Peripheral Vascular Disease (PVD)NCT05246410
A Clinical Trial to Evaluate the Efficacy and Safety of a Spot Stent System Used in Femoropopliteal Arteries.
A study testing Spot stent system and Self-expanding peripheral stent system in people with Peripheral Vascular Disease (PVD) and Peripheral Arterial Disease (PAD), run by Acotec Scientific Co., Ltd at 2 sites in China.
Trial summary
A prospective randomized trial designed to compare the efficacy and safety of spot stent system versus self-expanding peripheral stent system in the endovascular treatment of femoropopliteal arterial stenotic disease. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Peripheral Vascular Disease (PVD), Peripheral Arterial Disease (PAD)
- What is being tested?
- Spot stent system and Self-expanding peripheral stent system
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 196 participants
- Where
- 2 sitesChina
- Study dates
- 17 Aug 2022to 30 Dec 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
- Target lesion is in the superficial femoral artery (SFA) and/or proximal popliteal artery (above the knee), located ≥1 cm below the common femoral artery (CFA) bifurcation to the distal segment of the proximal popliteal artery at the superior end of the patella.
- Target lesion had severe stenosis (stenosis degree ≥70%) or occlusion.
- Presence of at least one patent infrapopliteal vessel.
- The length of target lesion ≥10 cm.
- After predilation, the target lesion has <30% residual stenosis and presence of at least one flow-limiting dissection (by visual estimate).
- 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.
- The patient had underwent lower-limb arterial surgery or thrombolysis on the target limb within 6 weeks.
- Previously implanted stent in the target lesion.
- The guide wire can not cross the target lesion.
- Angiographic evidence of calcification severe enough that it renders the target lesion non-dilatable.
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- Patient has a known allergy to anticoagulant drugs, anti-platelet drugs 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.
- Patient who planned to do above the ankle amputation before the operation.
- Patient who had severe hemorrhage or coagulation disorder which judged by the investigator.
- The investigator think the patient is not suitable for participation in the clinical trial.
Trial locations and contacts
2 sites in 1 country.
China2 sites, 2 recruiting
- Recruiting
Chinese PLA General Hospital
Beijing, Beijing Municipality, 100853
Wei Guo, MD, 010-66887329, pla301dml@vip.sina.com
- Recruiting
Zhejiang Provincial People'S Hospital
Zhejiang, Zhejiang, 310014
Jinsong Jiang, jiangjinsong082022@126.com
About this study
Official title: A Prospective, Multicenter and Randomized Controlled Trial to Evaluate the Efficacy and Safety of a Spot Stent System Using in the Percutaneous Transluminal Angioplasty of Femoropopliteal Arteries.
A prospective randomized trial designed to compare the efficacy and safety of spot stent system versus self-expanding peripheral stent system in the endovascular treatment of femoropopliteal arterial stenotic disease.
Read the detailed description
The objective of this clinical investigation is to assess the efficacy and safety of spot stent system ,which is indicated for use in patients with atherosclerotic disease of the superficial femoral artery (SFA) or proximal popliteal arteries and for the treatment of insufficient results after percutaneous transluminal angioplasty.
- Being tested
- Spot stent system, Self-expanding peripheral stent system
- Medical subject headings
- Peripheral Vascular Diseases, Peripheral Arterial Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Spot stent systemDevice
Spot stent system designed and produced by Acotec
Self-expanding peripheral stent systemDevice
Self-expanding peripheral stent system designed and produced by Ev3, Inc
| Study group | Role | What they receive |
|---|---|---|
| Spot stent system | Experimental | A system that loaded multi low radial force stents on one catheter. Receives: Device: Spot stent system |
| Self-Expanding peripheral stent system | Active comparator | A conventional stent system that commonly used. Receives: Device: Self-expanding peripheral stent system |
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 (6)
Rate of device success
Defined as successful delivery, release and retrieval of the device.
Measured: immediate post-procedure
Rate of procedural success
Defined as no provisional stent implanted or major adverse event occured prior to discharge.
Measured: 7 days post-procedure
Rate of clinically driven target lesion revascularization within 12 months post-procedure
Defined as any reintervention at the target lesion due to the following symptoms: drop of ABI >20% or ABI >0.15 compared to the post-procedure ABI
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 all cause death, major target limb amputation (above-the-ankle amputation), clinically driven target lesion revascularization (CD-TLR) 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 posted18 Feb 2022
- Study start17 Aug 2022
- Primary completion28 Nov 2024 (estimated)
- Study completion30 Dec 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Peripheral Vascular Disease (PVD)Studies 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
- 196 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
- NCT05246410
- Sponsor's protocol ID
- Acoart-08
- Status last verified
- Nov 2023
- First submitted
- 8 Feb 2022
- Last updated
- 29 Nov 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 29 Nov 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective, Multicenter and Randomized Controlled Trial to Evaluate the Efficacy and Safety of a Spot Stent System Using in the Percutaneous Transluminal Angioplasty of Femoropopliteal Arteries.
- ClinicalTrials.gov ID
- NCT05246410
- Acronym / sponsor ID
- Acoart-08
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 196 participants (estimated)
- Lead sponsor
- Acotec Scientific Co., LtdIndustry (pharma, biotech, devices)
- Study start
- 17 Aug 2022 (actual)
- Primary completion
- 28 Nov 2024 (estimated)
- Study completion
- 30 Dec 2024 (estimated)
- First posted
- 18 Feb 2022 (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 spot stent system versus self-expanding peripheral stent system in the endovascular treatment of femoropopliteal arterial stenotic disease.
Detailed description
The objective of this clinical investigation is to assess the efficacy and safety of spot stent system ,which is indicated for use in patients with atherosclerotic disease of the superficial femoral artery (SFA) or proximal popliteal arteries and for the treatment of insufficient results after percutaneous transluminal angioplasty.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Spot stent system | Experimental | Device: Spot stent systemA system that loaded multi low radial force stents on one catheter. |
| Self-Expanding peripheral stent system | Active comparator | Device: Self-expanding peripheral stent systemA conventional stent system that commonly used. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Age ≥18 years old and ≤80 years old
- Had lower extremity arterial occlusive diseases, and Rutherford classification is 2-5
- Target lesion is in the superficial femoral artery (SFA) and/or proximal popliteal artery (above the knee), located ≥1 cm below the common femoral artery (CFA) bifurcation to the distal segment of the proximal popliteal artery at the superior end of the patella.
- Target lesion had severe stenosis (stenosis degree ≥70%) or occlusion.
- Presence of at least one patent infrapopliteal vessel.
Key exclusion criteria (13 listed)
- The plasma creatinine level is higher than 150 umol/L.
- Thrombolysis or thrombectomy is required.
- The patient had underwent lower-limb arterial surgery or thrombolysis on the target limb within 6 weeks.
- Previously implanted stent in the target lesion.
- The guide wire can not cross the target lesion.
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 |
|---|---|---|
| Spot stent systemSpot stent system designed and produced by Acotec | Device | Spot stent system |
| Self-expanding peripheral stent systemSelf-expanding peripheral stent system designed and produced by Ev3, Inc | Device | Self-Expanding peripheral stent system |
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)
6 secondary outcomes
Rate of device success
Time frame: immediate post-procedure
Rate of procedural success
Time frame: 7 days post-procedure
Rate of clinically driven target lesion revascularization within 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 29 Nov 2023.
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
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Spot stent system and Self-expanding peripheral stent system in people with Peripheral Vascular Disease (PVD) and Peripheral Arterial Disease (PAD), run by Acotec Scientific Co., Ltd at 2 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 8 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: status not confirmed, as of the sponsor's last update on 29 Nov 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 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?
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 29 Nov 2023.