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

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

Overview

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.

Interventions

• Device Sperstent® peripheral spot stent system
  Sperstent® peripheral spot stent system, Percutaneous Transluminal Angioplasty (PTA), Digital Subtraction Angiography（DSA）
• Device Everflex® self-expanding peripheral stent system
  Everflex® self-expanding peripheral stent system, Percutaneous Transluminal Angioplasty (PTA), Digital Subtraction Angiography（DSA）

Primary outcome measures

• Primary Patency [Time frame: 12 months post-operation]
• Freedom from Major Adverse Events (MAEs) [Time frame: 30 days post-operation]

Secondary outcome measures (9)

• 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]

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

Randomized

Model

Parallel assignment

Masking

Open label

Primary purpose

Treatment

Study locations

China · 12 centers

• Beijing Friendship Hospital, Capital Medical University — Beijing
• The First Affiliated Hospital of Chongqing Medical University — Chongqing
• The Second Hospital of Hebei Medical University — Shijiazhuang
• First Affiliated Hospital of Zhengzhou University — Zhengzhou
• Liyuan Hospital, Tongji Medical College, Huazhong University of Science and Technology — Wuhan
• Nanjing Drum Tower Hospital — Nanjing
• Affiliated Hospital of Nantong University — Nantong
• Renji Hospital, Shanghai Jiao Tong University School of Medicine — Shanghai
• … and 4 more centers

Identifiers

NCT: NCT06539689 · FA001

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗