NCT06539689 A Trail of Sperstent® Used for Residual Lesions of Femoropopliteal Arteries
| NCT ID | NCT06539689 |
| Status | Recruiting |
| Phase | — |
| Sponsor | FrontAce Scientific Co., Ltd |
| Condition | Peripheral Arterial Disease |
| Study Type | INTERVENTIONAL |
| Enrollment | 240 participants |
| Start Date | 2024-06-04 |
| Primary Completion | 2026-12-04 |
Eligibility & Interventions
Eligibility Fast-Check
Enter your details for a quick preliminary check. This does not replace medical advice.
What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 240 participants in total. It began in 2024-06-04 with a primary completion date of 2026-12-04.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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 dissections in femoral and proximal popliteal arteries.
Eligibility Criteria
Inclusion Criteria: * 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: * 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). Exclusion Criteria: * 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; * 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.
Contact & Investigator
Frequently Asked Questions
Who can join the NCT06539689 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 85 Years, studying Peripheral Arterial Disease. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06539689 currently recruiting?
Yes, NCT06539689 is actively recruiting participants. Contact the research team at zhouminnju@126.com for enrollment information.
Where is the NCT06539689 trial being conducted?
This trial is being conducted at Beijing, China, Chongqing, China, Shijiazhuang, China, Zhengzhou, China and 8 additional locations.
Who is sponsoring the NCT06539689 clinical trial?
NCT06539689 is sponsored by FrontAce Scientific Co., Ltd. The trial plans to enroll 240 participants.