloon Catheter and Paclitaxel Coated Balloon Catheter in the Treatment of Femoropopliteal Artery Stenosis.
- ClinicalTrials.gov ID
- NCT04982367
- Acronym / sponsor ID
- Acoart SCB SFA
- Conditions
- Peripheral Artery Disease
- Keywords
- Drug eluting balloon catheter, Peripheral Artery Disease
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 166 participants (estimated)
- Lead sponsor
- Acotec Scientific Co., LtdIndustry (pharma, biotech, devices)
- Study start
- 8 Dec 2021 (actual)
- Primary completion
- Jul 2024 (estimated)
- Study completion
- Jul 2024 (estimated)
- First posted
- 29 Jul 2021 (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.
A prospective randomized trial designed to compare the efficacy and safety of Sirolimus coated balloon (SCB) versus paclitaxel coated balloon (DCB) in the treatment of femoropopliteal artery stenosis
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Sirolimus-eluting balloon angioplasty | Experimental | Device: Sirolimus-eluting balloon catheterUsing Sirolimus Coated Balloon Catheter in the treatment of stenosis or occlusion in superficial femoral artery(SFA) and/or popliteal artery |
| Paclitaxel-eluting balloon angioplasty | Active comparator | Device: Paclitaxel-eluting balloon catheterUsing Paclitaxel Coated Balloon Catheter in the treatment of stenosis or occlusion in superficial femoral artery(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 ≥18 years old and ≤80 years old
- Had lower extremity arterial occlusive diseases, and Rutherford classification is 2-5
- SFA and/or popliteal artery had severe stenosis (stenosis degree ≥70%) or occlusion.
- The length of target lesion less than 20 cm
- Subject (or legal guardian) understands the study requirements and procedures and provides written Informed Consent before any study tests or procedures are performed
Key exclusion criteria (12 listed)
- The plasma creatinine level is higher than 150 umol/L
- Thrombolysis or thrombectomy is required
- There are more than 2 lesion need to treat in the target vessel.
- The patient had underwent lower-limb arterial surgery or thrombolysis on the target limb within 6 weeks.
- The target lesion had residual stenosis>30% or flow-limit dissection after pre-dilatation.
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 |
|---|---|---|
| Sirolimus-eluting balloon catheterAlso: Sirolimus coated balloon catheterSirolimus-eluting balloon catheter designed and produced by Acotec | Device | Sirolimus-eluting balloon angioplasty |
| Paclitaxel-eluting balloon catheterAlso: Paclitaxel coated balloon catheterPaclitaxel-eluting balloon catheter (trade name:DHALIA) | Device | Paclitaxel-eluting balloon angioplasty |
Primary outcome
The primary patency rate of target lesion at 12 months post-procedure
Time frame: 12 months post-procedure
Defined as freedom from clinically driven target lesion revascularization (CD-TLR) and binary restenosis (restenosis defined as duplex ultrasound (DUS) peak systolic velocity ratio (PSVR) ≥2.4)
5 secondary outcomes
Rate of device success
Time frame: immediate post-procedure
Rate of clinically driven target lesion revascularization (CD-TLR) at 12 months post-procedure
Time frame: 12 months post-procedure
The change of Rutherford class from baseline
Time frame: 12 months post-procedure
The change of ankle-brachial index (ABI) from baseline
Time frame: 12 months post-procedure
Rate of composite safety endpoint
Time frame: 30 days post-procedure
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Oct 2023.
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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.
Guo Wei, MD principal investigator
Chinese PLA General Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Sirolimus-eluting balloon catheter and Paclitaxel-eluting balloon catheter in people with Peripheral Artery Disease, run by Acotec Scientific Co., Ltd at 1 site 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: status not confirmed, as of the sponsor's last update on 18 Oct 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Guo Wei, MD (010-66887329, pla301dml@vip.sina.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The primary patency rate of target lesion at 12 months post-procedure (time frame: 12 months post-procedure). 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 18 Oct 2023.