A Trail of Sperstent® Used for Residual Lesions of Femoropopliteal Arteries
NCT ID: NCT06539689
Last Updated: 2024-08-06
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
RECRUITING
NA
240 participants
INTERVENTIONAL
2024-06-04
2026-12-31
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
A Study of the Temporary Spur Stent for the Treatment of Narrowing and Blockages in the Arteries Below the Knee
NCT03807531
A Prospective, Multi-center, Single Arm Study Evaluating the Express™ Renal Premounted Stent System in the Treatment of Atherosclerotic Lesions in the Aortorenal Ostium.
NCT00597142
Timing Carotid Stent Clinical Study for the Treatment of Carotid Artery Stenosis（Timing Trial）
NCT05574972
Safety and Effectiveness of the Peripheral Balloon-Expandable Covered Stent System for Iliac Artery Stenosis/Occlusion. (SELECT)
NCT06605209
Safety and Efficacy Study of Abdominal Aortic Aneurysm Stent Graft System
NCT03687489
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
Sperstent® peripheral spot stent system
subjects using the Sperstent® peripheral spot 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
subjects using the Everflex® self-expanding peripheral stent system
Everflex® self-expanding peripheral stent system
Everflex® self-expanding peripheral stent system, Percutaneous Transluminal Angioplasty (PTA), Digital Subtraction Angiography（DSA）
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
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）
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* 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.
* 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
* 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.
* 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.
18 Years
85 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
FrontAce Scientific Co., Ltd
INDUSTRY
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Beijing Friendship Hospital, Capital Medical University
Beijing, Beijing Municipality, China
The First Affiliated Hospital of Chongqing Medical University
Chongqing, Chongqing Municipality, China
The Second Hospital of Hebei Medical University
Shijiazhuang, Hebei, China
First Affiliated Hospital of Zhengzhou University
Zhengzhou, Henan, China
Liyuan Hospital, Tongji Medical College, Huazhong University of Science and Technology
Wuhan, Hubei, China
Nanjing Drum Tower Hospital
Nanjing, Jiangsu, China
Affiliated Hospital of Nantong University
Nantong, Jiangsu, China
Renji Hospital, Shanghai Jiao Tong University School of Medicine
Shanghai, Shanghai Municipality, China
The Affiliated Hospital of Southwest Medical University
Luzhou, Sichuan, China
The First Affiliated Hospital, Zhejiang University School of Medicine
Hangzhou, Zhejiang, China
Hospital of Chengdu University of TCM
Chengdu, , China
Shanghai East Hospital
Shanghai, , China
Countries
Review the countries where the study has at least one active or historical site.
Central Contacts
Reach out to these primary contacts for questions about participation or study logistics.
Facility Contacts
Find local site contact details for specific facilities participating in the trial.
Hai Feng
Role: primary
Yu Zhao
Role: primary
Wei Bi
Role: primary
Zhen Li
Role: primary
Zibo Feng
Role: primary
Min Zhou
Role: primary
Hui Zhao
Role: primary
Meng Ye
Role: primary
Yong Liu
Role: primary
Hongkun Zhang
Role: primary
Chunshui He
Role: primary
Xiang Wang
Role: primary
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
FA001
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.