A Trail of Sperstent® Used for Residual Lesions of Femoropopliteal Arteries

Launched by FRONTACE SCIENTIFIC CO., LTD · Aug 1, 2024

Keywords

ClinConnect Summary

This clinical trial is studying the effectiveness and safety of a device called Sperstent® compared to another device called Everflex® for treating blockages or tears in certain arteries in the leg, specifically after a treatment called balloon angioplasty. The goal is to see which stent works better for patients with Peripheral Arterial Disease, which causes reduced blood flow to the legs and can lead to pain and other serious issues.

To be eligible for this trial, participants must be between 18 and 85 years old and have specific blockages in their superficial femoral artery or proximal popliteal artery. They should have symptoms that fit a certain classification and must be able to sign consent to participate. If you join the study, you will receive one of the two stent treatments and be monitored for safety and effectiveness. It’s important to know that there are specific conditions that might exclude someone from participating, such as having severe kidney issues or recent major health problems. This trial is currently looking for participants, so if you or a loved one meets the criteria and is interested, it could be a good opportunity to contribute to important medical research.

Gender

ALL

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.