Actively Recruiting
A Trail of Sperstent® Used for Residual Lesions of Femoropopliteal Arteries
Led by FrontAce Scientific Co., Ltd · Updated on 2024-08-06
240
Participants Needed
12
Research Sites
134 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
A Trail of Sperstent® Used for Residual Lesions of Femoropopliteal Arteries
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age 18 to 85 years, 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
- Informed consent provided after understanding the study
- Stenosis rate at least 70% or 100% occluded lesion with length less than 150 mm by angiography
- Reference vessel diameter between 3 mm and 7.5 mm, total lesion length between 50 mm and 250 mm
- Residual lesion after balloon angioplasty with over 30% residual narrowing and/or at least one dissection
- Unobstructed or successfully treated inflow with residual stenosis 50% or less
- At least one unobstructed outflow tract at distal end with stenosis degree less than 70% before intervention
You will not qualify if you...
- Previous open surgery like bypass or in-stent restenosis in target vessel
- Serum creatinine over 2.5 mg/dl or on long-term dialysis
- Severe coagulation disorders
- Major vascular-related diseases such as acute ischemia, active coagulopathy, thromboangiitis obliterans, deep vein thrombosis, or aneurysms in therapeutic vessels
- History of major organ failure or serious illness including severe heart disease or mental illness
- Myocardial infarction or symptomatic stroke within 3 months before enrollment
- Recent thrombolysis within 72 hours before surgery with incomplete thrombus dissolution
- Systemic or uncontrolled infection in the target limb
- Known allergy to contrast agents, nickel, titanium, heparin, aspirin, clopidogrel, or anesthetics
- Women pregnant, breastfeeding, or planning pregnancy within 1 year
- Planned major lower limb amputation on the target side
- Endovascular or surgical procedures on target limb within 30 days before or after surgery
- Participation in other clinical trials of medical devices or drugs
- Investigator judges patient unsuitable for the trial
- Guidewire failure to pass lesion
- Planned or performed volume reduction procedures on target lesion
- Target lesion unsuitable for stent implantation due to thrombosis
- Severely calcified lesions or grade 4 calcification
- Acute vascular occlusion or thrombosis in target lesion
- Previous stent implantation in target vessel before enrollment
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
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.
CONTACT
X
Xiang Wang, Dr.
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
Not the Right Trial for You?
Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.
Already have an account? Log in here