Peripheral Arterial DiseaseSURFNCT06539689
A Trail of Sperstent® Used for Residual Lesions of Femoropopliteal Arteries
A study testing Sperstent® peripheral spot stent system and Everflex® self-expanding peripheral stent system in people with Peripheral Arterial Disease and Stenosis, run by FrontAce Scientific Co., Ltd at 12 sites in China.
Trial summary
This is a prospective, multi-center, randomized trial designed to investigate the efficacy and safety of Sperstent® peripheral spot stent system versus Everflex® self-expanding peripheral stent system in the endovascular treatment of post-balloon angioplasty (post-PTA) residual lesions including stenoses and/or… Read more about this study
- Who is it for?
- Ages 18 to 85 years
- Conditions the study is for
- Peripheral Arterial Disease, Stenosis, Dissection
- What is being tested?
- Sperstent® peripheral spot stent system and Everflex® self-expanding peripheral stent system
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 240 participants
- Where
- 12 sitesChina
- Study dates
- 4 Jun 2024to 31 Dec 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 18-85 years old, male or female;
- The target lesion is located in the superficial femoral artery or the proximal popliteal artery;
- Peripheral arterial stenosis or occlusive disease with symptoms consistent with the Rutherford classification 2 to 5;
- Estimated life expectancy >1 year;
- Subject has been informed of and understands the nature of the study and provides signed informed consent to participate in the study.
- Angiographic Inclusion Criteria:
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- Stenosis rate ≥70% under DSA by visual estimate, or 100% occluded lesion with a total lesion length less than 150mm (by visual estimate);
- Reference vessel diameter is between 3 mm and 7.5 mm, 50mm≤Total cumulative length of target lesions≤250mm; (In the case of bilimb lesions, a single target lesion with one limb meeting the protocol criteria is selected by the investigator; More than 2cm between lesions are considered as 2 lesions);
- After PTA treatment by DCB, there exists residual lesions, such as the target lesion has over 30% residual DS and/or presence of at least one post-PTA dissection (Type A-F) (by visual estimate);
- Patients with unobstructed inflow tract or successfully treated, visual residual stenosis ≤50%;
- Angiography showed at least one outflow tract was unobstructed at the distal end (Stenosis degree ≤70% before intervention).
Who cannot join
- Target vessel had undergone open surgery such as bypass surgery or the target lesion is in-stent restenosis;
- Patients with serum creatinine >2.5mg/dl during screening or undergoing long-term hemodialysis or peritoneal dialysis;
- Severe coagulation disorder;
- Patients with major vascular-related diseases, including acute lower extremity ischemia, active disseminated intravascular coagulation, thromboangiitis obliterans, deep vein thrombosis, and aneurysms of therapeutic lateral vessels (deep femur, superficial femur, or popliteal artery);
- A history of major organ failure or other serious illness (including severe coronary heart disease, severe cardiac insufficiency, severe neurosis, or mental illness); Have received or plan organ transplantation, severe gastrointestinal bleeding);
- Myocardial infarction or symptomatic stroke occurred within 3 months prior to enrollment;
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- Thrombolysis of target vessel within 72 hours before surgery, did not completely dissolve the thrombus;
- Systemic infection or uncontrolled infection within the target limb;
- Known allergy to contrast agents, nickel or titanium (Nitinol), heparin, aspirin, clopidogrel, anesthetics;
- Women who are pregnant or breast-feeding, or women of childbearing age who have family plans within 1 year;
- Patients who are planning to have major lower limb amputations on the target side of the lesion;
- Endovascular or surgical procedures are performed on the target limb within 30 days before or 30 days after surgery;
- Participating in clinical trials of other medical devices or drugs;
- The investigator considers the patient is not suitable for participation in the clinical trial.
- Angiographic Exclusion Criteria:
- Failure of the guidewire to pass through the lesion；
- During the procedure, the target lesions had received or were scheduled to receive volume reduction procedures such as cryogenic angioplasty, laser angioplasty, and percutaneous intracavity plaque gyrotomy；
- The target lesion before stent implantation is thrombotic obliteration, which is not suitable for stent implantation；
- The target lesions were severely calcified and could not fully predilate; Or grade 4 calcification；
- Acute vascular occlusion or acute or subacute thrombosis in the target lesion；
- Stent was implanted into the target vessel before enrollment.
Trial locations and contacts
12 sites in 1 country. Contact the study team or a site near you to ask about taking part.
12 sites in 1 country
China12 sites, 12 recruiting
- Not yet recruiting
Beijing Friendship Hospital, Capital Medical University
Beijing, Beijing Municipality
Hai Feng
- Not yet recruiting
Hospital of Chengdu University of TCM
Chengdu
Chunshui He
- Not yet recruiting
The First Affiliated Hospital of Chongqing Medical University
Chongqing, Chongqing Municipality
Yu Zhao
- Not yet recruiting
The First Affiliated Hospital, Zhejiang University School of Medicine
Hangzhou, Zhejiang
Hongkun Zhang
- Not yet recruiting
The Affiliated Hospital of Southwest Medical University
Luzhou, Sichuan
Yong Liu
- Recruiting
Nanjing Drum Tower Hospital
Nanjing, Jiangsu
Min Zhou
- Not yet recruiting
Affiliated Hospital of Nantong University
Nantong, Jiangsu
Hui Zhao
- Not yet recruiting
Renji Hospital, Shanghai Jiao Tong University School of Medicine
Shanghai, Shanghai Municipality
Meng Ye
- Recruiting
Shanghai East Hospital
Shanghai
Xiang Wang
- Not yet recruiting
The Second Hospital of Hebei Medical University
Shijiazhuang, Hebei
Wei Bi
- Recruiting
Liyuan Hospital, Tongji Medical College, Huazhong University of Science and Technology
Wuhan, Hubei
Zibo Feng
- Not yet recruiting
First Affiliated Hospital of Zhengzhou University
Zhengzhou, Henan
Zhen Li
About this study
Official title: A Prospective, Multicenter and Randomized Controlled Trial to Evaluate the Efficacy and Safety of Sperstent® Peripheral Spot Stent System Used for the Residual Lesions After Percutaneous Transluminal Angioplasty of Femoropopliteal Arteries
This is a prospective, multi-center, randomized trial designed to investigate the efficacy and safety of Sperstent® peripheral spot stent system versus Everflex® self-expanding peripheral stent system in the endovascular treatment of post-balloon angioplasty (post-PTA) residual lesions including stenoses and/or dissections in femoral and proximal popliteal arteries.
- Conditions
- Peripheral Arterial Disease, Stenosis, Dissection
- Being tested
- Sperstent® peripheral spot stent system, Everflex® self-expanding peripheral stent system
- Keywords
- Peripheral Arterial Disease, Spot stent
- Medical subject headings
- Peripheral Arterial Disease, Constriction, Pathologic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Sperstent® peripheral spot stent systemDevice
Sperstent® peripheral spot stent system, Percutaneous Transluminal Angioplasty (PTA), Digital Subtraction Angiography（DSA）
Everflex® self-expanding peripheral stent systemDevice
Everflex® self-expanding peripheral stent system, Percutaneous Transluminal Angioplasty (PTA), Digital Subtraction Angiography（DSA）
| Study group | Role | What they receive |
|---|---|---|
| Sperstent® peripheral spot stent system | Experimental | subjects using the Sperstent® peripheral spot stent system Receives: Device: Sperstent® peripheral spot stent system |
| Everflex® self-expanding peripheral stent system | Active comparator | subjects using the Everflex® self-expanding peripheral stent system Receives: Device: Everflex® self-expanding peripheral stent system |
What is being measured
The primary outcome is the main question the study is designed to answer.
Primary Patency
Primary patency defined as freedom from clinically driven target lesion revascularization (CD-TLR) and freedom from duplex ultrasound derived binary restenosis at 12 months post-operation.(defined as PSVR >2.5)
Measured: 12 months post-operation
Freedom from Major Adverse Events (MAEs)
Freedom from the occurrence of any new-onset MAEs defined as all-cause death, index limb amputation (above the ankle), or clinically-driven target lesion revascularization (CD-TLR) at 30 days post-operation.
Measured: 30 days post-operation
Secondary outcomes (9)
Rate of Device Success
Defined as successful delivery, release and retrieval of the device.
Measured: immediately post-operation
Rate of Procedural Success
Demonstrated vessel patency (<30% residual DS, by visual estimate) without the use of a bailout stent or the occurrence of MAE upon completion of the index procedure.
Measured: immediately post-operation
Primary Patency at 30 days and 6 months
defined as freedom from clinically driven target lesion revascularization (CD-TLR) and freedom from duplex ultrasound derived binary restenosis at 30 days and 6 months post-operation (defined as PSVR >2.5)
Measured: 30 days and 6 months post-operation
Rate of clinically driven target lesion revascularization (CD-TLR)
Clinically driven target lesion revascularization (CD-TLR) was defined as an endovascular reintervention performed for a >50% diameter stenosis of the target vessel in the presence of a recurrent PAD symptom after the initial endovascular procedure.
Measured: 30 days, 6 months and 12 months post-operation
Changes from Baseline in Rutherford Classification
Defined as change in target limb Rutherford class from baseline. Rutherford Classification is defined as follows, with increasing severity:
Rutherford Category 0 - Asymptomatic. Rutherford Category 1 - Mild Claudication. Rutherford Category 2 - Moderate Claudication. Rutherford Category 3 - Severe Claudication. Rutherford Category 4 - Ischemic Rest Pain. Rutherford Category 5 - Minor Tissue Loss (minor exertion). Rutherford Category 6 - Major Tissue Loss (gangrene).
Measured: 30 days, 6 months and 12 months post-operation
Changes from Baseline in Ankle-brachial Index (ABI)
Defined as change of target limb ABI from baseline. The Ankle Brachial Index (ABI) is the systolic pressure at the ankle, divided by the systolic pressure at the arm.
Measured: 30 days, 6 months and 12 months post-operation
Duplex Ultrasound (DUS) Derived Lesion Patency
Lesion Patency is evaluated by Duplex Ultrasound (DUS)
Measured: 30 days, 6 months and 12 months post-operation
Rate of major adverse event(s) (MAEs)
MAEs defined as all-cause death, index limb amputation (above the ankle), or clinically-driven target lesion revascularization (CD-TLR) .
Measured: 6 months and 12 months post-operation
Rate of Stent Fracture
Stent fractures will be analyzed by X-ray at 12 months post-operation. The stents implanted into a certain subject will be analyzed collectively in the assessment. Stent fractures will be assessed with Grade I, II, III or IV as follow.
Grade I - a single strut fracture only. Grade II - multiple single strut fractures that occur at different sites of a stent or different stents.
Grade III - multiple nitinol stent fractures resulting in complete transverse linear fracture.
Grade IV - a spiral dissection of a stent. Fractures of Grade I are least severe, increasing in severity to Grade IV.
Measured: 12 months post-operation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Aug 2024
- Study start4 Jun 2024
- Primary completion4 Dec 2026 (estimated)
- Study completion31 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Peripheral Arterial 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
- 240 participants (estimated)
Sponsor and investigators
- Lead sponsor
- FrontAce Scientific Co., Ltd
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06539689
- Sponsor's protocol ID
- FA001
- Acronym
- SURF
- Status last verified
- Jul 2024
- First submitted
- 29 Jul 2024
- Last updated
- 6 Aug 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Aug 2024. 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 Sperstent® Peripheral Spot Stent System Used for the Residual Lesions After Percutaneous Transluminal Angioplasty of Femoropopliteal Arteries
- ClinicalTrials.gov ID
- NCT06539689
- Acronym / sponsor ID
- SURF / FA001
- Conditions
- Peripheral Arterial Disease, Stenosis, Dissection
- Keywords
- Peripheral Arterial Disease, Spot stent
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 240 participants (estimated)
- Lead sponsor
- FrontAce Scientific Co., LtdIndustry (pharma, biotech, devices)
- Study start
- 4 Jun 2024 (actual)
- Primary completion
- 4 Dec 2026 (estimated)
- Study completion
- 31 Dec 2026 (estimated)
- First posted
- 6 Aug 2024 (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.
This is a prospective, multi-center, randomized trial designed to investigate the efficacy and safety of Sperstent® peripheral spot stent system versus Everflex® self-expanding peripheral stent system in the endovascular treatment of post-balloon angioplasty (post-PTA) residual lesions including stenoses and/or dissections in femoral and proximal popliteal arteries.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Sperstent® peripheral spot stent system | Experimental | Device: Sperstent® peripheral spot stent systemsubjects using the Sperstent® peripheral spot stent system |
| Everflex® self-expanding peripheral stent system | Active comparator | Device: Everflex® self-expanding peripheral stent systemsubjects using the Everflex® self-expanding peripheral stent system |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- Age 18-85 years old, male or female;
- The target lesion is located in the superficial femoral artery or the proximal popliteal artery;
- Peripheral arterial stenosis or occlusive disease with symptoms consistent with the Rutherford classification 2 to 5;
- Estimated life expectancy >1 year;
- Subject has been informed of and understands the nature of the study and provides signed informed consent to participate in the study.
Key exclusion criteria (21 listed)
- Target vessel had undergone open surgery such as bypass surgery or the target lesion is in-stent restenosis;
- Patients with serum creatinine >2.5mg/dl during screening or undergoing long-term hemodialysis or peritoneal dialysis;
- Severe coagulation disorder;
- Patients with major vascular-related diseases, including acute lower extremity ischemia, active disseminated intravascular coagulation, thromboangiitis obliterans, deep vein thrombosis, and aneurysms of therapeutic lateral vessels (deep femur, superficial femur, or popliteal artery);
- A history of major organ failure or other serious illness (including severe coronary heart disease, severe cardiac insufficiency, severe neurosis, or mental illness); Have received or plan organ transplantation, severe gastrointestinal bleeding);
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 |
|---|---|---|
| Sperstent® peripheral spot stent systemSperstent® peripheral spot stent system, Percutaneous Transluminal Angioplasty (PTA), Digital Subtraction Angiography（DSA） | Device | Sperstent® peripheral spot stent system |
| Everflex® self-expanding peripheral stent systemEverflex® self-expanding peripheral stent system, Percutaneous Transluminal Angioplasty (PTA), Digital Subtraction Angiography（DSA） | Device | Everflex® self-expanding peripheral stent system |
Primary outcome
Primary Patency
Time frame: 12 months post-operation
Primary patency defined as freedom from clinically driven target lesion revascularization (CD-TLR) and freedom from duplex ultrasound derived binary restenosis at 12 months post-operation.(defined as PSVR >2.5)
Freedom from Major Adverse Events (MAEs)
Time frame: 30 days post-operation
Freedom from the occurrence of any new-onset MAEs defined as all-cause death, index limb amputation (above the ankle), or clinically-driven target lesion revascularization (CD-TLR) at 30 days post-operation.
9 secondary outcomes
Rate of Device Success
Time frame: immediately post-operation
Rate of Procedural Success
Time frame: immediately post-operation
Primary Patency at 30 days and 6 months
Time frame: 30 days and 6 months post-operation
Rate of clinically driven target lesion revascularization (CD-TLR)
Time frame: 30 days, 6 months and 12 months post-operation
Changes from Baseline in Rutherford Classification
Time frame: 30 days, 6 months and 12 months post-operation
Changes from Baseline in Ankle-brachial Index (ABI)
Time frame: 30 days, 6 months and 12 months post-operation
Duplex Ultrasound (DUS) Derived Lesion Patency
Time frame: 30 days, 6 months and 12 months post-operation
Rate of major adverse event(s) (MAEs)
Time frame: 6 months and 12 months post-operation
Rate of Stent Fracture
Time frame: 12 months post-operation
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Aug 2024.
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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.
12 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Sperstent® peripheral spot stent system and Everflex® self-expanding peripheral stent system in people with Peripheral Arterial Disease and Stenosis, run by FrontAce Scientific Co., Ltd at 12 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 11 inclusion and 21 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: looking for participants now, as of the sponsor's last update on 6 Aug 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 12 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Min Zhou, Dr. (01186-25-83106666 ext. 60770, zhouminnju@126.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Primary Patency (time frame: 12 months post-operation). The study lists 2 primary outcomes in all. 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 6 Aug 2024.