Actively Recruiting
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
Led by FrontAce Scientific Co., Ltd · Updated on 2024-08-06
240
Participants Needed
12
Research Sites
3 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are conducting a prospective, multicenter, randomized trial to assess the effectiveness and safety of the Sperstent® peripheral spot stent system compared to the Everflex® self-expanding peripheral stent system. The study focuses on treating residual lesions such as stenoses and dissections that remain after balloon angioplasty in the femoral and proximal popliteal arteries. These conditions are common in patients with peripheral arterial disease and affect blood flow in the legs. Participants will receive either the Sperstent® peripheral spot stent system or the Everflex® self-expanding peripheral stent system during endovascular treatment following percutaneous transluminal angioplasty (PTA). Both treatments involve placing a stent to open narrowed or blocked arteries, guided by digital subtraction angiography (DSA). The trial compares these two devices to understand their impact on artery patency and safety over time. Throughout the study, participants will be closely monitored with follow-up assessments including imaging to check artery openness, clinical evaluations of symptoms using Rutherford classification and ankle-brachial index (ABI), and tracking of major adverse events. Key outcomes include primary patency at 12 months and freedom from major adverse events at 30 days after the procedure. The study period includes evaluations immediately after treatment and at 30 days, 6 months, and 12 months to monitor device success, procedural success, and changes in clinical status.
CONDITIONS
Brief Title
A Trail of Sperstent® Used for Residual Lesions of Femoropopliteal Arteries
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age 18-85 years old, male or female
- Target lesion located in the superficial femoral artery or proximal popliteal artery
- Peripheral arterial stenosis or occlusive disease with symptoms consistent with Rutherford classification 2 to 5
- Estimated life expectancy greater than 1 year
- Signed informed consent after understanding the study
- Stenosis rate 70% or more by digital subtraction angiography, or 100% occluded lesion with total length less than 150 mm
- Reference vessel diameter between 3 mm and 7.5 mm
- Total length of target lesions between 50 mm and 250 mm
- Residual lesions over 30% stenosis and/or post-PTA dissection present after balloon angioplasty
- Unobstructed inflow tract or successfully treated with residual stenosis 50% or less
- At least one outflow tract unobstructed at distal end
You will not qualify if you...
- Target vessel has had prior open surgery or target lesion is in-stent restenosis
- Serum creatinine over 2.5 mg/dl or on long-term dialysis
- Severe coagulation disorder
- Major vascular diseases such as acute lower extremity ischemia, disseminated intravascular coagulation, thromboangiitis obliterans, deep vein thrombosis, or aneurysms of certain vessels
- History of major organ failure, serious illness, or organ transplantation
- Myocardial infarction or symptomatic stroke within 3 months before enrollment
- Thrombolysis of target vessel within 72 hours before surgery without complete thrombus dissolution
- Systemic or uncontrolled infection in target limb
- Known allergy to contrast agents, nickel, titanium, heparin, aspirin, clopidogrel, or anesthetics
- Women who are pregnant, breastfeeding, or plan pregnancy within 1 year
- Planning major lower limb amputation on target side
- Endovascular or surgical procedures on target limb within 30 days before or after surgery
- Participation in other clinical trials involving medical devices or drugs
- Investigator considers patient unsuitable for participation
- Failure of guidewire to pass lesion
- Planned or prior volume reduction procedures on target lesions
- Target lesion unsuitable for stent implantation due to thrombotic obliteration
- Severely calcified lesions not fully predilated or grade 4 calcification
- Acute vascular occlusion or thrombosis in target lesion
- Stent already implanted in target vessel before enrollment
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Day of surgery
Participants undergo implantation of either the Sperstent® peripheral spot stent system or the Everflex® self-expanding peripheral stent system after Percutaneous Transluminal Angioplasty (PTA).
1 visit (in-person)
Duration - 12 months post-operation
Participants are followed up to monitor device success, procedural success, patency, adverse events, and clinical outcomes after stent implantation.
Visits at 30 days, 6 months, and 12 months post-operation
Trial Site Locations
Total: 12 locations
1
Beijing Friendship Hospital, Capital Medical University
Beijing, Beijing Municipality, China
Not Yet Recruiting
2
The First Affiliated Hospital of Chongqing Medical University
Chongqing, Chongqing Municipality, China
Not Yet Recruiting
3
The Second Hospital of Hebei Medical University
Shijiazhuang, Hebei, China
Not Yet Recruiting
4
First Affiliated Hospital of Zhengzhou University
Zhengzhou, Henan, China
Not Yet Recruiting
5
Liyuan Hospital, Tongji Medical College, Huazhong University of Science and Technology
Wuhan, Hubei, China
Actively Recruiting
6
Nanjing Drum Tower Hospital
Nanjing, Jiangsu, China
Actively Recruiting
7
Affiliated Hospital of Nantong University
Nantong, Jiangsu, China
Not Yet Recruiting
8
Renji Hospital, Shanghai Jiao Tong University School of Medicine
Shanghai, Shanghai Municipality, China
Not Yet Recruiting
9
The Affiliated Hospital of Southwest Medical University
Luzhou, Sichuan, China
Not Yet Recruiting
10
The First Affiliated Hospital, Zhejiang University School of Medicine
Hangzhou, Zhejiang, China
Not Yet Recruiting
11
Hospital of Chengdu University of TCM
Chengdu, China
Not Yet Recruiting
12
Shanghai East Hospital
Shanghai, China
Actively Recruiting
Research Team
M
Min Zhou, Dr.
X
Xiang Wang, Dr.
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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