Clinical trial NCT06539689: 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
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Peripheral Arterial Disease
Stenosis
Dissection
Keywords: Peripheral Arterial Disease
Spot stent
Lead sponsor: FrontAce Scientific Co., Ltd
Sponsor class: INDUSTRY
First posted: 2024-08-06
Enrollment: 240
Sex: ALL
Minimum age (years): 18
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Primary outcomes:
measure: Primary Patency
timeFrame: 12 months post-operation
measure: Freedom from Major Adverse Events (MAEs)
timeFrame: 30 days post-operation
Secondary outcomes:
measure: Rate of Device Success
timeFrame: immediately post-operation
measure: Rate of Procedural Success
timeFrame: immediately post-operation
measure: Primary Patency at 30 days and 6 months
timeFrame: 30 days and 6 months post-operation
measure: Rate of clinically driven target lesion revascularization (CD-TLR)
timeFrame: 30 days, 6 months and 12 months post-operation
measure: Changes from Baseline in Rutherford Classification
timeFrame: 30 days, 6 months and 12 months post-operation
measure: Changes from Baseline in Ankle-brachial Index (ABI)
timeFrame: 30 days, 6 months and 12 months post-operation
measure: Duplex Ultrasound (DUS) Derived Lesion Patency
timeFrame: 30 days, 6 months and 12 months post-operation
measure: Rate of major adverse event(s) (MAEs)
timeFrame: 6 months and 12 months post-operation
measure: Rate of Stent Fracture
timeFrame: 12 months post-operation
Other outcomes:
Locations:
city: Beijing
country: China
facility: Beijing Friendship Hospital, Capital Medical University
state: Beijing
city: Chongqing
country: China
facility: The First Affiliated Hospital of Chongqing Medical University
state: Chongqing
city: Shijiazhuang
country: China
facility: The Second Hospital of Hebei Medical University
state: Hebei
city: Zhengzhou
country: China
facility: First Affiliated Hospital of Zhengzhou University
state: Henan
city: Wuhan
country: China
facility: Liyuan Hospital, Tongji Medical College, Huazhong University of Science and Technology
state: Hubei
city: Nanjing
country: China
facility: Nanjing Drum Tower Hospital
state: Jiangsu
city: Nantong
country: China
facility: Affiliated Hospital of Nantong University
state: Jiangsu
city: Shanghai
country: China
facility: Renji Hospital, Shanghai Jiao Tong University School of Medicine
state: Shanghai
city: Luzhou
country: China
facility: The Affiliated Hospital of Southwest Medical University
state: Sichuan
city: Hangzhou
country: China
facility: The First Affiliated Hospital, Zhejiang University School of Medicine
state: Zhejiang
city: Chengdu
country: China
facility: Hospital of Chengdu University of TCM
city: Shanghai
country: China
facility: Shanghai East Hospital
Study officials:
References: