Recruiting
Not applicable
A Trail of Sperstent® Used for Residual Lesions of Femoropopliteal Arteries
Condition(s) studied
Peripheral Arterial DiseaseStenosisDissection
Investigational drug(s) / intervention(s)
Sperstent® peripheral spot stent systemEverflex® self-expanding peripheral stent system
Sperstent® peripheral spot stent system: Sperstent® peripheral spot stent system, Percutaneous Transluminal Angioplasty (PTA), Digital Subtraction Angiography(DSA)
Everflex® self-expanding peripheral stent system: Everflex® self-expanding peripheral stent system, Percutaneous Transluminal Angioplasty (PTA), Digital Subtraction Angiography(DSA)
Study 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
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.
Primary outcome measure(s)
- Primary Patency — 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) — 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.
Trial sites (12)
| Facility | City | Region | Status |
| Beijing Friendship Hospital, Capital Medical University |
Beijing |
Beijing Municipality |
Not Yet Recruiting |
| The First Affiliated Hospital of Chongqing Medical University |
Chongqing |
Chongqing Municipality |
Not Yet Recruiting |
| The Second Hospital of Hebei Medical University |
Shijiazhuang |
Hebei |
Not Yet Recruiting |
| First Affiliated Hospital of Zhengzhou University |
Zhengzhou |
Henan |
Not Yet Recruiting |
| Liyuan Hospital, Tongji Medical College, Huazhong University of Science and Technology |
Wuhan |
Hubei |
Recruiting |
| Nanjing Drum Tower Hospital |
Nanjing |
Jiangsu |
Recruiting |
| Affiliated Hospital of Nantong University |
Nantong |
Jiangsu |
Not Yet Recruiting |
| Renji Hospital, Shanghai Jiao Tong University School of Medicine |
Shanghai |
Shanghai Municipality |
Not Yet Recruiting |
| The Affiliated Hospital of Southwest Medical University |
Luzhou |
Sichuan |
Not Yet Recruiting |
| The First Affiliated Hospital, Zhejiang University School of Medicine |
Hangzhou |
Zhejiang |
Not Yet Recruiting |
| Hospital of Chengdu University of TCM |
Chengdu |
China |
Not Yet Recruiting |
| Shanghai East Hospital |
Shanghai |
China |
Recruiting |