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Clinical Trials in China / NCT06539689
Recruiting Not applicable

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

NCT06539689 · tracked via the Priya Life Science China tracker
Sponsor
FrontAce Scientific Co., Ltd
Phase
Not applicable
Started
2024-06-04
Last updated
2024-08-06

Condition(s) studied

Peripheral Arterial DiseaseStenosisDissection

Investigational drug(s) / intervention(s)

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

Study 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

Sex
ALL
Min age
18 Years
Max age
85 Years
Healthy volunteers
No
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 outcome measure(s)

Trial sites (12)

FacilityCityRegionStatus
Beijing Friendship Hospital, Capital Medical University Beijing Beijing Municipality Not Yet Recruiting
The First Affiliated Hospital of Chongqing Medical University Chongqing Chongqing Municipality Not Yet Recruiting
The Second Hospital of Hebei Medical University Shijiazhuang Hebei Not Yet Recruiting
First Affiliated Hospital of Zhengzhou University Zhengzhou Henan Not Yet Recruiting
Liyuan Hospital, Tongji Medical College, Huazhong University of Science and Technology Wuhan Hubei Recruiting
Nanjing Drum Tower Hospital Nanjing Jiangsu Recruiting
Affiliated Hospital of Nantong University Nantong Jiangsu Not Yet Recruiting
Renji Hospital, Shanghai Jiao Tong University School of Medicine Shanghai Shanghai Municipality Not Yet Recruiting
The Affiliated Hospital of Southwest Medical University Luzhou Sichuan Not Yet Recruiting
The First Affiliated Hospital, Zhejiang University School of Medicine Hangzhou Zhejiang Not Yet Recruiting
Hospital of Chengdu University of TCM Chengdu China Not Yet Recruiting
Shanghai East Hospital Shanghai China Recruiting
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06539689 on ClinicalTrials.gov ↗ ← All trials in China